Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
- Conditions
- Unspecified Adult Solid Tumor, Protocol SpecificBrain and Central Nervous System TumorsLeukemiaUnspecified Childhood Solid Tumor, Protocol Specific
- Registration Number
- NCT00890435
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between study questionnaire answers and patient demographics Length of study Correlation between study questionnaire answers and time required by pharmacokinetic sampling Length of study Correlation between study questionnaire answers and the need for additional IV Length of study
- Secondary Outcome Measures
Name Time Method