Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
RATIONALE: Gathering information about why patients or their guardians agree or decline to participate in the optional pharmacokinetic portion of a phase I treatment study may help doctors plan clinical trials in the future.
PURPOSE: This clinical trial is looking at decision making about participating in pharmacokinetic studies in patients enrolled in a phase I treatment clinical trial.
Brain and Central Nervous System Tumors
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Other: questionnaire administration
Procedure: psychosocial assessment and care
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pharmacokinetic Participation Questionnaire Study|
- Correlation between study questionnaire answers and patient demographics [ Time Frame: Length of study ] [ Designated as safety issue: No ]
- Correlation between study questionnaire answers and time required by pharmacokinetic sampling [ Time Frame: Length of study ] [ Designated as safety issue: No ]
- Correlation between study questionnaire answers and the need for additional IV [ Time Frame: Length of study ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||January 2011|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
- To use a simple 2-page survey to gather preliminary information on why patients or parents/guardians (if patient is a minor) do or do not agree to participate in the optional pharmacokinetic portion of a phase I treatment study while consenting to participate in the phase I treatment study.
OUTLINE: This is a multicenter study.
Patients or parents/guardians (if patient is a minor) complete a short questionnaire on the reasons for agreeing/declining to participation in the optional pharmacokinetic sampling component of the phase I clinical trial.
Patient demographics and other relevant information are collected.
|Principal Investigator:||Elizabeth Fox, MD||National Cancer Institute (NCI)|