Abstract of thesis entitled

“Evidence-based guideline on Home-based exercise for the prevention of

treatment related lymphoedema on breast cancer patients”

Submitted by

Lam Hoi Yuk

for the degree of Master of Nursing

at the University of Hong Kong

In July 2015

Lymphoedema following breast cancer surgery remains a common and serious

treatment complication for cancer survivors, affecting their physical, psychological

and social well-being. Current evidences indicated that Home-based exercise (HBE),

a low cost and time-saving everyday exercise at home, does prevent lymphoedema

but is yet to be widely adopted in Hong Kong. This translational research proposal is

aimed at formulating a Home-based exercise programme (HBEP) for preventing

treatment related lymphoedema on breast cancer patients based on the best available

research evidences. The objectives are to evaluate the literatures on the efficacy of

HBE in preventing lymphoedema, identify essential components in implementing a

HBEP and develop an evidence-based guideline on HBEP as well as to develop an

implementation and evaluation plan for the HBEP guideline and determine its

transferability to other settings.

In evaluating the effectiveness of HBE in preventing lympohoedema due to breast

cancer treatment, an integrated and systematic review of literatures was carried out.

Eight relevant studies were identified and critically appraised by the Scottish

Intercollegiate Guidelines Network (SIGN) checklist on randomized control trial. The

findings indicated HBE had a significant effect on the prevention of breast cancer

related lymphoedema. An evidence-based guideline on HBEP was developed with

recommendations on patient recruitment, intervention and evaluation. All

recommendations were graded according to the SIGN guideline. The implementation

potential of the proposed intervention in the designated clinical setting was assessed

in terms of transferability, feasibility and cost-benefit ratio. Results of the assessment

indicated the proposed guideline is feasible to implement in the designated unit.

Furthermore, to facilitate the adoption of the innovation, a concrete and effective

communication plan, 2-month pilot study and evaluation plan were subsequently

established.

From bringing better patient outcome to reducing medical expenses, it is worth

and essential to implement this evidence-based guideline of Home-based exercise to

prevent life-long patients suffering and guide a safe and coherence nursing practice.

Evidence-based guideline on Home-based Exercise for the prevention

of treatment related lymphoedema on breast cancer patients

by

Lam Hoi Yuk

BN, RN

A thesis submitted in partial fulfilment of the requirements for the degree of

Master of Nursing at The University of Hong Kong.

July 2015

i

Declaration

I declare that this thesis represents my own work, except where due

acknowledgement is made, and that it has not been previously included in a thesis,

dissertation or report submitted to this University or to any other institution for a

degree, diploma or other qualifications.

_____________________

Lam Hoi Yuk

July 2015

ii

Acknowledgements

No major undertaking is accomplished alone, my supervisor, my family and my

friends are invaluable when working with my dissertation in this two years. I would

like to express my deep appreciation and the warmth thanks to my supervisor Dr.

Joyce Oi-Kwan Chung, Lecturer, for her enlightenment, ongoing guidance and

invaluable support and assistance in the past two years.

I am also grateful to my classmate of the Master of Nursing Programme 2015, my

colleagues and my friends Dominic Chow and Vivian Yuen for their generosity,

understanding and support throughout the years.

Finally, I would like to express my gratitude to my family for their unending love,

encouragement and invaluable support throughout my life.

iii

Contents

Declaration…………………………………………………………………………….i

Acknowledgements………………………………………………………….…………ii

Table of Contents…………………………………………………...…………………iii

List of Appendice………….............................................................................………..vi

Chapter 1 Introduction

Background………………………………………………………………………1

Affirming the need……………………………………………………………….3

Objectives and Significance…………………………………………….………..5

Chapter 2 Critical Appraisal

Search and Appraisal Strategies

Identification of studies………………………………………………………8

Inclusion/ exclusion criteria………………………………………………….8

Data extraction & appraisal strategies……………………………………......9

Results

Characteristics of selected studies……………………………………….….10

Methodology quality………………………………………………….…….12

Summary and Synthesis……………………………………………………...…14

iv

Chapter 3 Translation and Application

Implementation potential

Target audiences and setting…….………………………………………..…21

Transferability of the findings

Comparability of target audiences and setting………………….……….….22

Philosophy of care……………………………………………………..……23

Number of clients benefit from the innovation………………………….…24

Estimated timing for implementation and evaluation………………………24

Feasibility

Freedom of implementation………………………………………….……..25

Interfere on current staff function…………………………………………..26

Administrative support…………………………………………………..…27

Consensus with other healthcare professionals……………………….…….27

Staff development & resources needed……………………………….……28

Available evaluation tools…………………………………………..………29

Cost-benefit ration of the innovation

Possible risks and benefits……………………………………….…………29

Cost…………………………………………………………………………31

Evidence-based practice guideline/protocol……………………………………32

v

Chapter 4 Implementation Plan

Communication plan with potential users

Identification of stakeholders……………………………………………....33

Communication process…………………………………………………….35

Pilot study plan…………………………………………………………………37

Patient recruitment strategies……………………………………………….38

Intervention evaluation……………………………………………………...38

Outcome measurement…………………………………………………...…39

Evaluation plan………………………………………………………………….40

Patient outcomes……………………………………………………………40

Staff outcomes………………………………………………………………42

System outcomes……………………………………………………………42

Nature and number of clients…………………………………………….…43

Data collection and analysis…..………………………………………...…..44

Basis for practice effectiveness…………………………………………..…45

Chapter 5

Conclusion……………………………………………………………..……47

Appendices………………………………………………………………………..…48

References…………………………………………………………………….……..79

vi

List of Appendices

Appendix 1

Search Table……………………………………………………………………..48

Appendix 2

Tables of Evidence………………………………………………………………49

Appendix 3

Quality assessments of studies………………………………………………..…52

Appendix 4

Timeline of HBEP………………………………………………………..………68

Appendix 5

Estimated total cost of implementing HBEP…………………………….……….69

Appendix 6

Estimated total cost of not implementing HBEP………………………………...71

Appendix 7

Evidence-based guideline of HBEP………………………………..…………….72

1

Chapter 1

Introduction

1.1 Background

Breast cancer is the second most common cancer in the world and remains as the

top cancer in women causing around 521,000 of deaths worldwide in 2012 (IARC,

2014). Comparing to other Asian countries, Hong Kong especially has the highest

incidence rate of 61 per 100,000 people while that of China was only 22.1

(Sankaranarayanan, Swaminathan & Lucas, 2011). In Hong Kong, the annual number

of breast cancer cases diagnosed has tripled in the past two decade, as it dramatically

increased from 1152 cases diagnosed in 1993 to 3419 cases in 2011 (Hong Kong

Cancer Registry, 2013). Despite the high incident rate and rising trend of breast

cancer in Hong Kong, the 5-year survival rate was the highest among Asia with

almost 90% (Sankaranarayanan, Swaminathan & Lucas, 2011). The phenomenon may

attribute to the early detection of breast cancer in recent years from increasing public

awareness and education on self-examination, as well as the availability of advanced

surgical and oncological management.

Management strategies on breast cancer include surgery, radiotherapy, systemic

hormonal therapy and chemotherapy (HA Central Oncology Committee, 2009).

Surgery is widely considered as the primary and standard treatment for early breast

2

cancer, aimed at tumour resection and clearance of involved marginal lymph node in

minimizing the chance of recurrence (HA Central Oncology Committee, 2009;

National Cancer Institute, 2013a).

Despite the survival chance of patients were greatly increased, cancer survivors

still have a long journey to live with the subsequent problems arise from the

symptoms of breast cancer related lymphoedema, emotional effects as well as side

effect from adjuvant therapy etc. (Britton & Purushotham,2009; National Cancer

Institute, 2013b).

Breast cancer related lymphoedema (BCRL) is the disturbance on the lymphatic

system causing chronic swelling over upper limb after excision of axillary lymph

node and adjuvant therapy, affecting up to 28-34% of patients (Britton &

Purushotham,2009; Rinder, 2013). Empirical studies supported that treatments on

breast cancer are highly related to lymphoedema, removal of axillary lymph node may

lower the lymph carrying capacity of fluid, axillary dissection may increase blood

flow, altered axillary vessels and overloading the lymphatic system (Britton &

Purushotham,2009; National Cancer Institute, 2013a). More, adjuvant radiotherapy

would cause lymph node fibrosis and lead to lymphatic system obstruction (Britton &

Purushotham, 2009; Rinder, 2013). With the growing numbers of patient being

diagnosed and offered surgery, it can be estimated that the incidence of developing

3

BCRL will be further increase; therefore it is worth to review the existing

management of the issue.

Recently, there is a new trend of implementing Home-based exercise (HBE)

rehabilitation programme on preventing lymphoedema in foreign countries but is yet

to be widely adopted in Hong Kong (Box et al., 2002; Kilgour, Jones & Keyserlingk,

2008; Kilbreath et al., 2013). Therefore, this paper will discuss about the

evidence-based practice of HBE on breast cancer survivors at risk for lymphoedema,

aims to provide better patient outcomes.

1.2 Affirming the need

In caring breast cancer patient in a surgical unit, patients usually discharge on the

next day of operation if there is no post-operative complication after an over-night

observation. They will have routine follow-up for wounds and afterwards

chemotherapy as well as radiotherapy. Patients underwent mastectomy with axillary

lymph node excision will be offered an extra and elective session by physiotherapists

on introducing manual drainage, exercise and after surgery care, charged for $150 for

an hours. Since, patient with only an hour session of exercise programme, they may

not able to understand well about the aims, importance and steps of exercise. Due to

the low awareness on the issue, some of them may even not willing to attend the

4

session by spending extra time and money or even think it is just helpless. Current

practices on preventing BCRL are clearly inefficient and hence causing a low

participation rate as well as poor compliance of preventive exercise.

Increasing numbers of patients admitted for BCRL associated pain, swelling,

reducing range-of-motion in these years, treatments are usually unimpressive while

oedematous conditions are always irreversible from increasing swelling to developing

blister, wounds and infections. Numerous studies revealed that BCRL not only

affecting cancer survivor’s physical mobility, self-caring ability but also putting

additional psychological disturbance related to poor self-image, chronic pain, hence

reducing their quality-of-life and causing lots of suffers at their cancer journey

(Britton & Purushotham, 2009; National Cancer Institute, 2013b; Gautam, Maiya &

Vidyasagar, 2011; Pusic et al., 2013). In order to better managing the incurable BCRL,

to prevent is always better than control. With increasing trend of patients diagnosed

with breast cancer and offered management, it is estimated that greater numbers of

cancer survivors will be suffered from BCRL. There is a pressing need for implement

a standardized and evidence-based programme.

Numerous studies revealed that exercise increase lymphatic drainage by

enhancing lymph flow from extremities to proximal body, hence is effective in

managing BCRL (National Cancer Institute, 2013b; Stuiver et al., 2012). In recent

5

years, foreign countries are introducing Home-based exercise in promoting low cost

and time-saving everyday exercise at home (Jeff & Wiseman,2012; Gautam, Maiya &

Vidyasagar, 2011). Nurses play an essential role on disease prevention by educating

patients on post-operative exercise, knowledge of lymphoedema and the awareness of

its early sign (Sisman et al., 2012). Information leaflets are given to patients whereas

exercise classes are held to introduce simple exercise, enabling patients can do it at

home safely and freely (Box, 1998; Kilbreath et al., 2013).

In view of its beneficial effects on patients’ outcome, it is worth and essential to

evaluate this intervention and hence develop an evidence-based guidelines for guiding

safe and consistent nursing practice.

1.3 Objectives and Significance

The clinical question of this study is “What is the effect of home-based exercise

programme (HBEP) compared with usual care on the incidence of lymphoedema for

women with breast cancer?”

