Trial Information

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

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.