Evaluating Patient Participation in Phase I Clinical Trials

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials

Conditions
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Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Enrolled in a phase I clinical trial within the past week Signed an informed consent for a phase I trial PATIENT CHARACTERISTICS: Age 18 and over Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other 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 Surgery Not specified Other Prior participation in a phase I clinical trial allowed

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: psychosocial assessment and care|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of age and education on perception 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 |  |  | 
| 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 |  |  | 
| Influence of gender upon perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific