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

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00890435

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors Leukemia Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific	Other: questionnaire administration Procedure: psychosocial assessment and care

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

Actual Enrollment :

53 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Pharmacokinetic Participation Questionnaire Study

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Jan 1, 2011

Outcome Measures

Primary Outcome Measures

Correlation between study questionnaire answers and patient demographics [Length of study]
Correlation between study questionnaire answers and time required by pharmacokinetic sampling [Length of study]
Correlation between study questionnaire answers and the need for additional IV [Length of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)