MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorRoswell Park Cancer Institute

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Parent is unwilling or unable to follow protocol requirements.

Trial design

Treatments tested in this trial

  • Best Practice
  • Biospecimen Collection
  • Electronic Health Record Review
  • Interview
  • Medical Device Usage and Evaluation
  • Medical Device Usage and Evaluation
  • Survey Administration

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Roswell Park Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator