Evaluating Holistic Needs Assessment in Outpatient Cancer · should be sharing what decisions, or how this may or may not impact upon outcomes [6]. Therefore, evidence grounded in

For peer review only

Evaluating Holistic Needs Assessment in Outpatient Cancer

Care: a Randomised Controlled Trial- the study protocol.

Journal: BMJ Open

Manuscript ID: bmjopen-2014-006840

Article Type: Protocol

Date Submitted by the Author: 06-Oct-2014

Complete List of Authors: Snowden, Austyn; University of the West of Scotland, Young, Jenny; University of the West of Scotland, Mental Health White, Craig; Scottish Government, Quality Unit, Health and Social Care Murray, Esther; NHS Ayrshire and Arran, Psychological Services Richard, Claude; MEDICODE, Lussier, Marie-Therese; MEDICODE, Storey, Dawn; Beatson, West of Scotland cancer Centre, Colorectal Schipani, Stefano; Beatson, West of Scotland cancer Centre, Head and

Neck MacArthur, Ewan; University of the West of Scotland, Statistics Wheatley, Duncan; Royal Cornwall Hospital, Oncology

<b>Primary Subject Heading</b>:

Oncology

Secondary Subject Heading: Communication, Evidence based practice, Patient-centred medicine

Keywords: ONCOLOGY, SOCIAL MEDICINE, Organisation of health services < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, MENTAL HEALTH, MEDICAL EDUCATION & TRAINING

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Evaluating Holistic Needs Assessment in Outpatient Cancer Care: a Randomised Controlled Trial- the

study protocol.

Austyn Snowden, Jenny Young, Craig White, Esther Murray, Claude Richard, Marie-Therese Lussier,

Ewan MacArthur, Dawn Storey, Stefano Schipani, Duncan Wheatley

ABSTRACT

Introduction

People living with and beyond cancer are vulnerable to a number of physical, functional and

psychological issues. Undertaking a Holistic needs assessment (HNA) is one way to support a

structured discussion of patients' needs within a clinical consultation. However, there is little

evidence on how HNA impacts upon the dynamics of the clinical consultation. This study aims to

establish a) how HNA affects the type of conversation that goes on during a clinical consultation and

b) how these putative changes impact on shared decision-making and self-efficacy.

Methods and Analysis

The study is hosted by ten outpatient oncology clinics in the West of Scotland and South West

England. Participants are patients with a diagnosis of head and neck, breast, urological,

gynaecological and colorectal cancer who have received treatment for their cancer. Patients are

randomised to an intervention or control group. The control group entails standard care - routine

consultation between the patient and clinician. In the intervention group the patient completes a

holistic needs assessment prior to consultation. The completed assessment is then given to the

clinician where it informs a discussion based on the patient’s needs and concerns as identified by

them.

The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and

preponderance of initiative (PI) within the consultation. The secondary outcome measures are

shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater

patient participation within the consultation and that shared decision-making and feelings of self-

efficacy will increase as a function of the intervention.

Ethics and Dissemination

This study has been given a favourable opinion by the West of Scotland Research Ethics Committee

and NHS Research & Development. Study findings will be disseminated through peer reviewed

publications and conference attendance.

Registration details- UKCRN ID Number- 16760

ARTICLE SUMMARY

Article focus

• This protocol is designed to examine the impact of holistic needs assessment on patient

participation and shared decision making within the clinical consultation and subsequent

patient reported self-efficacy.

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Key messages

• An increasing number of cancer patients are living with the effects of their diagnosis. It is

recognised at both a moral and political level that patient experience needs to improve in

order to improve satisfaction, reduce distress, offer support and save money by facilitating

self-care.

• Holistic needs assessment enables the patient to articulate needs that are personally

important. This assists the clinician with the identification of any patient distress. We

hypothesise that consultations where the HNA has informed a discussion around patient

needs there will be increased patient participation, a greater sense of shared decision

making and increased feelings of self-efficacy than treatment as usual.

• The importance of effective communication within the patient/clinician relationship is well

documented. Yet, the dynamics of interventions designed to facilitate collaboration are not

well understood. Therefore, evidence grounded in the evaluation of an intervention (HNA)

that aims to reduce unmet needs and simultaneously analyse any perceived benefits to the

quality of the clinician/patient relationship is both timely and essential.

Strengths and limitations of the study

• To our knowledge this is the first randomized controlled trial to examine the impact of HNA

on the dynamics of conversation and any subsequent impact on shared decision making and

self-efficacy.

• We are only collecting data from one consultation per patient. However, it is recommended

that HNA should be administered across the patient pathway (at diagnosis, pre-treatment,

and then post-treatment). Therefore, we are unable to comment on the impact of HNA on

the patient/clinician dynamic over time.

Title 1 Evaluating Holistic Needs Assessment in Outpatient Cancer Care: a

Randomised Controlled Trial.

Trial registration 2a UKCRN ID Number- 16760

Protocol version 3 27/5/14 V2

Funding 4 Macmillan Cancer Support UK

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Roles and

responsibilities

5a Austyn Snowden, Principal Investigator and lead protocol developer

Jenny Young, Research Assistant and protocol developer

Craig White, Principal Investigator and protocol developer

Esther Murray, HNA training and protocol developer

Claude Richard, MEDICODE analyst and protocol developer

Marie-Therese Lussier, MEDICODE analyst and protocol developer

Ewan MacArthur, Statistician

Dawn Storey, Consultant Oncologist and protocol developer

Stefano Schipani, Consultant Oncologist and protocol developer

Duncan Wheatley, Clinical Lead and protocol developer

5b Name and contact information for the trial sponsor

Ian Bishop, Innovation and Research office, University of the West of

Scotland, Paisley, PA1 2BE

5c Role of study sponsor and funders, if any, in study design; collection,

management, analysis, and interpretation of data; writing of the report;

and the decision to submit the report for publication, including whether

they will have ultimate authority over any of these activities

None

5d Composition, roles, and responsibilities of the coordinating centre,

steering committee, endpoint adjudication committee, data

management team, and other individuals or groups overseeing the

trial, if applicable (see Item 21a for data monitoring committee)

Steering committee: all authors AND Noeline Young.

Data management team: AS, JY, CR, EMacA.

INTRODUCTION

Background and rationale

There is currently a concerted political, ethical and philosophical push towards improving patient

experience and care in the UK National Health Service [1,2]. Government initiatives such as ‘Better

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Cancer Care: An Action Plan’ [3] and policy guidelines such as ‘Improving supportive and palliative

care for adults with cancer’ [4] address the need to improve satisfaction, reduce distress, offer

support and save money by facilitating self-care. Improved collaboration between patient and

clinician is central to this agenda [5]. However, it is not clear how collaboration is optimised, who

should be sharing what decisions, or how this may or may not impact upon outcomes [6]. Therefore,

evidence grounded in the systematic analysis of the process and impact of collaboration is both rare

and important.

Communication in cancer care is a well-researched field. Effective communication between the

health professional and the patient is associated with improved psychological functioning of the

patient [7,8], adherence to treatment and pain control [9] and higher quality of life and satisfaction

[10]. In contrast, it has been suggested [11] that poor communication may have a number of

negative effects upon the patient and the treatment process, including the nature and quality of

information transmission, decision making and the psychosocial experience of the patient.

There are inherent methodological and philosophical challenges attached to this line of enquiry.

Most notably the idea of ‘poor’ or ‘effective’ communication is subjective, with factors such as

patient behaviour, time, resources and previous training all affecting clinician communication style

[12]. The aim of the current study is to understand more about the factors that may impact on the

quality of communication within the clinical consultation.

The intervention in this study is holistic needs assessment (HNA). HNA is a checklist completed by

the patient prior to consultation. It signposts issues of emotional, practical, financial and clinical

concern. The purpose of a HNA is to identify patient’s individual needs in order to facilitate better

collaboration [13]. During consultation the HNA facilitates a dialogue that will have the patient’s

concerns at the centre. In conjunction with a subsequent care plan the process supports timely

intervention based on a collaborative, person centred discussion [13].

In order to gather pertinent data we are going to audio record clinical consultations. We recognise

that this action may have an impact in itself, potentially changing the subtle dynamics of the

consultation we intend to study. Nevertheless, this is the same for both arms of the study and a

valuable method of analysis [14]. Through detailed examination of communication patterns within

the consultation we intend to ascertain if and how a structured conversation derived from

personally identified patient needs impacts on subsequent outcomes. To our knowledge this is the

first randomized controlled trial to examine the impact of HNA on patient /clinician communication

and the subsequent impact on shared decision-making and patient reported self-efficacy.

Objectives

The objectives are to examine:

1. The impact of HNA on consultation style.

2. The impact of HNA on shared decision making

3. The impact of HNA on patient reported self-efficacy.

In order to meet these objectives the study will test the following hypotheses:

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1. Use of HNA within clinical consultation will facilitate increased levels of patient

participation

2. Use of HNA within clinical consultation will facilitate increased levels of shared decision

making

3. Use of HNA within clinical consultation will facilitate increased feelings of self-efficacy.

METHOD

Study design and setting

This protocol follows SPIRIT 2013 guidelines.

It is a randomised controlled trial. The randomisation pertains to the patients within each clinic. Data

collection will occur within a post-treatment, outpatient cancer clinic. Ten clinics from the West of

Scotland and West of England will participate. The clinics care for patients with head and neck,

breast, urological, gynaecological and colorectal cancer.

Pre-consultation the patient will complete a demographic questionnaire. Those in the intervention

group will then complete a holistic needs assessment titled the ‘Concerns Checklist’ (Appendix 1).

Within the control group there will be no additional intervention, care will continue as normal.

Within both groups the consultation will be audio recorded.

Post consultation the patient will complete two secondary outcome measures; CollaboRATE [5] and

The Lorig Self-efficacy scale [15]. CollaboRATE measures patient perception of shared decision-

making. One of the strengths of CollaboRATE is the ability to complete it in less than thirty seconds.

The Lorig self-efficacy scale is the optimal measure for self-reported self-efficacy in chronic disease

management according to Davies, (2009).

Analysis of the audio-recordings will be done by MEDICODE [17]. The MEDICODE system ascertains

the type of participation occurring within the consultation according to two main measures:

Dialogue Ratio and Preponderance of Initiative. Dialogue Ratio (DR) is assessed by coding how much

of the consultation is discussion and how much is instruction. Preponderance of Initiative (PI) is

assessed by recording which participant initiates aspects of conversation within the consultation.

These two measures (DR & PI) together give a summary score of who is talking, what about and for

how long. These measures can then be analysed alongside the secondary outcome measures.

Eligibility criteria

The study sample will be composed of patients over the age of 18. Eligible patients have undergone

treatment for their diagnosis and are attending a post-treatment clinic. Exclusion criteria includes

those deemed incapable of consenting to participate as defined by the Adults with Incapacity

(Scotland) Act (2000) and any reason which in the opinion of the clinician/investigator interferes

with the ability of the patient to participate in the study. A sample of 156 patients will be recruited.

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The clinicians who deliver and assist with the clinics (n-16) span four professional groups: Consultant

Oncologist, Cancer Nurse Specialist, Radiographer and Surgeon.

Intervention

All participating clinicians will attend training in the use of HNA to enhance standardisation and

concordance with protocol. The training will be delivered by the study consultant psychologist (EM)

and will equip the clinicians with the skills and confidence to respond to the patient’s needs and

concerns as identified through the assessment. These responses may range from simply listening to

the patient to referring the patient to a member of the wider team, such as a clinical psychologist, a

chaplain, financial advice or social work.

Individuals in the intervention group will be given the HNA (Concerns Checklist: Appendix 1) to

complete before consultation. Each clinic has identified a quiet area where the researcher can sit

with the patient, talk through the form and then leave them to complete it. They will be asked to

hand it to their clinician when they enter the consultation room. Any actions taken by the patient or

clinician will be recorded in a care plan. A copy of the care plan will stay in patient notes, the patient

will keep a copy and a copy will be sent to any other members of the multidisciplinary team who are

involved in the patient’s care.

If at any point during this process the patient decides to withdraw they will be freely available to

without question. All patients will be informed that withdrawing from the study will not impact the

care they receive in any way.

Outcomes

Socio-demographic data: sex, age, postcode, ethnicity, relationship status, and education.

Clinical data: cancer type and stage and form of treatment received.

Clinician data: Gender, profession and years of experience.

Data will also be obtained on who is present in the consultation room. For example, the patient may

bring a family member with them.

This will allow the research team to examine what, if any impact variables such as sex, age, ethnicity,

support network, and education have on the research aims. Previous literature corroborates the

influence of these variables on distress within cancer patients [18–20].

Primary outcome measure:

The primary outcome measure is patient participation as measured by dialogue ratio (DR) and

preponderance of initiative (PI) using the conversational coding software ‘MEDICODE’ (Richard &

Lussier, 2006). Preponderance of Initiative (PI) measures the extent to which conversations are

started by the clinician or the patient. The whole consultation is then summarised by this measure

according to who begins most of the conversation. It generates an overall score of -1 (all clinician) to

+1 (all patient). Dialogue Ratio (DR) measures the extent to which the whole consultation consists of

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monologues, dyads and discussions. It generates an overall score of 0 (monologue) to 1 (dialogue).

The output is a graphical representation of these two summary measures.

Secondary outcome measures:

1. Shared decision making as measured by the CollaboRATE scale [5].

CollaboRATE is a survey-based validated tool [21] designed to create a fast way to measure how

much effort clinicians make to explain their patients’ health issues; how much effort they make to

listen to the issues that matter most to their patients and how much effort they make to integrate

the patients’ views and health beliefs.

2. Self-efficacy as measured by the Lorig self- efficacy scale.

The Lorig Self-Efficacy for Managing Chronic Disease 6-Item Scale post consultation encompasses

several domains common to many chronic diseases including; symptom control, role function,

emotional functioning and communicating with physicians. The scale has good internal consistency

and construct validity [16,22]. It is free and easy to use and it has been extensively used at both a

clinical and research level within this patient population [23,24]

Sample size calculation

To achieve statistical significance 78 patients are needed in the experimental group and 78 into the

control. The power calculation was done on G*Power 3 [25]. It is based on the following

assumptions:

The standard setting of alpha was adjusted from 0.05 to 0.0125 to account for the four primary

endpoints [DR, PI, CollaboRATE and Lorig] [26].Power of 0.8 was assumed as sufficient to claim a

difference between groups as a consequence of the intervention. The anticipated effect size of d=0.5

is an estimate. There are no data on the specific effect of the holistic needs assessment technique

proposed here. The value of d=0.5 was arrived at by aggregating the reported effect sizes of other

comparable psychological interventions targeted at improving psychological well-being in the cancer

population [27,28]. Reported effect sizes range from negligible (d=0.33 in older meta-analyses of

interventions to reduce anxiety in cancer patients) to large effects (d=0.77) claimed in some more

recent trials (Schou et al, 2008). Sheard & McGuire also noted that the higher quality trials tended to

produce much higher effect sizes than those of lower quality (0.63 vs. 0.24). Given that this study

proposal meets their quality criteria for a high quality trial (randomised and >40 sample size) 0.5 can

be considered a coherent and conservative effect size estimate.

Recruitment

While we plan to standardise recruitment as far as possible by selecting patients at the same point in

their treatment journey we need to account for the different pathways operating in the clinics. To

this end there are two recruitment strategies:

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1. Following treatment the patient will spend time in hospital. A member of the clinical care

team will approach the patient and introduce the study. If the patient expresses an initial

interest the clinician will give the patient a study pack. This will contain a welcome letter, a

participant information sheet and a consent form.

OR

2. During treatment the patient will attend the clinic. The clinician will introduce the study to

the patient at one of their scheduled appointments and hand over a study pack.

Contact with patients will be done in person where possible. However, in exceptional circumstances

if the clinician has not made personal contact with the patient, the hospital will write to the patient

on behalf on the research team and invite them to participate. The letter will be sent in a plain

envelope to protect the patients’ privacy.

Randomisation

Blocked randomisation will be carried out by the research team, using a computer generated

sequence to ensure an almost equal number of patients within each group. Stratified randomisation

will be used to ensure that patient groups are similar with respect to prognostic factors such as age

and sex. Patients will provide written informed consent to participate before they are informed as to

which group (intervention or control) they will be in. This is to avoid potential bias from patients

who may request to be in a certain group. The randomisation sequence will be managed by the

research assistant using sealed envelopes. The coders who analyse the audio recordings will be

blind to the allocation of patients to the intervention or control group.

Data collection, management and analysis

There will be a two-week pilot. This is to test the study protocol in practice and enable the

construction of an optimal coding framework for MEDICODE. It is our intention to structure the

coding framework around the theory of holistic needs assessment, coding clinical conversation

according to topic discussed. This period will allow for the testing of such a coding framework.

Changes to the protocol and coding framework will be made accordingly. The pilot will also allow

time for broader reflection. The research team will ask the clinicians to review their training, the

patients’ response to the HNA, time and ease to complete the HNA and how their service is

managing any referrals. If the pilot uncovers any deficiencies in the design this can be reviewed with

the team and addressed.

Following this phase the process is as follows. The researcher will meet the patient in the waiting

area of the clinic. The researcher will summarise the study process again, ensure the patient is happy

to continue, collect their consent form and then ask them to complete a demographic questionnaire.

While the patient is completing their demographic form the researcher will randomise the

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participant into an intervention or control group. Individuals in the intervention group will be given

the HNA (Concerns Checklist appendix 1) to complete.

When the patient is called the researcher will accompany them to the consultation room and start

the recording device. The researcher will then leave the consultation room. The clinician will stop

the recording device at the end of the consultation. All patients (in both groups) will return to the

researcher post consultation and complete the Lorig self-efficacy scale and CollaboRATE . (See figure

1 for flow chart summary).

Figure 1-Flow Diagram

Data Management

Research data and patient-related information will be managed in accordance with relevant regulatory approvals. Data analysis

The following statistical methods will be used for analysing the data:


participation

Patient participation within the consultation will be measured by the two Medicode measures:

Preponderance of Initiative (PI) and Dialogue Ratio (DR). The data will first be tested for outliers

using boxplots and for normality using combination of PP, QQ plots and Shapiro Wilk test. If

normality is found, homogeneity of variance between groups will be tested with Levene’s test.

Subsequent calculations will be based on the outcomes of these assumption tests. If normality and

homogeneity of variance are established mean PI and DR will be compared between the

intervention and control group using t-test. If normality and/or homogeneity of variance cannot be

established, a corresponding nonparametric method will be employed.


making

Shared decision will be measured with CollaboRATE. As above the data will be tested for outliers,

normality and homogeneity of variance. If normality and homogeneity of variance are established

mean collaboRATE scores will be compared between the intervention and control group using a t-

test. If not, a corresponding nonparametric method will be employed.


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Self-efficacy will be measured with the Lorig self-efficacy scale. As above the data will be tested for

outliers, normality and homogeneity of variance. If normality and homogeneity of variance are

established mean Lorig scores will be compared between the intervention and control group using a

t-test. If not, a corresponding nonparametric method will be employed.

Methods for any additional analyses

In addition, exploratory analyses will be carried out on various associations. For example,

associations will be tested between the outcome variables and demographic data. We will also test

for any potential associations between dialogue ratio and/or preponderance of initiative with

CollaboRATE and Lorig self-efficacy across the whole sample. The purpose of this is to ascertain any

potential relationships between these measures regardless of study group. For example it seems

intuitive that people who are demonstrably more involved in their consultations as evidenced by

high patient PI and DR scores would be more likely to score highly for self-efficacy and collaboration

regardless of study group.

It is acknowledged that a disadvantage of randomising by patient is that the clinician will carry out

consultations with patients who are in both the intervention and control group. Therefore, ‘learning’

from the consultations where a HNA is applied may crossover into their interactions with the control

group. This would not impact on clinician ability to identify needs personal to the patient as the

patient would not have thought about this in the same manner as those completing a HNA.

Nevertheless this ‘learning’ could potentially contaminate the effect on communication between the

groups. However, since the time when HNA will be introduced into their consultations is known, we

can use this information to investigate whether there is a trend in communication efficacy through

time. Fitting a trend line to the full dataset can do this. ‘Time’ can then be used as a covariate in the

analysis to remove any confounding effect of ‘learning’.

Missing data

Cases will be excluded listwise by default [29].

Discussion

Applying a holistic approach to patient care has many benefits [13,30]. Yet, only around 25% of

cancer survivors in the UK receive a holistic needs assessment and care plan [13]. We therefore wish

to gain a greater insight into the delivery and experience of HNA in the clinical environment. The aim

is to support evidence based implementation of HNA in the UK.

The role of communication on patient outcome has received considerable attention in the field of

cancer care. Nevertheless, to our knowledge there are no published randomised controlled trials

that focus on the patterns of communication between the patient and clinician when a holistic

needs assessment is used or not. This study has a unique focus on the relationship between

communication style, shared decision making and self-efficacy. Traditionally in the UK medical

consultations are led by the clinician but there is evidence collaboration can be facilitated by training

the clinicians in person centred care [31]. What we don’t know is whether this can also be achieved

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by prioritising patients’ needs through the use of HNA. Further, we do not know whether this leads

to improve feelings of self-efficacy and a sense of shared decision making.

Perception of self-efficacy is particularly important, as it is a critical feature of chronic disease

management and can predict the success of self-management programmes among patients [32,33].

Findings from this study may pave the way for exploring the impact of HNA over time. For example

longitudinal follow up could ascertain whether there is any association between self-efficacy, self-

management and the patient’s subsequent use of the health service.

There are limitations to the study. Guidance suggests that HNA should be delivered across the

patient pathway, not just at the post-treatment stge. We selected the post-treatment stage only to

accommodate anticipated difficulties around ensuring the patient sees the same clinician

throughout. In practice this is not always the case which would confound our results in this RCT.

There were also pragmatic reasons. Practically the clinics felt most able to support this study at the

post-treatment stage. This is because at this stage there would be no need for any radical changes to

clinical practice. This was considered paramount, as should we find any favourable results they are

more likely to be transferable to routine practice in future.

Ethics and dissemination plans

This study was given a favourable opinion by the West of Scotland Research Ethics Committee

(14/WS/0126) on 3rd June 2014. NHS Research & Development approval followed on 26 August

2014.This study was also approved by the Clinical Trials Executive Committee within the Beatson

West of Scotland Cancer Centre on 13th June 2014.

Recruitment will begin in October 2014 and completion will occur upon reaching the necessary

sample size within each group. It is predicted it will take 12 months to reach completion. It is

recognised that as the patient's symptoms fluctuate, as might their capacity to consent. Consent will

be assessed by the clinician on the day of the study. Patients without capacity to consent will be

excluded from data collection.

The dissemination of the findings will be predominately carried out through publications in peer

reviewed journals and attendance at national and international conferences. In addition, this body of

work will be promoted through the funders of the study, Macmillan Cancer Support.

References

1 Coulter A, Collins A. Making shared decision making a reality. No decision about me , without me. London: 2011.

2 The Scottish Government. The Quality Strategy. 2010. http://www.scotland.gov.uk/Topics/Health/NHS-Scotland/NHSQuality/QualityStrategy

3 Scottish Executive. Better Cancer Care: An Action Plan. Edinburgh: 2008.

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4 National Institute for Health and Clinical Excellence. Improving supportive and palliative care for adults with cancer. 2004. http://www.nice.org.uk/guidance/csgsp

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6 Cribb A. Involvement, Shared Decision-Making and Medicines. London: 2011.

7 McCormack LA, Treiman K, Rupert D, et al. Measuring patient-centered communication in cancer care: A literature review and the development of a systematic approach. Soc Sci Med 2011;72:1085–95.

8 Ford S, Fallowfield L, Lewis S. Doctor-patient interactions in oncology. Soc Sci Med 1996;42:1511–9.

9 Brown JE, Brown RF, Miller RM, et al. Testing health care professionals’ communication skills: The usefulness of highly emotional standardized role-playing sessions with simulators. Psychooncology 2000;9:293–302.

10 Fukui S, Ogawa K, Yamagishi A. Effectiveness of communication skills training of nurses on the quality of life and satisfaction with healthcare professionals among newly diagnosed cancer patients: a preliminary study. Psychooncology 2011;20:1285–91. doi:10.1002/pon.1840

11 Thorne S, Bultz BD, Baile WF. Is There a cost to Poor Communication in Cancer Care?: a Review of the Literature. Psychooncology 2005;14:875–84.

12 Fagerlind H, Kettis Å, Glimelius B, et al. Barriers against psychosocial communication: oncologists’ perceptions. J Clin Oncol 2013;31:3815–22. doi:10.1200/JCO.2012.45.1609

13 Snowden A, White C. Assessment and care planning for cancer survivors: a concise evidence review. Macmillan Cancer Support UK: 2014. http://be.macmillan.org.uk/be/p-21255-assessment-and-care-planning-for-cancer-survivors-a-concise-evidence-review.aspx

14 Elwyn G. Patients ’ recordings of consultations are a valuable addition to the medical evidence base. 2014;2078:10–1. doi:10.1136/bmj.g2078

15 Lorig KR, Sobel DS, Ritter PL, et al. Effect of a self-management program on patients with chronic disease. Eff Clin Pract ECP 2001;4:256–62.http://www.ncbi.nlm.nih.gov/pubmed/11769298

16 Davies N. SELF-MANAGEMENT PROGRAMMES FOR CANCER SURVIVORS : A STRUCTURED REVIEW OF OUTCOME MEASURES. 2009. http://www.ncsi.org.uk/wp-content/uploads/Outcome-Measures-for-Evaluating-Cancer-Aftercare.pdf

17 Richard C, Lussier M-T. MEDICODE: an instrument to describe and evaluate exchanges on medications that occur during medical encounters. Patient Educ Couns 2006;64:197–206. doi:10.1016/j.pec.2006.02.002

18 Mertz BG, Bistrup PE, Johansen C, et al. Psychological distress among women with newly diagnosed breast cancer. Eur J Oncol Nurs 2012;16:439–43.

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19 Waller A, Williams A, Groff SL, et al. Screening for distress, the sixth vital sign: Examining self-referral in people with cancer over a one-year period. Psychooncology 2013;22:388–95.

20 Agarwal J, Powers K, Pappas L, et al. Correlates of elevated distress thermometer scores in breast cancer patients. Support Care Cancer 2013;21:2125–36.

21 Barr PJ, Thompson R, Walsh T, et al. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res 2014;16:e2.http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3906697&tool=pmcentrez&rendertype=abstract

22 Lorig, K., Stewart A, Ritter P. Outcome Measures for Health Education and Other Health Care

Interventions. London.: : Sage Publications 1996.

23 Nielsen BK, Mehlsen M, Jensen AB, et al. Cancer-related self-efficacy following a consultation with an oncologist. Psychooncology 2013;22:2095–101.

