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

NCT ID: NCT00890435

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-01-31

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 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

questionnaire administration

Intervention Type: OTHER

psychosocial assessment and care

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Children's Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Fox, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Other Identifiers

COG-ADVL08N1

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-08-C-0223

Identifier Type: -

Identifier Source: secondary_id

CDR0000616064

Identifier Type: OTHER

Identifier Source: secondary_id

ADVL08N1

Identifier Type: -

Identifier Source: org_study_id