Evaluating Patient Participation in Phase I Clinical Trials

• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00043030
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 120
• Location: 1
• Duration (Months): 83
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Psychosocial Effects of Cancer and Its Treatment; Unspecified Adult Solid Tumor, Protocol Specific	Procedure: psychosocial assessment and care	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Official Title: Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Dec 1, 2006
• Actual Study Completion Date: May 1, 2009

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Influence of age and education on perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial []

2. 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 []

3. Changes in patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial []

4. 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 []

5. Patient's perceptions of information given as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial []

6. Influence of gender upon perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support	Bethesda	Maryland	United States	20892-1182

Sponsors and Collaborators

• National Institutes of Health Clinical Center (CC)
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Arlene Berman, RN, MS, OCN, National Cancer Institute (NCI)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00043030
• Other Study ID Numbers: 020204; 02-C-0204; CDR0000069497
• First Posted: Jan 27, 2003
• Last Update Posted: Mar 15, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by , ,: psychosocial effects of cancer and its treatment; unspecified adult solid tumor, protocol specific

Study Results

No Results Posted as of Mar 15, 2012