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


N/A
18 Years
N/A
Not Enrolling
Both
Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label

Principal Investigator

Manish Agrawal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

Unspecified

Study ID:

030063

NCT ID:

NCT00054223

Start Date:

January 2003

Completion Date:

November 2005

Related Keywords:

  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
  • psychosocial effects of cancer and its treatment
  • unspecified adult solid tumor, protocol specific

Name

Location

M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Cancer Therapy and Research CenterSan Antonio, Texas  78229
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182