Status:
COMPLETED
Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Leukemia
Eligibility:
All Genders
18+ years
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 clinic...
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 pharmacoki...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Patients or their parents/guardians (if patient is a minor) consented to participate in a phase I treatment clinical trial with an optional pharmacokinetic (PK) component, within the past 4 weeks
- Must not have withdrawn consent for the phase I treatment study
- Patients or their parents/guardians are eligible regardless of whether they initially agreed to participate in the PK sampling
- Must not withdraw consent for PK sampling prior to completing the study questionnaire if initially agreed to optional PK sampling
- Patients or their parents/guardians are eligible regardless of whether they actually completed PK sampling (provided reasons for not completing the sampling was not withdrawal of the initial consent to the phase I treatment study)
- PATIENT CHARACTERISTICS:
- Not cognitively or physically impaired
- May participate no more than once in the study questionnaire survey
- PRIOR CONCURRENT THERAPY:
- No limit on participation in the number of prior phase I trials or other studies
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00890435
Start Date
July 1 2008
End Date
January 1 2011
Last Update
October 21 2015
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