Trial Title:
A Study of Different Programs to Help ALL Patients With Taking Maintenance Medicine at Home
NCT ID:
NCT06639958
Condition:
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Mercaptopurine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Adherers arm IV (pIP)
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Behavioral
Intervention name:
Compliance Monitoring
Description:
Receive DST
Arm group label:
Adherers arm IV (pIP)
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Intervention type:
Other
Intervention name:
Health Promotion and Education
Description:
Receive customized printed medication schedules
Arm group label:
Adherers arm IV (pIP)
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Intervention type:
Other
Intervention name:
Informational Intervention
Description:
Receive Patient Supply Kit
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Intervention type:
Other
Intervention name:
Media Intervention
Description:
View MIPE program videos
Arm group label:
Adherers arm III (EDU)
Arm group label:
Adherers arm IV (pIP)
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Intervention type:
Other
Intervention name:
Media Intervention
Description:
Review booster MIPE videos
Arm group label:
Non-adherers arm II (U-iIP)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Use MEMS® with TrackCap™
Arm group label:
Adherers arm III (EDU)
Arm group label:
Adherers arm IV (pIP)
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Intervention type:
Drug
Intervention name:
Mercaptopurine
Description:
Given PO
Arm group label:
Adherers arm IV (pIP)
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Other name:
3H-Purine-6-thiol
Other name:
6 MP
Other name:
6 Thiohypoxanthine
Other name:
6 Thiopurine
Other name:
6-Mercaptopurine
Other name:
6-Mercaptopurine Monohydrate
Other name:
6-MP
Other name:
6-Purinethiol
Other name:
6-Thiopurine
Other name:
6-Thioxopurine
Other name:
6H-Purine-6-thione, 1,7-dihydro- (9CI)
Other name:
7-Mercapto-1,3,4,6-tetrazaindene
Other name:
Alti-Mercaptopurine
Other name:
Azathiopurine
Other name:
Bw 57-323H
Other name:
Flocofil
Other name:
Ismipur
Other name:
Leukerin
Other name:
Leupurin
Other name:
Mercaleukim
Other name:
Mercaleukin
Other name:
Mercaptina
Other name:
Mercaptopurinum
Other name:
Mercapurin
Other name:
Mern
Other name:
NCI-C04886
Other name:
Puri-Nethol
Other name:
Purimethol
Other name:
Purine, 6-mercapto-
Other name:
Purine-6-thiol (8CI)
Other name:
Purine-6-thiol, monohydrate
Other name:
Purinethiol
Other name:
Purinethol
Other name:
U-4748
Other name:
WR-2785
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Adherers arm III (EDU)
Arm group label:
Adherers arm IV (pIP)
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Intervention type:
Behavioral
Intervention name:
Telephone-Based Intervention
Description:
Receive automated customized electronic reminders via smartphone
Arm group label:
Adherers arm IV (pIP)
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Intervention type:
Behavioral
Intervention name:
Telephone-Based Intervention
Description:
Receive additional automated reminder
Arm group label:
Non-adherers arm II (U-iIP)
Intervention type:
Behavioral
Intervention name:
Telephone-Based Intervention
Description:
Receive electronic reminders with successive alerts (using the "snooze" function)
Arm group label:
Adherers arm IV (pIP)
Intervention type:
Behavioral
Intervention name:
Training and Education
Description:
Undergo training for prompting and supervising 6MP
Arm group label:
Adherers arm III (EDU)
Arm group label:
Adherers arm IV (pIP)
Arm group label:
Non-adherers arm I (IP)
Arm group label:
Non-adherers arm II (U-iIP)
Summary:
This phase III 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. MEMS® TrackCap™ may help patients to remember to take their 6MP medication.
Detailed description:
PRIMARY OBJECTIVES:
I. Collect data on the feasibility of a phase 3 adherence-enhancing 2 parallel 2-arm
randomized clinical trial.
Ia. Estimate participation rates, refusal reasons, and attrition rates. Ib. Evaluate
rates of completeness of all aspects of the study (surveys [rates of missing elements];
MEMS® TrackCap™ return rates; maintenance form return rates from site clinical research
assistants [CRAs]; blood samples for pharmacogenetics and deoxyribonucleic acid
[DNA]-incorporated thioguanine nucleotide [DNA-TG] levels).
SECONDARY OBJECTIVES:
I. Among baseline non-adherers, estimate the impact of ultra-intensified intervention
package (U-iIP) versus (vs.) intervention package (IP) on 6MP adherence.
II. Among baseline adherers, estimate the impact of patient-empowered intervention
package (pIP) vs. education alone (EDU ) on 6MP adherence.
OUTLINE:
Patients receive the Patient Supply Kit containing an empty MEMS® medication bottle with
TrackCap™ with child resistant medication bottles and child resistant standard caps, and
written instructions for the patient and pharmacist, along with their 6MP prescription.
Beginning on day 1 cycle 1 of Maintenance Therapy, patients start using the MEMS®
medication bottle with TrackCap™. Clinical research assistants contact patients and
parents by telephone the next day to confirm that TrackCap™ is being used, to identify
any obstacles, and to determine solutions. Patients are instructed to return the first
MEMS® TrackCap™ to the clinic on day 1 of Maintenance cycle 2. Patients are then assigned
to 1 of 2 groups based on baseline adherence rates (adherers [adherence rate >= 95%] and
non-adherers [adherence rate < 95%]).
