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

Leukemia Clinical Trial

Official title:

A Pharmacokinetic Participation Questionnaire Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890435
• Other study ID #: ADVL08N1
• Secondary ID: COG-ADVL08N1NCI-
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: October 20, 2015
• Start date: July 2008
• Est. completion date: January 2011

Study information

• Verified date: February 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: January 2011
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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• Must not have withdrawn consent for the phase I treatment study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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Leukemia
• Nervous System Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Other:
• questionnaire administration

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between study questionnaire answers and patient demographics		Length of study	No
Primary	Correlation between study questionnaire answers and time required by pharmacokinetic sampling		Length of study	No
Primary	Correlation between study questionnaire answers and the need for additional IV		Length of study	No