Intervention to improve medication adherence in children with leukemia
MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence
This study is testing a new support program to help families of children with leukemia stick to their medication routine and see if it works better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06323044 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify and address barriers to medication adherence among families of children diagnosed with acute lymphoblastic leukemia (ALL). The MedSupport intervention is a multilevel approach targeting organizational, healthcare team, and caregiver levels to enhance adherence to the oral chemotherapy drug 6-mercaptopurine (6-MP). By comparing adherence rates between families receiving the MedSupport intervention and those receiving usual care, the study seeks to understand the experiences of families managing their child's chemotherapy at home. The trial also explores potential mediators and moderators of intervention efficacy through statistical modeling.
Who should consider this trial
Good fit: Ideal candidates for this study are parents of children aged 1 to 18 years who are receiving first-line therapy for acute lymphoblastic leukemia and are prescribed oral 6-mercaptopurine.
Not a fit: Patients whose parents are unwilling or unable to follow the protocol requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication adherence, reducing the risk of cancer relapse and improving overall health outcomes for pediatric ALL patients.
How similar studies have performed: Other studies have shown success with similar interventions aimed at improving medication adherence in pediatric populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kara M Kelly — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.