Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06323044 |
| Other study ID # |
I-3920723 |
| Secondary ID |
NCI-2024-01734I- |
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2024 |
| Est. completion date |
June 15, 2029 |
Study information
| Verified date |
April 2024 |
| Source |
Roswell Park Cancer Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