The objectives of this dissertation targeting women at risk for BCRL are:

1. To examine the effect of HBE on the incidence of lymphoedema

2. To identify the essential components in implementing the HBEP

3. To develop an evidence-based guideline for HBE

6

4. To develop an implementation plan for the HBE guideline

5. To determine the transferability of the evidence-based guideline to other settings

As aforementioned, BCRL is a prevalence and serious complications for breast

cancer survivors, affecting their physical and psychological well-being. Introducing

an effective HBEP could benefit the patient, nurses and the institution.

For patients, development of BCRL causing long term sufferings and

inconveniences, greatly affecting their quality-of-life. From minimizing the incidence

of developing BCRL to bringing better patient outcomes, its worth for implementing

this simple, time-saving and costless intervention to prevent life-long suffering.

As stated in the Vision and Mission of the Hospital Authority (2014), healthcare

providers should dedicate ourselves to provide high quality services on patients to

empower them to regain and stay healthy. In view of the long-term suffering on

patients with lymphoedema, nurses should be innovative and active to participate on

for example education, follow up and management on implementing HBE for better

patient outcomes. Nurses could empower themselves and develop professionalism

through implementing a nurse-led programme.

For institutes, patients with BCRL usually admitted repeatedly due to pain, wound

infection, progressively increase swelling etc. Due to its incurable nature, treatments

7

in hospital mainly focused on symptom control by analgesics, antibiotics and offering

wound dressing as well as fitting pressure garment by occupational therapist and

providing pneumatic pumping or manual drainage by physiotherapist. Patients with

symptoms alleviated will be discharged and most of them will be relapsed and

admitted repeatedly. Multiple team consultations, long length-of-stays and repeatedly

admission put a huge impact on especially the health care system in Hong Kong by

increasing medical expenses. With effective intervention on lowering the incidence of

BCRL, the cost can be reduced.

Therefore, a newly, safely, low-cost intervention on prevention of BCRL should

be evaluated and later bring into practice to give better patient outcome and help

reducing medical expenses. A clear and evidence-based guideline should be

developed for guiding a safe and coherence nursing practice.

8

Chapter 2

Critical Appraisal

2.1 Search and Appraisal Strategies

2.11 Identification of studies

The electronic databases used for searching include PubMed, CINAHL PLUS

(EBSCOHOST), Cochrane Library (Trials) and ProQuest.

Four groups of keywords related to breast cancer (tumor, neoplasm, carcinoma,

malignancy), breast surgery (mastectomy, lumpectomy, lymph node dissection),

lymphoedema (swelling, edema, edematous, arm circumference, limb circumference)

and exercise (physical activity, physical therapy, physiotherapy, rehabilitation,

training, breathing, aerobic, stretching, weightlifting, weight bearing, flexibility,

resistance) were used and combined for searching relevant studies from the electronic

databases.

The titles and abstracts of the retrieved articles were screened. Articles that

fulfilled the inclusion criteria were selected. The Reference lists of these selected

articles were screened to identify additional relevant studies.

2.12 Inclusion/ exclusion criteria

The inclusion criteria are (1) interventional studies evaluating Home-based

9

exercise on breast cancer patient in preventing lymphoedema, (2) patients underwent

breast surgery (mastectomy, modified radical mastectomy, lumpectomy, breast

conserving surgery +/- lymph node dissection), (2) written in English, (3) retrievable

in full-text. Subjects with (1) age >80, (2) men and (3) women with existing

lymphoedema were excluded.

2.13 Data extraction & appraisal strategies

Data extracted from the selected studies were summarized in the Table of

Evidence (attached in the appendix 2) and presented in the descendant order of

publication year. The following data of each studies were recorded: The citation,

study type, evidence level, population, sample & design, length of follow-up, outcome

measures and effect size.

In assessing the quality of the studies, the Scottish Intercollegiate Guidelines

Network (SIGN) checklist on randomized control trial was used. It was developed in

1993, which assists healthcare professionals in evaluating the methodology of

literatures systemically, hence guiding the best evidence for developing practical

guidelines (SIGN, 2014). All selected studies were then rated with the hierarchy of

evidence according to this guideline.

10

2.2 Results

The search was carried out from the early February to 18 of September in 2014, a

total of 34,898 potential relevant studies were identified after initial keyword searches

through the four databases. Among these, 595 studies met all the inclusion and

exclusion criteria. Upon screening the topics and abstracts, 56 studies were identified

for further consideration. The full-text review of these studies led to the inclusion of

17 studies. However, 10 studies were excluded due to duplication but an additional

study was identified through the review of reference lists. Finally, a total of 8 eligible

studies (Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al., 2012;

Cinar et al., 2008; Kilgour, Jones & Keyserlingk, 2008; Todd et al., 2008; Box et al.,

2002; Wingate, 1985) were selected for this review. The search history was attached

in Appendix 1.

2.21 Characteristics of selected studies

Of the eight selected studies, five of them were randomized controlled trials (RCT)

(Kilbreath et al., 2013; Cinar et al., 2008; Kilgour, Jones & Keyserlingk, 2008; Todd

et al., 2008; Box et al., 2002) and the others were quasi experiments (Singh, Vera &

Campbell, 2013; Scaffidi et al., 2012; Wingate, 1985). They were published between

1985 and 2013, and originated from six countries, including two from Australia

11

(Kilbreath et al., 2013; Box et al., 2002), two from Canada (Singh, Vera & Campbell,

2013; Kilgour, Jones & Keyserlingk, 2008) and one each from Italy (Scaffidi et al.,

2012), Turkey (Cinar et al., 2008), United Kingdom (Todd et al., 2008) and United

State (Wingate, 1985). All studies included women who had scheduled or undergone

breast surgery of modified radical mastectomy, simple mastectomy, lumpectomy or

breast conserving surgery with or without axillary lymph node dissection as the

subjects. Women with cognitive and neurological deficit as well as having underlying

shoulder problems including sustained fracture and with previous surgery were

commonly excluded. The mean age of participants ranged from 50 to 60 years. The

study data were extracted and tabulated in Appendix 2 for a quick summary.

The major outcomes of all studies were incidence of lymphoedema and shoulder

range-of-motion. Others less frequently assessed outcomes were quality-of-life, pain

and upper limb function, as well as length-of-stay in hospital. The incidence of

lymphoedema was an objective measurement determined by arm circumference

(Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Cinar et

al., 2008; Kilgour, Jones & Keyserlingk, 2008; Box et al., 2002; Wingate, 1985),

water displacement method (Todd et al., 2008; Box et al., 2002) and multi-frequency

bioimpedance analysis (Box et al., 2002; Kilbreath et al., 2013). Box et al., (2002)

was the only study compared the three methods and multi-frequenct bioimedance

12

analysis was considered as the most reliable method with 100% consistency with

clinical significant, while the other two methods might underestimate the incidence by

33% to 42%. Shoulder range-of-motion was measured by the Goniometer (Singh,

Vera & Campbell, 2013; Scaffidi et al., 2012; Cinar et al., 2008; Kilgour, Jones &

Keyserlingk, 2008; Todd et al., 2008; Wingate, 1985). The upper limb function was

measured using the Constant & Murley Score (Scaffidi et al., 2012), Disabilities of

Arm, Shoulder and Hand Score (DASH) (Singh, Vera & Campbell, 2013) and the

functional questionnaire developed by Wingate (1985) (Cinar et al, 2008; Wingate,

1985). Quality-of-life was evaluated using the Functional Assessment of Cancer

Therapy- Breast (FACT-B+4) (Singh, Vera & Campbell, 2013; Todd et al., 2008). Pain

level was measured by the Visual Analogue Scale (Singh, Vera & Campbell, 2013)

and the Borg’s Category Scale (Kilgour, Jones & Keyserlingk, 2008).

2.22 Methodology quality

As aforementioned, appraisal assessments were conducted on each selected

studies using the SIGN checklist and the details were attached in Appendix 3. All

studies did address the research question appropriately and clearly. In three RCTs,

subjects were randomized using the random number table or computerized random

number list (Kilbreath et al., 2013; Kilgour, Jones & Keyserlingk, 2008; Todd et al.,

13

2008), however the methods of randomization were not indicated in the other two

RCTs (Cinar et al., 2008; Box et al., 2002) and hence whether the assignments were

truly random were unable to verify. Of the two quasi experiments with acceptable

rating, subjects allocated to groups according to the time period (Scaffifi et al., 2012),

which were before and after the renovation of rehabilitation service and according to

the location (Singh, Vera & Campbell, 2012), where were two different sites within

the same authority. The baseline characteristics between the study groups of these

studies were similar. Detail report on demographic data and health history was

included in all studies except on the study of Wingate (1985). In this study, patient

assignment was made by the preference of physician (Wingate, 1985). Subjects in the

intervention group had significantly greater number of axillary lymph node being

removed, which may higher the incidence of lymphedema, adding an associated risk

of bias on the study outcomes.

Moreover, only two studies used opaque, sealed envelopes and employed an

objective third person for groups allocation to ensure adequate concealment

(Kilbreath et al., 2013; Todd et al., 2008). Blinding on subjects was uncommon in all

studies. Owing to the nature of the study, patient blinding was not clinically feasible

and unethical. There is an indication for explaining the possible risks of the study and

obtaining informed consent for this new intervention. Instead, blinding on investigator

14

was possible in minimizing bias in measuring the study outcomes and was attempted

in five studies (Kilbreath et al., 2013; Cinar et al., 2008; Kilgour, Jones & Keyserlingk,

2008; Todd et al., 2008; Box et al., 2002). All outcomes were measured with reliable

tools and in a standard and valid way. The percentage of participant dropout from the

studies were ranged from 0 to 12%, which is far below the considerable level of 20%.

After performing quality assessments in all studies, only the study of Wingate

(1985) was rejected, as it committed significant flaws in the study design by

convenience sampling and recruited subjects with significant between group

differences, which was likely affecting the study outcomes. All the others studies had

minor flaws in the design correlated to a low risk of bias were ranked as acceptable

with methodologically moderate to strong in quality.

2.3 Summary and Synthesis

In summary, six out of eight studies examined the effect of HBE. For the other

two studies, one study compared the effects of early and delay HBE on lymphoedema

(Todd et al., 2008) and the other study compared the differences between supervised

and Home-based exercises (Cinar et al., 2008). Cinar et al. (2008) indicated that

supervised exercise and HBE had only small difference in maintaining shoulder ROM

and upper limb function on patients. In addition, there were no significant difference

15

in arm circumference and incidence of developing lymphoedema. Supervised group

received 15 exercise sessions while the control group received HBE with return

demonstration during hospitalization. The result indicated that HBE shares the same

effectiveness in preventing lymphoedema and is feasible when clear instructions of

HBE were given with return demonstration.

HBE was effective in preventing lymphoedema, maintaining and improving

shoulder ranged-of-motion and upper limb function on breast cancer patients.

However, there were no difference between groups on quality-of-life and pain level.

Three studies reported an associated risk of developing lymphoedema in the HBE

group was significantly decreased by 2.6 to 3.8 times. (Kilbreath et al., 2013; Box et

al., 2002; Scaffidi et al., 2012). That means women in the control group had more

than two times the risk of developing lymphoedema compared with those in the HBE

group. A study with moderate methodological quality also reported the risk of

developing lymphoedema was 3.9 times greater in the non-HBE group but was unable

to achieve a statistical significance (Singh, Vera & Campbell, 2013). Women

underwent axillary dissection was not an inclusion criteria in this study, only half of

the included subjects had 5 or more lymph node being dissected. These subjects were

of lower risk of lymphoedema and therefore the reducing number of incidence may

influence the result in reaching a statistical significance. Another RCT reported small

16

but statistically significant decrease of arm circumference for a two-week programme

(Kilgour, Jones & Keyserlingk, 2008), showing that the immediate effect on

lymphoedema was not obvious. The study of Wingate (1985) was the only study that

reported an increase of arm circumference in the HBE group. As aforementioned, the

study had significant methodological flaws affecting the study outcomes, therefore the

contraindicated result of this study should be abandoned.

