Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
研究概览
简要总结
RATIONALE: Understanding why patients participate in a phase I clinical trial may help doctors plan better treatment for cancer.
PURPOSE: This clinical trial is studying to determine the reasons for participation, perceptions, and expectations of patients receiving treatment for cancer in phase I clinical trials.
详细描述
OBJECTIVES:
- Describe the motivations, perceptions, and expectations of patients enrolled in a phase I clinical trial.
- Assess the influence of age, education, and gender upon the perception of these patients.
- Compare the difference in perceptions, motivations, and expectations of patients who have previously participated in a phase I clinical trial vs those who have not.
- Determine whether patients' perceptions, motivations, and expectations change while enrolled in a phase I clinical trial.
- Validate an interviewer-administered tool measuring the perceptions, motivations, and expectations of these patients.
- Assess patients' perception of the information they were given while enrolled in a phase I clinical trial.
OUTLINE: Patients are interviewed over the phone to evaluate their perceptions, motivations, and expectations of phase I clinical trials. Patients complete a questionnaire comprising 24 questions over 30-45 minutes. Interviews are conducted within 1 week after enrolling in a phase I clinical trial (prior to the first dose of study agent) and then again 2 months later (or at the time the patient stops treatment). The first 10 patients enrolled complete an additional 6 questions over 15 minutes during the first interview to validate the questionnaire, but do not complete a second interview.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 1 year.
研究设计
- 研究类型
- Interventional
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:
- •Enrolled in a phase I clinical trial within the past week
- •Signed an informed consent for a phase I trial
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Able to follow basic verbal instructions as witnessed by the investigator or a representative
- •Able to understand and speak English as determined by the investigator or a representative
- •Access to a telephone
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •Prior participation in a phase I clinical trial allowed
排除标准
- 未提供
结局指标
主要结局
Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
次要结局
- Influence of age and education on perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
- Changes in patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
- Validate measurement of patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
- Patient's perceptions of information given as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
- Compare difference between patients who have and who have not previously participated in phase I clinical trials as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
- Influence of gender upon perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial