A Couples Approach to Enhance Breast Cancer Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 4
- 主要终点
- Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning
研究概览
简要总结
The purpose of the proposed study is to evaluate the efficacy of a new couple-based intervention for women with recently diagnosed, early stage breast cancer and their spouses or male partners. This cancer-focused relationship enhancement intervention adapts well-validated cognitive-behavioral interventions to teach patients and partners specific relationship skills, such as problem-solving skills, communication, and maximizing positive interactions, that they can use in addressing breast cancer. This project's major goals are to improve the patient's individual functioning and specific aspects of the couple's relationship affected by breast cancer (e.g., mood, role functioning, sexual functioning, and social support). In the current investigation, cancer-focused relationship enhancement will be compared to (a) a couple-based Cancer Education intervention and (b) a Treatment-as-Usual condition.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with early stage breast cancer within last year
- •No history of breast cancer, or other cancers in last 5 years (except skin cancer)
- •Living together in a committed heterosexual relationship
- •read and speak English
- •Agree to participate
排除标准
- •Stage 3b and above breast cancer
- •Notable psychopathology, including severe depression with suicidality
结局指标
主要结局
Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning
时间窗: Pre, post, 6 month follow-up, 12 month follow-up
次要结局
- Observational coding of couples social support and decision making conversations(pre, post, 6 month follow-up, 12 month follow-up)