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Evaluating Patient Participation in Phase I Clinical Trials
This study has been completed.
Study NCT00043030   Information provided by National Cancer Institute (NCI)
First Received: August 5, 2002   Last Updated: July 20, 2009   History of Changes

August 5, 2002
July 20, 2009
June 2002
May 2009   (final data collection date for primary outcome measure)
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 ]
Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
Complete list of historical versions of study NCT00043030 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Influence of age and education on perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
  • 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
  • Changes in patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
  • 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
  • Patient's perceptions of information given as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
  • Influence of gender upon perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
 
Evaluating Patient Participation in Phase I Clinical Trials
Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials

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.

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.

 
Interventional
Other
  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
Procedure: psychosocial assessment and care
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
 
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00043030
 
CDR0000069497, NCI-02-C-0204
National Cancer Institute (NCI)
 
Principal Investigator: Arlene Berman, RN, MS, OCN National Cancer Institute (NCI)
National Cancer Institute (NCI)
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP