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

August 13, 2013 updated by: Karen Fergus, Canadian Breast Cancer Research Alliance

A Randomized Controlled Trials of Couplelinks.ca: The First Online Couples Intervention for Young Women Dealing With Breast Cancer and Their Male Partners

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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L3
        • Recruiting
        • British Columbia Cancer Agency Research Centre
        • Contact:
        • Principal Investigator:
          • Joanne Stephen, PhD
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Recruiting
        • CancerCare Manitoba
        • Contact:
        • Principal Investigator:
          • Jill Taylor-Brown, MSW, RSW
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Recruiting
        • Queen Elizabeth II Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Deborah McLeod, R.N., PhD
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Contact:
      • Toronto, Ontario, Canada, M3J1P3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 53 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Behavioral: Couplelinks.ca website
Participation in the Couplelinks.ca program, an online intervention.
Other Names:
  • Couplelinks.ca program
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

This is where you will find people and organizations involved with this study.

Sponsor

Canadian Breast Cancer Research Alliance

Collaborators

Sunnybrook Health Sciences Centre
British Columbia Cancer Agency
York University
Queen Elizabeth II Health Sciences Centre
CancerCare Manitoba

Investigators

  • Principal Investigator: Karen Fergus, PhD, York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (Estimate)

March 19, 2010

Study Record Updates

Last Update Posted (Estimate)

August 14, 2013

Last Update Submitted That Met QC Criteria

August 13, 2013

Last Verified

August 1, 2013

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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