NCT06323044 MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence
| NCT ID | NCT06323044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2025-02-11 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 * Parent has a smartphone or computer access 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.
Contact & Investigator
Kara M Kelly
PRINCIPAL INVESTIGATOR
Roswell Park Cancer Institute
Frequently Asked Questions
Who can join the NCT06323044 clinical trial?
This trial is open to participants of all sexes, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06323044 currently recruiting?
Yes, NCT06323044 is actively recruiting participants. Visit ClinicalTrials.gov or contact Roswell Park Cancer Institute to inquire about joining.
Where is the NCT06323044 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT06323044 clinical trial?
NCT06323044 is sponsored by Roswell Park Cancer Institute. The principal investigator is Kara M Kelly at Roswell Park Cancer Institute. The trial plans to enroll 150 participants.
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