MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence

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.

Conditions

Acute Lymphoblastic Leukemia

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Study Overview

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Study Details

Study overview

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.

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

MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence

Condition
Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Buffalo

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Parent is unwilling or unable to follow protocol requirements.

Ages Eligible for Study

365 Days to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Roswell Park Cancer Institute,

Kara M Kelly, PRINCIPAL_INVESTIGATOR, Roswell Park Cancer Institute

Study Record Dates

2029-06-15