MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence

Not Applicable

Recruiting

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Procedure: Biospecimen Collection; Other: Best Practice; Other: Electronic Health Record Review; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Survey Administration

• Registration Number: NCT06323044
• Lead Sponsor: Roswell Park Cancer Institute

Brief 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.

Detailed Description

PRIMARY OBJECTIVE:

I. To compare the proportion of pediatric ALL patients with 6-mercaptopurine (6-MP) chemotherapy adherence 95% or higher based on Medication Event Monitoring System (MEMS) data collected during the Consolidation II (1st year of therapy) and Continuation (2nd year of therapy) treatment phases in patients randomized to either MedSupport intervention or usual care.

EXPLORATORY OBJECTIVES:

I. To compare the proportion of pediatric acute lymphoblastic leukemia (ALL) patients with 6-mercaptopurine chemotherapy adherence based on 6-MP metabolite analysis of peripheral blood biospecimens collected during the Consolidation II and Continuation phases of treatment in patients randomized to either MedSupport intervention or usual care. (PATIENT) II. To use statistical modeling to examine potential mechanisms/mediators (medication barriers verse \[vs.\] social support, medication beliefs) of intervention efficacy in patients randomized to either MedSupport intervention or usual care. (PATIENT) III. To use statistical modeling to explore potential moderators of intervention efficacy including child age, caregiver socioeconomic status, race, ethnicity, and household structure in patients randomized to either MedSupport intervention or usual care. (PATIENT) IV. To determine parent intervention uptake by examining engagement with the screening questionnaire among parents from the intervention arm as a percentage based upon the ratio of the number of screening questionnaires completed to the number of questionnaires the participant was eligible to complete. (CAREGIVER) V. To assess whether parents from the intervention arm engaged with the educational videos as a percentage based upon the ratio of the number of minutes of videos watched compared to the number of minutes of educational videos the participant was prompted to view. (CAREGIVER) VI. To examine the strategies that may hinder or support implementation within routine care by assessing how parents from the intervention arm rated the acceptability, appropriateness, and feasibility of the MedSupport intervention. (CAREGIVER) VII. To explore barriers and facilitators to adoption, feasibility, and sustainability of the MedSupport intervention by examining the responses of a sample of 20 parent participants from the intervention arm who participate in semi-structured qualitative interviews. (CAREGIVER) VIII. To determine healthcare provider uptake by examining documentation of 4 weeks of adherence/medication-related consultations from intervention arm patient's Electronic Health Record (EHR) following a medication barrier alert. (INSTITUTIONAL) IX. To examine strategies that may hinder or support implementation within routine care by assessing healthcare provider ratings of the acceptability, appropriateness, and feasibility of the MedSupport intervention. (INSTITUTIONAL) X. To explore barriers and facilitators to adoption, feasibility, implementation, organizational/contextual factors that support maintenance and cost of the MedSupport intervention by examining the responses of a sample of 20 healthcare providers who participated in semi-structured qualitative interviews. (INSTITUTIONAL)

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP A: 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.

GROUP B: 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.

After completion of study intervention, participants are followed up at 1 year and 2 years.

Study Timeline

• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-21
• Study Start: 2025-02-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-20
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B (usual care)	Electronic Health Record Review	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.
Arm A (MedSupport)	Interview	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.
Arm B (usual care)	Interview	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.
Arm B (usual care)	Survey Administration	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.
Arm A (MedSupport)	Electronic Health Record Review	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.
Arm B (usual care)	Medical Device Usage and Evaluation	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.
Arm A (MedSupport)	Biospecimen Collection	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.
Arm A (MedSupport)	Medical Device Usage and Evaluation	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.
Arm B (usual care)	Best Practice	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.
Arm B (usual care)	Biospecimen Collection	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.
Arm A (MedSupport)	Survey Administration	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.

Primary Outcome Measures

Name	Time	Method
Medication adherence	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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States