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Survey Of Patient's Motivations, Perceptions, And Expectations In Phase I Clinical Trials


N/A
18 Years
N/A
Not Enrolling
Both
Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Survey Of Patient's Motivations, Perceptions, And Expectations 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

N/A

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Arlene Berman, RN, MS, OCN

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

020204

NCT ID:

NCT00043030

Start Date:

June 2002

Completion Date:

May 2009

Related Keywords:

  • Psychosocial Effects of Cancer and Its Treatment
  • Unspecified Adult Solid Tumor, Protocol Specific
  • psychosocial effects of cancer and its treatment
  • unspecified adult solid tumor, protocol specific

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182