24 Mystakidou K, Tsilika E, Parpa E, et al. Relationship of general self-efficacy with anxiety, symptom severity and quality of life in cancer patients before and after radiotherapy treatment. Psychooncology 2013;22:1089–95.

25 Faul F, Erdfelder E, Lang A-G, et al. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods 2007;39:175–91. doi:10.3758/BF03193146

26 Cabin RJ, Mitchell RJ. To Bonferroni or not to Bonferroni: when and how are the questions. Bull Ecol Soc Am 2000;81:246–8.http://www.jstor.org/stable/20168454

27 Sheard T, Maguire P. The Effect Of Psychological Interventions On Anxiety And Depression In Cancer Patients. Results Of Two Meta-analyses. Br J Cancer 1999;80:1770–80.

28 Schou I, Ekeberg O, Karesen R, et al. Psychosocial intervention as a component of routine breast cancer care who participates and does it help? Psychooncology 2008;17:716–20.

29 Field A. Discovering Statistics Using SPSS. 2nd ed. London: : Sage Publications Ltd; 2005.

30 Brennan J, Gingell P, Brant H, et al. Refinement of the Distress Management Problem List as the basis for a holistic therapeutic conversation among UK patients with cancer. Psychooncology 2012;21:1346–56.

31 Latter S, Sibley A, Skinner TC, et al. The impact of an intervention for nurse prescribers on consultations to promote patient medicine-taking in diabetes: a mixed methods study. Int J

Nurs Stud 2010;47:1126–38. doi:10.1016/j.ijnurstu.2010.02.004

32 Verevkina N, Shi Y, Fuentes-Caceres VA, et al. Attrition in Chronic Disease Self-Management Programs and Self-Efficacy at Enrollment. Heal Educ Behav Published Online First: 2014. doi:10.1177/1090198114529590

33 Farrell K, Wicks MN, Martin JC. Chronic disease self-management improved with enhanced self-efficacy. Clin Nurs Res 2004;13:289–308.

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Author’s Contributions

AS, CW, CR, MT, SL & EM devised the study protocol and are all members of the steering group for

this research.

AS is principal investigator and drafted the manuscript

JY oversees the day to day organisation of the study, drafted the manuscript and is a member of the

steering group.

EMcA provided guidance on statistical analysis

DS, SS, DW drafted the manuscript

Funding

This work was supported by Macmillan Cancer Support UK.

Competing Interests

None

Ethics Approval

West of Scotland Research Ethics Committee 14/WS/0126 IRAS ref: 114947

R&D Approval - GN14ON242

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Figure 2 The Concerns Checklist

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Figure 1-Flow Diagram

Patients from identified sites are

invited to participate

Exclusion criteria

- Under 18

- Deemed incapable to consent

- Any reason which in the opinion of

the clinician/investigator

interferes with the ability of the

patient to participate in the study

Return to researcher and complete:

• Lorig self-efficacy scale

• CollaboRATE

Allocated to intervention group

• Patient completes demographic

questionnaire

• Patient completes HNA and takes it into

consultation

• Audio-record the consultation


• Lorig self-efficacy scale

• CollaboRATE

Allocated to control group

• Patient completes demographic

questionnaire

• Patient attends consultation as normal

• Audio-record the consultation

• Calculate dialogue ratio (DR) and

Preponderance of Initiative (PI)

• Analyse mean/median differences in:

o DR

o PI

o Lorig self-efficacy

o CollaboRATE

• Associations between demographics and

all outcome measures

Allocation

Analysis

Post-consultation

Randomisation

Enrolment

Patient declines

Recruitment

- Clinician approaches

patient during their

hospital stay or at a

routine clinic during

treatment

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SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and

related documents*

Section/item ItemNo

Description

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions,

and, if applicable, trial acronym

Trial registration 2a Trial identifier and registry name. If not yet registered, name of

intended registry

2b All items from the World Health Organization Trial Registration Data

Set

Protocol version 3 Date and version identifier

Funding 4 Sources and types of financial, material, and other support

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors










Introduction

Background and

rationale

6a Description of research question and justification for undertaking the

trial, including summary of relevant studies (published and

unpublished) examining benefits and harms for each intervention

6b Explanation for choice of comparators

Objectives 7 Specific objectives or hypotheses

Trial design 8 Description of trial design including type of trial (eg, parallel group,

crossover, factorial, single group), allocation ratio, and framework (eg,

superiority, equivalence, noninferiority, exploratory)

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Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital)

and list of countries where data will be collected. Reference to where

list of study sites can be obtained

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility

criteria for study centres and individuals who will perform the

interventions (eg, surgeons, psychotherapists)

Interventions 11a Interventions for each group with sufficient detail to allow replication,

including how and when they will be administered

11b Criteria for discontinuing or modifying allocated interventions for a

given trial participant (eg, drug dose change in response to harms,

participant request, or improving/worsening disease)

11c Strategies to improve adherence to intervention protocols, and any

procedures for monitoring adherence (eg, drug tablet return,

laboratory tests)

11d Relevant concomitant care and interventions that are permitted or

prohibited during the trial

Outcomes 12 Primary, secondary, and other outcomes, including the specific

measurement variable (eg, systolic blood pressure), analysis metric

(eg, change from baseline, final value, time to event), method of

aggregation (eg, median, proportion), and time point for each

outcome. Explanation of the clinical relevance of chosen efficacy and

harm outcomes is strongly recommended

Participant

timeline

13 Time schedule of enrolment, interventions (including any run-ins and

washouts), assessments, and visits for participants. A schematic

diagram is highly recommended (see Figure)

Sample size 14 Estimated number of participants needed to achieve study objectives

and how it was determined, including clinical and statistical

assumptions supporting any sample size calculations

Recruitment 15 Strategies for achieving adequate participant enrolment to reach

target sample size

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-

generated random numbers), and list of any factors for stratification.

To reduce predictability of a random sequence, details of any planned

restriction (eg, blocking) should be provided in a separate document

that is unavailable to those who enrol participants or assign

interventions

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Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central

telephone; sequentially numbered, opaque, sealed envelopes),

describing any steps to conceal the sequence until interventions are

assigned

Implementation 16c Who will generate the allocation sequence, who will enrol participants,

and who will assign participants to interventions

Blinding

(masking)

17a Who will be blinded after assignment to interventions (eg, trial

participants, care providers, outcome assessors, data analysts), and

how

17b If blinded, circumstances under which unblinding is permissible, and

procedure for revealing a participant’s allocated intervention during

the trial

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other

trial data, including any related processes to promote data quality (eg,

duplicate measurements, training of assessors) and a description of

study instruments (eg, questionnaires, laboratory tests) along with

their reliability and validity, if known. Reference to where data

collection forms can be found, if not in the protocol

18b Plans to promote participant retention and complete follow-up,

including list of any outcome data to be collected for participants who

discontinue or deviate from intervention protocols

Data

management

19 Plans for data entry, coding, security, and storage, including any

related processes to promote data quality (eg, double data entry;

range checks for data values). Reference to where details of data

management procedures can be found, if not in the protocol

Statistical

methods

20a Statistical methods for analysing primary and secondary outcomes.

Reference to where other details of the statistical analysis plan can be

found, if not in the protocol

20b Methods for any additional analyses (eg, subgroup and adjusted

analyses)

20c Definition of analysis population relating to protocol non-adherence

(eg, as randomised analysis), and any statistical methods to handle

missing data (eg, multiple imputation)

Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role

and reporting structure; statement of whether it is independent from

the sponsor and competing interests; and reference to where further

details about its charter can be found, if not in the protocol.

Alternatively, an explanation of why a DMC is not needed

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21b Description of any interim analyses and stopping guidelines, including

who will have access to these interim results and make the final

decision to terminate the trial

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and

spontaneously reported adverse events and other unintended effects

of trial interventions or trial conduct

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and

whether the process will be independent from investigators and the

sponsor

Ethics and dissemination

Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board

(REC/IRB) approval

Protocol

amendments

25 Plans for communicating important protocol modifications (eg,

changes to eligibility criteria, outcomes, analyses) to relevant parties

(eg, investigators, REC/IRBs, trial participants, trial registries, journals,

regulators)

Consent or assent 26a Who will obtain informed consent or assent from potential trial

participants or authorised surrogates, and how (see Item 32)

26b Additional consent provisions for collection and use of participant data

and biological specimens in ancillary studies, if applicable

Confidentiality 27 How personal information about potential and enrolled participants will

be collected, shared, and maintained in order to protect confidentiality

before, during, and after the trial

Declaration of

interests

28 Financial and other competing interests for principal investigators for

the overall trial and each study site

Access to data 29 Statement of who will have access to the final trial dataset, and

disclosure of contractual agreements that limit such access for

investigators

Ancillary and

post-trial care

30 Provisions, if any, for ancillary and post-trial care, and for

compensation to those who suffer harm from trial participation

Dissemination

policy

31a Plans for investigators and sponsor to communicate trial results to

participants, healthcare professionals, the public, and other relevant

groups (eg, via publication, reporting in results databases, or other

data sharing arrangements), including any publication restrictions

31b Authorship eligibility guidelines and any intended use of professional

writers

31c Plans, if any, for granting public access to the full protocol, participant-

level dataset, and statistical code

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Appendices

Informed consent

materials

32 Model consent form and other related documentation given to

participants and authorised surrogates

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological

specimens for genetic or molecular analysis in the current trial and for

future use in ancillary studies, if applicable

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013

Explanation & Elaboration for important clarification on the items. Amendments to the

protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT

Group under the Creative Commons “Attribution-NonCommercial-NoDerivs 3.0 Unported”

license.

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Evaluating Holistic Needs Assessment in Outpatient Cancer

Care: a Randomised Controlled Trial- the study protocol.

Journal: BMJ Open

Manuscript ID: bmjopen-2014-006840.R1

Article Type: Protocol

Date Submitted by the Author: 10-Mar-2015

Complete List of Authors: Snowden, Austyn; University of the West of Scotland, Young, Jenny; University of the West of Scotland, Mental Health White, Craig; Scottish Government, Quality Unit, Health and Social Care Murray, Esther; NHS Ayrshire and Arran, Psychological Services Richard, Claude; MEDICODE, Lussier, Marie-Therese; MEDICODE, MacArthur, Ewan; University of the West of Scotland, Statistics Storey, Dawn; Beatson, West of Scotland cancer Centre, Colorectal

Schipani, Stefano; Beatson, West of Scotland cancer Centre, Head and Neck Wheatley, Duncan; Royal Cornwall Hospital, Oncology McMahon, Jeremy; The Southern General Hospital, Oncology Ross, Elaine; The Southern General Hospital, Oncology

<b>Primary Subject Heading</b>:

Oncology

Secondary Subject Heading: Communication, Evidence based practice, Patient-centred medicine, Mental health, Research methods

Keywords: ONCOLOGY, SOCIAL MEDICINE, Organisation of health services < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, MENTAL HEALTH, MEDICAL

EDUCATION & TRAINING, STATISTICS & RESEARCH METHODS


BMJ Open on S

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1

Title page

Evaluating Holistic Needs Assessment in Outpatient Cancer Care: a Randomised Controlled Trial-

the study protocol.

Austyn Snowden, Jenny Young, Craig White, Esther Murray, Claude Richard, Marie-Therese

Lussier, Ewan MacArthur, Dawn Storey, Stefano Schipani, Duncan Wheatley, Jeremy McMahon,

Elaine Ross

Professor Austyn Snowden Jenny Young

University of the West of Scotland University of the west of Scotland

Ayr Campus Paisley

Ayr Scotland

KA8 0SX

01292 886336

[email protected]

Professor Craig White Dr Esther Murray

Scottish Government Ayrshire Central Hospital

Edinburgh Irvine

Scotland Scotland

Claude Richard Marie- Thérèse Lussier

The Université du Québec à Montréal The Université du Québec à Montréal

Canada Canada

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2

Dr Ewan MacArthur Dr Dawn Storey

University of the West of Scotland The Beatson West of Scotland Cancer Centre

Paisley Glasgow

Scotland Scotland

Dr Stefano Schipani Dr Duncan Wheatley

The Beatson West of Scotland Cancer Centre Royal Cornwall Hospital

Glasgow Truro

Scotland England

Dr Jeremy McMahon Elaine Ross

The Southern General Hospital The Southern General Hospital

Glasgow Glasgow

Scotland Scotland

Key words: Oncology, Communication, Patient centred medicine, Mental health, Statistics and

research methods

Word Count: 4, 563

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ABSTRACT

Introduction

People living with and beyond cancer are vulnerable to a number of physical, functional and

psychological issues. Undertaking a Holistic needs assessment (HNA) is one way to support a

structured discussion of patients' needs within a clinical consultation. However, there is little

evidence on how HNA impacts upon the dynamics of the clinical consultation. This study aims to

establish a) how HNA affects the type of conversation that goes on during a clinical consultation and

b) how these putative changes impact on shared decision-making and self-efficacy.

Methods and Analysis

The study is hosted by ten outpatient oncology clinics in the West of Scotland and South West

England. Participants are patients with a diagnosis of head and neck, breast, urological,

gynaecological and colorectal cancer who have received treatment for their cancer. Patients are

randomised to an intervention or control group. The control group entails standard care - routine

consultation between the patient and clinician. In the intervention group the patient completes a

holistic needs assessment prior to consultation. The completed assessment is then given to the

clinician where it informs a discussion based on the patient’s needs and concerns as identified by

them.

The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and

preponderance of initiative (PI) within the consultation. The secondary outcome measures are

shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater

patient participation within the consultation and that shared decision-making and feelings of self-

efficacy will increase as a function of the intervention.

Ethics and Dissemination

This study has been given a favourable opinion by the West of Scotland Research Ethics Committee

and NHS Research & Development. Study findings will be disseminated through peer reviewed

publications and conference attendance.

Registration details- Clinical Trials.gov: NCT02274701

ARTICLE SUMMARY

Article focus

• This protocol is designed to examine the impact of holistic needs assessment on patient

participation and shared decision making within the clinical consultation and subsequent

patient reported self-efficacy.

Key messages

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• An increasing number of cancer patients are living with the effects of their diagnosis. It is

recognised at both a moral and political level that patient experience needs to improve in

order to improve satisfaction, reduce distress, offer support and save money by facilitating

self-care.

• Holistic needs assessment enables the patient to articulate needs that are personally

important. This assists the clinician with the identification of any patient distress. We

hypothesise that consultations where the HNA has informed a discussion around patient

needs there will be increased patient participation, a greater sense of shared decision

making and increased feelings of self-efficacy than treatment as usual.

• The importance of effective communication within the patient/clinician relationship is well

documented. Yet, the dynamics of interventions designed to facilitate collaboration are not

well understood. Therefore, evidence grounded in the evaluation of an intervention (HNA)

that aims to reduce unmet needs and simultaneously analyse any perceived benefits to the

quality of the clinician/patient relationship is both timely and essential.

Strengths and limitations of the study

• To our knowledge this is the first randomized controlled trial to examine the impact of HNA

on the dynamics of conversation and any subsequent impact on shared decision making and

self-efficacy.

• We are only collecting data from one consultation per patient. However, it is recommended

that HNA should be administered across the patient pathway (at diagnosis, pre-treatment,

and then post-treatment). Therefore, we are unable to comment on the impact of HNA on

the patient/clinician dynamic over time.

Title 1 Evaluating Holistic Needs Assessment in Outpatient Cancer Care: a

Randomised Controlled Trial.

Trial registration 2a Clinical Trials.gov: NCT02274701

Protocol version 3 27/5/14 V2

Funding 4 Macmillan Cancer Support UK

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5

Roles and

responsibilities

5a Austyn Snowden, Principal Investigator and lead protocol developer

Jenny Young, Research Assistant and protocol developer

Craig White, Principal Investigator and protocol developer

Esther Murray, HNA training and protocol developer

Claude Richard, MEDICODE analyst and protocol developer

Marie-Therese Lussier, MEDICODE analyst and protocol developer

Ewan MacArthur, Statistician

Dawn Storey, Consultant Oncologist and protocol developer

Stefano Schipani, Consultant Oncologist and protocol developer

Duncan Wheatley, Clinical Lead and protocol developer

Jeremy McMahon, Consultant Maxillofacial head and neck surgeon

Elaine Ross, Macmillan Head and neck Cancer Nurse Specialist


Ian Bishop, Innovation and Research office, University of the West of

Scotland, Paisley, PA1 2BE





None





Steering committee: all authors AND Noeline Young.

Data management team: AS, JY, CR, EMacA.

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INTRODUCTION

Background and rationale

There is currently a concerted political, ethical and philosophical push towards improving patient

experience and care in the UK National Health Service [1,2]. Government initiatives such as ‘Better

Cancer Care: An Action Plan’ [3] and policy guidelines such as ‘Improving supportive and palliative

care for adults with cancer’ [4] address the need to improve satisfaction, reduce distress, offer

support and save money by facilitating self-care. Improved collaboration between patient and

clinician is central to this agenda [5]. However, it is not clear how collaboration is optimised, who

should be sharing what decisions, or how this may or may not impact upon outcomes [6]. Therefore,

evidence grounded in the systematic analysis of the process and impact of collaboration is both rare

and important.

Communication in cancer care is a well-researched field. Effective communication between the

health professional and the patient is associated with improved psychological functioning of the

patient [7,8], adherence to treatment and pain control [9] and higher quality of life and satisfaction

[10]. In contrast, it has been suggested [11] that poor communication may have a number of

negative effects upon the patient and the treatment process, including the nature and quality of

information transmission, decision making and the psychosocial experience of the patient.

There are inherent methodological and philosophical challenges attached to this line of enquiry.

Most notably the idea of ‘poor’ or ‘effective’ communication is subjective, with factors such as

patient behaviour, time, resources and previous training all affecting clinician communication style

[12]. The aim of the current study is to understand more about the factors that may impact on the

quality of communication within the clinical consultation.

