Clinical trial · Observational
Decision Making About Participating in Pharmacokinetic Studies in Patients Enrolled in a Phase I Treatment Clinical Trial
A Pharmacokinetic Participation Questionnaire Study
NCT00890435CI-TRIAL-00019551completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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* Must not have withdrawn consent for the phase I treatment study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 studiesReferences
Publications (0)
Data not yet available
No reference posted for this study.