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

February 5, 2003
March 14, 2012
January 2003
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Complete list of historical versions of study NCT00054223 on ClinicalTrials.gov Archive Site
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Study of Decision Making in Patients Participating in Phase I Clinical Trials
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.

Interventional
Not Provided
Masking: Open Label
  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
Procedure: psychosocial assessment and care
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
November 2005
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054223
030063, 03-CC-0063, CDR0000269911
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Study Chair: Manish Agrawal, MD National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
March 2012

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