Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639958
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
A Study of Different Programs to Help ALL Patients With Taking Maintenance Medicine at Home
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Risk-Based 6MP Adherence Enhancement Strategies in Children Adolescent and Young Adults With ALL - A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 theyre 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 patientparentother adult education MIPE program that features video clips of ALL patients and their parentsother adults discussing Maintenance treatment in the clinic on day 1 of cycle 3 A designated parentother 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 parentother 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 parentother 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 andor the parentother adult receive automated customized electronic reminders delivered via smartphone according to the patients 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 parentsother adults discussing Maintenance treatment in the clinic on day 1 of cycle 3 A designated parentother 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 parentother 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 parentother 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 andor the parentother adult receive automated customized electronic reminders delivered via smartphone according to the patients electronic 6MP schedule If there is no response by the designated parentother 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 executingconfirming directly supervised therapy DST with each dose and review common barriers to 6MP ingestion and DST execution eg patient away from home change in daily schedule address additional barriers significantly associated with DST execution and feature examples of patientsother adults self-identifying barriers eg 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 parentsother 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 parentsother adults discussing Maintenance treatment in the clinic on day 1 of cycle 3 A designated parentother 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 parentother 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 parentother adult to prompt initiation of the dose Patients andor the parentother adult receive automated customized electronic reminders delivered via smartphone according to the patients electronic 6MP schedule If there is no response by the designated parentother adult indicating 6MP ingestion the patient and their designated parentother 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
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 patientparentother adult education MIPE program that features video clips of ALL patients and their parentsother adults discussing Maintenance treatment in the clinic on day 1 of cycle 3 A designated parentother 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 parentother 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 parentother 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 andor the parentother adult receive automated customized electronic reminders delivered via smartphone according to the patients 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 parentsother adults discussing Maintenance treatment in the clinic on day 1 of cycle 3 A designated parentother 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 parentother 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 parentother 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 andor the parentother adult receive automated customized electronic reminders delivered via smartphone according to the patients electronic 6MP schedule If there is no response by the designated parentother 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 executingconfirming directly supervised therapy DST with each dose and review common barriers to 6MP ingestion and DST execution eg patient away from home change in daily schedule address additional barriers significantly associated with DST execution and feature examples of patientsother adults self-identifying barriers eg 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 parentsother 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 parentsother adults discussing Maintenance treatment in the clinic on day 1 of cycle 3 A designated parentother 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 parentother 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 parentother adult to prompt initiation of the dose Patients andor the parentother adult receive automated customized electronic reminders delivered via smartphone according to the patients electronic 6MP schedule If there is no response by the designated parentother adult indicating 6MP ingestion the patient and their designated parentother 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None