Comparing hospital and telephone follow-

up after treatment for breast cancer: a

randomised controlled trial

Kinta BeaverProfessor of Nursing

University of Manchester, UK

NCRN Trial ID 1477 kinta.beaver@manchester.ac.uk

Why bother?

The way in which hospital follow-up is conducted at present in the UK has little benefit for patients and health professionals

Aim to detect recurrence but routine clinical examination rarely detects recurrence in asymptomatic patients

Recurrence detected – patient report, mammography

Increasing number of routine follow-up patients – screening extended

Standard practice (hospital follow-up)

with New intervention (telephone follow-up by specialist

breast care nurses)

Patients randomised to Hospital or Telephone Two centre study (Northwest England)

Comparison

Standard Practice (control group) Routine hospital visits Regular but decreasing intervals Duration 3-10 years (current guidelines 3yrs) Patients often seen by junior doctor In UK increase in nurse led clinics

Telephone follow-up (new Intervention) Shift in focus from searching for recurrence to

providing information and support Structured (specific questions); allows for repetition of

information Uses and develops the skills of BCN’s (7 nurses

trained to deliver intervention) Developed from previous work on information needs

of women with breast cancer (patient led)

Why telephone follow-up?

Convenient for patients No long waiting times in clinic No parking problems No travelling, own home (saves money)

Why specialist nurses?

Specialist knowledge and expertise Meeting physical & psycho-social needs

histology, genetic risk, side effects, breast reconstruction, breast prosthesis, body image issues

Appropriate referrals lymphoedema, GP, surgeon, oncologist, psychologist

Written information Continuity of care

Telephone Intervention Previous issues Any changes? Information about spread of disease Information about treatments and side

effects Information about genetic risk Information about sexual attractiveness Information about caring for self Concerns about how family are coping Anything else? Mammograms (request if necessary) Next Appointment

Practicalities

Telephone clinics Telephone appointments (appointment cards) Appointments entered on Hospital Information

System

Giving the telephone appointments credibility

Inclusion criteria

Known diagnosis of breast cancer Completed treatment (surgery, radiotherapy,

chemotherapy) No evidence of local/regional recurrence or metastatic

disease Attending outpatient clinics for the purposes of

surveillance Defined as low/moderate risk of recurrence Not taking part in any other clinical trial Access to a telephone Hearing acceptable

Outcomes

Psychological morbidity STAI - 20 items, 4 point scale, range 20-80 GHQ-12 - 12 items, 4 point scale, range 0-12

Patient satisfaction with information Rating scale - very satisfied to very unsatisfied

Patient satisfaction with service Rating scale 1- 10 (higher scores = higher levels

of satisfaction) Cost effectiveness Time to detection of recurrence (days)

Sample Size

Study powered on psychological morbidity for equivalence

Aimed to demonstrate that telephone group no more anxious as a result of foregoing clinical examination and face to face contact

Target sample size – 324 (162 in each group)

Flow of participants through trialMedical notes assessed for eligibility at 968 clinic sessions n=24,362

Patients identified as routine breast cancer follow-up n= 2,542

Excluded n=2169 Did not meet inclusion criteria (n= 1646)Refused consent (n=255)Missed by researchers (n=172)Patient did not attend (n=95)

Randomised n=374

Telephone follow-up (n= 191) Hospital follow-up (n= 183)

Lost to follow-up: n=22 Lost to follow-up: n=11

Returned baseline measures 91.6%Returned end trial measures 80.6%

Returned baseline measures 93.4%Returned end trial measures 79.2%

Psychological Morbidity

Differences between groups were not statistically significant at baseline, mid or end-trial

Equivalence demonstrated

Telephone group were not more anxious

Patient satisfaction with information given

Telephone group significantly more satisfied at mid and end-trial (p < 0.001)

Patient satisfaction with follow-up service

0

10

20

30

40

50

60

70

80

1 2 3 4 5 6 7 8 9 10

HospitalTelephone

Score

n

Cost effectiveness

Data on 561 telephone appointments and 555 hospital appointments

No significant differences in number of tests/investigations ordered between groups

No differences in contacts with other health professionals e.g. GP

Telephone FU was not a cheaper option in terms of NHS Telephone FU was not a cheaper option in terms of NHS savings. savings.

Hospital Telephone p

Type of recurrence

Local 4 4 p=0.34

Distant metastases 2 7

Pt died (breast cancer related)

Yes 2 6 p=0.62

No 4 5

Presentation:

Pt contacted GP 3 6 p=0.89

Pt phoned BCN with problem 1 1

Pt presented symptoms to BCN during routine appt

0 2

Routine mammogram 2 2

Routine/interval visit

Routine, symptomatic 0 2 p=0.79

Interval, symptomatic 4 7

Interval, routine mammogram 2 2

Totals 6 11

Recurrence

Time to detection of recurrence

Median time to confirmation: Hospital: 60 days (range 37 to 131) Telephone: 39 days (range 10 to 152)

This apparently large difference between groups, at least in terms of the medians, was not statistically significant (Mann-Whitney U = 21.0, p = 0.228).

ConclusionsConclusions Specialist nurses can deliver a high quality

follow-up service over the telephone Shifts focus away from clinical examinations with

limited value to meeting the information needs of patients.

High levels of patient satisfaction in T group Reduced burden on hospital outpatient clinics Savings for patients (money, time) Suitable for patients with long travelling

distances

Beaver et al (2009). Comparing hospital and telephone follow-up after treatment for breast cancer: randomised equivalence trial. British Medical Journal. 338; a3147

Colleagues

Clinical: NursingSr L Bracegirdle (BCN)Sr J Faraut (OPD Manager)S/N S Foster (Nurse Researcher)Sr S Greer (Oncology Unit Manager)Sr M Noblet (BCN Practitioner)Sr F O’Regan (BCN)Sr L Thomson (BCN Practitioner)Mrs C Turner (Lead Cancer Nurse)Sr D Tysver-Robinson (Nurse Consultant)

AcademicDr M Campbell (Lecturer in Statistics)Professor G Dunn (Professor of Biomedical Statistics)Dr W Hollingworth (Health Economist) Professor K Luker (Professor of Nursing)Dr R McDonald (Senior Research Fellow/)Ms M Twomey (Research Associate)Dr S Williamson (Research Fellow)

Clinical: SurgeryMr A Baildam (Consultant Surgeon)Mr L Barr (Consultant Surgeon)Professor N Bundred (Consultant Surgeon)Mr G Byrne (Consultant Surgeon)Mr P Kiriparan (Consultant Surgeon)Mr ME Lambert (Consultant Surgeon)Mr S Rajan (Consultant Surgeon)

Clinical: OncologyDr F Danwata (Specialist Registrar)Dr A Hindley (Consultant Clinical Oncologist)Dr S Susnerwala (Consultant Clinical Oncologist)

Admin: Medical RecordsMs N Billington (Medical Records Clerk)Ms A Bowes (Medical Records Clerk)

Admin: SecretarialMrs J Linihan (Secretary) Mrs S Tizini (Secretary)