Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Evaluating Patient Participation in Phase I Clinical Trials

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Educational/Counseling/Training	Completed	18 and over	NCI	NCI-02-C-0204 NCT00043030

Objectives

1. Describe the motivations, perceptions, and expectations of patients enrolled in a phase I clinical trial.
2. Assess the influence of age, education, and gender upon the perception of these patients.
3. 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.
4. Determine whether patients' perceptions, motivations, and expectations change while enrolled in a phase I clinical trial.
5. Validate an interviewer-administered tool measuring the perceptions, motivations, and expectations of these patients.
6. Assess patients' perception of the information they were given while enrolled in a phase I clinical trial.

Entry Criteria

Disease Characteristics:

• Enrolled in a phase I clinical trial within the past week
  • Signed an informed consent for a phase I trial

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

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

Expected Enrollment

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

Outcomes

Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial

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

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Arlene Berman, RN, MS, OCN, Principal investigator		Ph: 301-435-5609

Registry Information
Official Title		Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials
Trial Start Date		2002-06-01
Trial Completion Date		2009-05-05
Registered in ClinicalTrials.gov		NCT00043030
Date Submitted to PDQ		2002-06-05
Information Last Verified		2007-02-06

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