NCT00890435

Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial

A Pharmacokinetic Participation Questionnaire Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 53 (actual)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Brain and Central Nervous System Tumors
• Leukemia
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	questionnaire administration
PROCEDURE	psychosocial assessment and care

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-08-01
• Completion: 2011-01-01
• First posted: 2009-04-29
• Last updated: 2015-10-21