NON-ADHERERS: Patients are randomized to 1 of 2 arms during cycle 2 of Maintenance
therapy.
ARM I: Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1 of
Maintenance cycle 3 and for the remaining duration of the study. Patients and their
caregiver view the multimedia interactive patient/parent/other adult education (MIPE)
program that features video clips of ALL patients and their parents/other adults
discussing Maintenance treatment in the clinic on day 1 of cycle 3. A designated
parent/other adult is selected and trained briefly in prompting and supervising the
patient to take 6MP daily by the CRA on day 1 of Maintenance cycle 3. Once the designated
parent/other adult receives the reminder for 6MP, they are instructed to prompt
initiation of the 6MP dose (if necessary), and to supervise the ingestion of the
prescribed 6MP (in all instances). If the patient is not present when the dose of 6MP is
due, the patient receives a call from the designated parent/other adult to prompt
initiation of the dose. Patients also receive customized printed medication schedules
approximately every 4 weeks (days 1, 29, and 57) during Maintenance cycles 3-5 (during
scheduled clinic visits) from their healthcare provider. Patients and/or the parent/other
adult receive automated customized electronic reminders delivered via smartphone
according to the patient's electronic 6MP schedule. Additionally, patients undergo blood
sample collection on the study.
ARM II: Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1
of Maintenance cycle 3 and for the remaining duration of the study. Patients and their
caregiver view the MIPE program that features video clips of ALL patients and their
parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3.
A designated parent/other adult is selected and trained briefly in prompting and
supervising the patient to take 6MP daily by the CRA on day 1 of Maintenance cycle 3.
Once the designated parent/other adult receives the reminder for 6MP, they are instructed
to prompt initiation of the 6MP dose (if necessary), and to supervise the ingestion of
the prescribed 6MP (in all instances). If the patient is not present when the dose of 6MP
is due, the patient receives a call from the designated parent/other adult to prompt
initiation of the dose. Patients also receive customized printed medication schedules
approximately every 4 weeks (days 1, 29, and 57) during Maintenance cycles 3-5 (during
scheduled clinic visits) from their healthcare provider. Patients and/or the parent/other
adult receive automated customized electronic reminders delivered via smartphone
according to the patient's electronic 6MP schedule. If there is no response by the
designated parent/other adult indicating 6MP ingestion within 1 hour of the scheduled
time, an additional automated reminder is sent during Maintenance cycles 3-5. Patients
(and their designated caregiver) review booster MIPE videos with content that reinforce
the importance of 6MP in treating leukemia, having a daily routine for 6MP ingestion, and
executing/confirming directly supervised therapy (DST) with each dose, and review common
barriers to 6MP ingestion and DST execution (e.g., patient away from home, change in
daily schedule), address additional barriers significantly associated with DST execution,
and feature examples of patients/other adults self-identifying barriers (e.g., parent not
always home at time of 6MP, lack of organizational skills, etc.), and provide specific
steps to overcome the barriers every 4 weeks (days 1, 29 and 57) during Maintenance
cycles 3-5. Additionally, patients undergo blood sample collection on the study.
ADHERERS: Patients are randomized to 1 of 2 arms during cycle 2 of Maintenance therapy.
ARM III: Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1
of Maintenance cycle 3 and for the remaining duration of the study. Patients and their
caregiver view the MIPE program that features video clips of ALL patients and their
parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3.
Additionally, patients undergo blood sample collection on the study.
ARM IV: Patients receive another Patient Supply Kit and MEMS® TrackCap™ to use on day 1
of Maintenance cycle 3 and for the remaining duration of the study. Patients and their
caregiver view the MIPE program that features video clips of ALL patients and their
parents/other adults discussing Maintenance treatment in the clinic on day 1 of cycle 3.
A designated parent/other adult is selected and trained briefly in prompting and
supervising the patient to take 6MP daily by the CRA on day 1 of Maintenance cycle 3.
Once the designated parent/other adult receives the reminder for 6MP, they are instructed
to prompt initiation of the 6MP dose (if necessary), and to supervise the ingestion of
the prescribed 6MP (in all instances). If the patient is not present when the dose of 6MP
is due, the patient receives a call from the designated parent/other adult to prompt
initiation of the dose. Patients and/or the parent/other adult receive automated
customized electronic reminders delivered via smartphone according to the patient's
electronic 6MP schedule. If there is no response by the designated parent/other adult
indicating 6MP ingestion the patient and their designated parent/other adult receive
electronic reminders with successive alerts (using the "snooze" function) until DST
execution occurs during Maintenance cycles 3-5. Additionally, patients undergo blood
sample collection on the study.
Criteria for eligibility:
Criteria:
Inclusion 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
10 Years
Maximum age:
25 Years
Healthy volunteers:
No
Start date:
April 2, 2025
Completion date:
January 29, 2027
Lead sponsor:
Agency:
Children's Oncology Group
Agency class:
Other
Source:
Children's Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06639958
