Recruiting
Phase 3

Couplelinks.ca

Sponsor:

Canadian Breast Cancer Research Alliance

Code:

NCT01089764

Conditions

Distress

Breast Cancer

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 18 - 53

Healthy Volunteers: Accepted

Interventions

Couplelinks.ca website

Study Details

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.

Conditions

Distress

Breast Cancer

Depression

Anxiety

Study ID

NCT01089764

Start date

Nov, 2010

Status verified date

Aug, 2013

Completion date

Jun, 2015

Anticipated

Primary completion date

May, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 53

Healthy Volunteers: Accepted

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

Enrollment

260 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Couplelinks.ca Intervention

Intervention arm - Couple participates in the Couplelinks.ca program.

no intervention: No Intervention

Couple is waitlisted for participation in the Couplelinks.ca program.

Interventions

Couplelinks.ca website

Participation in the Couplelinks.ca program, an online intervention.

Primary outcome measure

  • Revised Dyadic Adjustment Survey RDAS [ Time Frame: T0= 0 weeks, T1= 8 weeks, T3= 3 months ]
  • Dyadic Coping [ Time Frame: T0= 0 weeks, T1= 8 weeks, T3= 3 months ]

Central Contacts and Locations

Central contacts

Locations

British Columbia Cancer Agency Research Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1L3

Contacts

Principal Investigator:

Joanne Stephen, PhD

CancerCare Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0V9

Contacts

Principal Investigator:

Jill Taylor-Brown, MSW, RSW

Queen Elizabeth II Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 1V7

Contacts

Principal Investigator:

Deborah McLeod, R.N., PhD

York University

Recruiting

Toronto, Ontario, Canada, M3J1P3

Contacts

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

More Information

Sponsor

Canadian Breast Cancer Research Alliance

Last update posted

Aug 14, 2013

Last verified

Aug, 2013

Keywords

  • breast neoplasm
  • breast cancer
  • behavioral intervention
  • online support
  • relationship distress
  • dyadic coping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Breast Cancer Research Alliance on 2013-08-14.