RecruitingNot ApplicableNCT06323044

MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence

MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence


Sponsor

Roswell Park Cancer Institute

Enrollment

150 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing a support program called MedSupport to help parents of children with acute lymphoblastic leukemia (ALL — a type of blood cancer) give their child's oral chemotherapy medication consistently. Missing doses of this medication can reduce how well treatment works. **You may be eligible if:** - You are the parent or caregiver of a child between 1 and 18 years old who has been diagnosed with ALL - Your child is currently receiving first-line treatment that includes oral 6-mercaptopurine (6-MP) - You can speak English, French, or Spanish - You have access to a smartphone or a computer with internet **You may NOT be eligible if:** - You are unwilling or unable to follow the study protocol requirements - Your child is not on 6-mercaptopurine as part of their treatment plan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBest Practice

Receive usual care

PROCEDUREBiospecimen Collection

Undergo blood sample collection

OTHERElectronic Health Record Review

Ancillary studies

OTHERInterview

Ancillary studies

OTHERMedical Device Usage and Evaluation

Receive MedSupport intervention

OTHERMedical Device Usage and Evaluation

Use MEMS device

OTHERSurvey Administration

Ancillary studies


Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT06323044


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