A Pilot Study for Optimizing Mental Wellbeing and Heart Health for Black Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Proportion of Completers
研究概览
简要总结
Pilot study to determine the feasibility of providing psychosocial and cardiac rehabilitation services to address socioeconomic health disparities and improve wellbeing for black men with prostate cancer.
详细描述
Subjects will see an oncology Associate Clinical Social Worker at Stanford's Cancer Center for a two hour psychosocial assessment. Subsequently participants will complete the psychosocial intake support session and elective additional counseling sessions (Part A) at the end of up to 8 counseling sessions (maximum sessions possible) or 20 weeks (+/- 4 weeks), whichever comes first. For participants who continue onto cardiac services (Part B), the participant will complete the cardiac rehabilitation exercise program within 12 weeks (+/- 2 weeks) of the first day of exercise start. The end of study will occur after the last cardiac rehabilitation exercise session (+ 2 weeks).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Proportion of Completers
时间窗: 12 weeks
Proportion of screened eligible participants who complete the initial 2-hour psychosocial support session intake. The pilot study is considered feasible if the primary endpoint is met in at least 50% of patients. We will evaluate the 95% CI of the feasibility rate.
次要结局
- Difference of General Anxiety Disorder-7 (GAD-7) score(12 weeks)
- Difference of Functional Assessment of Cancer Therapy-Prostate (FACT-P) score(12 weeks)
- Difference in Patient Health Questionnaire-9 (PHQ-9)(12 weeks)
研究者
Alice Fan
Associate Professor of Medicine (Oncology) and, by courtesy, of Urology
Stanford University