Study of Decision Making in Patients Participating in Phase I Clinical Trials - Tabular View

Tracking Information

First Received Date ^ICMJE

February 5, 2003

Last Updated Date

July 14, 2009

Start Date ^ICMJE

January 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00054223 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Open Label

Condition ^ICMJE

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

Intervention ^ICMJE

Procedure: psychosocial assessment and care

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

250

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00054223

Responsible Party

Study ID Numbers ^ICMJE

CDR0000269911, NCI-03-C-0063

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Manish Agrawal, MD

National Cancer Institute (NCI)

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP