Comparing hospital and telephone follow-up after treatment for breast cancer: a randomised controlled trial

1. Comparing hospital and telephone follow-up after treatment for breast cancer: a randomised controlled trial Kinta Beaver Professor of Nursing University of Manchester, UK NCRN Trial ID 1477 kinta.beaver@manchester.ac.uk

2. 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

3. Comparison • 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)

4. 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

5. 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)

6. Why telephone follow-up? • Convenient for patients • No long waiting times in clinic • No parking problems • No travelling, own home (saves money)

7. 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

8. 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

9. Practicalities • Telephone clinics • Telephone appointments (appointment cards) • Appointments entered on Hospital Information System Giving the telephone appointments credibility

10. 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

11. 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)

12. 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)

13. Flow of participants through trial Medical 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%

14. Psychological Morbidity • Differences between groups were not statistically significant at baseline, mid or end-trial • Equivalence demonstrated • Telephone group were not more anxious

15. Patient satisfaction with information given • Telephone group significantly more satisfied at mid and end-trial (p < 0.001)

16. Patient satisfaction with follow-up service n Score

17. 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 savings.

18. Recurrence

19. 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).

20. Conclusions • 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

21. Colleagues • Clinical: Surgery • Mr 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) • Academic • Dr 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: Oncology • Dr F Danwata (Specialist Registrar) • Dr A Hindley (Consultant Clinical Oncologist) • Dr S Susnerwala (Consultant Clinical Oncologist) • Clinical: Nursing • Sr 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) Admin: Medical Records Ms N Billington (Medical Records Clerk) Ms A Bowes (Medical Records Clerk) Admin: Secretarial Mrs J Linihan (Secretary) Mrs S Tizini (Secretary)