Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Children's Oncology Group
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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* Must not have withdrawn consent for the phase I treatment study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
Clareo Health | Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
