A Study of Different Programs to Help ALL Patients With Taking Maintenance Medicine at Home
- Conditions
- Acute Lymphoblastic LeukemiaChildhood Acute Lymphoblastic Leukemia
- Interventions
- Procedure: Biospecimen CollectionOther: Informational InterventionBehavioral: Compliance MonitoringOther: Media InterventionOther: Health Promotion and EducationOther: Medical Device Usage and EvaluationOther: Questionnaire AdministrationBehavioral: Training and EducationBehavioral: Telephone-Based Intervention
- Registration Number
- NCT06639958
- Lead Sponsor
- Children's Oncology Group
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 64
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adherers arm III (EDU) Biospecimen Collection 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. Adherers arm III (EDU) Informational Intervention 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. Adherers arm III (EDU) Media Intervention 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. Adherers arm III (EDU) Medical Device Usage and Evaluation 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. Adherers arm III (EDU) Questionnaire Administration 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. Adherers arm III (EDU) Training and Education 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. Adherers arm IV (pIP) Biospecimen Collection See Detailed Description. Adherers arm IV (pIP) Compliance Monitoring See Detailed Description. Adherers arm IV (pIP) Informational Intervention See Detailed Description. Adherers arm IV (pIP) Media Intervention See Detailed Description. Adherers arm IV (pIP) Medical Device Usage and Evaluation See Detailed Description. Adherers arm IV (pIP) Mercaptopurine See Detailed Description. Adherers arm IV (pIP) Questionnaire Administration See Detailed Description. Adherers arm IV (pIP) Telephone-Based Intervention See Detailed Description. Adherers arm IV (pIP) Training and Education See Detailed Description. Non-adherers arm I (IP) Biospecimen Collection See Detailed Description. Non-adherers arm I (IP) Compliance Monitoring See Detailed Description. Non-adherers arm I (IP) Health Promotion and Education See Detailed Description. Non-adherers arm I (IP) Informational Intervention See Detailed Description. Non-adherers arm I (IP) Media Intervention See Detailed Description. Non-adherers arm I (IP) Medical Device Usage and Evaluation See Detailed Description. Non-adherers arm I (IP) Mercaptopurine See Detailed Description. Non-adherers arm I (IP) Questionnaire Administration See Detailed Description. Non-adherers arm I (IP) Telephone-Based Intervention See Detailed Description. Non-adherers arm I (IP) Training and Education See Detailed Description. Non-adherers arm II (U-iIP) Biospecimen Collection See Detailed Description. Non-adherers arm II (U-iIP) Compliance Monitoring See Detailed Description. Non-adherers arm II (U-iIP) Health Promotion and Education See Detailed Description. Non-adherers arm II (U-iIP) Informational Intervention See Detailed Description. Non-adherers arm II (U-iIP) Media Intervention See Detailed Description. Non-adherers arm II (U-iIP) Medical Device Usage and Evaluation See Detailed Description. Non-adherers arm II (U-iIP) Mercaptopurine See Detailed Description. Non-adherers arm II (U-iIP) Questionnaire Administration See Detailed Description. Non-adherers arm II (U-iIP) Telephone-Based Intervention See Detailed Description. Non-adherers arm II (U-iIP) Training and Education See Detailed Description.
- Primary Outcome Measures
Name Time Method Participation At baseline (by day 1 of maintenance chemotherapy) We will calculate and report the proportion of patients eligible for the study who participate and will report a corresponding 95% confidence interval.
Refusal reasons At baseline (by day 1 of maintenance chemotherapy) A single question in a study case report form prompts refusal reason. For each available reason, we will calculate and report the proportion of patients reporting that refusal reason as well as corresponding 95% confidence intervals.
Attrition By 60 weeks from day 1 of maintenance chemotherapy We will calculate and report the proportion of patients who drop out of the study prior to completion among those eligible and enrolled and will report the corresponding 95% confidence interval.
Completion of study measures By 60 weeks from day 1 of maintenance chemotherapy We will calculate and report the proportion of patients who complete the following measures by the end of the study follow-up period: study survey submission, MEMS® TrackCap™ return, maintenance form return, and blood sample submission. We will also report the corresponding 95% confidence intervals.
- Secondary Outcome Measures
Name Time Method 6-mercaptopurine (6MP) adherence (baseline non-adherers) By 60 weeks from day 1 of maintenance chemotherapy Among baseline non-adherers, the proportion of days with protocol defined appropriate medication use during the study follow up period will be captured for each patient using the MEMS cap. We will calculate and report the mean proportion of adherence days by arm and the corresponding 95% confidence interval.
6MP adherence (baseline adherers) By 60 weeks from day 1 of maintenance chemotherapy Among baseline adherers, protocol defined appropriate medication use during the study follow up period will be captured for each patient using the MEMS cap. We will calculate and report the proportion with \>= 95% adherence over the study follow up period by arm with a corresponding 95% confidence interval.
Trial Locations
- Locations (25)
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Kaiser Permanente-Oakland
🇺🇸Oakland, California, United States
Alfred I duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Golisano Children's Hospital of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Nemours Children's Clinic-Jacksonville
🇺🇸Jacksonville, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Nemours Children's Hospital
🇺🇸Orlando, Florida, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Sunrise Hospital and Medical Center
🇺🇸Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
🇺🇸Las Vegas, Nevada, United States
Summerlin Hospital Medical Center
🇺🇸Las Vegas, Nevada, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Prisma Health Richland Hospital
🇺🇸Columbia, South Carolina, United States
Dell Children's Medical Center of Central Texas
🇺🇸Austin, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Saint Vincent Hospital Cancer Center Green Bay
🇺🇸Green Bay, Wisconsin, United States