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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00054223

Enrollment

250

Registered

2003-02-06

Start date

2003-01-31

Completion date

2005-11-30

Last updated

2012-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

Keywords

psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific

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.

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.

Interventions

PROCEDUREpsychosocial assessment and care

Study design

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026