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

October 20, 2015 updated by: Children's Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A patient (family) who has consented to participate in a Phase I trial.

Description

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- Must not have withdrawn consent for the phase I treatment study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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between study questionnaire answers and patient demographics Time Frame: Length of study	Length of study
Correlation between study questionnaire answers and time required by pharmacokinetic sampling Time Frame: Length of study	Length of study
Correlation between study questionnaire answers and the need for additional IV Time Frame: Length of study	Length of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Elizabeth Fox, MD, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 28, 2009

First Submitted That Met QC Criteria