Ignite Creation Date:
2024-05-05 @ 10:20 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01089764
Status:
UNKNOWN
Last Update Posted:
2013-08-14
First Post:
2010-03-17
Brief Title:
Couplelinksca - An Online Intervention for Couples Affected by Breast Cancer
Sponsor:
Canadian Breast Cancer Research Alliance
Organization:
Canadian Breast Cancer Research Alliance
Study Overview
Official Title:
A Randomized Controlled Trials of Couplelinksca The First Online Couples Intervention for Young Women Dealing With Breast Cancer and Their Male Partners
Status:
UNKNOWN
Status Verified Date:
2013-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
couplelinks
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:
Couplelinksca 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 Couplelinksca 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 programs 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 Couplelinksca educational program to those who have not participated and were instead put on a wait-list for participation
A funded pilot study examining the feasibility and benefit of Couplelinksca 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 programs 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 Couplelinksca educational program to those who have not participated and were instead put on a wait-list for participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None