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NCT Number: NCT00890435

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

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.

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Key information

Conditions

Brain and Central Nervous System Tumors Astrocytoma Bone Marrow Diseases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Cerebral Ventricle Neoplasms Choroid Plexus Neoplasms Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Neoplasms Craniopharyngioma Disease Attributes Eye Diseases Familial ependymoma Glioma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Biphenotypic, Acute Leukemia, Hairy Cell Leukemia, Large Granular Lymphocytic Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Mast-Cell Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Leukemia, Prolymphocytic Leukemia, T-Cell Lymphatic Diseases Lymphoproliferative Disorders Mast Cell Activation Disorders Mastocytosis Mastocytosis, Systemic Medulloblastoma Meningeal Neoplasms Meningioma Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Vascular Tissue Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Oligodendroglioma Optic Nerve Diseases Optic Nerve Glioma Optic Nerve Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Neoplasms Pinealoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Other

psychosocial assessment and care

Procedure

Primary outcomes

  1. Correlation between study questionnaire answers and patient demographics

    Time frame: Length of study

  2. Correlation between study questionnaire answers and time required by pharmacokinetic sampling

    Time frame: Length of study

  3. Correlation between study questionnaire answers and the need for additional IV

    Time frame: Length of study

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pharmacokinetic Participation Questionnaire Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2011
First posted
Apr 29, 2009
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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