NCT00890435

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2008

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 29, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

October 21, 2015

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

April 28, 2009

Last Update Submit

October 20, 2015

Conditions

Brain and Central Nervous System TumorsLeukemiaUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificunspecified childhood solid tumor, protocol specificrecurrent childhood brain stem gliomarecurrent childhood cerebellar astrocytomarecurrent childhood cerebral astrocytomarecurrent childhood medulloblastomarecurrent childhood supratentorial primitive neuroectodermal tumorrecurrent childhood ependymomarecurrent childhood pineoblastomarecurrent childhood subependymal giant cell astrocytomarecurrent childhood visual pathway and hypothalamic gliomarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiachildhood choroid plexus tumorchildhood craniopharyngiomachildhood ependymoblastomachildhood medulloepitheliomachildhood meningiomachildhood mixed gliomachildhood oligodendrogliomaadult astrocytic tumorsadult brain stem gliomaadult choroid plexus tumoradult craniopharyngiomaadult ependymoblastomaadult medulloblastomaadult supratentorial primitive neuroectodermal tumor (PNET)adult ependymal tumorsadult meningeal tumoradult mixed gliomaadult oligodendroglial tumorsadult pineal parenchymal tumorrecurrent adult brain tumorrelapsing chronic myelogenous leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiaadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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 leukemiaacute undifferentiated leukemiamast cell leukemiaatypical chronic myeloid leukemia, BCR-ABL1 negativeT-cell large granular lymphocyte leukemiarefractory chronic lymphocytic leukemiachildhood chronic myelogenous leukemiachronic myelomonocytic leukemiajuvenile myelomonocytic leukemiarefractory hairy cell leukemiaprolymphocytic leukemia

Outcome Measures

Primary Outcomes (3)

  • Correlation between study questionnaire answers and patient demographics

    Length of study

  • Correlation between study questionnaire answers and time required by pharmacokinetic sampling

    Length of study

  • Correlation between study questionnaire answers and the need for additional IV

    Length of study

Interventions

questionnaire administrationOTHER
psychosocial assessment and carePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Central Nervous System NeoplasmsLeukemiaAstrocytomaMedulloblastomaFamilial ependymomaOptic Nerve GliomaPrecursor Cell Lymphoblastic Leukemia-LymphomaChoroid Plexus NeoplasmsMeningiomaOligodendrogliomaCraniopharyngiomaNeuroectodermal Tumors, PrimitiveMeningeal NeoplasmsGliomaPinealomaBrain NeoplasmsLeukemia, Myeloid, AcuteCongenital AbnormalitiesLeukemia, Biphenotypic, AcuteLeukemia, Mast-CellLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeLeukemia, Large Granular LymphocyticLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Myelomonocytic, ChronicLeukemia, Myelomonocytic, JuvenileLeukemia, Hairy CellLeukemia, Prolymphocytic

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCerebral Ventricle NeoplasmsBrain DiseasesCentral Nervous System DiseasesNeoplasms, Vascular TissueLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMastocytosis, SystemicMastocytosisMast Cell Activation DisordersMyelodysplastic-Myeloproliferative DiseasesBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, T-CellLeukemia, B-Cell

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Elizabeth Fox, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2009

First Posted

April 29, 2009

Study Start

July 1, 2008

Primary Completion

August 1, 2009

Study Completion

January 1, 2011

Last Updated

October 21, 2015

Record last verified: 2014-02