The intervention in this study is holistic needs assessment (HNA). HNA is a checklist completed by

the patient prior to consultation. It signposts issues of emotional, practical, financial and clinical

concern. The purpose of HNA is to identify patient’s individual needs in order to facilitate better

collaboration [13]. During consultation the HNA facilitates a dialogue that will have the patient’s

concerns at the centre. In conjunction with a subsequent care plan the process supports timely

intervention based on a collaborative, person centred discussion [13].

In order to gather pertinent data we are going to audio record clinical consultations. We recognise

that this action may have an impact in itself, potentially changing the subtle dynamics of the

consultation we intend to study. Nevertheless, this is the same for both arms of the study and a

valuable method of analysis [14]. Through detailed examination of communication patterns within

the consultation we intend to ascertain if and how a structured conversation derived from

personally identified patient needs impacts on subsequent outcomes. To our knowledge this is the

first randomized controlled trial to examine the impact of HNA on patient /clinician communication

and the subsequent impact on shared decision-making and patient reported self-efficacy.

Objectives

The objectives are to examine:

1. The impact of HNA on consultation style.

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2. The impact of HNA on shared decision making

3. The impact of HNA on patient reported self-efficacy.

In order to meet these objectives the study will test the following hypotheses:


participation


making


METHOD

Study design and setting

This protocol follows SPIRIT [15] 2013 guidelines.

It is a randomised controlled trial. The randomisation pertains to the patients within each clinic. Data

collection will occur within a post-treatment, outpatient cancer clinic. Ten clinics from the West of

Scotland and West of England will participate. The clinics care for patients with head and neck,

breast, urological, gynaecological and colorectal cancer.

Pre-consultation the patient will complete a demographic questionnaire. Those in the intervention

group will then complete a holistic needs assessment titled the ‘Concerns Checklist’ (Figure 1).

Within the control group there will be no additional intervention, care will continue as normal.

Within both groups the consultation will be audio recorded.

Post consultation the patient will complete two secondary outcome measures; CollaboRATE [5] and

The Lorig Self-efficacy scale [16]. CollaboRATE measures patient perception of shared decision-

making. One of the strengths of CollaboRATE is the ability to complete it in less than thirty seconds.

The Lorig self-efficacy scale is the optimal measure for self-reported self-efficacy in chronic disease

management according to Davies [17].

Analysis of the audio-recordings will be done by MEDICODE [18]. The MEDICODE system ascertains

the type of participation occurring within the consultation according to two main measures:

Dialogue Ratio and Preponderance of Initiative. Dialogue Ratio (DR) is assessed by coding how much

of the consultation is discussion and how much is instruction. Preponderance of Initiative (PI) is

assessed by recording which participant initiates aspects of conversation within the consultation.

These two measures (DR & PI) together give a summary score of who is talking, what about and for

how long. These measures can then be analysed alongside the secondary outcome measures.

Eligibility criteria

The study sample will be composed of patients over the age of 18. Eligible patients have undergone

treatment for their diagnosis and are attending a post-treatment clinic. Exclusion criteria includes

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those deemed incapable of consenting to participate as defined by the Adults with Incapacity

(Scotland) Act (2000) and any reason which in the opinion of the clinician/investigator interferes

with the ability of the patient to participate in the study. A sample of 156 patients will be recruited.

The clinicians who deliver and assist with the clinics (n-16) span four professional groups: Consultant

Oncologist, Cancer Nurse Specialist, Radiographer and Surgeon.

Intervention

All participating clinicians will attend a training session in the use of HNA to enhance standardisation

and concordance with the protocol. The training will be delivered by the study consultant

psychologist (EM) and will last for two hours. It will involve a variety of teaching methods including

presentation slides, interactive exercises and finishes with a DVD that provides an example of a

patient and clinician using the HNA together. There will also be an opportunity for the clinicians to

complete the HNA themselves. The aim is to equip the clinicians with the skills and confidence to

respond to the patient’s needs and concerns as identified through the assessment. These responses

may range from simply listening to the patient to referring the patient to a member of the wider

team, such as a clinical psychologist, a chaplain, financial advice or social work.

Individuals in the intervention group will be given the HNA (Concerns Checklist: Figure 1) to

complete before consultation. Each clinic has identified a quiet area where the researcher can sit

with the patient, talk through the form and then leave them to complete it. They will be asked to

hand it to their clinician when they enter the consultation room. Any actions taken by the patient or

clinician will be recorded in a care plan. A copy of the care plan will stay in patient notes, the patient

will keep a copy and a copy will be sent to any other members of the multidisciplinary team who are

involved in the patient’s care.

If at any point during this process the patient decides to withdraw they will be freely available to

without question. All patients will be informed that withdrawing from the study will not impact the

care they receive in any way.

Figure 1. The Concerns Checklist

Outcomes

Socio-demographic data: sex, age, postcode, ethnicity, relationship status, and education.

Clinical data: cancer type and stage and form of treatment received.

Clinician data: Gender, profession and years of experience.

Data will also be obtained on who is present in the consultation room. For example, the patient may

bring a family member with them.

This will allow the research team to examine what, if any impact variables such as sex, age, ethnicity,

support network, and education have on the research aims. Previous literature corroborates the

influence of these variables on distress within cancer patients [19–21].

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Primary outcome measure:

The primary outcome measure is patient participation as measured by dialogue ratio (DR) and

preponderance of initiative (PI) using the conversational coding software ‘MEDICODE’ [22].

Preponderance of Initiative (PI) measures the extent to which conversations are started by the

clinician or the patient. The whole consultation is then summarised by this measure according to

who begins most of the conversation. It generates an overall score of -1 (all clinician) to +1 (all

patient). Dialogue Ratio (DR) measures the extent to which the whole consultation consists of

monologues, dyads and discussions. It generates an overall score of 0 (monologue) to 1 (dialogue).

The output is a graphical representation of these two summary measures.

MEDICODE was constructed to measure conversations about medicine management [23] and has

not been used previously to analyse cancer consultations. However, the principles of dialogue ratio

and preponderance of initiative are transferable to any clinical consultation, and were chosen for

this study as the best way of capturing the subtle shifts in conversation hypothesised to occur.

Secondary outcome measures:

1. Shared decision making as measured by the CollaboRATE scale [5].

CollaboRATE is a survey-based validated tool [24] designed to create a fast way to measure how

much effort clinicians make to explain their patients’ health issues; how much effort they make to

listen to the issues that matter most to their patients and how much effort they make to integrate

the patients’ views and health beliefs.

2. Self-efficacy as measured by the Lorig self- efficacy scale.

The Lorig Self-Efficacy for Managing Chronic Disease 6-Item Scale post consultation encompasses

several domains common to many chronic diseases including; symptom control, role function,

emotional functioning and communicating with physicians. The scale has good internal consistency

and construct validity [17,25]. It is free and easy to use and it has been extensively used at both a

clinical and research level within this patient population [26,27]. We acknowledge that a limitation

of the tool is that it has not been widely used with all cancer types. However, it appears to be the

best generic tool for this purpose [17].

Sample size calculation

To achieve statistical significance 78 patients are needed in the experimental group and 78 into the

control. The power calculation was done on G*Power 3 [28]. It is based on the following

assumptions:

The standard setting of alpha was adjusted from 0.05 to 0.0125 to account for the four primary

endpoints [DR, PI, CollaboRATE and Lorig] [29].Power of 0.8 was assumed as sufficient to claim a

difference between groups as a consequence of the intervention. The anticipated effect size of d=0.5

is an estimate. There are no data on the specific effect of the holistic needs assessment technique

proposed here. The value of d=0.5 was arrived at by aggregating the reported effect sizes of other

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comparable psychological interventions targeted at improving psychological well-being in the cancer

population [30,31]. Reported effect sizes range from negligible (d=0.33 in older meta-analyses of

interventions to reduce anxiety in cancer patients) to large effects (d=0.77) claimed in some more

recent trials (Schou et al, 2008). Sheard & McGuire also noted that the higher quality trials tended to

produce much higher effect sizes than those of lower quality (0.63 vs. 0.24). Given that this study

proposal meets their quality criteria for a high quality trial (randomised and >40 sample size) 0.5 can

be considered a coherent and conservative effect size estimate.

Recruitment

While we plan to standardise recruitment as far as possible by selecting patients at the same point in

their treatment journey we need to account for the different pathways operating in the clinics. To

this end there are two recruitment strategies:

1. Following treatment the patient will spend time in hospital. A member of the clinical care

team will approach the patient and introduce the study. If the patient expresses an initial

interest the clinician will give the patient a study pack. This will contain a welcome letter, a

participant information sheet and a consent form.

OR

2. During treatment the patient will attend the clinic. The clinician will introduce the study to

the patient at one of their scheduled appointments and hand over a study pack.

Contact with patients will be done in person where possible. However, in exceptional circumstances

if the clinician has not made personal contact with the patient, the hospital will write to the patient

on behalf on the research team and invite them to participate. The letter will be sent in a plain

envelope to protect the patients’ privacy.

