Clinical trial NCT01089764: Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Distress
Breast Cancer
Depression
Anxiety
Keywords: breast neoplasm
breast cancer
behavioral intervention
online support
relationship distress
dyadic coping
Lead sponsor: Canadian Breast Cancer Research Alliance
Sponsor class: OTHER
Collaborators: name: York University
name: Sunnybrook Health Sciences Centre
name: British Columbia Cancer Agency
name: CancerCare Manitoba
name: Queen Elizabeth II Health Sciences Centre
First posted: 2010-03-19
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: Revised Dyadic Adjustment Survey RDAS
timeFrame: T0= 0 weeks, T1= 8 weeks, T3= 3 months
measure: Dyadic Coping
timeFrame: T0= 0 weeks, T1= 8 weeks, T3= 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency Research Centre
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: York University
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)
name: Karen Fergus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fergus K, Ahmad S, McLeod DL, Stephen J, Gardner S, Pereira A, Warner E, Carter W. Couplelinks - an online intervention for young women with breast cancer and their male partners: study protocol for a randomized controlled trial. Trials. 2015 Jan 29;16:33. doi: 10.1186/s13063-014-0534-8.