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Study of Decision Making in Patients Participating in Phase I Clinical Trials
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), September 2006
First Received: February 5, 2003   Last Updated: July 14, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054223
  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: 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 Cancer Institute (NCI):

Estimated Enrollment: 250
Study Start Date: January 2003
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 Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer     312-695-1301     cancer@northwestern.edu    
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892
Contact: Contact Person     Not Available        
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi     215-728-4790        
United States, Texas
Cancer Therapy and Research Center Recruiting
San Antonio, Texas, United States, 78229
Contact: Clinical Trials Office - Cancer Therapy and Research Center     210-616-5798        
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Sponsors and Collaborators
Investigators
Study Chair: Manish Agrawal, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000269911, NCI-03-C-0063
Study First Received: February 5, 2003
Last Updated: July 14, 2009
ClinicalTrials.gov Identifier: NCT00054223     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 10, 2009