Outcomes of the breast cancer follow-up study

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
[email protected]
Why bother?
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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
Comparison
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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)
Standard Practice (control group)
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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)
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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?
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Convenient for patients
 No long waiting times in clinic
 No parking problems
 No travelling, own home (saves money)
Why specialist nurses?
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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
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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
Giving the telephone appointments credibility
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Telephone clinics
Telephone appointments (appointment cards)
Appointments entered on Hospital Information
System
Inclusion criteria
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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
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Psychological morbidity
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Patient satisfaction with information
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Rating scale - very satisfied to very unsatisfied
Patient satisfaction with service
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STAI - 20 items, 4 point scale, range 20-80
GHQ-12 - 12 items, 4 point scale, range 0-12
Rating scale 1- 10 (higher scores = higher levels
of satisfaction)
Cost effectiveness
Time to detection of recurrence (days)
Sample Size
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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 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)
Lost to follow-up: n=22
Returned baseline measures 91.6%
Returned end trial measures 80.6%
Hospital follow-up (n= 183)
Lost to follow-up: n=11
Returned baseline measures 93.4%
Returned end trial measures 79.2%
Psychological Morbidity
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Differences between groups were not statistically
significant at baseline, mid or end-trial
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Equivalence demonstrated
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Telephone group were not more anxious
Patient satisfaction with information given
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Telephone group significantly more
satisfied at mid and end-trial (p < 0.001)
Patient satisfaction with follow-up service
80
70
60
50
n
Hospital
Telephone
40
30
20
10
0
1
2
3
4
5
6
Score
7
8
9 10
Cost effectiveness
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Data on 561 telephone appointments and 555 hospital
appointments
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No significant differences in number of tests/investigations
ordered between groups
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No differences in contacts with other health professionals
e.g. GP
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Telephone FU was not a cheaper option in terms of NHS
savings.
Recurrence
Hospital
Telephone
p
Local
4
4
p=0.34
Distant metastases
2
7
Yes
2
6
No
4
5
Pt contacted GP
3
6
Pt phoned BCN with problem
1
1
Pt presented symptoms to BCN during routine
appt
0
2
Routine mammogram
2
2
Routine, symptomatic
0
2
Interval, symptomatic
4
7
Interval, routine mammogram
2
2
Totals
6
11
Type of recurrence
Pt died (breast cancer related)
p=0.62
Presentation:
p=0.89
Routine/interval visit
p=0.79
Time to detection of recurrence
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Median time to confirmation:
 Hospital:
60 days (range 37 to 131)
 Telephone: 39 days (range 10 to 152)
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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).
Conclusions
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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
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: 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)
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Mr A Baildam (Consultant Surgeon)
Mr L Barr (Consultant Surgeon)
Professor N Bundred (Consultant
Surgeon)
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Mr P Kiriparan (Consultant Surgeon)
Mr ME Lambert (Consultant Surgeon)
Mr S Rajan (Consultant Surgeon)
Clinical: Oncology
Dr F Danwata (Specialist Registrar)
Dr A Hindley (Consultant Clinical Oncologist)
Dr S Susnerwala (Consultant Clinical
Oncologist)
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