Clinical trial · Interventional
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
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Medical Device Usage and Evaluation | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (MedSupport)
- description
- Participants receive the MedSupport intervention consisting of three components: universal screening for adherence barriers, tailored virtual education enhancement, and communication of barriers to activate multidisciplinary healthcare teams for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
- Other: Interview
- Other: Medical Device Usage and Evaluation
- Other: Survey Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm B (usual care)
- description
- Participants receive usual care consisting of medical consultations and supportive care for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Parent of a child diagnosed with acute lymphoblastic leukemia (ALL) * Child patient 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. * Verbal fluency in English, or Spanish * Parent has a smartphone or computer access 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.
References
Publications (0)
Data not yet available