- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089764
Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer (couplelinks)
A Randomized Controlled Trials of Couplelinks.ca: The First Online Couples Intervention for Young Women Dealing With Breast Cancer and Their Male Partners
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Couplelinks.ca is a custom-designed website offering a professionally facilitated, couple-centred intervention that entails informational, experiential, and interactive components. Six Dyadic Learning Modules (DLM) form the core of the program and are undertaken on a weekly basis.
A funded pilot study examining the feasibility and benefit of Couplelinks.ca utilized a non-randomized, pre-post test design to assess the process and outcomes of the intervention. Qualitative feedback also informed the evaluation. Preliminary findings were promising and provided justification for further evaluation of the program's effectiveness.
The current study is the next logical step: a larger-scale Phase III study to determine whether this BC-specific, relationship-enhancement program leads to improved relationship and psychological outcomes for young couples affected by BC. It is a randomized controlled trial (RCT) comparing level of distress and dyadic adjustment in couples who have participated in the Couplelinks.ca educational program to those who have not participated and were instead put on a wait-list for participation.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Karen Fergus, PhD
- Phone Number: 1243 416-480-5000
- Email: Karen.Fergus@sunnybrook.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1L3
- Recruiting
- British Columbia Cancer Agency Research Centre
-
Contact:
- Joanne Stephen, PhD
- Phone Number: 4960 1.800.663.3333
- Email: jstephen@bccancer.bc.ca
-
Principal Investigator:
- Joanne Stephen, PhD
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0V9
- Recruiting
- CancerCare Manitoba
-
Contact:
- Jill Taylor-Brown, MSW,RSW
- Phone Number: 204-787-2109
- Email: jill.taylorbrown@cancercare.mb.ca
-
Principal Investigator:
- Jill Taylor-Brown, MSW, RSW
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 1V7
- Recruiting
- Queen Elizabeth II Health Sciences Centre
-
Contact:
- Deborah McLeod, R.N., PhD
- Phone Number: 902 473-2964
- Email: deborahl.mcleod@cdha.nshealth.ca
-
Principal Investigator:
- Deborah McLeod, R.N., PhD
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Health Sciences Centre
-
Contact:
- Amanda Pereira, BA
- Phone Number: 44028 416-736-2100
- Email: coordinator@couplelinks.ca
-
Toronto, Ontario, Canada, M3J1P3
- Recruiting
- York University
-
Contact:
- Amanda Pereira, BA
- Phone Number: 44028 416-736-2100
- Email: coordinator@couplelinks.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- couples where woman has received a diagnosis of nonmetastatic breast carcinoma;
- diagnosis was within the last 36 months;
- woman is age less than or equal to 50 at age of diagnosis;
- completed or are nearing the end of active treatment;
- couples must be in a committed, heterosexual relationship;
- fluent in English with the ability to read and write in English.
Exclusion Criteria:
- non-heterosexual couples;
- women older than 50;
- previous diagnosis of moderate to severe psychological problems that may interfere with capacity to benefit from the intervention;
- couples who plan to participate in couple counselling during the 5-month study duration.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Couplelinks.ca Intervention
Intervention arm - Couple participates in the Couplelinks.ca
program.
|
Participation in the Couplelinks.ca
program, an online intervention.
Other Names:
|
No Intervention: No Intervention
Couple is waitlisted for participation in the Couplelinks.ca
program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Dyadic Adjustment Survey RDAS
Time Frame: T0= 0 weeks, T1= 8 weeks, T3= 3 months
|
The Revised Dyadic Adjustment Survey (RDAS) is a brief version of the 33 question Dyadic Adjustment Survey that assesses relationship adjustment.
|
T0= 0 weeks, T1= 8 weeks, T3= 3 months
|
Dyadic Coping
Time Frame: T0= 0 weeks, T1= 8 weeks, T3= 3 months
|
Dyadic Coping assesses the degree to which partners feel that their coping efforts are reciprocal
|
T0= 0 weeks, T1= 8 weeks, T3= 3 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Karen Fergus, PhD, York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H10-00300
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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