Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
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.
Interventions
PROCEDUREpsychosocial assessment and care
Sponsors
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients' perceptions, motivations, and expectations as assessed by survey prior to and 2 months after enrollment on a phase I clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Influence of age and education on perception 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 | — |
| 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 | — |
Countries
United States
Outcome results
None listed