Evaluating Patient Participation in Phase I Clinical Trials

Not Applicable

Completed

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

• Registration Number: NCT00043030
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief 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.

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-08-05
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-12
• Study Completion: 2009-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Influence of gender upon perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
Influence of age and education on perception 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
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

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support; 🇺🇸 Bethesda, Maryland, United States