Randomisation

Blocked randomisation will be carried out by the research team, using a computer generated

sequence to ensure an almost equal number of patients within each group. Stratified randomisation

will be used to ensure that patient groups are similar with respect to prognostic factors such as age

and sex. Patients will provide written informed consent to participate before they are informed as to

which group (intervention or control) they will be in. This is to avoid potential bias from patients

who may request to be in a certain group. The randomisation sequence will be managed by the

research assistant using sealed envelopes. The coders who analyse the audio recordings will be

blind to the allocation of patients to the intervention or control group.

Data collection, management and analysis

There will be a two-week pilot. This is to test the study protocol in practice and enable the

construction of an optimal coding framework for MEDICODE. It is our intention to structure the

coding framework around the theory of holistic needs assessment, coding elements of the clinical

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conversation according to concern discussed: Physical, Practical, Family/Relationship, Emotional,

Spiritual and Lifestyle (see Figure 1). This period will allow for the testing of such a coding

framework. Changes to the protocol and coding framework will be made accordingly.

The pilot will also allow time for broader reflection. The research team will ask the clinicians to

review their training, the patients’ response to the HNA, time and ease to complete the HNA and

how their service is managing any referrals. If the pilot uncovers any deficiencies in the design this

can be reviewed with the team and addressed.

Following this phase the process is as follows. The researcher will meet the patient in the waiting

area of the clinic. The researcher will summarise the study process again, ensure the patient is happy

to continue, collect their consent form and then ask them to complete a demographic questionnaire.

While the patient is completing their demographic form the researcher will randomise the

participant into an intervention or control group. Individuals in the intervention group will be given

the HNA (Concerns Checklist Figure 1) to complete. At this stage the patient will also have the

opportunity to add their contact details should they wish to take part in future follow up interviews

to discuss their experiences of HNA (or not) and subsequent use of support services.

When the patient is called the researcher will accompany them to the consultation room and start

the recording device. The researcher will then leave the consultation room. The clinician will stop

the recording device at the end of the consultation. All patients (in both groups) will return to the

researcher post consultation and complete the Lorig self-efficacy scale and CollaboRATE. (See Figure

2 for flow chart summary). Data collection will run for 12 months.

Figure 2 –The Study Flow

Data Management

Research data and patient-related information will be managed in accordance with relevant regulatory approvals. Data analysis

The following statistical methods will be used for analysing the data:


participation

Patient participation within the consultation will be measured by the two Medicode measures:

Preponderance of Initiative (PI) and Dialogue Ratio (DR). The data will first be tested for outliers

using boxplots and for normality using combination of PP, QQ plots and Shapiro Wilk test. If

normality is found, homogeneity of variance between groups will be tested with Levene’s test.

Subsequent calculations will be based on the outcomes of these assumption tests. If normality and

homogeneity of variance are established mean PI and DR will be compared between the

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intervention and control group using t-test. If normality and/or homogeneity of variance cannot be

established, a corresponding nonparametric method will be employed.


making

Shared decision will be measured with CollaboRATE. As above the data will be tested for outliers,

normality and homogeneity of variance. If normality and homogeneity of variance are established

mean collaboRATE scores will be compared between the intervention and control group using a t-

test. If not, a corresponding nonparametric method will be employed.


Self-efficacy will be measured with the Lorig self-efficacy scale. As above the data will be tested for

outliers, normality and homogeneity of variance. If normality and homogeneity of variance are

established mean Lorig scores will be compared between the intervention and control group using a

t-test. If not, a corresponding nonparametric method will be employed.

Methods for any additional analyses

In addition, exploratory analyses will be carried out on various associations. For example,

associations will be tested between the outcome variables and demographic data. We will also test

for any potential associations between dialogue ratio and/or preponderance of initiative with

CollaboRATE and Lorig self-efficacy across the whole sample. The purpose of this is to ascertain any

potential relationships between these measures regardless of study group. For example it seems

intuitive that people who are demonstrably more involved in their consultations as evidenced by

high patient PI and DR scores would be more likely to score highly for self-efficacy and collaboration

regardless of study group.

We also plan to conduct subgroup analyses according to characteristics of the clinicians. For

example, we have information on gender, profession and years of experience. These can be used to

explore any potential trends in greater depth.

It is acknowledged that a disadvantage of randomising by patient is that the clinician will carry out

consultations with patients who are in both the intervention and control group. Therefore, ‘learning’

from the consultations where a HNA is applied may crossover into their interactions with the control

group. This would not impact on clinician ability to identify needs personal to the patient as the

patient would not have thought about this in the same manner as those completing a HNA.

Nevertheless this ‘learning’ could potentially contaminate the effect on communication between the

groups. However, since the time when HNA will be introduced into their consultations is known, we

can use this information to investigate whether there is a trend in communication efficacy through

time. Fitting a trend line to the full dataset can do this. ‘Time’ can then be used as a covariate in the

analysis to remove any confounding effect of ‘learning’.

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Missing data

Cases will be excluded listwise by default [32].

Discussion

Applying a holistic approach to patient care has many benefits [13,33]. Yet, only around 25% of

cancer survivors in the UK receive a holistic needs assessment and care plan [13]. We therefore wish

to gain a greater insight into the delivery and experience of HNA in the clinical environment. The aim

is to support evidence based implementation of HNA in the UK.

The role of communication on patient outcome has received considerable attention in the field of

cancer care. Nevertheless, to our knowledge there are no published randomised controlled trials

that focus on the patterns of communication between the patient and clinician when a holistic

needs assessment is used or not. This study has a unique focus on the relationship between

communication style, shared decision making and self-efficacy. Traditionally in the UK medical

consultations are led by the clinician but there is evidence collaboration can be facilitated by training

the clinicians in person centred care [34]. What we don’t know is whether this can also be achieved

by prioritising patients’ needs through the use of HNA. Further, we do not know whether this leads

to improve feelings of self-efficacy and a sense of shared decision making.

Perception of self-efficacy is particularly important, as it is a critical feature of chronic disease

management and can predict the success of self-management programmes among patients [35,36].

Findings from this study may pave the way for exploring the impact of HNA over time. For example

longitudinal follow up could ascertain whether there is any association between self-efficacy, self-

management and the patient’s subsequent use of the health service.

There are limitations to the study. As discussed above there is a risk of crossover learning from the

experimental to the control. We could have mitigated this using a cluster randomised trial design,

but this was not an option due to the increased number of participants required. Further, whilst

crossover learning is a risk, we do not consider it will undermine the key objectives as the main

intervention is the concerns checklist, not the skills of the clinician.

Guidance suggests that HNA should be delivered across the patient pathway, not just at the post-

treatment stage. We selected the post-treatment stage only to accommodate anticipated difficulties

around ensuring the patient sees the same clinician throughout. In practice this is not always the

case which would confound our results in this RCT. There were also pragmatic reasons. Practically

the clinics felt most able to support this study at the post-treatment stage. This is because at this

stage there would be no need for any radical changes to clinical practice. This was considered

paramount, as should we find any favourable results they are more likely to be transferable to

routine practice in future.

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Ethics and dissemination plans

This study was given a favourable opinion by the West of Scotland Research Ethics Committee

(14/WS/0126) on 3rd June 2014. NHS Research & Development approval followed on 26 August

2014. This study was also approved by the Clinical Trials Executive Committee within the Beatson

West of Scotland Cancer Centre on 13th June 2014.

Recruitment began in January 2015 and completion will occur upon reaching the necessary sample

size within each group. It is predicted it will take 12 months to reach completion. It is recognised that

as the patient's symptoms fluctuate, so may their capacity to consent. Consent will be assessed by

the clinician on the day of the study. Patients without capacity to consent will be excluded from data

collection.

The dissemination of the findings will be predominately carried out through publications in peer

reviewed journals and attendance at national and international conferences. In addition, this body of

work will be promoted by the funders of the study, Macmillan Cancer Support UK.

Figure legends:

Figure 1. The Concerns Checklist

Figure 2. The study flow.

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5 Elwyn G, Barr PJ, Grande SW, et al. Developing CollaboRATE: A fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns 2013;93:102–7. doi:10.1016/j.pec.2013.05.009

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33 Brennan J, Gingell P, Brant H, et al. Refinement of the Distress Management Problem List as the basis for a holistic therapeutic conversation among UK patients with cancer. Psychooncology 2012;21:1346–56.

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Nurs Stud 2010;47:1126–38. doi:10.1016/j.ijnurstu.2010.02.004

35 Verevkina N, Shi Y, Fuentes-Caceres VA, et al. Attrition in Chronic Disease Self-Management Programs and Self-Efficacy at Enrollment. Heal Educ Behav Published Online First: 2014. doi:10.1177/1090198114529590

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Author’s Contributions

AS, JY, CW, CR, MT & EM devised the study protocol and are all members of the steering group for

this research.

AS is principal investigator and drafted the manuscript

JY oversees the day to day organisation of the study, drafted the manuscript and is a member of the

steering group.

EMcA provided guidance on statistical analysis

DS, SS, DW, JMcM, ER drafted the manuscript

Funding

This work was supported by Macmillan Cancer Support UK.

