CompletedNot Applicable

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

53 participantsStarted 2008-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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I treatment clinical trial with an optional pharmacokinetic (PK) component, within the past 4 weeks * Must not have withdrawn consent for the phase I treatment study * Patients or their parents/guardians are eligible regardless of whether they initially agreed to participate in the PK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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Correlation between study questionnaire answers and patient demographics

Timeframe: Length of study

Correlation between study questionnaire answers and time required by pharmacokinetic sampling

Timeframe: Length of study

Correlation between study questionnaire answers and the need for additional IV

Timeframe: Length of study

Trial details

NCT IDNCT00890435

SponsorChildren's Oncology Group

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2009-08

View on ClinicalTrials.gov More Brain and Central Nervous System Tumors trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Correlation between study questionnaire answers and patient demographics

Timeframe: Length of study

Correlation between study questionnaire answers and time required by pharmacokinetic sampling

Timeframe: Length of study

Correlation between study questionnaire answers and the need for additional IV

Timeframe: Length of study