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

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.

Conditions

• Acute Lymphoblastic Leukemia
• Childhood Acute Lymphoblastic Leukemia

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

Sponsors & Collaborators

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Smita Bhatia · Children's Oncology Group

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-04

Primary Completion

2027-03-03

Completion

2027-03-03

Countries

• United States

Study Locations