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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Canadian Breast Cancer Research Alliance
Sponsor:
Collaborators:
York University
Sunnybrook Health Sciences Centre
British Columbia Cancer Agency
CancerCare Manitoba
Queen Elizabeth II Health Sciences Centre
Information provided by (Responsible Party):
Karen Fergus, Canadian Breast Cancer Research Alliance
ClinicalTrials.gov Identifier:
NCT01089764
First received: March 17, 2010
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Distress
Breast Cancer
Depression
Anxiety
Behavioral: Couplelinks.ca website
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trials of Couplelinks.ca: The First Online Couples Intervention for Young Women Dealing With Breast Cancer and Their Male Partners

Resource links provided by NLM:


Further study details as provided by Canadian Breast Cancer Research Alliance:

Primary Outcome Measures:
  • Revised Dyadic Adjustment Survey RDAS [ Time Frame: T0= 0 weeks, T1= 8 weeks, T3= 3 months ] [ Designated as safety issue: No ]
    The Revised Dyadic Adjustment Survey (RDAS) is a brief version of the 33 question Dyadic Adjustment Survey that assesses relationship adjustment.

  • Dyadic Coping [ Time Frame: T0= 0 weeks, T1= 8 weeks, T3= 3 months ] [ Designated as safety issue: No ]
    Dyadic Coping assesses the degree to which partners feel that their coping efforts are reciprocal


Estimated Enrollment: 260
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 53 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089764

Contacts
Contact: Karen Fergus, PhD 416-480-5000 ext 1243 Karen.Fergus@sunnybrook.ca

Locations
Canada, British Columbia
British Columbia Cancer Agency Research Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 1L3
Contact: Joanne Stephen, PhD    1.800.663.3333 ext 4960    jstephen@bccancer.bc.ca   
Principal Investigator: Joanne Stephen, PhD         
Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Contact: Jill Taylor-Brown, MSW,RSW    204-787-2109    jill.taylorbrown@cancercare.mb.ca   
Principal Investigator: Jill Taylor-Brown, MSW, RSW         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Deborah McLeod, R.N., PhD    902 473-2964    deborahl.mcleod@cdha.nshealth.ca   
Principal Investigator: Deborah McLeod, R.N., PhD         
Canada, Ontario
York University Recruiting
Toronto, Ontario, Canada, M3J1P3
Contact: Amanda Pereira, BA    416-736-2100 ext 44028    coordinator@couplelinks.ca   
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Amanda Pereira, BA    416-736-2100 ext 44028    coordinator@couplelinks.ca   
Sponsors and Collaborators
Canadian Breast Cancer Research Alliance
York University
Sunnybrook Health Sciences Centre
British Columbia Cancer Agency
CancerCare Manitoba
Queen Elizabeth II Health Sciences Centre
Investigators
Principal Investigator: Karen Fergus, PhD York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)
  More Information

Additional Information:
No publications provided

Responsible Party: Karen Fergus, PhD, Canadian Breast Cancer Research Alliance
ClinicalTrials.gov Identifier: NCT01089764     History of Changes
Other Study ID Numbers: H10-00300
Study First Received: March 17, 2010
Last Updated: August 13, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Canadian Breast Cancer Research Alliance:
breast neoplasm
breast cancer
behavioral intervention
online support
relationship distress
dyadic coping

Additional relevant MeSH terms:
Anxiety Disorders
Breast Neoplasms
Depression
Depressive Disorder
Mental Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 20, 2014