Evaluating Patient Participation in Phase I Clinical Trials

National Institutes of Health Clinical Center (CC)

Status: Completed

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

Treatments: Procedure: psychosocial assessment and care

Study type: Interventional

Funder types: NIH

Identifiers

NCT00043030

CDR0000069497

02-C-0204

020204

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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