Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer
couplelinks
A Randomized Controlled Trials of Couplelinks.ca: The First Online Couples Intervention for Young Women Dealing With Breast Cancer and Their Male Partners
1 other identifier
interventional
260
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2010
Longer than P75 for phase_3
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
March 19, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedAugust 14, 2013
August 1, 2013
4.5 years
March 17, 2010
August 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Couplelinks.ca Intervention
EXPERIMENTALIntervention arm - Couple participates in the Couplelinks.ca program.
No Intervention
NO INTERVENTIONCouple is waitlisted for participation in the Couplelinks.ca program.
Interventions
Participation in the Couplelinks.ca program, an online intervention.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Canadian Breast Cancer Research Alliancelead
- York Universitycollaborator
- Sunnybrook Health Sciences Centrecollaborator
- British Columbia Cancer Agencycollaborator
- CancerCare Manitobacollaborator
- Queen Elizabeth II Health Sciences Centrecollaborator
Study Sites (5)
British Columbia Cancer Agency Research Centre
Vancouver, British Columbia, V5Z 1L3, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7, Canada
York University
Toronto, Ontario, M3J1P3, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (1)
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.
PMID: 25630357DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Fergus, PhD
York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 17, 2010
First Posted
March 19, 2010
Study Start
November 1, 2010
Primary Completion
May 1, 2015
Study Completion
June 1, 2015
Last Updated
August 14, 2013
Record last verified: 2013-08