Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890435
|Principal Investigator:||Elizabeth Fox, MD||National Cancer Institute (NCI)|