Outcomes of the breast cancer followup study

1
Follow-up after treatment for breast cancer
alternative strategies
Kinta Beaver Professor of Nursing School of
Nursing, Midwifery Social Work, University of
Manchester Central Manchester University
Hospitals NHS Foundation Trust UK
kinta.beaver_at_manchester.ac.uk
2
Overview

• Presentation 1
• History of work on information needs
• Sources of information at diagnosis beyond
• Follow-up after initial treatment
• Hospital follow-up clinics

3
Overview

• Presentation 2
• Alternative strategies for follow-up
• Nurse led telephone interventions
• Comparing telephone and hospital follow-up
• Is it better?
• Is it cheaper?

4
Follow-up

• Traditional hospital follow-up has little benefit
  for pts and HPs
• Busy hospital clinics
• Limited time to discuss concerns 6 mins
• Recurrences primarily detected as interval events
• Patients reassured by visits
• Historically based practice
• Need to consider alternative strategies

5
Alternative approaches

• General practitioner
• Minimalist
• Radiographer follow-up
• Nurse-led clinics
• Nurse-led telephone follow-up

6
General Practitioner

• Grunfeld et al (1996)
• Compared GP with hospital follow-up (RCT)
• Outcomes - time to diagnosis of recurrence,
  quality of life
• Sample - 296 women with breast cancer in
  remission receiving regular follow up care at
  district general hospitals in England.

Grunfeld et al (1996). Routine follow up of
breast cancer in primary care randomised trial.
British Medical Journal. 313665-669
7
General Practitioner

• No differences in time to detection of
  recurrences
• No differences in anxiety levels
• Most recurrences detected by women as interval
  events and present to the GP, irrespective of
  continuing hospital follow up.

Grunfeld et al (1996). Routine follow up of
breast cancer in primary care randomised trial.
British Medical Journal. 313665-669
8
General Practitioner

• Feasible and effective approach
• Follow-up remained in secondary care
• Training issues not addressed
• Resource issues not addressed

Grunfeld et al (1996). Routine follow up of
breast cancer in primary care randomised trial.
British Medical Journal. 313665-669
9
Minimalist

• Brown, Payne, Royle (2002)
• 61 women with breast cancer
• Hospital or patient initiated FU (RCT)
• Pt initiated written info on signs of
  recurrence, ring BCN if problem
• Outcomes quality of life, patient satisfaction
• No diffs between groups

Brown L, Payne S, Royle G (2002). Patient
initiated follow-up of breast cancer.
Psycho-Oncology. 11346-355
10
Minimalist

• Alternative to standard hospital follow-up
• Cost savings
• Convenient for pt initiated group
• Empowering gives responsibility back to pts
• Does not appear to have been adopted in practice
  (small study)

Brown L, Payne S, Royle G (2002). Patient
initiated follow-up of breast cancer.
Psycho-Oncology. 11346-355
11
Radiographer follow-up

• Vaile Barrett-Lee (2004)
• Cancer centre in Wales
• Annual mammography, no clinic visit
• 3 years post diagnosis/recurrence
• Not involved in clinical trial
• No evidence of metastases
• Radiographer administers health questionnaire
• Problems referred to breast team

Vaile D, Barrett-Lee P (2004). Breast cancer
follow-up a radiographer led service. Breast
Cancer Res. 6(suppl 1) P56
12
Radiographer follow-up

• Extends skills of radiographers
• Reduces burden on busy clinics
• Pts have only one appt a year
• Cost savings
• Implemented since 2003 at this location
• ? not formally evaluated

Vaile D, Barrett-Lee P (2004). Breast cancer
follow-up a radiographer led service. Breast
Cancer Res. 6(suppl 1) P56
13
Nurse-led clinics

• Baildam et al (2002)
• 525 women treated for breast cancer
• BCN vs doctor follow-up (RCT)
• 86 women psychological distress at visit 1
• BCN failed to recognise in 46
• Dr failed to recognise in 92
• Pts spent more time with BCN than Dr

Baildam et al (2002) Nurse led follow-up clinics
for women treated for primary breast cancer a
randomised controlled trial. European Journal of
Cancer. 38(suppl. 3) 136
14
Nurse-led clinics

• Those seen by BCN were more satisfied
• No differences in detection of recurrence
• Only 1 recurrence was not interval event
• Melanoma diagnosed by BCN
• Recommended as a novel model for patient
  support.

Baildam et al (2002) Nurse led follow-up clinics
for women treated for primary breast cancer a
randomised controlled trial. European Journal of
Cancer. 38(suppl. 3) 136
15
Nurse-led telephone follow-up clinics

• Nurse-led clinics
• Continuity of care
• Meeting physical psycho-social needs
• Telephone
• Triage
• Advice and support
• Counselling
• Cost effective
• Convenient

16
Nurse-led telephone interventions

• Reviewed 16 studies
• Mostly small scale
• Few RCTs (n3)
• Dated back to late 1980s

17
Overview of Studies
Non RCTS 1989-1999
18
Overview of Studies
Non RCTS 2000-2006
19
Overview of Studies
RCTS
20
Key Features

• High levels of patient satisfaction
• Promoted self management, pt centred
• Skills and knowledge of the nurses conducting the
  intervention important
• Continuity of care
• Structured nature of the intervention

21
Key Features

• Convenient for patients
• More appointments in less time
• Cost savings for health service
• Re-organisation of service from dr to nurse

22
Apply to breast cancer follow-up

• Using research findings to directly inform the
  development of an intervention
• Patient-led not health professional led
• Adapt a research instrument (INQ) for use as a
  clinical intervention guide
• Implementation of the intervention into clinical
  practice within the confines of existing
  resources (staff shortages etc).

