Study of Decision Making in Patients Participating 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

NCT00054223

CDR0000269911

030063

03-CC-0063

Details and patient eligibility

About

RATIONALE: Studying individuals who are enrolled in phase I clinical trials may help to improve the way in which clinical trials are conducted.

PURPOSE: This clinical trial is studying patients' personality traits, reasons for participating in the trial, and understanding of their medical situation, prognosis, and risks and benefits of participating in a phase I trial.

Full description

OBJECTIVES:

• Determine the range of personality traits of patients enrolled in a phase I clinical trial.
• Determine these patients' understanding of their medical situation and prognosis.
• Determine these patients' understanding of risks and benefits of phase I clinical trials.
• Determine these patients' reasons for participating in a phase I clinical trial.
• Determine the risk/benefit trade-offs of these patients.
• Determine the existential outlook of these patients.
• Determine the information gathering nature of these patients.

OUTLINE: This is a multicenter study.

Before beginning phase I clinical trial treatment, patients complete a survey over 30-45 minutes administered by an interviewer. Patients then self-administer the Temperament and Character Inventory assessment over 30 minutes.

PROJECTED ACCRUAL: Approximately 250 patients will be accrued for this study within 6 months.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Consented to enrollment in a phase I cancer clinical 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

• Understands written English

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent enrollment in other clinical trials evaluating phase I patient attitudes