For the short to long term effect of HBE, the results were consistent as the

intervention significantly reduced the incidence of BCRL (Kilbreath et al., 2013; Box

et al., 2002; Scaffidi et al., 2012; Singh, Vera & Campbell, 2013). The baseline

characteristics of patients enrolled in these studies were similar and with no

significant difference. All studies were common in delivering “a package of”

home-based exercise programme, which comprised of preoperative education,

postoperative exercise and instruction on performing continuous HBE as well as

regular follow-up in monitoring the progress of HBE.

In these selected studies, preoperative education was given verbally or in written

booklets. The contents were similar and comprised of education on lymphoedema,

possible risk of developing lymphoedema and introduction of postoperative exercise.

Postoperative exercise from these studies varies from the starting time to the type of

exercise. In most studies, postoperative exercise was introduced by either

17

physiotherapists or nurses and started on postoperative day 1 to day 4 during

hospitalization (Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al.,

2012; Todd et al., 2008; Box et al., 2002).

Various types of exercise were introduced, including deep breathing exercise

(Singh, Vera & Campbell, 2013; Scaffidi et al., 2012), stretching exercise (Kilbreath

et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Cinar et al., 2008;

Kilgour, Jones & Keyserlingk, 2008; Todd et al., 2008), range-of-motion (ROM)

exercise (Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Cinar et al., 2008;

Kilgour, Jones & Keyserlingk, 2008; Todd et al., 2008; Box et al., 2002; Wingate,

1985), and resistance exercise (Kilbreath et al., 2013; Wingate, 1985).

Deep breathing exercise in both studies were started on postoperative day one

(Singh, Vera & Campbell, 2013; Scaffidi et al., 2012). For stretching exercise,

Kilbreath et al. (2013) implemented three stretches of shoulder flexion to elevate the

arm overhead, arm abduction to 90˚and 135˚ in supine position. Each stretch was

instructed to maintain 5 to 15 minutes. And the stretching exercise introduced by the

other studies was focused on the side flexion of neck muscles, elevation and

abduction of shoulder limited by 90˚ as well as flexion and extension of elbow, three

times a day for around 15 to 30 minutes in each session or 10 repetitions for each

stretch (Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Cinar et al., 2008;

18

Kilgour, Jones & Keyserlingk, 2008; Todd et al., 2008). Two studies in additionally

introduced advanced stretching exercise of raising arms overhead and wall climbing

hand exercise after drain removal or when drain output was less than 100ml per day

(Singh, Vera & Campbell, 2013; Box et al., 2002). For the range-of-motion exercise,

studies were common in commencing neck, hand and elbow exercise. Shoulder ROM

exercise was taken into caution and was introduced on postoperative day three to

seven (Singh, Vera & Campbell, 2013; Cinar et al., 2008; Todd et al., 2008; Box et al.,

2002). And the study by Todd et al. (2008) further explained that patients performing

active, vigorous full-shoulder exercise on day two after operation had 2.7 times

greater risk of developing lymphoedema when compared with patients undertaking

shoulder exercise limited by 90˚on movement in the first week after operation.

Subjects of these study were advised to perform the whole set of range-of-motion

exercise for two to three times in each day and stay pain-free. More, Kilbreath et al.

(2013) introduced resistance exercise by using Thera-band and obtained significant

results. Wingate (1985) suggested resistance exercise for HBEP had adversely

increased the incidence of developing lymphoedema, however whether the result was

attributed to the methodological flaw or the intervention itself was unknown.

Breathing, stretching and range-of-motion exercise are considered as low risk

when compared with vigorous, resistance exercise. Employing exercise with lower

19

risk may secure the safety of patients performing daily HBE. Introducing early

exercise and delayed full shoulder range-of-motion exercise during hospitalization

were beneficial to the subjects.

Except the study performed by Singh, Vera & Campbell (2013), all studies

provided written information of steps and safety reminders of HBE to patients while

the programme performed by Kilgour, Jones & Keyserlingk (2008) in additionally

distributed video for guidance. Except the two weeks HBEP of Kilgour, Jones &

Keyserlingk (2008), all studies included regular follow-ups in monitoring the progress

and checking the accuracy and safety of the HBE. For the HBEP lasted for 6 to 7

months, 1 to 2 follow-up sessions were offered to participants, while for 2-years

exercise programme and programme introduced resistance exercise, 8 follow-up

sessions were given.

Other than the study performed by Box et al. (2002) & Kilbreath et al. (2013), all

studies measured the interventional effects on arm or shoulder range-of-motion. Four

studies found a statistically significant increase in range-of-motion over the exercise

group when compared with the control group and ranged from 4.92 to 32 degree

(Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Kilgour, Jones & Keyserlingk,

2008; Wingate, 1985). The results showed that HBE was not only useful in preventing

lymphoedema, but also helpful in improving the shoulder range-of-motion.

20

To conclude, the outcomes of these studies were significant and their contents

were consistent, which is feasible and transferrable to my clinical setting in

preventing the incidence of lymphoedema.

21

Chapter 3

Translation and Application

Integrated review in the previous chapter supported that Home-based exercise

programme (HBEP) is safe and effective in preventing breast cancer related

lymphoedema to give better patient outcome. In view of its potential transferability to

the local clinical setting, it is essential to assess the implementation potential of this

intervention before implementing it. The assessment includes examining the

transferability of findings, the feasibility and the cost-benefit ratio of the innovation

for patient in a breast surgical unit (Polit & Beck, 2014).

3.1 Implementation potential

3.1.1 Target audiences and setting

The Home-based exercise programme is considered to be implemented in the

breast surgical unit of a regional hospital in Hong Kong. It is a teaching hospital for

local universities and regarded as a leading hospital among its cluster. The setting

consists of twenty-four beds and is shared between breast and two other surgical

teams. It is an integrated surgical unit with a multipurpose room and an interview

room for counselling and education.

The unit admits patients clinically for scheduled operation and emergency cases

22

from the Accident & Emergency Department. In this setting, the majority of breast

patients are admitted for operation while the others are admitted for the new case

work up or management of disease complications. The target audiences of the HBEP

are those who scheduled surgery for breast cancer.

3.1.2 Transferability of the findings

According to Polit & Beck (2014), transferability of findings means to which

extent the innovations fit in the new settings. In assessing the suitability of

implementing the HBEP in the target setting, the demographic characteristics of the

target audiences and setting would be compared with the reviewed studies. In addition,

the Philosophy of care, the number of clients could be benefited and the timing of

implementation and evaluation would be discussed.

3.1.2.1 Comparability of target audiences and setting

According to the data extracted from the CMS system of the Hospital Authority,

the mean age range of the target audience was 45 to 60 years which is similar to the

range of 50 to 60 years in the reviewed studies. In line with the evidence, the target

audience of the intervention are women who scheduled for breast cancer surgery

including mastectomy, modified radical mastectomy (MRM) and lumpectomy with

23

axillary lymph node dissection. The Home-based exercise programmes from all the

reviewed studies were conducted in hospital-based clinical setting, which are similar

to the target setting of a surgical unit in a public hospital.

Although all of the reviewed studies were performed in Western countries, the

effect of exercising should be the same across cultures. The characteristics of target

audiences and settings are similar to the selected studies, therefore the programmes

are considered to be suitable for applying in the target setting.

3.1.2.2 Philosophy of care

The Vision and Mission of the Hospital Authority (2014) stated that healthcare

providers should dedicate ourselves to provide high quality services on patients to

empower them to regain and stay health. The HBEP is of sufficiently high quality that

can prevent breast cancer related lymphoedema and thus preventing life-long

suffering (Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al., 2012;

Kilgour et al., 2008; Box et al., 2002).

With respect to the guideline for specialty nursing service in the target unit, nurses

need to provide holistic and continuity care to patients. The philosophy of care

underlying the intervention is to empower nurses to provide holistic perioperative care

to patients in preventing lymphoedema, thus is consensus with the Vision and Mission

24

of the Hospital Authority and the nursing service guideline of the target setting.

3.1.2.3 Number of clients benefit from the innovation

The target surgical setting admits around 300 patients with breast disease annually.

Among the total number of admissions, over 70% of them are admitted clinically for

scheduled operation, which is around 210 patients in each year. Of these,

approximately around 150 patients (3 to 4 cases per week) undergo breast cancer

operation. Therefore, the estimated number of patients meeting the inclusion and

exclusion criteria, willing to participate in the 12 months HBEP and being recruited in

first 5 months will be 55.

With the increasing number of patients being diagnosed at early stage and offered

surgery as discussed before, it can be estimated that the number of clients requiring

the home-based exercise service will be further increase. Thus, there is sufficiently

large number of clients can benefit from the innovation.

3.1.2.4 Estimated timing for implementation and evaluation

All selected studies delivered “a package of” HBEP including preoperative

education and counselling, postoperative education on performing daily home-based

exercise, and regular face-to-face and phone follow-up in monitoring the progress of

25

the home-based exercise. The recommended duration for implementing the

programme was at least six months to a year in showing the positive result (Singh,

Vera & Campbell, 2013; Scaffidi et al, 2012; Cinar et al., 2008; Kilbreath et al., 2013;

Todd et al., 2008). Therefore, it will take around 24 months to implement and evaluate

the proposed programme including 3 months for preparation and communication, 2

months for pilot test and evaluation and then another 19 months for actual

implementation of the programme and evaluation. The proposed timeline was

attached in Appendix 4.

In evaluating the process of the programme, the number of patients utilizing the

service and the satisfaction feedback on the programme would be considered. The

outcomes could be evaluated by the incident rate of lymphoedema, quality of life and

the adherence and admission rate of lymphoedema cases.

3.1.3 Feasibility

3.1.3.1 Freedom of implementation

The World Health Organization (2015) stated that “Nursing” is using the

autonomy and collaborative care in promoting health and prevention of illness. In the

target unit, by providing sufficient evidence in highlighting the significance of the

innovation and gaining support from the colleagues and the administrative level,

26

nurses do have the autonomy to implement innovation. An example of utilizing the

research innovation in the setting is the implementation of the drain care education to

postoperative breast patients advocated by the Breast Nurse in a few years ago. For

this year, a Registered Nurse identified there was no protocol in caring the chest drain

in the unit. With reference to the protocol from the Cardiothoracic Unit and the latest

literatures, an update and clear guideline was developed and put into practice. With

sufficient quality evidences and clear guidelines, nurses in this setting do have the

freedom of implementing innovation.

3.1.3.2 Interfere on current staff function

At this stage, the implementation of the Home-based exercise programme will

involve the Breast Nurse, a Registered Nurse, ward nurses and a clerical staff. Breast

Nurse will be invited to provide expert opinion, guidance and support on the

intervention. Minimal time will be needed to minimize conflicts with her current

duties.

The current nurse-to-patient ratio of the target setting is 1:6 to 8. Involving ward

nurses in the programme and assigning a full-time Registered Nurse in coordinating

and administrating the programme from the unit may increase the workload of the

current staffs, the cost-effectiveness of the programme must be evaluated.

27

The clerical staff in the target setting will be assigned to help the programme for a

half-day on Saturday without interfering the working time and nature. Thus, the

influence on implementing the programme on current staff function are minimal.

3.1.3.3 Administrative support

Being a teaching hospital for local universities, the setting provides a research

ground for healthcare professionals. The Department Head of the target unit

consistently emphasizes the mission of the department is to conduct clinical research

and transform the discoveries into innovative techniques and procedures, and bring

them to benefit patients. The Division Head of the breast surgery is also open for both

translational and clinical research in the area of breast cancer (Department of Surgery,

2014). The Department Operation Manager and Ward Manager are open-minded to

promote and implement new practices on enhancing service quality. This shows that

adequate support could be granted from the administrative level.

3.1.3.4 Consensus with other healthcare professionals

In the preparation phase, the programme coordinator will invite the surgeon,

breast nurse and physiotherapist to give vulnerable advice in planning the content of

the Home-based exercise programme. Holding communication meeting in addressing

28

the concern of different parties could promote multidisciplinary collaboration.

