Recruiting

Medication Adherence

Sponsor:

Roswell Park Cancer Institute

Code:

NCT06323044

Conditions

Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Best Practice

Biospecimen Collection

Electronic Health Record Review

Interview

Medical Device Usage and Evaluation

Study Details

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.

Conditions

Acute Lymphoblastic Leukemia

Study ID

NCT06323044

Start date

Feb 11, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm A (MedSupport)

Participants receive the MedSupport intervention consisting of three components: universal screening for adherence barriers, tailored virtual education enhancement, and communication of barriers to activate multidisciplinary healthcare teams for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.

active comparator: Arm B (usual care)

Participants receive usual care consisting of medical consultations and supportive care for 12 months. Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up. Patients also undergo blood sample collection throughout the study.

Interventions

Best Practice

Receive usual care

Biospecimen Collection

Undergo blood sample collection

Electronic Health Record Review

Ancillary studies

Interview

Ancillary studies

Medical Device Usage and Evaluation

Receive MedSupport intervention

Medical Device Usage and Evaluation

Use MEMS device

Survey Administration

Ancillary studies

Primary outcome measure

  • Medication adherence [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Kara M. Kelly

716-845-2333Kara.Kelly@RoswellPark.org

Principal Investigator:

Kara M. Kelly

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-08-12.