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

Official Title: “A Pharmacokinetic Participation Questionnaire Study”

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.

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.

Intervention(s) in this Clinical Trial

• Other: questionnaire administration
• Procedure: psychosocial assessment and care

Primary Measures

• Correlation between study questionnaire answers and patient demographics
  • Safety Issue?: No
• Correlation between study questionnaire answers and time required by pharmacokinetic sampling
  • Safety Issue?: No
• Correlation between study questionnaire answers and the need for additional IV
  • Safety Issue?: No

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• Must not have withdrawn consent for the phase I treatment study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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Children's Oncology Group Other

Overall Clinical Trial Officials and Contacts

Elizabeth Fox, MD Principal Investigator NCI - Pediatric Oncology Branch  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00890435

Study ID Number: CDR0000616064

ClinicalTrials.gov Identifier: NCT00890435

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database