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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01089764
Other study ID # H10-00300
Secondary ID
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


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
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