NCT00054223已完成不适用
Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 10
研究概览
简要总结
RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to improve the way in which clinical trials are conducted.
PURPOSE: This clinical trial is studying patients' personality traits, reasons for participating in the trial, and understanding of their medical situation, prognosis, and risks and benefits of participating in a phase I trial.
详细描述
OBJECTIVES:
- Determine the range of personality traits of patients enrolled in a phase I clinical trial.
- Determine these patients' understanding of their medical situation and prognosis.
- Determine these patients' understanding of risks and benefits of phase I clinical trials.
- Determine these patients' reasons for participating in a phase I clinical trial.
- Determine the risk/benefit trade-offs of these patients.
- Determine the existential outlook of these patients.
- Determine the information gathering nature of these patients.
OUTLINE: This is a multicenter study.
Before beginning phase I clinical trial treatment, patients complete a survey over 30-45 minutes administered by an interviewer. Patients then self-administer the Temperament and Character Inventory assessment over 30 minutes.
PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study within 6 months.
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Consented to enrollment in a phase I cancer clinical trial
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Understands written English
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •No concurrent enrollment in other clinical trials evaluating phase I patient attitudes
排除标准
- 未提供
研究者
研究点 (10)
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