3.1.3.5 Staff development & resources needed

Most of the nurses in the target units are degree holders. The chosen programme

coordinator should be experienced and equipped with specialty and postgraduate

qualification in breast and surgical nursing. Additional trainings on staff mainly focus

on familiarizing the steps of the proposed exercise and programme, communication

skills and evaluation skills.

Apart from staffing, the venue, education materials and evaluation equipment are

needed in implementing the innovation. The multipurpose room could be utilized for

implementing the programme. The room is spacious enough for both group and

individual education session, exercise and return demonstration, which also equipped

with a CMS system accessible computer, projector and chairs facilitating education

and documentation. Education materials including PowerPoint, video and pamphlets

will be prepared in the preparation phase. For evaluation, equipment such as

measuring tape and goniometer for lymphoedema measurement are needed.

Measuring tape is available in the setting and the goniometer would be purchased to

place in the room.

29

3.1.3.6 Available evaluation tools

Evaluation plays a significant role in effective implementation, continuous

improvement and allocation of resources. For the outcomes evaluation, the

circumferential measurement used in the selected studies is easy, appropriate and

sensitive in determining the incidence of lymphoedema. The goniometer is widely

known as a standard tool in measuring the range-of-motion. The Function Assessment

of Cancer Therapy- Breast (FACT-B+4), which includes four specific questions on

evaluating arm symptoms will be used for assessing the quality of life (Singh, Vera &

Campbell, 2013). All the evaluation tools used are readily available.

3.1.4 Cost-benefit ratio of the innovation

3.1.4.1 Possible risks and benefits

In patient aspect

Exercise is widely recognized as a safe practice and has significant benefits to

health. Home-based exercise is of relatively low risk to patients compared with other

invasive or pharmacological interventions. The exercise educated in the programme

are of low intensity and proved to be safe and effective in preventing lymphoedema

from the integrated review. The programme is of low and insignificant risk of injury,

pain and formation of seroma (Wintage, 1985; Singh, Vera & Campbell, 2013). To

30

further minimize the risk, clear instructions and guideline for exercise will be given,

every exercise will be instructed with return demonstration and follow-up sessions

will be given in monitoring the progress.

According to the reviewed studies, the implementation of the HBEP reduced the

incidence of lymphoedema by 2.6 to 3.9 times (Kilbreath et al, 2013; Box et al., 2002;

Scaffidi et al., 2012; Singh, Vera & Campbell, 2013). Breast cancer related

lymphoedema causing chronic and incurable suffering from pain and swelling,

reducing patients’ physical mobility, affecting their self-caring ability and altering

self-image hence reducing their quality-of-life. The implementation of programme

prevents patients from long-term suffering and hence promotes health.

In staff and institution aspect

The low participation rate and exercise adherence rate of the current practice

indicated that providing an hour of physiotherapy session solely after operation could

not prevent patients from BCRL effectively. Increasing number of breast cancer

patients developing lymphoedema will increase the workload of staffs and cause a

huge financial burden on especially the institution.

On the contrary, implementing the innovation could bring various benefits to both

the staffing and institution. For the staff, nurses could empower themselves and

31

promote professionalism through implementing the nurse-led programme, hence

increasing staff morale and job satisfaction. For institutes, the innovation could reduce

medical cost for managing patients with lymphoedema and the increase of service

quality could bring good reputation to the hospital.

3.1.4.2 Cost

The total cost of implementing the Home-based exercise programme in serving 55

patients will be approximately HKD$233,286. The details were illustrated in

Appendix 5. The cost is estimated in terms of manpower, training and materials cost.

In this programme, the manpower cost are mainly considered as the time for staffs to

prepare the materials, coordinate and implement the programme.

The target setting provides a free venue and equipment including computers,

stationary and projector for meetings, trainings and programme implementation.

Therefore, the material cost for implementing the programme are mainly the printing

cost for education materials, log books and documents and the production cost for

education video and goniometer (tool for evaluation).

If the Home-based exercise programme is not implemented, around 30 patients

may develop lymphoedema in the 12 months period by estimation. Most of them

readmitted in every four to five months and the average length-of-stay is seven days.

32

The estimated total cost for the management of lymphoedema is HKD$3,823,290,

which is 16 times much higher than the cost of implementing the innovation. The

details were provided in Appendix 6.

The programme could effectively reduce the overall medical expenses of the

institution. Together with the non-material cost of improving patients’ quality of life

by preventing the disease and enhancing staff morale by advocating nursing

professionalism, it is worth to implement the programme in the target setting.

In summary, the potential benefits on patients, nurses and institutions outweigh

the risk of implementation. The Home-based exercise programme is transferable to

the target audience and feasible to implement in the target setting.

3.2 Evidence-based practice guideline/protocol

Developing an evidence-based guideline for the innovation is essential for guiding

quality, safe and consistent nursing practice. The evidence-based guideline for the

Home-based exercise programme in preventing breast cancer related lymphoedema

was attached in Appendix 7.

The recommendations from the selected reviews were extracted and graded

according to The Scottish Intercollegiate Guideline Network (SIGN) guideline in

relation to the strength of the available evidence (SIGN, 2011).

33

Chapter 4

Implementation plan

4.1 Communication plan with potential users

The implementation assessment in previous chapter supported the new practice of

Home-based exercise programme (HBEP) and thus an evidence-based guideline was

developed. The next crucial steps are to initiate and facilitate the adoption of

innovation by developing a concrete and effective communication plan (Stetler, 2001;

Schmidt & Brown, 2008). Rogers’ model on Diffusion of Innovation was adopted in

developing the plan in light of its effectiveness in facilitating the practice of an

innovation (Rogers, 2003).

4.1.1 Identification of stakeholders

According to the model of Diffusion of Innovation, communicating with members

of a social system is a key element towards success (Rogers, 2003). Members of the

social system are those influencing and being affected by the new practice, including

the administrators, opinion leaders, operators and users (Lobiondo-wood & Haber,

2002; Rogers, 2003).

Administrators stand on a highly influential position in the system, which exert

either positive or negative influence on the implementation (Lobiondo-wood & Haber,

34

2002). In this setting, the Chief of Service (COS), the Division Chief of Breast

Surgery, the Department Operations Manager of Surgery (DOM) and the Ward

Manager (WM) are considered as the administrators. They are at an upper level that

possesses the authority power to approve the adoption of a new practice and provide

financial support to set-up and operate an innovation, while the Ward Manager, in

addition, is responsible for daily operations in ward and duty arrangement of staff.

Opinion leaders are also a key member within the social systems, who plays a

significant role in providing expert opinions and advice about the practice (Rogers,

2003; Lobiondo-wood & Haber, 2002). In the breast unit, the surgeons, the Advanced

Practice Nurse (Breast specialist) and the physiotherapists are identified as the

opinion leaders. They are specialists in the concerned area, technically competent and

experienced to evaluate the proposed innovation and provide practical feedbacks. The

Breast specialist, who is in additionally work as a partner with the development team

in planning, implementing and monitoring the programme as well as communicating

the innovation to administrators and frontline staffers. With the support of the opinion

leaders, an active adoption of the practice can be led, posing a positive influence on

the implementation.

The mostly affected members in the system are the operators and users (Schmidt

& Brown, 2008; Lobiondo-wood & Haber, 2002). Operators of the programme are the

35

Breast Specialist, co-ordinating nurse and all Registered Nurses in the breast unit,

who frequently contact patients for promoting and implementing the programme. On

the other side of the coin, nurses who are reluctant to change, or who perceive that the

innovation would increase their workload may lead an active opposition and

contribute to negative outcome.

Users of the innovation are patients with breast cancers. The HBEP is carried out

to prevent breast cancer-related lymphoedema. Patients’ understanding and perception

on the innovation would affect the participation and adherence to the programme

(Kilgour, Jones & Keyserlingk, 2008).

4.1.2 Communication process

Effective communication with every member in the systems could enhance mutual

understanding and co-operation in adopting a new practice (Lobiondo-wood & Haber,

2002; Rogers, 2003). The entire communication process is a very social process and

the strategies are again based on Roger’s model of Diffusion of Innovations.

Homophilous communication is the most effective strategy for initiating

information exchange, which is the sharing of ideas between individuals with similar

beliefs and interests (Rogers, 2003). To begin with, the co-ordinating nurse will

introduce the benefits, cost-effectiveness and feasibility of the new practice to the

36

Breast Specialist (APN) and surgeons informally. These opinion leaders share the

same visions and interests with the co-ordinating nurse in providing quality breast

services to patients, who are most likely to be convinced and are also able to provide

expert opinion on the innovation. Thereafter, the co-ordinating nurse will share the

ideas with the Ward Manager in an informal meeting. By valuing the innovation,

providing operational feedbacks and supports on the new practice, he is an essential

stakeholder in marking the program a reality for the unit.

With initial support from the opinion leaders and WM, the co-ordinator will work

with the Breast Specialist to develop a detailed proposal comprising the reviewed

evidence, implementation potentials and proposed guidelines of the HBEP with

tentative timeline and a concise implementation plan to seek administrative approval.

The proposal will be illustrated clearly with PowerPoint presentation with tables in a

formal meeting to the COS, Division Chief of Breast surgery, DOM and WM in

addressing their concerns. The necessity for adoption, significances, cost and benefits

of the programme will be emphasized in gaining their support.

Upon approval from the administrative level, the co-ordinating nurse will

integrate various expert opinions in planning the programme, preparing the necessary

materials for operation and then begin to communicate with the frontline staff.

Frontline staffers are potential operators involved in giving advice and education on

37

HBEP to patients during hospitalization. Knowledge and persuasion are essential to

them for adopting an innovation (Rogers, 2003). Holding semi-formal ward meetings

to share the reviewed evidence, significance and details of the new practice among

peers with printouts could enhance their understanding and interest. Performing

further persuasion actions such as emphasizing the benefits of HBEP on patients,

answering individual’s concerns and clarifying uncertainties could promote their

support to the adoption of new practice.

This communication and preparation process may take approximately three

months. By getting into the implementation phase, the co-ordinating nurse will

perform interval process evaluation in the first and every four months for monitoring.

The comments and information are valuable and practical in guiding the revision of

the guideline. Throughout the whole preparation and implementation period, every

members of the system will be kept abreast of the progress of the HBEP via internal

email bi-monthly.

4.2 Pilot study plan

Piloting an innovation has positive influence on adoption of new practice for

testing its feasibility and the acceptability among staffs and patients (Lobiondo-wood

& Haber, 2002; Rogers, 2003). Before actual implementation, piloting the HBEP for

38

two months in the unit aimed at identifying unexpected difficulties, reviewing the

logistics and feasibility of the programme and hence modifying the guideline when

necessary. Several aspects including the patient recruitment strategies, implementation

process, evaluation methods and outcomes will be reviewed.

4.2.1 Patient recruitment strategies

Potential participants were screened from the scheduled lists of operation by the

co-ordinating nurse and being informed of the study during their pre-operative

assessment visit. Physicians are advised to encourage patients to participate in the

HBEP actively. Patients who fulfilled inclusion and exclusion criteria of the

programme and provided informed consent will be recruited in the pilot scheme. Five

cases are expected to be recruited in two weeks. The co-ordinating nurse will record

the number of cases approached, number of cases successfully recruited and barriers

encountered for process evaluation.

4.2.2 Intervention evaluation

The proposed HBEP comprising preoperative education, postoperative skills

revision and pre-discharge education as well as follow-ups in monitoring the progress.

Additional guides including pamphlet, CD and logbook will be given for references

39

and record. Ward nurses are mainly responsible for skills revision and education to

hospitalized patients.

Pilot test is necessary to identify flaws and problems during implementation

process (LoBiondo-Wood & Haber, 2002). In evaluating the workflow, the

co-ordinating nurse will hold a focus group with frontline staff in the week after

implementation to identify problems encountered, collect feedbacks and evaluate

staff’s perception and satisfaction towards the practice.

