MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence

NCT06323044 | Recruiting

• 3 other identifiers: I-3920723NCI-2024-01734R01CA283501
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Medication adherence

  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.

  Up to 1 year

Study Arms (2)

Arm A (MedSupport)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Survey Administration

Arm B (usual care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Survey Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm A (MedSupport); Arm B (usual care)

Electronic Health Record Review OTHER

Ancillary studies

Arm A (MedSupport); Arm B (usual care)

Interview OTHER

Ancillary studies

Arm A (MedSupport); Arm B (usual care)

Survey Administration OTHER

Ancillary studies

Arm A (MedSupport); Arm B (usual care)

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm B (usual care)

Medical Device Usage and Evaluation OTHER

Receive MedSupport intervention

Arm A (MedSupport)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Parent is unwilling or unable to follow protocol requirements.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Practice Guidelines as Topic; Standard of Care; Specimen Handling; Interviews as Topic

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Kara M Kelly

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)