Evaluating Patient Participation in Phase I Clinical Trials

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00043030
First received: August 5, 2002
Last updated: March 14, 2012
Last verified: March 2012
  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
Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: psychosocial assessment and care

Study Type: Interventional
Official Title: Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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
Study Completion Date: May 2009
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
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, MS, OCN National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00043030     History of Changes
Other Study ID Numbers: 020204, 02-C-0204, CDR0000069497
Study First Received: August 5, 2002
Last Updated: March 14, 2012
Health Authority: United States: Federal Government

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 April 17, 2014