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Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer

Phase 3
Conditions
Distress
Breast Cancer
Depression
Anxiety
Interventions
Behavioral: Couplelinks.ca website
Registration Number
NCT01089764
Lead Sponsor
Canadian Breast Cancer Research Alliance
Brief Summary

Women diagnosed with breast cancer (BC) at or before the age of 50 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 couple 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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
260
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Couplelinks.ca InterventionCouplelinks.ca websiteIntervention arm - Couple participates in the Couplelinks.ca program.
Primary Outcome Measures
NameTimeMethod
Revised Dyadic Adjustment Survey RDAST0= 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.

Dyadic CopingT0= 0 weeks, T1= 8 weeks, T3= 3 months

Dyadic Coping assesses the degree to which partners feel that their coping efforts are reciprocal

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (5)

CancerCare Manitoba

🇨🇦

Winnipeg, Manitoba, Canada

Sunnybrook Health Sciences Centre

🇨🇦

Toronto, Ontario, Canada

British Columbia Cancer Agency Research Centre

🇨🇦

Vancouver, British Columbia, Canada

York University

🇨🇦

Toronto, Ontario, Canada

Queen Elizabeth II Health Sciences Centre

🇨🇦

Halifax, Nova Scotia, Canada

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