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OpenTrials
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NCT Number: NCT00054223

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

psychosocial assessment and care

Procedure

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Feb 6, 2003
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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