After piloting the HBEP, the co-ordinating nurse will conduct unstructured

interviews with individual participants in reviewing the appropriateness of the venue,

timing, the quality of education sessions and materials as well as their perception and

satisfaction on the programme.

4.2.3 Outcome measurements

All measurements will be undertaken by the co-ordinator and Breast nurse. The

study outcomes will be measured on the day before operation (baseline), at a week

and three weeks after the operation to determine the short-term effect of the practice

and most importantly to test the appropriateness of the data-collection tools and

workflow. Patients’ outcomes include measuring the limb circumference by tape, the

shoulder range-of-motion (ROM) by goniometer and assessing the psychosocial

40

aspects with questionnaire (FACT-B+4). Apart from monitoring the patient outcomes

and their safety, logistics workflow for outcome measurement including the feasibility

of using these evaluation methods in the setting, the accuracy and time spent are

examined.

In summary, by reviewing the recruitment strategies, outcome measurement and

integrating both patients and staffs’ opinions on the workflow in the pilot, the

co-ordinator could make further improvements and modifications on the guideline and

logistics arrangement for a better programme.

4.3 Evaluation plan

Evaluation plays a significant role in health programmes for effective planning,

continuous improvement and appropriate resource allocation (Lobiondo-wood &

Haber, 2002). It is vital to evaluate the quality and effectiveness of an innovation,

hence provides objective information necessary to ensure its sustainability. The

outcomes measure to be evaluated are identified as patient outcomes, staff outcomes

and system outcomes.

4.3.1 Patient outcomes

Previous research synthesis demonstrated that HBEP effectively reduces the

41

incidence of lymphoedema, thus the primary patient outcome for innovation efficacy

is the incidence of lymphoedema. The presence of lymphoedema will be identified

using non-invasively measurement on arm size. By using circumferential tape,

measurements will be taken with both arms supported on a flat surface at six points

(mid-point of the third metacarpophalangeal joint, the ulnar styloid process and at 10,

20, 30 and 40cm proximal from the ulnar styloid process). An increase of 2cm or

more and >10% comparing to the unoperated arm at any of the six measurement

points indicate lymphoedema (Kilbreath et al., 2013; Singh, Vera & Campbell, 2013;

Cinar et al., 2008; Box et al., 2002).

Secondary patient outcomes are the shoulder range of motion (ROM) and quality

of life (QOL). Shoulder ROM (flexion, abduction and external rotation) will be

assessed using a universal goniometer in a sitting position. According to the reviewed

studies, HBEP significantly improves shoulder ROM and takes effect in short term

(Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Cinar et

al., 2008; Kilgour, Jones & Keyserlingk, 2008). This outcome is a vital motivator to

positively reinforce patients the adherence of daily HBE.

Patient’ QOL will be evaluated using the Functional Assessment of Cancer

Therapy- Breast questionnaire with for additional questions on arm symptoms

(FACT-B+4). It has a high sensitivity and specificity in assessing outcome in patients

42

with lymphoedema and breast cancer, thus showing excellent statistically and

clinically reliable result (Singh, Vera & Campell, 2013; Todd et al., 2008).

4.3.2 Staff outcomes

Nurses are key persons to conduct the innovation, therefore the staff outcomes are

an equally important part of the evaluation. The satisfaction and confidence level of

nurses in operating the program will be assessed after training and programme

implementation using self-reviewing questionnaire and focus group discussion to

evaluate the effectiveness of training sessions and identify barriers and difficulties in

the operating process for process evaluation.

4.3.3 System Outcome

System outcomes measure the system effectiveness through assessing patients’

adherence to the program, adverse events encountered and costs. Patients’ adherence

reflect the efficacy of proposed guideline and will be assessed using logbook and in

follow-ups. Any adverse events encountered in carrying out the program should be

carefully considered to ensure the safety and effectiveness of practice by continuously

monitoring in every follow-ups and self-reports from participants. The operational

cost will be reviewed and monitored in every four months for regular financial reports

43

to the administrators.

4.3.4 Nature and number of clients

In line with the reviewed literatures, pilot and proposed clinical guideline in

previous chapters, the nature of clients in actual implementation are women aged 18

to 80 years old who had scheduled for breast cancer surgery and will admit to the

target breast unit without any underlying shoulder problems, existing lymphoedema

and physical, cognitive and neurological deficits.

With reference to the study of Kilbreath et al. (2013), the standard deviation for

change in arm circumference at 9 months after surgery was 4. The sample size

estimated by an online computer program is approximately 44 (Lenth, 2006-9). This

will give 90% power to detect a different of 2cm for arm circumference with a

significance level of 5% for a two-tailed t-test. Allowing an attrition rate of 20% due

to mortality and loss to follow-up on especially a 12 months program, the actual

number of samples required for evaluation is 55.

In the target unit, the average admission rate of patient undergo breast cancer

surgery is approximately 12 patients in each month. Therefore, the proposed period

for patient recruitment in actual implementation is five months. The minimum

available number of potential cases should be 60.

44

4.3.5 Data collection

All measurements will be collected by the co-ordinating nurse and Breast Nurse.

Based on the table of evidence, the recommended duration for functional and physical

outcomes to take effect was 3 weeks (shoulder ROM) to 18 months (QOL) and 6

months to a year (Incidence of lymphoedema) respectively. In this study, variables

will be measured on the day before operation as baseline, at 3 weeks, 6 months and 12

months after operation to determine the short, intermediate and long term effect of the

innovation. Demographic data of patients will be obtained from patients’ medical

records and collected at the baseline assessment.

4.3.6 Data analysis

For a longitudinal study with four time-points, the data will be analyzed for the

short term, intermediate and long term effect. For the primary outcome measure, the

change from baseline and unoperated arm for arm circumference will be determined

to indicate a reduction in the incidence of lymphoedema. The mean change will be

compared by two-tailed paired t-test.

For measure of shoulder ROM, the data will be analyzed in the same way as the

primary outcomes to determine if the ROM is improved. For quality of life score, the

mean change from baseline will be compared with different time-points using

45

two-tailed paired t-test to test if the score is increased.

For other aspects of staff and system outcomes, data will be collected using

qualitative method of unstructured interviews and self-reviewing questionnaire, then

followed by coding the data into categories and theme for further analysis and

interpretation.

4.3.7 Basis for practice effectiveness

The innovation is regarded as effective only if the patient outcomes, staff

outcomes and system outcomes fulfill the bases that synthesized from the reviewed

studies. For primary patient outcome, the programme is considered as effective with a

significant reduction on the incidence of lymphoedema by 30%. Such criteria is in

line with the literatures that HBEP reduced the risk of lymphoedema by three times

(Kilbreath et al., 2013; Box et al., 2002; Scaffidi et al., 2012; Singh, Vera & Campbell,

2013). For secondary outcomes, the targets are achieving improvement in shoulder

ROM by more than 10 degree and QOL score with FACT-B+4 by 2 points.

With respect to the staff outcomes, the objectives are over 80% of nurses show

positive satisfaction and confidence in operating the practice, which can be identified

in both questionnaire and focus group.

For system outcomes, the target adherence rate to achieve is over 70% for

46

programme efficacy. Regarding the cost, the estimated operational cost for serving 55

patients in 24 months (12months for each patient) is HKD$148,161. The objective is

to keep reviewing and maintaining the cost below HKD$ 160,000.

47

Chapter 5

Conclusion

Based on the reviewed evidence, Home-based exercise programme is effective in

reducing the incidence of lymphoedema, improving shoulder range of motion and

quality of life of breast cancer patients following surgeries. No specific side effect

was indicated among the studies. Other than reducing medical expenses of institution,

the adoption of this innovation prevents patients from life-long sufferings and

conveniences of breast cancer-related lymphoedema. In view of its beneficial effects

on patients and institution, an evidence-based guideline, the implementation and

evaluation plan of HBEP was developed to facilitate the adoption of practice in the

unit. It is hoped that the evidence-based guideline of HBEP could be useful in guiding

safe and consistence nursing practice.

48

Appendix 1 – Search history

PubMed

CINAHL Plus Cochrane Library

(Trials) ProQuest

I I I I

By keyword search:

1. breast cancer OR breast tumor OR breast neoplasm OR breast carcinoma OR breast malignancy

2. breast surgery OR mastectomy OR lumpectomy OR lymph node dissection

3. Lymphedema OR swelling OR edema OR edematous OR arm circumference OR limb circumference

4. exercise OR physical activity OR physical therapy OR physiotherapy OR training OR breathing

OR rehabilitation OR aerobic OR stretching OR weightlifting OR weight bearing OR flexibility

OR resistance

I I

I

PubMed

899 articles

CINAHL Plus

260 articles

ProQuest

33601 articles

I I I

Limits (English

clinical trials,

humans)

Limits (English,

academic journals)

Cochrane Library

138 articles

Limits (Clinical trial,

controlled clinical trial,

RCT, English; excluded

news, review and study

on men & age >80)

I I I

PubMed

145 articles

CINHAL Plus

142 articles

ProQuest

170 articles

I I I

Reviewed by titles and abstracts

I I I I

PubMed

16 articles

CINHAL PLUS

13 articles

(8 articles from

google scholar)

Cochrane Library

23 articles

ProQuest

4 articles

I I I I

Reviewed by full paper

I I I I

PubMed

4 articles

CINHAL PLUS

5 articles

Cochrane Library

6 articles

ProQuest

2 articles

I I I I

Total checklist for review after elimination of duplication: 7 + 1 (from reference list) = 8_

49

Appendix 2 - Table of evidence (Citation 1-3)

1. BCRL = Breast Cancer-related lymphedema; SM= Simple mastectomy; MRM = Modified radical mastectomy; AD = Axillary dissection; BCS = Breast Conserving Surgery

2. IG= Intervention group; CG= Control group; HBE= Home-based exercise; LE= lymphoedema; ROM = Range-of-motion

3. aRR= adjusted risk ratio of CG: IG, UL function = Upper limb function

4. Values given as differences in means (intervention/control-baseline); ∆Gp = Between group difference (intervention-control)

Citation Study type/

Evidence Populations1 Samples & Design2

Length of

follow-up Outcome measures3 Effect size4

1.

