Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer (couplelinks)
Primary Purpose
Distress, Breast Cancer, Depression
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Couplelinks.ca website
Sponsored by
About this trial
This is an interventional supportive care trial for Distress focused on measuring breast neoplasm, breast cancer, behavioral intervention, online support, relationship distress, dyadic coping
Eligibility Criteria
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.
Sites / Locations
- British Columbia Cancer Agency Research CentreRecruiting
- CancerCare ManitobaRecruiting
- Queen Elizabeth II Health Sciences CentreRecruiting
- York UniversityRecruiting
- Sunnybrook Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Couplelinks.ca Intervention
No Intervention
Arm Description
Intervention arm - Couple participates in the Couplelinks.ca program.
Couple is waitlisted for participation in the Couplelinks.ca program.
Outcomes
Primary Outcome Measures
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.
Dyadic Coping
Dyadic Coping assesses the degree to which partners feel that their coping efforts are reciprocal
Secondary Outcome Measures
Full Information
NCT ID
NCT01089764
First Posted
March 17, 2010
Last Updated
August 13, 2013
Sponsor
Canadian Breast Cancer Research Alliance
Collaborators
York University, Sunnybrook Health Sciences Centre, British Columbia Cancer Agency, CancerCare Manitoba, Queen Elizabeth II Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01089764
Brief Title
Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer
Acronym
couplelinks
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 Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Canadian Breast Cancer Research Alliance
Collaborators
York University, Sunnybrook Health Sciences Centre, British Columbia Cancer Agency, CancerCare Manitoba, Queen Elizabeth II Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distress, Breast Cancer, Depression, Anxiety
Keywords
breast neoplasm, breast cancer, behavioral intervention, online support, relationship distress, dyadic coping
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Couplelinks.ca Intervention
Arm Type
Experimental
Arm Description
Intervention arm - Couple participates in the Couplelinks.ca program.
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Couple is waitlisted for participation in the Couplelinks.ca program.
Intervention Type
Behavioral
Intervention Name(s)
Couplelinks.ca website
Other Intervention Name(s)
Couplelinks.ca program
Intervention Description
Participation in the Couplelinks.ca program, an online intervention.
Primary Outcome Measure Information:
Title
Revised Dyadic Adjustment Survey RDAS
Description
The Revised Dyadic Adjustment Survey (RDAS) is a brief version of the 33 question Dyadic Adjustment Survey that assesses relationship adjustment.
Time Frame
T0= 0 weeks, T1= 8 weeks, T3= 3 months
Title
Dyadic Coping
Description
Dyadic Coping assesses the degree to which partners feel that their coping efforts are reciprocal
Time Frame
T0= 0 weeks, T1= 8 weeks, T3= 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Fergus, PhD
Phone
416-480-5000
Ext
1243
Email
Karen.Fergus@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Fergus, PhD
Organizational Affiliation
York University/Sunnybrook Health Sciences Centre (Odette Cancer Centre)
Official's Role
Principal Investigator
Facility Information:
Facility Name
British Columbia Cancer Agency Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joanne Stephen, PhD
Phone
1.800.663.3333
Ext
4960
Email
jstephen@bccancer.bc.ca
First Name & Middle Initial & Last Name & Degree
Joanne Stephen, PhD
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Taylor-Brown, MSW,RSW
Phone
204-787-2109
Email
jill.taylorbrown@cancercare.mb.ca
First Name & Middle Initial & Last Name & Degree
Jill Taylor-Brown, MSW, RSW
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah McLeod, R.N., PhD
Phone
902 473-2964
Email
deborahl.mcleod@cdha.nshealth.ca
First Name & Middle Initial & Last Name & Degree
Deborah McLeod, R.N., PhD
Facility Name
York University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J1P3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Pereira, BA
Phone
416-736-2100
Ext
44028
Email
coordinator@couplelinks.ca
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Pereira, BA
Phone
416-736-2100
Ext
44028
Email
coordinator@couplelinks.ca
12. IPD Sharing Statement
Citations:
PubMed Identifier
25630357
Citation
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.
Results Reference
derived
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Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer
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