RECRUITING

MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-15
Study Completion:2029-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06323044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:365 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Parent of a child who is diagnosed and receiving first line therapy for acute lymphoblastic leukemia (ALL) at a study site.
  2. * Parent's child patient is age 365 days to \< 19 years at time of study entry.
  3. * Parent's child patient's therapy must include 6-mercaptopurine (6-MP) administered orally or by nasogastric (NG) tube.
  4. * Parent has verbal English, French, or Spanish fluency.
  5. * Parent has a smartphone or access to a computer with an Internet connection.
  6. * 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.
  1. * Parent is unwilling or unable to follow protocol requirements.

Contacts and Locations

Principal Investigator

Kara M Kelly
PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute

Study Locations (Sites)

Roswell Park Cancer Institute
Buffalo, New York, 14263
United States

Collaborators and Investigators

Sponsor: Roswell Park Cancer Institute

  • Kara M Kelly, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-15
Study Completion Date2029-06-15

Study Record Updates

Study Start Date2025-01-15
Study Completion Date2029-06-15

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia