Prostate Cancer: Family Care for Patients and Spouses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 6
- 主要终点
- Quality of Life
研究概览
简要总结
The purpose of this study is to determine if a family-based intervention (The FOCUS Program) can improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouses.
详细描述
The purpose of this study was to determine if a family-based intervention (The FOCUS Program) could improve the long-term quality of life and other psycho-social outcomes of men with prostate cancer and their spouse/partners. Aim 1. The first aim was to determine if the family intervention could improve several proximal clinical outcomes (less negative appraisal of illness or caregiving, less uncertainty, less hopelessness, better family communication, higher self-efficacy, and more problem-focused coping) and improve the distal clinical outcome, quality of life, in a culturally and economically diverse sample of men with prostate cancer and their spouses. Aim 2. The second aim was to test a stress-coping model designed to predict which prostate cancer patients and their spouses are at higher risk of poorer long-term quality of life.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of prostate cancer
- •Willing spousal partner
- •Speaks and understands English
- •Mentally and physically able to participate
- •Minimum life expectancy of 12 months
- •Lives within 70 miles
排除标准
- •Multiple primary cancers
- •Watchful waiting status
- •Spouse with cancer diagnosis in previous year
结局指标
主要结局
Quality of Life
时间窗: Baseline, 4, 8 and 12 months
次要结局
- Threat appraisal(Baseline, 4, 8 and 12 months)
- Family Communication(Baseline, 4, 8 and 12 months)
- Uncertainty(Baseline, 4, 8 and 12 months)
- Coping(Baseline, 4, 8 and 12 months)
- Hopelessness(Baseline, 4, 8 and 12 months)
- Self-Efficacy(Baseline, 4, 8 and 12 months)