Evaluating Patient Participation in Phase I Clinical Trials

• Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  

• Influence of age and education on perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  
• 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 [ Designated as safety issue: No ]
  
• Changes in patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  
• 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 [ Designated as safety issue: No ]
  
• Patient's perceptions of information given as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  
• Influence of gender upon perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  

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.