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SUSPENDED
NCT06639958
NA

A Study of Different Programs to Help ALL Patients With Taking Maintenance Medicine at Home

Sponsor: Children's Oncology Group

View on ClinicalTrials.gov

Summary

This clinical trial tests different programs to help patients with acute lymphoblastic leukemia (ALL) remember to take their medications during maintenance therapy at home. One problem with ALL maintenance treatment is remembering to take medicines at home like patients are supposed to. In maintenance, a medicine called 6-mercaptopurine or "6MP" is taken by mouth every day at home. In this study, 6MP prescriptions are filled into a special medication bottle called MEMS® which is fitted with a special cap called TrackCap™ that electronically records when the medication bottle is opened. Researchers are trying a new program to help patients be better at taking their 6MP like they're supposed to. This new program may help patients to remember to take their 6MP medication.

Official title: Risk-Based 6MP Adherence Enhancement Strategies in Children, Adolescent and Young Adults With ALL - A Pilot Study

Key Details

Gender

All

Age Range

10 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2024-12-04

Completion Date

2027-03-03

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BEHAVIORAL

Compliance Monitoring

Receive DST

BEHAVIORAL

Compliance Monitoring

Healthcare provider reviews DST response rates with the patient and any challenges they are having with 6MP adherence every 4 weeks at clinic visits

OTHER

Health Promotion and Education

Receive customized printed medication schedules

OTHER

Informational Intervention

Receive Patient Supply Kit

OTHER

Media Intervention

View MIPE program videos

OTHER

Media Intervention

Review booster MIPE videos

OTHER

Medical Device Usage and Evaluation

Use MEMS® with TrackCap™

DRUG

Mercaptopurine

Given PO

OTHER

Questionnaire Administration

Ancillary studies

BEHAVIORAL

Telephone-Based Intervention

Receive automated customized electronic reminders via smartphone

BEHAVIORAL

Telephone-Based Intervention

Receive additional automated reminders

BEHAVIORAL

Telephone-Based Intervention

Manually activate daily smartphone reminders with successive alerts (using the "snooze" function)

BEHAVIORAL

Telephone-Based Intervention

Receive electronic reminders with successive alerts (using the "snooze" function)

BEHAVIORAL

Training and Education

Undergo training for prompting and supervising 6MP

Locations (27)

Children's Hospital of Alabama

Birmingham, Alabama, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Nemours Children's Hospital

Orlando, Florida, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Renown Regional Medical Center

Reno, Nevada, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Prisma Health Richland Hospital

Columbia, South Carolina, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

Methodist Children's Hospital of South Texas

San Antonio, Texas, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Madigan Army Medical Center

Tacoma, Washington, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States