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

Children's Oncology Group

Status: Completed

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

Treatments: Other: questionnaire administration; Procedure: psychosocial assessment and care

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT00890435

ADVL08N1

COG-ADVL08N1 (Other Identifier)

NCI-08-C-0223

CDR0000616064 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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  • Must not have withdrawn consent for the phase I treatment study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