Competing Interests

None

Ethics Approval

West of Scotland Research Ethics Committee 14/WS/0126 IRAS ref: 114947

R&D Approval - GN14ON242

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This document is copyright NCSI © 2012. Macmillan Cancer Support, registered charity in England and Wales (261017), Scotland (SC039907) and the Isle of Man (604). MAC13689

National Cancer Survivorship Initiative – Your Holistic Needs Assessement Concerns checklist0001

Patient’s name or labelLiving with and beyond cancer – identifying your concernsCompleted by:

Date:

Designation:

Contact details:

This self assessment is optional, however it will help us understand the concerns and feelings you have. It will also help us identify any information and support you may need in the future.

If any of the problems below have caused you concern in the past week and if you wish to discuss them with a health care professional, please tick the box. Leave the box blank if it doesn’t apply to you or you don’t want to discuss it now.

I have questions about my diagnosis/treatment that I would like to discuss.

Physical concerns Breathing difficulties Passing urine Constipation Diarrhoea Eating or appetite Indigestion Sore or dry mouth Nausea or vomiting Sleep problems/nightmares Tired/exhausted or fatigued Swollen tummy or limb High temperature or fever Getting around (walking) Tingling in hands/feet Pain Hot flushes/sweating Dry, itchy or sore skin Wound care after surgery Memory or concentration Taste/sight/hearing Speech problems My appearance Sexuality

Practical concerns Caring responsibilities Work and education Money or housing Insurance and travel Transport or parking Contact/communication with NHS staff Housework or shopping Washing and dressing Preparing meals/drinks

Family/relationship concerns Partner Children Other relatives/friends

Emotional concerns Difficulty making plans Loss of interest/activities Unable to express feelings Anger or frustration Guilt Hopelessness Loneliness or isolation Sadness or depression Worry, fear or anxiety

Spiritual or religious concerns Loss of faith or other spiritual concern Loss of meaning or purpose of life Not being at peace with or feeling regret about the past

Lifestyle or information needs Support groups Complementary therapies Diet and nutrition Exercise and activity Smoking Alcohol or drugs Sun protection Hobbies Other

Please mark the scale to show the overall level of concern you’ve felt over the past week.

You may also wish to score the concerns you have ticked from 1 to 10. 1 2 3 4 5 6 7 8 9 10

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Patients from identified sites are invited to participate

Exclusion criteria -‐ Under 18 -‐ Deemed incapable to consent -‐ Any reason which in the opinion of

the clinician/investigator interferes with the ability of the patient to participate in the study


• Lorig self-‐efficacy scale • CollaboRATE

Allocated to intervention group

• Patient completes demographic questionnaire

• Patient completes HNA and takes it into consultation

• Audio-‐record the consultation


• Lorig self-‐efficacy scale • CollaboRATE

Allocated to control group

• Patient completes demographic questionnaire

• Patient attends consultation as normal • Audio-‐record the consultation

• Calculate dialogue ratio (DR) and Preponderance of Initiative (PI)

• Analyse mean/median differences in: o DR o PI o Lorig self-‐efficacy o CollaboRATE

• Associations between demographics and all outcome measures

Allocation

Analysis

Post-‐consultation

Randomisation

Enrolment

Patient declines

Recruitment -‐ Clinician approaches

patient during their hospital stay or at a routine clinic during treatment

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SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and

related documents*

Section/item ItemNo

Description

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions,

and, if applicable, trial acronym

Trial registration 2a Trial identifier and registry name. If not yet registered, name of

intended registry

2b All items from the World Health Organization Trial Registration Data

Set

Protocol version 3 Date and version identifier

Funding 4 Sources and types of financial, material, and other support

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors










Introduction

Background and

rationale

6a Description of research question and justification for undertaking the

trial, including summary of relevant studies (published and

unpublished) examining benefits and harms for each intervention

6b Explanation for choice of comparators

Objectives 7 Specific objectives or hypotheses

Trial design 8 Description of trial design including type of trial (eg, parallel group,

crossover, factorial, single group), allocation ratio, and framework (eg,

superiority, equivalence, noninferiority, exploratory)

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Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital)

and list of countries where data will be collected. Reference to where

list of study sites can be obtained

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility

criteria for study centres and individuals who will perform the

interventions (eg, surgeons, psychotherapists)

Interventions 11a Interventions for each group with sufficient detail to allow replication,

including how and when they will be administered

11b Criteria for discontinuing or modifying allocated interventions for a

given trial participant (eg, drug dose change in response to harms,

participant request, or improving/worsening disease)

11c Strategies to improve adherence to intervention protocols, and any

procedures for monitoring adherence (eg, drug tablet return,

laboratory tests)

11d Relevant concomitant care and interventions that are permitted or

prohibited during the trial

Outcomes 12 Primary, secondary, and other outcomes, including the specific

measurement variable (eg, systolic blood pressure), analysis metric

(eg, change from baseline, final value, time to event), method of

aggregation (eg, median, proportion), and time point for each

outcome. Explanation of the clinical relevance of chosen efficacy and

harm outcomes is strongly recommended

Participant

timeline

13 Time schedule of enrolment, interventions (including any run-ins and

washouts), assessments, and visits for participants. A schematic

diagram is highly recommended (see Figure)

Sample size 14 Estimated number of participants needed to achieve study objectives

and how it was determined, including clinical and statistical

assumptions supporting any sample size calculations

Recruitment 15 Strategies for achieving adequate participant enrolment to reach

target sample size

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-

generated random numbers), and list of any factors for stratification.

To reduce predictability of a random sequence, details of any planned

restriction (eg, blocking) should be provided in a separate document

that is unavailable to those who enrol participants or assign

interventions

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Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central

telephone; sequentially numbered, opaque, sealed envelopes),

describing any steps to conceal the sequence until interventions are

assigned

Implementation 16c Who will generate the allocation sequence, who will enrol participants,

and who will assign participants to interventions

Blinding

(masking)

17a Who will be blinded after assignment to interventions (eg, trial

participants, care providers, outcome assessors, data analysts), and

how

17b If blinded, circumstances under which unblinding is permissible, and

procedure for revealing a participant’s allocated intervention during

the trial

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other

trial data, including any related processes to promote data quality (eg,

duplicate measurements, training of assessors) and a description of

study instruments (eg, questionnaires, laboratory tests) along with

their reliability and validity, if known. Reference to where data

collection forms can be found, if not in the protocol

18b Plans to promote participant retention and complete follow-up,

including list of any outcome data to be collected for participants who

discontinue or deviate from intervention protocols

Data

management

19 Plans for data entry, coding, security, and storage, including any

related processes to promote data quality (eg, double data entry;

range checks for data values). Reference to where details of data

management procedures can be found, if not in the protocol

Statistical

methods

20a Statistical methods for analysing primary and secondary outcomes.

Reference to where other details of the statistical analysis plan can be

found, if not in the protocol

20b Methods for any additional analyses (eg, subgroup and adjusted

analyses)

20c Definition of analysis population relating to protocol non-adherence

(eg, as randomised analysis), and any statistical methods to handle

missing data (eg, multiple imputation)

Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role

and reporting structure; statement of whether it is independent from

the sponsor and competing interests; and reference to where further

details about its charter can be found, if not in the protocol.

Alternatively, an explanation of why a DMC is not needed

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21b Description of any interim analyses and stopping guidelines, including

who will have access to these interim results and make the final

decision to terminate the trial

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and

spontaneously reported adverse events and other unintended effects

of trial interventions or trial conduct

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and

whether the process will be independent from investigators and the

sponsor

Ethics and dissemination

Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board

(REC/IRB) approval

Protocol

amendments

25 Plans for communicating important protocol modifications (eg,

changes to eligibility criteria, outcomes, analyses) to relevant parties

(eg, investigators, REC/IRBs, trial participants, trial registries, journals,

regulators)

Consent or assent 26a Who will obtain informed consent or assent from potential trial

participants or authorised surrogates, and how (see Item 32)

26b Additional consent provisions for collection and use of participant data

and biological specimens in ancillary studies, if applicable

Confidentiality 27 How personal information about potential and enrolled participants will

be collected, shared, and maintained in order to protect confidentiality

before, during, and after the trial

Declaration of

interests

28 Financial and other competing interests for principal investigators for

the overall trial and each study site

Access to data 29 Statement of who will have access to the final trial dataset, and

disclosure of contractual agreements that limit such access for

investigators

Ancillary and

post-trial care

30 Provisions, if any, for ancillary and post-trial care, and for

compensation to those who suffer harm from trial participation

Dissemination

policy

31a Plans for investigators and sponsor to communicate trial results to

participants, healthcare professionals, the public, and other relevant

groups (eg, via publication, reporting in results databases, or other

data sharing arrangements), including any publication restrictions

31b Authorship eligibility guidelines and any intended use of professional

writers

31c Plans, if any, for granting public access to the full protocol, participant-

level dataset, and statistical code

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Appendices

Informed consent

materials

32 Model consent form and other related documentation given to

participants and authorised surrogates

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological

specimens for genetic or molecular analysis in the current trial and for

future use in ancillary studies, if applicable

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013

Explanation & Elaboration for important clarification on the items. Amendments to the

protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT

Group under the Creative Commons “Attribution-NonCommercial-NoDerivs 3.0 Unported”

license.

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