Clinical trial NCT06639958: A Study of Different Programs to Help ALL Patients With Taking Maintenance Medicine at Home
Official title: Risk-Based 6MP Adherence Enhancement Strategies in Children, Adolescent and Young Adults With ALL - A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
First posted: 2024-10-15
Enrollment: 64
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 (IP): 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. 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. Once the designated parent/other adult receives the customized electronic 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 designated parents/other adults will be instructed to electronically indicate when 6MP has been taken (indicative of directly supervised therapy \[DST\] execution). Additionally, patients undergo blood sample collection on the study.

ARM II (U-iIP): 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. 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. 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 designated parents/other adults will be instructed to electronically indicate when 6MP has been taken (indicative of DST execution). If there is no response by the designated parent/other adult indicating 6MP ingestion within 1 hour of the scheduled time, additional automated reminders are sent. The Adherence Study Coordinating Center will evaluate electronic responses (indicative of DST execution) every 4 weeks. The DST response rates will be communicated to the COG sites, identifying the patients as low DST responders (response rate: \< 85%) or high DST responders (response rate: ≥ 85%), along with instructions to serve as a guideline for communicating these results when reviewing them with their patient. DST response rates will be reviewed with the patient every 4 weeks at the clinic visit by the healthcare provider for all U-iIP patients (irrespective of response rate). Patients (and their designated caregiver) receive booster MIPE videos to view on their smartphone every 4 weeks (Days 1, 29, and 57) during Maintenance cycles 3-5, with content that reinforces 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. 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 (EDU: 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 (pIP): 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. On day 1 of Maintenance cycle 3, 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 Maintenance cycle 3, the patient and a designated parent/other adult are trained to set daily reminders on their smartphones at the time the 6MP is due, and to use the "snooze" function to allow repeated reminders in case the medication cannot be taken when the alarm first goes off. The designated parent/other adult is also trained briefly by the CRA in prompting and supervising the patient to take 6MP daily. Once the designated parent/other adult hears the smartphone alarm 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. Additionally, patients undergo blood sample collection on the study.

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

Primary outcomes:
measure: Participation
timeFrame: At baseline (by day 1 of maintenance chemotherapy)
measure: Refusal reasons
timeFrame: At baseline (by day 1 of maintenance chemotherapy)
measure: Attrition
timeFrame: By 60 weeks from day 1 of maintenance chemotherapy
measure: Completion of study measures
timeFrame: By 60 weeks from day 1 of maintenance chemotherapy
Secondary outcomes:
measure: 6-mercaptopurine (6MP) adherence (baseline non-adherers)
timeFrame: By 60 weeks from day 1 of maintenance chemotherapy
measure: 6MP adherence (baseline adherers)
timeFrame: By 60 weeks from day 1 of maintenance chemotherapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Children's Hospital of Alabama
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Oakland
country: United States
facility: Kaiser Permanente-Oakland
state: California
city: Wilmington
country: United States
facility: Alfred I duPont Hospital for Children
state: Delaware
city: Fort Myers
country: United States
facility: Golisano Children's Hospital of Southwest Florida
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic-Jacksonville
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hospital
state: Florida
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Alliance for Childhood Diseases/Cure 4 the Kids Foundation
state: Nevada
city: Las Vegas
country: United States
facility: Summerlin Hospital Medical Center
state: Nevada
city: Reno
country: United States
facility: Renown Regional Medical Center
state: Nevada
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Columbia
country: United States
facility: Prisma Health Richland Hospital
state: South Carolina
city: Austin
country: United States
facility: Dell Children's Medical Center of Central Texas
state: Texas
city: San Antonio
country: United States
facility: Methodist Children's Hospital of South Texas
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Children's Hospital of The King's Daughters
state: Virginia
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
Study officials:
affiliation: Children's Oncology Group
name: Smita Bhatia
role: PRINCIPAL_INVESTIGATOR
References: