Condition category
Cancer
Date applied
12/12/2006
Date assigned
05/03/2007
Last edited
16/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eva Grunfeld

ORCID ID

Contact details

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

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 measures

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

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 Allicance/National Institute of Canada (Canada)

Sponsor details

10 Alcorn Avenue
Suite 200
Toronto
M4V 3B1
Canada

Sponsor type

Charity

Website

http://www.ncic.cancer.ca

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24326740

Publication citations

Additional files

Editorial Notes