WCM Catchment Prostate Cancer Health Impact Program (pCHIP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Development of Evidence-Based Decision Navigation Intervention through Semi-Structured Interviews for AA and H/L men diagnosed with prostate cancer
研究概览
简要总结
This project focuses on African American (AA) men and Hispanic/Latino (H/L) men with prostate cancer (PCa) in Brooklyn/Queens catchment. Evidence from randomized clinical trials support the efficacy of decision navigation intervention, with navigated patients showing greater confidence in their decisions about cancer treatment and less regret. The investigators will develop and test the acceptability and feasibility of a decision navigation intervention for AA or H/L men with prostate cancer.
The primary aim for this study is to adapt and tailor an evidence based decision navigation intervention for AA and H/L men newly diagnosed with prostate cancer (PCa). The investigators hypothesize that men in the decision navigation intervention arm will report higher levels of decision self-efficacy, less decisional conflict, and regret about their treatment decisions compared to men engaged in standard of care.
详细描述
Objectives This study will develop and test the acceptability and feasibility of a decision navigation intervention (DNI) for AA or H/L men with PCa through consideration of the role of partners and family members in the decision-making process.
Hypotheses / Research Questions Among AA or H/L men diagnosed with early stage PCa, the primary aims of this study are to:
Aim 1:
Adapt and tailor an evidence-based decision navigation intervention (DNI) for AA and H/L men diagnosed with prostate cancer. The investigators hypothesize that key concepts around information sharing and counseling, health behavior coordination, and emotional social support will be elicited
Aim 2:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participant must be designated male at birth
- •Self-identified AA or H/L
- •Be 18 years of age or older
- •Fluent in English or Spanish
- •Able to provide informed consent.
排除标准
- •Patients or shared decision makers with cognitive or sensory impairment which impede their ability to provide informed consent as determined by consenting individual or documented in the medical record.
- •At Risk of Prostate Cancer Group:
- •Inclusion Criteria:
- •Participant must be designated male at birth
- •Self-identified AA or H/L
- •Be 18 years of age or older
- •Have stage I-III PCa, not yet begun cancer treatment
- •Have no evidence of progressive disease or second primary cancer
- •Exclusion Criteria:
- •Men who have already begun cancer treatment
- •Have evidence of progressive disease
- •Second primary cancer
结局指标
主要结局
Development of Evidence-Based Decision Navigation Intervention through Semi-Structured Interviews for AA and H/L men diagnosed with prostate cancer
时间窗: 1 Day
By conducting semi-structured interview, the investigators will adapt and tailor an evidence-based decision navigation intervention (DNI) for AA and H/L men diagnosed with prostate cancer. Semi-structured interviews consist of participant information and free-response questions. Participant information such as, contact information, health information, prostate cancer risk perception, basic demographic and chart abstractions will be recorded.
次要结局
- Decisional Self-Efficacy as measured by the Decisional Self-Efficacy Scale between Decision Navigation Intervention versus Standard of Care for AA and H/L men newly diagnosed with prostate cancer(Up to 6 months)
- Preference for Control in the Decision-making as measured by the Control Preference Scale between Decision Navigation Intervention versus Standard of Care for AA and H/L men newly diagnosed with prostate cancer(Up to 6 months)
- Health Information as measured by the Health Information National Trends Survey (HINTS) between Decision Navigation Intervention versus Standard of Care for AA and H/L men newly diagnosed with prostate cancer(Up to 6 months)
- Regret as Measured by the Decision Regret Scale between Decision Navigation Intervention versus Standard of Care for AA and H/L men newly diagnosed with prostate cancer(Up to 6 Months)