Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323044
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-03-14
Brief Title:
MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
MedSupport A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia Pediatric nonadherence noncompliance to medication is a significant public health problem and rigorous research repeatedly documents that nonadherence increases risk for hospitalization healthcare cost disease progression and death Pediatric acute lymphoblastic leukemia ALL patients who miss 5 of 6-mercaptopurine 6-MP doses within the 2-year 6-MP regimen have a 27-fold risk of cancer that comes back after a period of improvement relapse To address these families needs researchers have developed MedSupport a theory-based multilevel intervention with targets at the organizational healthcare team and caregiver levels that is designed to address root barriers to medication adherence This study is being done to better understand families experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication
Detailed Description:
PRIMARY OBJECTIVE
I To compare the proportion of pediatric ALL patients with 6-mercaptopurine 6-MP chemotherapy adherence 95 or higher based on Medication Event Monitoring System MEMS data collected during the Consolidation II 1st year of therapy and Continuation 2nd year of therapy treatment phases in patients randomized to either MedSupport intervention or usual care
EXPLORATORY OBJECTIVES
I To compare the proportion of pediatric acute lymphoblastic leukemia ALL patients with 6-mercaptopurine chemotherapy adherence based on 6-MP metabolite analysis of peripheral blood biospecimens collected during the Consolidation II and Continuation phases of treatment in patients randomized to either MedSupport intervention or usual care PATIENT II To use statistical modeling to examine potential mechanismsmediators medication barriers verse vs social support medication beliefs of intervention efficacy in patients randomized to either MedSupport intervention or usual care PATIENT III To use statistical modeling to explore potential moderators of intervention efficacy including child age caregiver socioeconomic status race ethnicity and household structure in patients randomized to either MedSupport intervention or usual care PATIENT IV To determine parent intervention uptake by examining engagement with the screening questionnaire among parents from the intervention arm as a percentage based upon the ratio of the number of screening questionnaires completed to the number of questionnaires the participant was eligible to complete CAREGIVER V To assess whether parents from the intervention arm engaged with the educational videos as a percentage based upon the ratio of the number of minutes of videos watched compared to the number of minutes of educational videos the participant was prompted to view CAREGIVER VI To examine the strategies that may hinder or support implementation within routine care by assessing how parents from the intervention arm rated the acceptability appropriateness and feasibility of the MedSupport intervention CAREGIVER VII To explore barriers and facilitators to adoption feasibility and sustainability of the MedSupport intervention by examining the responses of a sample of 20 parent participants from the intervention arm who participate in semi-structured qualitative interviews CAREGIVER VIII To determine healthcare provider uptake by examining documentation of 4 weeks of adherencemedication-related consultations from intervention arm patients Electronic Health Record EHR following a medication barrier alert INSTITUTIONAL IX To examine strategies that may hinder or support implementation within routine care by assessing healthcare provider ratings of the acceptability appropriateness and feasibility of the MedSupport intervention INSTITUTIONAL X To explore barriers and facilitators to adoption feasibility implementation organizationalcontextual factors that support maintenance and cost of the MedSupport intervention by examining the responses of a sample of 20 healthcare providers who participated in semi-structured qualitative interviews INSTITUTIONAL
OUTLINE Participants are randomized to 1 of 2 groups
GROUP A Participants receive the MedSupport intervention consisting of three components universal screening for adherence barriers tailored virtual education enhancement and communication of barriers to activate multidisciplinary healthcare teams for 12 months Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up Patients also undergo blood sample collection throughout the study
GROUP B Participants receive usual care consisting of medical consultations and supportive care for 12 months Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up Patients also undergo blood sample collection throughout the study
After completion of study intervention participants are followed up at 1 year and 2 years
I To compare the proportion of pediatric ALL patients with 6-mercaptopurine 6-MP chemotherapy adherence 95 or higher based on Medication Event Monitoring System MEMS data collected during the Consolidation II 1st year of therapy and Continuation 2nd year of therapy treatment phases in patients randomized to either MedSupport intervention or usual care
EXPLORATORY OBJECTIVES
I To compare the proportion of pediatric acute lymphoblastic leukemia ALL patients with 6-mercaptopurine chemotherapy adherence based on 6-MP metabolite analysis of peripheral blood biospecimens collected during the Consolidation II and Continuation phases of treatment in patients randomized to either MedSupport intervention or usual care PATIENT II To use statistical modeling to examine potential mechanismsmediators medication barriers verse vs social support medication beliefs of intervention efficacy in patients randomized to either MedSupport intervention or usual care PATIENT III To use statistical modeling to explore potential moderators of intervention efficacy including child age caregiver socioeconomic status race ethnicity and household structure in patients randomized to either MedSupport intervention or usual care PATIENT IV To determine parent intervention uptake by examining engagement with the screening questionnaire among parents from the intervention arm as a percentage based upon the ratio of the number of screening questionnaires completed to the number of questionnaires the participant was eligible to complete CAREGIVER V To assess whether parents from the intervention arm engaged with the educational videos as a percentage based upon the ratio of the number of minutes of videos watched compared to the number of minutes of educational videos the participant was prompted to view CAREGIVER VI To examine the strategies that may hinder or support implementation within routine care by assessing how parents from the intervention arm rated the acceptability appropriateness and feasibility of the MedSupport intervention CAREGIVER VII To explore barriers and facilitators to adoption feasibility and sustainability of the MedSupport intervention by examining the responses of a sample of 20 parent participants from the intervention arm who participate in semi-structured qualitative interviews CAREGIVER VIII To determine healthcare provider uptake by examining documentation of 4 weeks of adherencemedication-related consultations from intervention arm patients Electronic Health Record EHR following a medication barrier alert INSTITUTIONAL IX To examine strategies that may hinder or support implementation within routine care by assessing healthcare provider ratings of the acceptability appropriateness and feasibility of the MedSupport intervention INSTITUTIONAL X To explore barriers and facilitators to adoption feasibility implementation organizationalcontextual factors that support maintenance and cost of the MedSupport intervention by examining the responses of a sample of 20 healthcare providers who participated in semi-structured qualitative interviews INSTITUTIONAL
OUTLINE Participants are randomized to 1 of 2 groups
GROUP A Participants receive the MedSupport intervention consisting of three components universal screening for adherence barriers tailored virtual education enhancement and communication of barriers to activate multidisciplinary healthcare teams for 12 months Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up Patients also undergo blood sample collection throughout the study
GROUP B Participants receive usual care consisting of medical consultations and supportive care for 12 months Participants also use the MEMS device to track oral chemotherapy adherence at baseline and follow-up Patients also undergo blood sample collection throughout the study
After completion of study intervention participants are followed up at 1 year and 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA283501 | NIH | Roswell Park Cancer Institute | httpsreporternihgovquickSearchR01CA283501 |
| NCI-2024-01734 | REGISTRY | None | None |
| I-3920723 | OTHER | None | None |