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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00890435
First received: April 28, 2009
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pharmacokinetic Participation Questionnaire Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Correlation between study questionnaire answers and patient demographics [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Correlation between study questionnaire answers and time required by pharmacokinetic sampling [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Correlation between study questionnaire answers and the need for additional IV [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: July 2008
Study Completion Date: January 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890435

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Elizabeth Fox, MD National Cancer Institute (NCI)
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00890435     History of Changes
Other Study ID Numbers: ADVL08N1, COG-ADVL08N1, NCI-08-C-0223, CDR0000616064
Study First Received: April 28, 2009
Last Updated: February 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
recurrent childhood brain stem glioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood medulloblastoma
recurrent childhood supratentorial primitive neuroectodermal tumor
recurrent childhood ependymoma
recurrent childhood pineoblastoma
recurrent childhood subependymal giant cell astrocytoma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
childhood choroid plexus tumor
childhood craniopharyngioma
childhood ependymoblastoma
childhood medulloepithelioma
childhood meningioma
childhood mixed glioma
childhood oligodendroglioma
adult astrocytic tumors
adult brain stem glioma
adult choroid plexus tumor
adult craniopharyngioma
adult ependymoblastoma
adult medulloblastoma
adult supratentorial primitive neuroectodermal tumor (PNET)
adult ependymal tumors
adult meningeal tumor
adult mixed glioma

Additional relevant MeSH terms:
Leukemia
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014