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

Breast Cancer Clinical Trial

— couplelinks  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01089764
• Other study ID #: H10-00300
• Status: Recruiting
• Phase: Phase 3
• First received: March 17, 2010
• Last updated: August 13, 2013
• Start date: November 2010
• Est. completion date: June 2015

Study information

• Verified date: August 2013
• Source: Canadian Breast Cancer Research Alliance
• Contact: Karen Fergus, PhD
• Phone: 416-480-5000
• Email: Karen.Fergus[@]sunnybrook.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 53 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Breast Cancer
• Breast Neoplasms
• Depression
• Distress

Intervention

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

Locations

Country	Name	City	State
Canada	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	York University	Toronto	Ontario
Canada	British Columbia Cancer Agency Research Centre	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (6)

Lead Sponsor	Collaborator
Canadian Breast Cancer Research Alliance	British Columbia Cancer Agency, CancerCare Manitoba, Queen Elizabeth II Health Sciences Centre, Sunnybrook Health Sciences Centre, York University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revised Dyadic Adjustment Survey RDAS	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	No
Primary	Dyadic Coping	Dyadic Coping assesses the degree to which partners feel that their coping efforts are reciprocal	T0= 0 weeks, T1= 8 weeks, T3= 3 months	No

External Links

•   Couplelinks: An online support for couples facing breast cancer