Clinical trial NCT00043030: Evaluating Patient Participation in Phase I Clinical Trials
Official title: Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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 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

Primary outcomes:
measure: Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
Secondary outcomes:
measure: Influence of age and education on perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
measure: 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
measure: Changes in patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
measure: 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
measure: Patient's perceptions of information given as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
measure: Influence of gender upon perception as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Arlene Berman, RN, MS, OCN
role: PRINCIPAL_INVESTIGATOR
References: