Clinical trial NCT00054223: Study of Decision Making in Patients Participating in Phase I Clinical Trials
Official title: Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-02-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
state: Maryland
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: M. D. Anderson Cancer Center at University of Texas
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center
state: Texas
Study officials:
affiliation: National Cancer Institute (NCI)
name: Manish Agrawal, MD
role: STUDY_CHAIR
References: