Breast Cancer Clinical Trial
— couplelinksOfficial title:
A Randomized Controlled Trials of Couplelinks.ca: The First Online Couples Intervention for Young Women Dealing With Breast Cancer and Their Male Partners
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.
Status | Recruiting |
Enrollment | 260 |
Est. completion date | June 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 53 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | York University | Toronto | Ontario |
Canada | British Columbia Cancer Agency Research Centre | Vancouver | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
Canadian Breast Cancer Research Alliance | British Columbia Cancer Agency, CancerCare Manitoba, Queen Elizabeth II Health Sciences Centre, Sunnybrook Health Sciences Centre, York University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
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