Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01
Study information
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
Acronym
FUP II
Study hypothesis
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
In progress. 1/8 clinical centres has received ethics as of 12th December 2006.
Study design
A pragmatic multi-centre Randomised Controlled Trial (RCT).
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
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
Overall trial start date
10/01/2006
Overall trial end date
30/06/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Not Specified
Gender
Female
Target number of participants
400
Participant 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
Recruitment start date
10/01/2006
Recruitment end date
30/06/2010
Locations
Countries of recruitment
Canada
Trial participating centre
Cancer Care Nova Scotia
Halifax
B3H 2Y9
Canada
Sponsor information
Organisation
Canadian Breast Cancer Research Alliance/National Cancer Institute of Canada
Sponsor details
10 Alcorn Avenue
Suite 200
Toronto
M4V 3B1
Canada
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Canadian Breast Cancer Research Alliance/National Institute of Canada (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24326740