Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
|ClinicalTrials.gov Identifier: NCT00890435|
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : October 21, 2015
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.
|Condition or disease||Intervention/treatment|
|Brain and Central Nervous System Tumors Leukemia Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific||Other: questionnaire administration Procedure: psychosocial assessment and care|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||53 participants|
|Official Title:||A Pharmacokinetic Participation Questionnaire Study|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||January 2011|
- Correlation between study questionnaire answers and patient demographics [ Time Frame: Length of study ]
- Correlation between study questionnaire answers and time required by pharmacokinetic sampling [ Time Frame: Length of study ]
- Correlation between study questionnaire answers and the need for additional IV [ Time Frame: Length of study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890435
|Principal Investigator:||Elizabeth Fox, MD||National Cancer Institute (NCI)|