Kilbreath

et

al.,(2013)

RCT-

(multi-cente

r)

(1+)

N = 160

Mean age: 53

Women

underwent AD

within 6 weeks

IG: n= 81

1. Advice on daily HBE + UC

(resistance & stretching)

2. 8 FUs monitor HBE

CG: n= 79

1. Written info: post-op Ex &

prevent LE;

2. In patient: Assisted stretch

Post op

1, 3, 9 &

15 month

Primary:

(1) Incidence of LE (aRR)

(1) At 3 month: 2.6 (p<0.02;

95% CI 0.9-7.4)

2. Singh,

Vera &

Campbell,

(2013)

Quasi

experiment

– not

randomized

(2+)

N=72

Mean age: 60

Women scheduled

for MRM/ SM/

BCS

IG: n=41

1. Post op D1-7: Breathing,

stretching, ROM Ex

2. After D7: Shoulder Ex

3. HBE+ UC

CG: n-31 1. Pre-op management:

Exercise, LE & scar

Pre-op,

post op 7

month

Primary:

(1) Incidence of LE (%)

(2) Shoulder ROM

(degree)

Secondary:

(3) QOL (FACT-B+4

score)

(4) Post-op Pain (VAS)

(5) UL function (DASH

score)

(1) IG: 2.5; CG: 9.7(p=0.19)

(2) Flexion IG: +0.63; CG:-6.06(p=0.03)

(3) IG:+1.9; CG:-1.4(p=0.43)

(4) IG:+7.5; CG:+8.5(p=0.74)

(5) Not significant

3. Scaffidi

et al.,

(2012)

Quasi

experiment

– not

randomized

(2+)

N= 83

Mean age: 51

Women scheduled

for (lumpectomy/

SM +/- AD)

IG: n=58

1. Written info: post-op S/E

2. Post op: Deep breathing,

stretching exercise

3. Instruct +FU HBE

CG: n=25

1. Verbal info. on post-op S/E

Pre-op,

post-op

Day 60,

180

Primary:

(1) Incidence of LE (%)

(2) Arm ROM (%)

Secondary:

(3) UL function (Constant

& Murley score)

At 180-day

(1) IG: 5.2 ; CG: 20 (p=0.036)

(2) IG: -12 ; CG: -44 (p=0.001)

(3) IG: 92.3;CG:79.8(p=0.001)

50

Appendix 2 - Table of evidence (Citation 4-6)

1. BCRL = Breast Cancer-related lymphedema; SM= Simple mastectomy; MRM = Modified radical mastectomy; AD = Axillary dissection; BCS = Breast Conserving Surgery

2. IG= Intervention group; CG= Control group; HBE= Home-based exercise; LE= lymphoedema; ROM = Range-of-motion

3. aRR= adjusted risk ratio of CG: IG, UL function = Upper limb function

4. Values given as differences in means (intervention/control-baseline); ∆Gp = Between group difference (intervention-control)

Citation Study type/

Evidence Populations1 Samples & Design2

Length of

follow-up Outcome measures3 Effect size4

4. Cinar et

al., (2008)

Double-

blinded

RCT

(1+)

N= 57

Mean age: 53

Women with

MRM done

IG: n=27 1. In patient: Stretching, hand/

shoulder/elbow ROM Ex

2. 15 supervised sessions to

monitor HBE

CG: n=30

1. HBE after drain removed

2. In- patient Ex (return demo +

written info)

Pre-op,

post-op

Day 5,

Month

1,3,6

Primary:

(1) Shoulder ROM

(degree)

(2) Arm circumference

(CM)

(3) Incidence of LE(%)

Secondary:

(4) UL function (score)

At 6 month

(1) Flexion IG: -1.06;

CG: -14.77(p<0.001)

Adduction

IG: +0.19(p<0.001); CG:

-1.31(p=0.006)

(2) (3) No significant ∆Gp

(4) IG:-0.76;CG:+0.93 (p<0.001)

5. Kilgour

et al.,

(2008)

Double-blin

ded RCT

(1+)

N = 27

Mean age: 50

Scheduled for

MRM+ AD

IG: n= 16

1. Video & guidelines of HBE

(ROM/ stretching)

2. Encourage daily HBE

3. Usual care

CG: n=11

1. Usual care: Written info on

diet, skin care & Ex

Post op

D3 &

D14

Primary:

(1) Shoulder ROM

(degree)

(2) Arm Circumference

(CM)

Secondary: (3) Pain (Borg’s

Category score)

(1) Flexion +10.67(p=0.003)

Abduction +4.92(p=0.036)

(2)Below lateral epicondyle

5cm IG:-0.4;CG:-0.1(p<0.001)

10cm IG:-0.4;CG:+0.2(p<0.001)

(3) No significant ∆Gp.

6. Todd et

al., (2008)

Single-

blinded

RCT

(1+)

N= 116

Mean age: 57

Women admitted

for AD

IG: n= 58

1. Post-op D1-6: limited

shoulder ROM <90˚ 2. From D7: full ROM

3. HBE + phone FU

CG: n=58

1. Post-op D2: full shoulder

mobilization & Ex + HBE

Pre-op &

post-op 1

year

Primary:

(1) Incidence of LE

(people)

Secondary:

(2) Shoulder ROM

(degree)

(3) QOL (FACT-B+4

score)

(1) IG: 6; CG: 16

Risk ratio: 2.7 (p=0.031)

(2) (3) No significant ∆Gp

51

Appendix 2 - Table of evidence (Citation 7-8)

1. BCRL = Breast Cancer-related lymphedema; SM= Simple mastectomy; MRM = Modified radical mastectomy; AD = Axillary dissection; BCS = Breast Conserving Surgery

2. IG= Intervention group; CG= Control group; HBE= Home-based exercise; LE= lymphoedema; ROM = Range-of-motion

3. aRR= adjusted risk ratio of CG: IG, UL function = Upper limb function

4. Values given as differences in means (intervention/control-baseline); ∆Gp = Between group difference (intervention-control)

Citation Study type/

Evidence Populations1 Samples & Design2

Length of

follow-up Outcome measures Effect size3

7. Box et

al., (2002)

Single-

blinded RCT

(1+)

N= 65

Mean age: 56

Women

scheduled for

(Local

excision

/MRM+ AD)

IG: n=32

1. Pre-op: Introduce LE/

HBE

2. Post-op: ROM Ex

3. Encourage HBE+UC+FU

CG: n=33

1. Usual care: Pamphlet

ofexercise

Pre-op,

post-op

Day5,

Month

1,3,6,12 &

24

Primary:

(1) Incidence of LE(%)

At month 24

(1) IG: 11 (95%CI,

0.7-22.9)

CG: 30 (95%CI,

13.6-46.4)

8.

Wingate,

(1985)

Quasi

experiment

-not

randomized

(2-0)

N= 90

Mean age: 57.3

Women

scheduled for

MRM

IG: n=49

In patient post-op:

1. daily ROM/resistance Ex

2. Instruct hand and arm

care

3. HBE for 8 weeks

CG: n=41

No treatment

Post op

Day 5 &

month 3

Primary:

(1) Arm Circumference

(cm)

(2) Shoulder ROM

(degree)

At 3 month

(1) At olecranon +0.5

7.5cm proximal -0.9

15cm proximal +0.5

(significant,ANOVA)

(2) Abduction

+15.7 (p<0.001)

Flexion +16.3(p<0.001)

52

Appendix 3 - Appraisal checklist

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Kilbreath, S. L., Lee, M-J., Refshauge, K. M., Beith, J. M., Ward, L. C., Simpson, J. M. et al. (2013). Transient

swelling versus lymphoedema in the first year following surgery of breast cancer. Support Care Cancer. 21: 2207-2215

Guideline topic: Home-based exercise of breast cancer related

lymphoedema

Key Question No: Reviewer:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study

design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled

clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention

Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes No

Can’t say (Computer generated randomisation list)

1.3 An adequate concealment method is used

Yes No

Can’t say (Use sealed opaque

envelopes & by a third person )

1.4 Subjects and investigators are kept ‘blind’ about treatment allocation Yes No

Can’t say (Did not mentioned

whether the subjects were

blinded or not)

1.5 The treatment and control groups are similar at the start of the trial Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under

investigation.

Yes No

Can’t say

53

1.7 All relevant outcomes are measured in a standard, valid and reliable

way.

Yes No

Can’t say (With reliable tools)

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

12% (Low compliance/time commitment, loss contact)

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes No

Can’t say Does not apply

(Treatment group was coded)

1.1

0

Where the study is carried out at more than one site, results are

comparable for all sites

Yes

Can’t say

No

Does not

apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++) Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your

evaluation of the methodology used, and the

statistical power of the study, are you certain that

the overall effect is due to the study intervention?

Yes.

(Power analysis was calculated with 80% power,

considered also 20% mortality and loss of contact.)

2.3 Are the results of this study directly applicable to

the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and

the extent to which it answers your question and mention any areas of uncertainty raised above.

- The study showed that lymphedema in the first year is likely to be transient and HBE reduce the

risk of developing swelling.

- The data of the risk factors (e.g. HBE, chemotherapy) were presented in a risk ratio with 95%

Confident interval & p-value.

- Whether the subjects were blinded to the group allocation were not mentioned.

54

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Singh, C., Vera, M. D. & Campbell, K. L. (2013). The effect of prospective monitoring and early

physiotherapy intervention on arm morbidity following surgery for breast cancer: A pilot study.

Physiotherapy Canada. 65(2): 183-191

Guideline topic: Home-based exercise of breast

cancer related lymphoedema

Key Question No: Reviewer:

Before completing this checklist, consider:

3. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt,

check the study design algorithm available from SIGN and make sure you have the

correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not

relevant, and the study cannot be rated higher than 1+

4. Is the paper relevant to key question? Analyse using PICO (Patient or Population

Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES

complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please

specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused

question

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is

randomised.

Yes No

Can’t say (according

to site)

1.3 An adequate concealment method is used.

Yes No

Can’t say (Not

mentioned)

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes No

Can’t say (Single

blinded-

subject)

1.5 The treatment and control groups are similar at the start of

the trial.

Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under

investigation.

Yes No

Can’t say

55

1.7 All relevant outcomes are measured in a standard, valid and

reliable way.

Yes No

Can’t say (With reliable

tools)

1.8 What percentage of the individuals or clusters recruited into

each treatment arm of the study dropped out before the study

was completed?

1.4% (Not complete 7

months program)

1.9 All the subjects are analysed in the groups to which they

were randomly allocated (often referred to as intention to

treat analysis).

Yes No

Can’t say Does not

apply

(Removed for

analysis)

1.1

0

Where the study is carried out at more than one site, results

are comparable for all sites.

Yes

Can’t say

No

Does not

apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise

bias?

Code as follows:

High quality (++) Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical

considerations, your evaluation of the

methodology used, and the statistical

power of the study, are you certain that the

overall effect is due to the study

intervention?

Yes.

(Subjects were allocated according to the

site.

? Not randomised. T-test was used to prove

the statistical significant.)

2.3 Are the results of this study directly

applicable to the patient group targeted by

this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment

of the study, and the extent to which it answers your question and mention any areas of

uncertainty raised above.

- The study showed that physiotherapy programme and follow up on HBE reduce

arm morbidity following breast cancer surgery.

- Small sample size, the therapist and investigators were not blinded to the group

allocation.

56

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Scaffidi, A., Vulpiani, M. C., Vetrano, M., Conforti, F., Marchetti, M. R., Bonifacino, A., et al. (2012).

Early rehabilitation reduces the onset of complications in the upper limb following breast cancer

surgery. European Journal of Physical and Rehabilitation Medicine. 48(4): 601-611

Guideline topic: Home-based exercise of breast

cancer related lymphoedema

Key Question No: Reviewer:

Before completing this checklist, consider:

5. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check

the study design algorithm available from SIGN and make sure you have the correct checklist.

If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study

cannot be rated higher than 1+

6. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention

Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly

focused question

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is

randomised.

Yes No

Can’t say (Before & after

renovation of rehab service)

1.3 An adequate concealment method is used

Yes No

Can’t say

1.4 Subjects and investigators are kept ‘blind’ about

treatment allocation.

Yes No

Can’t say (Double-blinded)

1.5 The treatment and control groups are similar at the

start of the trial.

Yes No

Can’t say □ (More subjects on IG)

1.6 The only difference between groups is the treatment

under investigation.

Yes No

Can’t say

1.7 All relevant outcomes are measured in a standard,

valid and reliable way.

Yes No

Can’t say (With reliable

measurement tools)

57

1.8 What percentage of the individuals or clusters

recruited into each treatment arm of the study dropped

out before the study was completed?

0% (Participants were excluded if

they were not fully adhere to the programme & FU.)

1.9 All the subjects are analysed in the groups to which

they were randomly allocated (often referred to as

intention to treat analysis).

Yes No

Can’t say Does not apply

1.10 Where the study is carried out at more than one site,

results are comparable for all sites

Yes

Can’t say

No

Does not apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to

minimise bias?

Code as follows:

High quality (++) Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical

considerations, your evaluation of the

methodology used, and the statistical

power of the study, are you certain

that the overall effect is due to the

study intervention?

Yes. (Two treatment groups are Mann-Whitney was used to calculate the statistical significance.)

2.3 Are the results of this study directly

applicable to the patient group

targeted by this guideline?

Yes.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the

study, and the extent to which it answers your question and mention any areas of uncertainty

raised above.

- The study showed that rehabilitation programme that included HBE and in-patient

education following breast cancer surgery reduce the incidence of postoperative

side-effects, including lymphoedema.

