NCT06323044 · Roswell Park Cancer Institute
MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence
What this study is about
This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death.
View original scientific description
This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication.
Interventions
OTHER
Best Practice
Receive usual care
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
OTHER
Electronic Health Record Review
Ancillary studies
OTHER
Interview
Ancillary studies
OTHER
Medical Device Usage and Evaluation
Receive MedSupport intervention
OTHER
Medical Device Usage and Evaluation
Use MEMS device
OTHER
Survey Administration
Ancillary studies
Primary outcome measures
Medication adherence
Time frame: Up to 1 year
Will be summarized by timepoint (baseline, 6-months, and 1-year) and condition using descriptive statistics and graphical summaries. The primary analysis will model log adherence as a function of condition, timepoint, their two-way interaction, and random family (accounting for the longitudinal measures within a family unit) and site (accounting for between cancer center variability) effects using a linear mixed model (LMM). Bonferroni adjusted tests about the appropriate contrasts of model estimates will be used to compare: 1) the mean change in adherence within each condition, 2) retention of effect at 12-months within each condition, and 3) the mean change in adherence between conditions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Parent of a child who is diagnosed and receiving first line therapy for acute lymphoblastic leukemia (ALL) at a study site.
- Parent's child patient is age 365 days to \< 19 years at time of study entry.
- Parent's child patient's therapy must include 6-mercaptopurine (6-MP) administered orally or by nasogastric (NG) tube.
- Parent has verbal English, French, or Spanish fluency.
- Parent has a smartphone or access to a computer with an Internet connection.
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Exclusion criteria
- Parent is unwilling or unable to follow protocol requirements.
Where
- Buffalo, New York
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 12, 2026 · Source of record for eligibility and locations