We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01089764
Recruitment Status : Unknown
Verified August 2013 by Karen Fergus, Canadian Breast Cancer Research Alliance.
Recruitment status was:  Recruiting
First Posted : March 19, 2010
Last Update Posted : August 14, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Distress Breast Cancer Depression Anxiety Behavioral: Couplelinks.ca website Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2010
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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 Name: Couplelinks.ca program
No Intervention: No Intervention
Couple is waitlisted for participation in the Couplelinks.ca program.


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 53 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karen Fergus, PhD, Canadian Breast Cancer Research Alliance
ClinicalTrials.gov Identifier: NCT01089764     History of Changes
Other Study ID Numbers: H10-00300
First Posted: March 19, 2010    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases