Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Enrolled in a phase I clinical trial within the past week - Signed an informed consent for a phase I trial PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Able to follow basic verbal instructions as witnessed by the investigator or a representative - Able to understand and speak English as determined by the investigator or a representative - Access to a telephone PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - Prior participation in a phase I clinical trial allowed


NCT ID:

NCT00043030


Primary Contact:

Principal Investigator
Arlene Berman, RN, MS, OCN
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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