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Evaluating Patient Participation in Phase I Clinical Trials
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00043030
  Purpose

RATIONALE: Understanding why patients participate in a phase I clinical trial may help doctors plan better treatment for cancer.

PURPOSE: This clinical trial is studying to determine the reasons for participation, perceptions, and expectations of patients receiving treatment for cancer in phase I clinical trials.


Condition Intervention
Cancer-Related Problem/Condition
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: psychosocial assessment and care

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Official Title: Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Influence of age and education on perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  • Compare difference between patients who have and who have not previously participated in phase I clinical trials as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  • Changes in patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  • Validate measurement of patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  • Patient's perceptions of information given as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]
  • Influence of gender upon perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • Describe the motivations, perceptions, and expectations of patients enrolled in a phase I clinical trial.
  • Assess the influence of age, education, and gender upon the perception of these patients.
  • Compare the difference in perceptions, motivations, and expectations of patients who have previously participated in a phase I clinical trial vs those who have not.
  • Determine whether patients' perceptions, motivations, and expectations change while enrolled in a phase I clinical trial.
  • Validate an interviewer-administered tool measuring the perceptions, motivations, and expectations of these patients.
  • Assess patients' perception of the information they were given while enrolled in a phase I clinical trial.

OUTLINE: Patients are interviewed over the phone to evaluate their perceptions, motivations, and expectations of phase I clinical trials. Patients complete a questionnaire comprising 24 questions over 30-45 minutes. Interviews are conducted within 1 week after enrolling in a phase I clinical trial (prior to the first dose of study agent) and then again 2 months later (or at the time the patient stops treatment). The first 10 patients enrolled complete an additional 6 questions over 15 minutes during the first interview to validate the questionnaire, but do not complete a second interview.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study within 1 year.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Enrolled in a phase I clinical trial within the past week

    • Signed an informed consent for a phase I 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

  • Able to follow basic verbal instructions as witnessed by the investigator or a representative
  • Able to understand and speak English as determined by the investigator or a representative
  • Access to a telephone

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Prior participation in a phase I clinical trial allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043030

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: Arlene Berman, RN National Cancer Institute (NCI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069497, NCI-02-C-0204C
Study First Received: August 5, 2002
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00043030  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
psychosocial effects/treatment
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on January 13, 2009