NCT00043030

Evaluating Patient Participation in Phase I Clinical Trials

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	psychosocial assessment and care

Timeline

• Start date: 2002-06-01
• Primary completion: 2006-12-01
• Completion: 2009-05-01
• First posted: 2003-01-27
• Last updated: 2012-03-15

Locations

1 site across 1 country: United States