A Multisite Randomized Controlled Trial of Couplelinks.ca: The First Online Intervention for Young Women With Breast Cancer and Their Male Partners
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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.
Karen Fergus, PhD
York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)
Canada: Ethics Review Committee