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Trial Title:
MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence
NCT ID:
NCT06323044
Condition:
Acute Lymphoblastic Leukemia
Conditions: Official terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive usual care
Arm group label:
Arm B (usual care)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm A (MedSupport)
Arm group label:
Arm B (usual care)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Ancillary studies
Arm group label:
Arm A (MedSupport)
Arm group label:
Arm B (usual care)
Intervention type:
Other
Intervention name:
Interview
Description:
Ancillary studies
Arm group label:
Arm A (MedSupport)
Arm group label:
Arm B (usual care)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Receive MedSupport intervention
Arm group label:
Arm A (MedSupport)
Intervention type:
Other
Intervention name:
Medical Device Usage and Evaluation
Description:
Use MEMS device
Arm group label:
Arm A (MedSupport)
Arm group label:
Arm B (usual care)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm A (MedSupport)
Arm group label:
Arm B (usual care)
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 2.7-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 mechanisms/mediators
(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 adherence/medication-related
consultations from intervention arm patient's 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, organizational/contextual 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Parent of a child who is diagnosed and receiving first line therapy for acute
lymphoblastic leukemia (ALL) at a study site.
- Parent's child patient is age 365 days to < 19 years at time of study entry.
- Parent's child patient's therapy must include 6-mercaptopurine (6-MP) administered
orally or by nasogastric (NG) tube.
- Parent has verbal English, French, or Spanish fluency.
- Parent has a smartphone or access to a computer with an Internet connection.
- Participant must understand the investigational nature of this study and sign an
Independent Ethics Committee/Institutional Review Board approved written informed
consent form prior to receiving any study related procedure.
Exclusion Criteria:
- Parent is unwilling or unable to follow protocol requirements.
Gender:
All
Minimum age:
365 Days
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Contact:
Last name:
Kara M. Kelly
Phone:
716-845-2333
Email:
Kara.Kelly@RoswellPark.org
Investigator:
Last name:
Kara M. Kelly
Email:
Principal Investigator
Start date:
November 15, 2024
Completion date:
June 15, 2029
Lead sponsor:
Agency:
Roswell Park Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Roswell Park Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06323044