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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Pharmacokinetic Participation Questionnaire Study

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 Summary:

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.


Sponsor: Children's Oncology Group

Current Primary Outcome:

  • 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 ]
  • Correlation between study questionnaire answers and the need for additional IV [ Time Frame: Length of study ]


Original Primary Outcome:

  • Correlation between study questionnaire answers and patient demographics
  • Correlation between study questionnaire answers and time required by pharmacokinetic sampling
  • Correlation between study questionnaire answers and the need for additional IV


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: April 28, 2009
Date Started: July 2008
Date Completion:
Last Updated: October 20, 2015
Last Verified: February 2014