23
Apply to breast cancer follow-up

• Compare traditional hospital follow-up to
  telephone follow-up by BCNs
• Telephone group
• Forego clinical examination
• Mammography as per hospital policy

24
Why telephone follow-up?

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

25
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

26
Telephone intervention

• Adapted from items in INQ measure
• Aimed at meeting information needs
• Shift focus from looking for recurrence to
  meeting information needs
• Administered by specialist breast care nurses
• Designed to be delivered over the telephone

27
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

28
Training

• Developed with BCN involvement
• Ownership
• Training workshops
• Amendments
• Discussions of how to respond to questions
• De-briefing sessions

29
A few hurdles

• No local hospitals prepared to host study
• Would not forego clinical examination
• Something would be missed
• Pts would find this approach unacceptable

30
Pilot work

• Add telephone follow-up to standard practice
• Acceptable to pts and HPs?
• 3 year pilot study
• 67 women in telephone group
• 68 women in control group

Beaver et al (2006).Meeting the information needs
of women with breast cancer piloting a nurse-led
intervention. European Journal of Oncology
Nursing. 10 378-90
31
Pilot work

• No diffs in psychological morbidity
• Fewer physical problems in telephone group
• Telephone group more likely to contact BCN if
  problem
• Hospital group more likely to use media sources
  if problem
• Acceptable to pts and HPs

Beaver et al (2006).Meeting the information needs
of women with breast cancer piloting a nurse-led
intervention. European Journal of Oncology
Nursing. 10 378-90
32
Comparing hospital and telephone follow-up after
treatment for breast cancer a randomised
controlled trial
Beaver et al 2009. Comparing hospital and
telephone follow-up after treatment for breast
cancer a randomised equivalence trial. British
Medical Journal. 338a3147
33
Study locations

• 2 locations
• Differences important
• Clinical reality
• Manchester breast specialist unit
• Blackpool large District General Hospital
• Both locations specialist breast care nurses
  (5, 4)
• Blackpool Nurse Consultant in breast care

34
Blackpool
35
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
• Data collection commenced March 2003

36

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

37

• Telephone FU (intervention group)
• Frequency of T appts same as hospital group
• Duration same as hospital group
• T appts conducted by BCNs
• No clinical examination
• Mammography as per hospital policy

38
Telephone Clinics

• Appointments entered on hospital computer system
• Appointment cards
• Routine investigations unaltered

39
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

40
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)

41
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)
42
Flow of participants through trial
Medical notes assessed for eligibility at 968
clinic sessions n24,362
Patients identified as routine breast cancer
follow-up n 2,542
Excluded n2169 Did not meet inclusion criteria
(n 1646) Refused consent (n255) Missed by
researchers (n172) Patient did not attend (n95)
Randomised n374
Telephone follow-up (n 191)
Hospital follow-up (n 183)
Lost to follow-up n22
Lost to follow-up n11
Returned baseline measures 91.6 Returned end
trial measures 80.6
Returned baseline measures 93.4 Returned end
trial measures 79.2
43
Psychological Morbidity

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

44
Patient satisfaction with information

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

45
Patient satisfaction with service
n
Score
46
Cost effectiveness

• Data on 561 telephone 555 hospital appts
• Telephone follow-up increased cost to health
  service (180 vs 124)
• Savings for pts (time from work, travel, parking)
• In terms of salaries, a 20-minute consultation
  with a band 8a nurse is not cheaper than a 10
  minute consultation with a junior doctor.

47
Cost effectiveness

• T appts longer (20 mins vs 10mins)
• Routine mammography requested more frequently in
  T group
• No significant differences in number of other
  tests/investigations ordered between groups
• Reduces burden on clinics

48
Recurrence
49
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).

50
Conclusions

• Specialist breast care nurses can deliver a high
  quality follow-up service over the telephone
• Shifts focus away from clinical examinations with
  little value to meeting the information needs of
  patients.
• High levels of patient satisfaction in T group
• Reduced burden on hospital outpatient clinics
• Suitable for patients with long travelling
  distances

Beaver et al 2009. Comparing hospital and
telephone follow-up after treatment for breast
cancer a randomised equivalence trial. British
Medical Journal. 338a3147
51
Implementation

• Working with BCNs
• Commitment of BCNs
• Not cheaper but better quality
• Adopted by one cancer network
• Prize money put towards training

Brian Booth Oncology Research Award. Rosemere
Cancer Foundation. 2008
52
(No Transcript)
53
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) 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 ORegan (BCN) Sr
L Thomson (BCN Practitioner) Mrs C Turner (Lead
Cancer Nurse) Sr D Tysver-Robinson (Nurse
Consultant)
Clinical Oncology Dr F Danwata (Specialist
Registrar) Dr A Hindley (Consultant Clinical
Oncologist) Dr S Susnerwala (Consultant Clinical
Oncologist)
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)