Clinical trial NCT00890435: Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
Official title: A Pharmacokinetic Participation Questionnaire Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain and Central Nervous System Tumors
Leukemia
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Keywords: 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
adult oligodendroglial tumors
adult pineal parenchymal tumor
recurrent adult brain tumor
relapsing chronic myelogenous leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
secondary acute myeloid leukemia
acute undifferentiated leukemia
mast cell leukemia
atypical chronic myeloid leukemia, BCR-ABL1 negative
T-cell large granular lymphocyte leukemia
refractory chronic lymphocytic leukemia
childhood chronic myelogenous leukemia
chronic myelomonocytic leukemia
juvenile myelomonocytic leukemia
refractory hairy cell leukemia
prolymphocytic leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-29
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A patient (family) who has consented to participate in a Phase I trial.

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.

Eligibility 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

Primary outcomes:
measure: Correlation between study questionnaire answers and patient demographics
timeFrame: Length of study
measure: Correlation between study questionnaire answers and time required by pharmacokinetic sampling
timeFrame: Length of study
measure: Correlation between study questionnaire answers and the need for additional IV
timeFrame: Length of study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Cancer Institute (NCI)
name: Elizabeth Fox, MD
role: PRINCIPAL_INVESTIGATOR
References: