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

C

Canadian Breast Cancer Research Alliance

Status and phase

Unknown
Phase 3

Conditions

Breast Cancer
Distress
Depression
Anxiety

Treatments

Behavioral: Couplelinks.ca website

Study type

Interventional

Funder types

Other

Identifiers

NCT01089764
H10-00300

Details and patient eligibility

About

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.

Full 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.

Enrollment

260 estimated patients

Sex

All

Ages

18 to 53 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

260 participants in 2 patient groups

Couplelinks.ca Intervention
Experimental group
Description:
Intervention arm - Couple participates in the Couplelinks.ca program.
Treatment:
Behavioral: Couplelinks.ca website
No Intervention
No Intervention group
Description:
Couple is waitlisted for participation in the Couplelinks.ca program.

Trial contacts and locations

5

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Central trial contact

Karen Fergus, PhD

Data sourced from clinicaltrials.gov

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