A randomised trial of a patient-centred strategy to facilitate transition of breast cancer survivors' routine Follow-UP from specialist to primary care

ISRCTN	ISRCTN86567908
DOI	https://doi.org/10.1186/ISRCTN86567908
Protocol serial number	01
Sponsor	Canadian Breast Cancer Research Alliance/National Cancer Institute of Canada
Funder	Canadian Breast Cancer Research Alliance/National Institute of Canada (Canada)

Submission date: 12/12/2006
Registration date: 05/03/2007
Last edited: 07/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eva Grunfeld
Scientific

Cancer Care Nova Scotia
1278 Tower Road, 5th Floor
Bethune Building, Rm 526
Halifax
B3H 2Y9
Canada

Study information

Primary study design	Interventional
Study design	A pragmatic multi-centre Randomised Controlled Trial (RCT).
Secondary study design	Randomised controlled trial
Scientific title	A randomised trial of a patient-centred strategy to facilitate transition of breast cancer survivors' routine Follow-UP from specialist to primary care
Study acronym	FUP II
Study objectives	Our hypotheses are that Health Related Quality of Life (HRQoL) and patient satisfaction will be positively affected by the intervention to 12 months post-randomisation, and that health service outcomes will be positively affected to 24 months.
Ethics approval(s)	In progress. 1/8 clinical centres has received ethics as of 12th December 2006.
Health condition(s) or problem(s) studied	Breast Cancer survivorship
Intervention	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 routine follow-up in primary care. Patients will be randomised to receive usual care or to receive the intervention. Patients will be followed for 24 months. The trial will involve centres in Nova Scotia, Quebec, Ontario and Alberta (eight clinical centres). An economic evaluation and a knowledge translation sub-study will be conducted alongside the clinical trial. The focus of the intervention is to facilitate the patient's transition from specialist care to follow-up by their FP. The intervention will be as consistent with usual practice as possible, so as to be generalisable to specialist cancer clinics and primary care settings in Canada. The intervention will be tailored to the specific patient and will include specially developed user friendly versions of a guideline on follow-up care both for the patient and for the FP, a follow-up care plan, an educational session with a nurse, and a supportive care resource kit.
Intervention type	Other
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	400
Key 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)
Key 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
Date of first enrolment	10/01/2006
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

Canada

Study participating centre

Cancer Care Nova Scotia

Halifax
B3H 2Y9
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2014		Yes	No

Editorial Notes

07/01/2020: Internal review.