- Participants enrolled in two period were then enrolled in two groups. No external

force influencing the allocation except the time they enrolled in the study.

58

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Cinar, N., Seckin, U., Keskin, D., Bodur, H., Bozkurt, B. & Cengiz, O. (2008.) The effectiveness of

Early Rehabilitation in Patient with Modified Radical Mastectomy. Cancer Nursing. 31(2): 160-165

Guideline topic: Home-based exercise of breast cancer

related lymphoedema

Key Question No: Reviewer:

Before completing this checklist, consider:

7. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the

study design algorithm available from SIGN and make sure you have the correct checklist. If it

is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be

rated higher than 1+

8. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention

Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes No

Can’t say (Not in

detail)

1.3 An adequate concealment method is used.

Yes No

Can’t say (Not mentioned)

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes No

Can’t say (Double blinded)

1.5 The treatment and control groups are similar at the start of the

trial.

Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under

investigation.

Yes No

Can’t say

1.7 All relevant outcomes are measured in a standard, valid and

reliable way.

Yes No

Can’t say (With reliable measurement tools

by other investigators blinded to the gorups)

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was completed?

0%

59

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat

analysis).

Yes No

Can’t say Does not

apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites

Yes

Can’t say

No

Does not

apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise

bias?

Code as follows:

High quality (++) Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations,

your evaluation of the methodology used, and

the statistical power of the study, are you

certain that the overall effect is due to the

study intervention?

Yes. (The randomisation and concealment

method were not clearly stated. T-test was used to calculate the significance of the study.)

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the

study, and the extent to which it answers your question and mention any areas of uncertainty

raised above.

- The study showed that early assisted rehabilitation programme improve shoulder

mobility after modified radical mastectomy.

- No significance different between the surprised exercise and HBE on the incidence of

lypmphoedema.

60

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Kilgour, R. D., Jones, D. H., & Keyserlingk, J. R. (2008). Effectiveness of a self-administered, home-based

exercise rehabilitation program for women following a modified radical mastectomy and axillary node

dissection: a preliminary study. Breast Cancer Research and Treatment. 109(2), 285-295.

Guideline topic: Home-based exercise of breast cancer

related lymphoedema

Key Question No: Reviewer:

Before completing this checklist, consider:

9. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the

study design algorithm available from SIGN and make sure you have the correct checklist. If it is a

controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated

higher than 1+

10. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention

Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes No

Can’t say

(Computerized number list)

1.3 An adequate concealment method is used.

Yes No

Can’t say

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes No

Can’t say (Double

blinded, patients & therapists)

1.5 The treatment and control groups are similar at the start of the

trial.

Yes

Can’t say □

No

(Shown in

table)

1.6 The only difference between groups is the treatment under

investigation.

Yes No

Can’t say (The HBE

program)

1.7 All relevant outcomes are measured in a standard, valid and

reliable way.

Yes No

Can’t say (All outcomes were

stated clearly and measured

with reliable tools by experienced therapist.)

61

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

0%

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat

analysis).

Yes

Can’t say

No

Does not

apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites

Yes

Can’t say

No

Does not

apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++) Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations,

your evaluation of the methodology used, and

the statistical power of the study, are you certain

that the overall effect is due to the study

intervention?

Yes.

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study,

and the extent to which it answers your question and mention any areas of uncertainty raised above.

- The study showed that the early onset and self-administered HBE programme improve

shoulder mobility and lymphedema after breast surgery.

- The sample size of this study is small, but it’s targeted on a vulnerable group of

participants who underwent mastectomy and also axillary node dissection. Power analysis

could be calculated to enhance the power of the study.

- The adherence rate of the program decrease with time and the reasons were also estimated

for future study or programme implementation.

62

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Todd, J., Scally, A., Dodwell, D., Horgan, K. & Topping, A. (2008). A Randomised controlled trail of two

programmes of shoulder exercise following axillary node dissection for invasive breast cancer.

Physiotherapy, 94, 265-273

Guideline topic: Home-based exercise of breast cancer

related lymphoedema

Key Question No: Reviewer:

Before completing this checklist, consider:

11. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the

study design algorithm available from SIGN and make sure you have the correct checklist. If it is a

controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated

higher than 1+

12. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention

Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes No

Can’t say (Random

number table)

1.3 An adequate concealment method is used.

Yes No

Can’t say (sealed envelope & by an

objective third person)

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes No

Can’t say (Single

blinded)

1.5 The treatment and control groups are similar at the start of the trial. Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under

investigation.

Yes No

Can’t say

1.7 All relevant outcomes are measured in a standard, valid and

reliable way.

Yes No

Can’t say (With

reliable measurement tools & confirmed by other

investigators)

63

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

6% (Died, left country, lack

of interest, consequence of allocation & elected to the

IG)

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat analysis).

Yes No

Can’t say Does not

apply

(Imputation done)

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes

Can’t say

No

Does not

apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias?

Code as follows:

High quality (++) Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations,

your evaluation of the methodology used, and

the statistical power of the study, are you

certain that the overall effect is due to the study

intervention?

Yes. (The participants were not masked by the

group allocation but they were reminded not to discuss with others. Participants who did not

satisfy the allocation would be dropped out in the

study. For the sample size, statistical power of this study was 80%. )

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the

study, and the extent to which it answers your question and mention any areas of uncertainty raised

above.

- The study showed that delay shoulder exercise for 1 week and HBE following axillary node

dissection reduce the incidence of lymphoedema.

- The adherence rate of the program was 73% throughout a year.

- The data of the study outcomes were presented and compared in-text only with 95%

Confident interval.

64

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Box, R. C., Reul-Hirche, H. M., Bullock-Saxton, J. E., & Furnival, C. M. (2002). Physiotherapy after

breast cancer surgery: results of a randomised controlled study to minimise lymphoedema. Breast Cancer Research and Treatment. 75, 51-64.

Guideline topic: Home-based exercise of breast cancer

related lymphoedema

Key Question No: Reviewer:

Before completing this checklist, consider:

13. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the

study design algorithm available from SIGN and make sure you have the correct checklist. If it

is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be

rated higher than 1+

14. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention

Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised. Yes

Can’t say

No

(Not in

detail)

1.3 An adequate concealment method is used.

Yes No

Can’t say (Not

mentioned)

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes No

Can’t say

(Single blinded, taken remedial strategies to

minimize the bias.)

1.5 The treatment and control groups are similar at the start of the

trial.

Yes

Can’t say □

No

(Shown in

table)

1.6 The only difference between groups is the treatment under

investigation.

Yes No

Can’t say

(The Exercise program)

65

1.7 All relevant outcomes are measured in a standard, valid and

reliable way.

Yes No

Can’t say (with reliable measurement tools &

outcomes stated clearly)

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

completed?

9% (unavailable for review/ final assessment, death,

relocation, with subsequent

operation)

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat

analysis).

Yes

Can’t say

No

Does not

apply

1.10 Where the study is carried out at more than one site, results are

comparable for all sites

Yes

Can’t say

No

Does not

apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise

bias?

Code as follows

High quality (++) Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations,

your evaluation of the methodology used, and

the statistical power of the study, are you

certain that the overall effect is due to the

study intervention?

Yes.

(Although the sample size was small, the power

analysis was calculated to ensure the study with 90% power. Statistical power of the data were

clearly stated.)

2.3 Are the results of this study directly

applicable to the patient group targeted by this

guideline?

Yes

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the

study, and the extent to which it answers your question and mention any areas of uncertainty

raised above.

- The study showed that the physiotherapy intervention programme reduce the

development of secondary lymphoedema after breast surgery. The study was clinically

significant with 95% confident interval.

- The study included a structured exercise programme and followed for 24 months which

was a comparatively good study to examine the long term effect on the participants.

66

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Wingate, L. (1985). Efficacy of physical therapy for patients who have undergone mastectomies- A

prospective study. Physical therapy. 65(6): 896-900

Guideline topic: Home-based exercise of breast cancer

related lymphoedema

Key Question No: Reviewer:

Before completing this checklist, consider:

15. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the

study design algorithm available from SIGN and make sure you have the correct checklist. If it is

a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be

rated higher than 1+

16. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention

Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised.

Yes No

Can’t say

1.3 An adequate concealment method is used.

Yes No

Can’t say

1.4 Subjects and investigators are kept ‘blind’ about treatment

allocation.

Yes No

Can’t say

1.5 The treatment and control groups are similar at the start of the

trial.

Yes No

Can’t say (Not in details,

significant more axillary node dissected out in IG.)

1.6 The only difference between groups is the treatment under

investigation.

Yes No

Can’t say

1.7 All relevant outcomes are measured in a standard, valid and

reliable way.

Yes No

Can’t say (With reliable

tools. But the investigator was the author, researcher

himself)

1.8 What percentage of the individuals or clusters recruited into each

treatment arm of the study dropped out before the study was

2%

(Relocation in another state)

67

completed?

1.9 All the subjects are analysed in the groups to which they were

randomly allocated (often referred to as intention to treat

analysis).

Yes No

Can’t say Does not

apply

(Not mentioned)

1.10 Where the study is carried out at more than one site, results are

comparable for all sites.

Yes

Can’t say

No

Does not

apply

SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise

bias?

Code as follows

High quality (++) Acceptable (+)

Unacceptable – reject 0

2.2 Taking into account clinical considerations,

your evaluation of the methodology used, and

the statistical power of the study, are you

certain that the overall effect is due to the

study intervention?

Can’t say. (The study was designed, outcomes were measured and analysed by the author,

the same person. The data were analysed by t-test, chi-square test and ANOVA.)

2.3 Are the results of this study directly applicable

to the patient group targeted by this guideline?

Yes.

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the

study, and the extent to which it answers your question and mention any areas of uncertainty

raised above.

- The study showed that physiotherapy enhance shoulder ROM on women underwent

mastectomies.

- No randomization, concealment, the outcomes were collected & analyzed by the author

himself.

68

Appendix 4 – Timeline of HBEP

Month Tasks 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Communication

meetings

Administrators

approval

Material preparation

Staff Training

Pilot - patient

recruitment (2 weeks)

Pilot test (5 weeks)

Pilot test- evaluation

Program amendment

Full implementation –

recruitment

Program

implementation

Interval program

evaluation

Whole program

evaluation

69

Appendix 5 – Estimated total cost of implementing HBEP (12 months for 55 patients)

Items Quantities

Cost/unit

(HKD)

Total cost

(HKD)

Set-up cost (For first 4 months)

Manpower cost

1 Experienced Registered Nurse

(RN as coordinator)

24hours/week

(Preparation)

$182/hour $69,888

1 Advanced Practice Nurse Breast

Nurse)

2 hours/week $260/hour $8,320

1 Clerical Staff 4 hours/ week $85/hour $5,440

Training Cost

Experienced Registered Nurse

(coordinator)

Communication course

Available in

hospital

/

2 hours training and

sharing session on

exercising

$182/hour $364

1 Breast Nurse $260/hour $520

1 Physiotherapist I $269/hour $538

Material Cost

Venue & stationary for training and meetings

Available in

hospital

/ Measuring tape for evaluation

Video marking – camera and software

Compact disc (CD) 5 sample disc $5/disc $25

Documents/pamphlets/ logbook/

handouts/ evaluation forms

Around 200 papers $0.15/A4paper $30

Total set-up cost: $85, 125

70

Operational cost (12 months, serving 55 patients)

Manpower Cost

Experienced Registered Nurse

Preparation/documentation 5hours/ week

$182/hour

$47,320

Education- Pre-op (group)/ Post-op

(individual)

4 hours/ week

(in first 6months)

$18,928

Face-to-face monitoring-

(Post-op 1 week & 2 week)

2times/15mins/

Patient

$5,005

Phone monitoring-

(Months 1-5; 7-11)

10 times/

10mins/patient

$16,683

Evaluation-

(Pre-op, Month 6 & 12)

3 times/

20mins/patient

$10,010

Program evaluation 10hours/week for last

2months

$14,560

1 Breast Nurse 4 hours/ month $260/hour $12,480

1 Clerical Staff 5 hours/ week $85/hour $22,100

Material Cost

Venue, computer, projector, stationary

Available

/

Evaluation tools- measure tape, tank /

Video CD 80 copies $5/disc $400

Pamphlets, handouts, log books &

evaluation forms

80 copies $0.15/A4 paper $600

Evaluation & Documents 500 papers $0.15/A4 paper $75

Total operation cost: $148,161

71

Appendix 6- Estimated total cost of not implementing HBEP for 12 months

(approximately 30 patients, readmitted for 4 episodes with 7 days each)

Items Quantities

Cost/unit

(HKD)

Total cost

(HKD)

Extra manpower cost (During hospitalization)

Daily limb Physiotherapy 20mins/day $153/hour $61,200

Occupational therapist for

pressure garment

3 hour/service $153/hour $13,770

Pain team consultation

(1 Doctor, 1 RN)

Once/admission

/ 30mins

$400/doctor/hour

+ $182/RN/hour

$34,920

Material Cost (During hospitalization)

Hospitalization cost 7days/ episode $4000/ day $3,360,000

Antibiotics (Injection/oral) 1course/episode $120/course $14,400

Dressing materials Daily $200/day $336,000

Pressure Garment once $100/piece $3000

Total cost for NOT implementing the HBEP: $3,823,290

72

Appendix 7 – Guideline of implementing Home-based exercise programme

(HBEP) for breast cancer patients

Aim and objectives

The aim of this guideline is to develop a clear and evidence-based protocol for guiding safe

and consistent nursing practice in implementing Home-based exercise programme on

prevention of breast cancer related lymphoedema among breast cancer patients.

