Study of Decision Making in Patients Participating in Phase I Clinical Trials
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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 |
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2003 |
| Study Completion Date: | November 2005 |
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 |
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| 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 | |
| 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 May 23, 2013