Research Participation: Decision Making and Outcomes in Cancer Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Decision satisfaction
研究概览
简要总结
RATIONALE: Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.
PURPOSE: This clinical trial is studying how patients with stage II, stage III, or stage IV pancreatic cancer or stage III or stage IV colon cancer or rectal cancer make decisions about participating in a clinical trial.
详细描述
OBJECTIVES:
- Determine the relationship between disease factors, patient factors, and understanding of the cancer clinical trial, and preferences for decision control in the decision to participate in a cancer clinical trial by patients with stage II-IV pancreatic cancer or stage III-IV colon or rectal cancer.
- Determine the relationship between disease factors, patient factors, understanding of the cancer clinical trial, and preferences for decision control with satisfaction with the decision to participate in a cancer clinical trial.
- Determine how quality of life, trust, and hope impact the decision to participate in a cancer clinical trial and the satisfaction with this decision.
OUTLINE: This is a cross-sectional study.
Patients complete 12 questionnaires to assess their symptom burden (e.g., nausea, pain, fatigue), sociodemographics, hope, quality of life, trust in the healthcare system, trust in health professionals, research decision control, perceived risks, adequacy of research information, clinical trial participation, and decision satisfaction.
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of 1 of the following:
- •Stage II-IV pancreatic cancer
- •Stage III-IV colon cancer
- •Stage III-IV rectal cancer
- •Offered the opportunity to participate in a phase I-III cancer clinical trial and agreed or declined to participate
- •First appointment at the Sidney Kimmel Comprehensive Cancer Center at John Hopkins
- •PATIENT CHARACTERISTICS:
- •Able to read English
- •PRIOR CONCURRENT THERAPY:
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Decision satisfaction
Participation
次要结局
未报告次要终点