A Randomized Controlled Trials of Couplelinks.ca: The First Online Couples Intervention for Young Women Dealing With Breast Cancer and Their Male Partners
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 260
- 试验地点
- 10
- 主要终点
- Revised Dyadic Adjustment Survey RDAS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 53 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Revised Dyadic Adjustment Survey RDAS
时间窗: T0= 0 weeks, T1= 8 weeks, T3= 3 months
The Revised Dyadic Adjustment Survey (RDAS) is a brief version of the 33 question Dyadic Adjustment Survey that assesses relationship adjustment.
Dyadic Coping
时间窗: T0= 0 weeks, T1= 8 weeks, T3= 3 months
Dyadic Coping assesses the degree to which partners feel that their coping efforts are reciprocal
次要结局
未报告次要终点
研究者
Karen Fergus
PhD
Canadian Breast Cancer Research Alliance