Breast Cancer survivorship Cancer Breast Cancer
Conditions
Interventions
We will conduct a pragmatic multi-centre Randomised Controlled Trial (RCT) with patients who have completed intensive treatment for breast cancer and are ready for transition from specialist care to r
Sponsors
Canadian Breast Cancer Research Alliance/National Cancer Institute of Canada
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women diagnosed with invasive breast cancer 2. Stage I, II, or IIIa having completed primary treatment 3. There is no evidence of recurrence; and 4. Patient's surgeon agrees to transfer follow-up care to the Family Practitioner (FP)
Exclusion criteria
Exclusion criteria: 1. Primary treatment (surgery, chemotherapy, radiotherapy) not completed at least three months previously, except for continued use of tamoxifen or an aromatase inhibitor 2. On herceptin or a potential candidate for herceptin (patients will become eligible following completion of herceptin therapy if ready for transition to primary care for routine follow-up) 3. Under investigation for possible recurrence (patients will become eligible if recurrence is ruled out) 4. Does not have a community-based FP to provide care (we will monitor the frequency with which patients are excluded because of this factor) 5. The patients' FP already has a patient enrolled in the trial (to avoid contamination) 6. Unable to comply with study protocol including completion of questionnaires 7. Previously enrolled in a study requiring ongoing follow-up by a cancer specialist; or 8. Actively followed by a cancer specialist for another primary cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the specific Health-Related Quality of Life (HRQoL) domain of adjustment to breast cancer at 12 months using the Impact of Events Scale (IES). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes will be: 1. Adjustment at 24 months, using other HRQL domains (including the Profile Of Moods States [POMS], the Short Form health survey [SF-36], Medical Outcomes Study [MOS], Patient Satisfaction Questionnaire 18 [PSQ 18], patient perceived preparedness for follow-up care using two questions used by Stanton and Ganz) 2. Health service outcomes include: a. guideline adherence as measured by an index of the manoeuvres recommended b. the extent to which patients in both arms will decline transfer to the FP c. the extent to which patients return to the cancer centre for routine follow-up d. follow-up visits with multiple practitioners (e.g., surgical, medical, radiation oncologist) for routine follow-up care e. return visit to the cancer centre for Aromatase Inhibitors (AIs) according to oncologist's recommendation f. continuity of care by using the Continuity and Coordination of Care Questionnaire which covers the key constructs relevant to continuity of care g. the awareness of which physician is responsible for follow-up care | — |
Countries
Canada
Outcome results
None listed