Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
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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 |
| Official Title: | A Pharmacokinetic Participation Questionnaire Study |
- Correlation between study questionnaire answers and patient demographics [ Designated as safety issue: No ]
- Correlation between study questionnaire answers and time required by pharmacokinetic sampling [ Designated as safety issue: No ]
- Correlation between study questionnaire answers and the need for additional IV [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2008 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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 |
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Must not have withdrawn consent for the phase I treatment study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 More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00890435 History of Changes |
| Other Study ID Numbers: | CDR0000616064, COG-ADVL08N1, NCI-08-C-0223 |
| Study First Received: | April 28, 2009 |
| Last Updated: | May 14, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 May 22, 2013