SUSPENDED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-12-04
Study Completion:2027-03-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:SUSPENDED

Study ID

NCT06639958

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.

Ages Eligible for Study:10 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age: \>= 10 years and =\< 25 years
  2. * Previously enrolled onto AALL1732
  3. * Consented to the AALL1732 mercaptopurine adherence correlative study
  4. * Maintenance therapy has not yet begun
  5. * English or Spanish-speaking (patient and parent/other adult)
  6. * Planning to receive 6MP (as tablets) during maintenance phase of therapy
  7. * Able and willing to use the MEMS® TrackCap™ (e.g., not using a pillbox or prescribed liquid 6MP)
  8. * 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
  9. * Patient/parent/other adult must be willing to use a smartphone to receive medication reminders
  10. * Receiving treatment at a Children's Oncology Group (COG) institution in the United States
  1. * Patients who have previously participated in or are currently participating in another intervention clinical trial designed to improve adherence
  2. * Regulatory requirements
  3. * All patients and/or their parents or legal guardians must sign a written informed consent
  4. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Contacts and Locations

Principal Investigator

Smita Bhatia
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama
Birmingham, Alabama, 35233
United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
United States
Kaiser Permanente-Oakland
Oakland, California, 94611
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
Nemours Children's Hospital
Orlando, Florida, 32827
United States
Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
United States
Renown Regional Medical Center
Reno, Nevada, 89502
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203
United States
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
United States
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042
United States
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
United States
Madigan Army Medical Center
Tacoma, Washington, 98431
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Smita Bhatia, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-04
Study Completion Date2027-03-03

Study Record Updates

Study Start Date2024-12-04
Study Completion Date2027-03-03

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia
  • Childhood Acute Lymphoblastic Leukemia