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

Sponsor
National Institutes of Health Clinical Center (CC) (NIH)
Overall Status
Completed
CT.gov ID
NCT00054223
Collaborator
National Cancer Institute (NCI) (NIH)
250
Enrollment
5
Locations
34
Duration (Months)
50
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: psychosocial assessment and care
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
250 participants
Masking:
None (Open Label)
Official Title:
Ethics Study To Understand The Decision Making Process Of Phase I Cancer Patients
Study Start Date :
Jan 1, 2003
Actual Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago Illinois United States 60611-3013
    2 Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Bethesda Maryland United States 20892
    3 Fox Chase Cancer Center - Philadelphia Philadelphia Pennsylvania United States 19111-2497
    4 M. D. Anderson Cancer Center at University of Texas Houston Texas United States 77030-4009
    5 Cancer Therapy and Research Center San Antonio Texas United States 78229

    Sponsors and Collaborators

    • National Institutes of Health Clinical Center (CC)
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Manish Agrawal, MD, National Cancer Institute (NCI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00054223
    Other Study ID Numbers:
    • 030063
    • 03-CC-0063
    • CDR0000269911
    First Posted:
    Feb 6, 2003
    Last Update Posted:
    Mar 16, 2012
    Last Verified:
    Mar 1, 2012
    Keywords provided by , ,
    psychosocial effects of cancer and its treatment
    unspecified adult solid tumor, protocol specific

    Study Results

    No Results Posted as of Mar 16, 2012