Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer (couplelinks)
Women diagnosed with breast cancer (BC) at or before the age of 40 experience more distress and poorer quality of life than women diagnosed later in life. Although adequate spousal support is a protective factor for women with BC, spouses are often unprepared to handle the myriad practical and emotional demands posed by the illness. Furthermore, despite the growing number of recommendations for couples interventions in relation to BC, traditional counselling approaches may fail to meet the needs of young couples who have unique concerns and tight constraints on their time. The proposed project addresses the void in the psycho-social support available to young couples via an innovative, online psychoeducational intervention tailored specifically to their needs.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Multisite Randomized Controlled Trial of Couplelinks.ca: The First Online Intervention for Young Women With Breast Cancer and Their Male Partners|
- Reduced distress [ Time Frame: 1 year ] [ Designated as safety issue: No ]Women and their male partners who participate in the Couplelinks program may demonstrate significant improvement on measures of relationship adjustment, mutuality, and intimacy as compared to couples assigned to a wait-list control condition; and that, participants in the treatment condition wmay also demonstrate significant improvement on measures of psychological distress and adjustment as compared to participants in the control condition.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Couplelinks.ca Intervention
Intervention arm - Couple participates in the Couplelinks.ca program.
Behavioral: Couplelinks.ca website
Participation in the Couplelinks.ca program, an online intervention.
Other Name: Couplelinks.ca program
No Intervention: No Intervention
Couple is waitlisted for participation in the Couplelinks.ca program.
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.
|Contact: Karen Fergus, PhD||416-480-5000 ext 1243||Karen.Fergus@sunnybrook.ca|
|Canada, British Columbia|
|British Columbia Cancer Agency Research Centre||Not yet recruiting|
|Vancouver, British Columbia, Canada, V5Z 1L3|
|Contact: Kate MacGregor, MPH firstname.lastname@example.org|
|Canada, Nova Scotia|
|Queen Elizabeth II Health Sciences Centre||Not yet recruiting|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Contact: Deborah McLeod, PhD|
|York University||Not yet recruiting|
|Toronto, Ontario, Canada, M3J1P3|
|Contact: Larisa Stankovich, MSc 416-736-2100 ext 44028 email@example.com|
|Sunnybrook Health Sciences Centre||Not yet recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Larisa Stankovich, MSc 416-736-2100 firstname.lastname@example.org|
|Principal Investigator:||Karen Fergus, PhD||York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)|