Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 611
- 试验地点
- 10
- 主要终点
- Mental Health Inventory
研究概览
简要总结
The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG), incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills) as well as basic relationship communication and support skills (e.g., expressing support needs constructively). The second group, a Couples' Support Group (SG), is a non-structured group where general topics are discussed. The investigators will evaluate the impact of each group condition on patients' psychological adaptation, social and role functioning, and cancer treatment adherence. The investigators will also evaluate whether patient and partner perceptions of relationship support, relationship intimacy, stress management skills, and intervention group support mediate the groups' effects on each other's psychological adaptation.
The investigators hypothesize that ECG will have stronger positive effects on patient general and cancer-related distress and well-being than SG.
The investigators hypothesize that group support will mediate greater improvements in patient psychological functioning in both groups but that the effects of group support will be significantly stronger in SG than ECG.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient has a primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
- •patient has had breast cancer surgery within the last twelve months
- •patient and partner married or cohabitating
- •patient and partner 18 years of age or older
- •patient and partner speak and read English
- •patient and partner can provide meaningful informed consent
- •patient and partner do not have any chronic physical or cognitive illness that would preclude participation in the group sessions
- •couple lives within 2 hour commuting distance to the center from which they are recruited
- •Exclusion criteria:
- •patient is male
排除标准
- 未提供
结局指标
主要结局
Mental Health Inventory
时间窗: time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention
Well-being Subscale of the Mental Health Inventory (MHI)
时间窗: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
Impact of Events Scale-Revised
时间窗: baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention
次要结局
- Mental Outcomes Survey (MOS SF-36)(baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention)
- Adherence to Chemotherapy(1 yr follow-up)
- Adherence to Radiation Therapy(1 yr follow-up)