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

Sponsor

Canadian Breast Cancer Research Alliance (Other)

Overall Status

Unknown status

CT.gov ID

NCT01089764

Collaborator

York University (Other), Sunnybrook Health Sciences Centre (Other), British Columbia Cancer Agency (Other), CancerCare Manitoba (Other), Queen Elizabeth II Health Sciences Centre (Other)

260

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Nov 1, 2010

Anticipated Primary Completion Date :

May 1, 2015

Anticipated Study Completion Date :

Jun 1, 2015

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

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.

Outcome Measures

Primary Outcome Measures

Revised Dyadic Adjustment Survey RDAS [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.
Dyadic Coping [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

Criteria

Ages Eligible for Study:

18 Years to 53 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	British Columbia Cancer Agency Research Centre	Vancouver	British Columbia	Canada	V5Z 1L3
2	CancerCare Manitoba	Winnipeg	Manitoba	Canada	R3E 0V9
3	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 1V7
4	York University	Toronto	Ontario	Canada	M3J1P3
5	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5