Study of Decision Making in Patients Participating in Phase I Clinical Trials

Status:	Archived
Conditions:	Cancer, Cancer, Psychiatric
Therapuetic Areas:	Oncology, Psychiatry / Psychology
Healthy:	No
Age Range:	Any
Updated:	7/1/2011

Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients

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.

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.

We found this trial at

sites

University of Texas M.D. Anderson Cancer Center

1515 Holcombe Blvd
Houston, Texas 77030

713-792-2121