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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00054223
First received: February 5, 2003
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: psychosocial assessment and care

Study Type: Interventional
Study Design: Masking: Open Label
Official Title: Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 250
Study Start Date: January 2003
Study Completion Date: November 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054223

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Investigators
Study Chair: Manish Agrawal, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00054223     History of Changes
Other Study ID Numbers: 030063, 03-CC-0063, CDR0000269911
Study First Received: February 5, 2003
Last Updated: March 14, 2012
Health Authority: Unspecified

Keywords provided by National Institutes of Health Clinical Center (CC):
psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on April 17, 2014