A Pharmacokinetic Participation Questionnaire Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Children's Oncology Group
- Enrollment
- 53
- Primary Endpoint
- Correlation between study questionnaire answers and the need for additional IV
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Correlation between study questionnaire answers and the need for additional IV
Time Frame: Length of study
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
Secondary Outcomes
No secondary outcomes reported