The objectives of the guideline are:

1. To prevent lymphoedema among breast patients after breast cancer surgery

2. To assist nurses and healthcare professionals to deliver a safe Home-based exercise

programme

3. To summarize the evidence of the Home-based exercise programme

4. To standardize the content of the Home-based exercise programme

5. To promote quality holistic patient-based care for breast cancer patients

Target group

Target User:

This guideline is designed for nurses and other healthcare professionals on the care of

patients who scheduled for breast cancer surgery.

Target populations:

Women who are admitted to the unit and scheduled for breast cancer surgery.

Inclusion criteria

Women aged 18 to 80 years

Scheduled for breast cancer surgery

73

Exclusion criteria

Having underlying shoulder problems

Having existing lymphoedema

Having physical, cognitive and neurological deficit

Recommendations

Assessment & recruitment

1. All women after breast surgery are suggested to perform HBE. (Grade A)

Evidence: Findings from the reviewed studies supported that HBE is effective and

significant in preventing lymphoedema and improving shoulder range-of-motion.

(Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Kilgour et al.,

2008; Box et al., 2002) (1+; 2+; 2+; 1+; 1+)

2. Women underwent breast surgery having physical, cognitive and neurological deficit

should be excluded. (Grade B)

Evidence: Patients with these deficits may not able to engage in exercises and follow the

guideline (Kilbreath et al., 2013; Box et al., 2002) (1+; 1+)

3. Women with underlying shoulder problems (i.e. sustained fracture, previous shoulder or

upper limb surgery, shoulder dysfunction) should be excluded. (Grade B)

Evidence: Women with underlying shoulder problems are of higher risk of injury, safety

issue is a concern. (Kilbreath et al., 2013; Scaffidi et al., 2012; Kilgour, Jones &

Keyserlingk, 2008) (1+; 2+; 1+)

4. Women with existing limb lymphedema should be excluded. (Grade A)

Evidence: Women with existing lymphedema are excluded in all studies due to safety

concern and the aims of preventing lymphedema. (Kilbreath et al., 2013; Singh, Vera &

74

Campbell, 2013; Scaffidi et al., 2012; Kilgour, Jones & Keyserlingk, 2008; Box et al.,

2002; Cinar et al., 2008; Todd et al., 2008) (1+; 2+; 2+; 1+; 1+; 1+; 1+)

Intervention

5. HBEP can be carried out by nurses and physiotherapists. (Grade A)

Evidence: These selected programmes were provided by either nurses or physiotherapists.

(Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Kilgour,

Jones & Keyserlingk, 2008; Box et al., 2002; Cinar et al., 2008; Todd et al., 2008) (1+; 2+;

2+; 1+; 1+; 1+; 1+) The only HBEP administrated by doctor was failed to attain a clinical

and statistical significant result. (Wingate, 1985) (2-)

6. HBEP is suggested to start on the day after operation. (Grade A)

Evidence: Five studies started the HBEP on the day after operation (Singh, Vera &

Campbell, 2013; Scaffidi et al., 2012; Todd et al., 2008; Box et al., 2002) (2+; 2+; 1+; 1+),

while other programmes were started on day four and seven. (Kilgour, Vera & Campbell,

2008; Cinar et al., 2008) (1+; 1+) Only one study began the HBE on four weeks after

operation (Kilbreath et al., 2013) (1+).

7. HBEP should last for at least 6 months to a year. (Grade A)

Evidence: Three studies implemented HBEP for 6 to 7 months (Singh, Vera & Campbell,

2013; Scaffidi et al., 2012; Cinar et al., 2008) (2+; 2+; 1+), while the others programmes

lasted for 1 to 2 years (Kilbreath et al., 2013; Todd et al., 2008; Box et al., 2002) (1+; 1+;

1+).

8. HBEP should comprise of A) preoperative education, B) individualized postoperative

exercise sessions and C) regular follow-ups. (Grade A)

Evidence: A) +B) + C) These were the common composition of the HBEP in the quality

studies and shown significant reduction in the incidence of developing lymphoedema.

75

(Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Box et al.,

2002) (1+; 2+; 2+; 1+)

A) + B) Both elements were described in programme shown statically significant in

preventing BCRL. (Kilgour, Jones & Keyserlingk, 2008) (1+)

9. Preoperative education should A) include introduction on lymphoedema, possible risk of

developing lymphoedema and postoperative exercise; B) deliver verbally or in written

format. (Grade A)

Evidence: A) + B) The same contents were delivered by either one or both means

preoperatively in these studies and shown significant results. (Kilbreath et al., 2013;

Singh, Vera & Campbell, 2013; Scaffidi et al., 2012; Kilgour, Jones & Keyserlingk, 2008;

Box et al., 2002) (1+; 2+; 2+; 1+; 1+)

10. Deep breathing, stretching and ROM exercise should be performed on the day after

operation. (Grade A)

Evidence: These types of exercise were used in combination in the quality programmes

contributed to significant results. (Singh, Vera & Campbell, 2013; Scaffidi et al., 2012;

Cinar et al., 2008; Kilgour, Jones & Keyserlingk, 2008; Todd et al., 2008; Box et al., 2002)

(2+; 2+; 1+; 1+; 1+; 1+)

11. Stretching A) on neck muscles, elevation and abduction of shoulder below 90˚and flexion

and extension of elbow; B) maintains for 5 to 15 minutes for each stretch are suggested.

(Grade A)

Evidence: Stretching exercise was introduced by the quality selected studies and

contributed significant results. (Kilbreath et al., 2013; Scaffidi et al., 2012; Kilgour, Jones

& Keyserlingk, 2008) (1+; 2+; 1+)

12. Range-of-motion exercise on hands, elbow and shoulder movement limited by 90˚(in the

76

first week after operation) are suggested. (Grade A)

Evidence: ROM exercise was included in the selected studies. (Singh, Vera & Campbell,

2013; Cinar et al., 2008; Todd et al., 2008; Box et al., 2002) (2+; 1+; 1+; 1+) The use of

full shoulder ROM had shown negative effect on lymphoedema. (Todd et al., 2008) (1+)

13. Stretching and ROM exercise A) should be performed in 2- 3 times per day and B)

patients should be reminded to stay pain-free. (Grade A)

Evidence: Studies suggested to repeat each set of ROM exercise for 2 – 3 times per day.

(Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al., 2013; Todd et al,

2008; Box et al., 2002) (1+; 2+; 2+; 1+; 1+) It is also important to avoid injury and

interfere on wound healing by performing HBE comfortably and free from pain.

(Kilbreath et al., 2013; Scaffidi et al., 2013; Kilgour, Jones & Keyserlingk, 2008) (1+; 2+;

1+)

14. Pamphlet or video of steps and safety reminders should be distributed. (Grade A)

Evidence: Pamphlet or videos are important in guiding and facilitating correct and safe

HBE. (Kilbreath et al., 2013; Scaffidi et al., 2013; Cinar et al., 2008; Kilgour, Jones &

Keyserlingk, 2008; Todd et al, 2008; Box et al., 2002; Kilgour, Jones & Keyserlingk,

2008) (1+; 2+; 1+; 1+; 1+; 1+; 1+)

15. At least two sessions of face-to-face or telephone follow-ups should be offered.(Grade A)

Evidence: Face-to-face follow-ups are important in monitoring the progress of HBE,

ensuring the accuracy and safety of HBE. (Kilbreath et al., 2013; Singh, Vera & Campbell,

2013; Scaffidi et al., 2013; Box et al., 2002) (1+; 2+; 2+; 1+;1+) Telephone follow-up was

only used by Todd et al. (2008) (1+)

77

Evaluation

16. The multi-frequency bioimpedance analysis, water displacement method and arm

measurement can detect lymphoedema. (Grade A)

Evidence: All quality studies used either one to all of them in determining the incidence

of lymphoedema. (Kilbreath et al., 2013; Singh, Vera & Campbell, 2013; Scaffidi et al.,

2013; Cinar et al., 2008; Kilgour, Jones & Keyserlingk, 2008; Todd et al., 2008; Box et al.,

2002) (1+; 2+; 2+; 1+; 1+; 1+; 1+)

17. The range-of-motion alone can be measured by the Goniometer. (Grade A)

Evidence: In these studies, Goniometer was used in measuring the ROM and obtained

significant results. (Singh, Vera & Campbell, 2013; Scaffidi et al., 2013; Cinar et al., 2008;

Kilgour, Jones & Keyserlingk, 2008; Todd et al., 2008; Wingate, 1985) (2+; 2+; 1+; 1+;

1+; 2-)

18. The adherence rate and problems encountered should be recorded in the logbook. (Grade

B)

Evidence: It is essential for progress monitoring and programme evaluation. (Kilbreath et

al., 2013; Kilgour, Jones & Keyserlingk, 2008) (1+; 1+)

Summary

According to the graded recommendation, the flow of Home-based exercise programme is

summarized in the chart attached below.

78

On admission

Home-based exercise programme flow

Profile assessment by nurse

Patients with Breast Cancer

_Inclusion criteria Exclusion criteria

‣ Women aged 18 – 80 ‣ Having underlying shoulder problem or

‣ Scheduled for breast cancer surgery lymphoedema

‣ With physical/ cognitive/neurological deficit

Fulfill ALL criteria

1st session: same session with PAC*

‣ (Group): Pre-op education

3 weeks before OT

After operation

2nd session: Day before OT

‣ Initial assessment (arm circumference, ROM, FACT-B+4)

‣ Exercise and education session

Patient with drain Patient without drain

3rd session: Post-op Day 1 (+ pamphlet & CD)

‣ Exercise session + Pre-discharge education

3 weeks after operation

4th session: 1 week after operation

‣ Reassurance / compliance / problem shooting

(Same with Breast nurse follow up) (Phone follow up)

Follow-ups

5th session: (same session with Breast team follow-up

‣ Play exercise video in waiting hall/ skills revision/ problem shooting

‣ 2nd assessment (arm circumference/ ROM/ FACT-B+4)

*PAC= Preoperative assessment clinics

Phone follow-ups: 2, 4, 9 months after operation ‣ Progress

Face-to-face follow-up: 6 & 12 months after operation

‣ For progress & assessment (Arm circumference/ROM/FACT-B +4)

79

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