Protocol Number: 02-C-0204
This study will evaluate patients' motivations, expectations, and perceptions regarding participation in phase I clinical trials. An analysis and characterization of these factors could be used to develop tools to help patients through the process of informed consent and lessen their fear and anxiety. A questionnaire was developed to ascertain patients' motivation (the factors that influence the patient to participate), expectation (expected benefit), and perception (his or her understanding of the purpose of the trial). Secondary objectives include: - to assess the influence of age and education on perception of phase I clinical trials. - to assess the difference between patients who had previously participated and those who have not. - to assess whether patients' perceptions, expectations, and motivations change while they are participating in a trial. - to validate an interviewer-administered tool measuring patients' perceptions, motivations, and expectations. - to assess patients' perceptions of the information they were given. - to assess the influence of gender on perception of phase I clinical trials. Patients must be 18 or older, within 1 week of enrolling of the phase I clinical trial, have the ability to follow basic verbal instructions as witnessed by the investigator or representative, be able to understand and speak English, have access to a phone, and have signed the informed consent for a phase I clinical trial. Patients will be interviewed again 2 months later. The first 10 patients will not be asked to do this second interview but will be asked additional questions to help improve the questionnaire. Use of an ID number will help ensure confidentiality. The questionnaire has 24 questions and takes 30-45 minutes to complete. Some of the interviews will be monitored for quality assurance.
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