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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Children's Hospital of Alabama, Birmingham, Alabama, United States, 35233

Oakland

Kaiser Permanente-Oakland, Oakland, California, United States, 94611

Wilmington

Alfred I duPont Hospital for Children, Wilmington, Delaware, United States, 19803

Fort Myers

Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States, 33908

Jacksonville

Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States, 32207

Orlando

AdventHealth Orlando, Orlando, Florida, United States, 32803

Orlando

Nemours Children's Hospital, Orlando, Florida, United States, 32827

Bangor

Eastern Maine Medical Center, Bangor, Maine, United States, 04401

Baltimore

Sinai Hospital of Baltimore, Baltimore, Maryland, United States, 21215

Las Vegas

University Medical Center of Southern Nevada, Las Vegas, Nevada, United States, 89102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age: \>= 10 years and =\< 25 years
  • * Previously enrolled onto AALL1732
  • * Consented to the AALL1732 mercaptopurine adherence correlative study
  • * Maintenance therapy has not yet begun
  • * English or Spanish-speaking (patient and parent/other adult)
  • * Planning to receive 6MP (as tablets) during maintenance phase of therapy
  • * Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
  • * Has a designated parent/other adult who is willing to enter into a mutual agreement with the patient to participate in a daily supervised medication administration routine
  • * Patient/parent/other adult must be willing to use a smartphone to receive medication reminders
  • * Receiving treatment at a Children's Oncology Group (COG) institution in the United States
  • * Patients who have previously participated in or are currently participating in another intervention clinical trial designed to improve adherence
  • * Regulatory requirements
  • * All patients and/or their parents or legal guardians must sign a written informed consent
  • * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Ages Eligible for Study

10 Years to 25 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Oncology Group,

Smita Bhatia, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

2027-03-03