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MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication

Award Number: R01CA283501
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2024
PERIOD OF PERFORMANCE END DATE: 03/31/2029

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MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication - Pediatric nonadherence 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. Participants in our previous studies have described medication adherence as “one of the most stressful parts” of pediatric cancer caregiving, and we found that 93% of parents experience barrier(s) to medication administration. We have designed MedSupport, a theory-based multilevel intervention that is designed to address root barriers to medication adherence. In Aim 1 we will determine if the MedSupport intervention increases the proportion of patients with chemotherapy adherence 95% or higher. Our study design leverages a unique opportunity as a companion study for an upcoming therapeutic trial and will enroll at 8 pediatric cancer programs. This will enhance methodological rigor through leveraging robust clinical trial infrastructure to achieve multi-site recruitment in diverse geographic and clinical sites. We will recruit families of pediatric patients with ALL (N = 150) on home-based chemotherapy. Families will be randomized 1:1 to (1) the MedSupport intervention and (2) usual care with standardized education control. We will use both MEMS electronic medication monitoring and innovative biomarkers of drug metabolites to measure adherence. In Aim 2 we will test a theory-based mechanism of intervention effectiveness. These results will increase conceptual significance through rigorous examination of mechanisms of action of the MedSupport intervention to inform future intervention optimization and translation. In Aim 3 we will use the Implementation Outcomes Framework to examine implementation effectiveness to enhance future dissemination of the MedSupport intervention. We will examine the relationship between implementation quality on intervention effectiveness (Aim 3a) and strategies that may hinder or support uptake within routine care to inform future implementation strategies (Aim 3b). Our design incorporates numerous elements that substantially increase rigor and reproducibility including leveraging a large therapeutic trial for multi-site participant recruitment and rigorous measurement of adherence through objective behavioral measures (electronic medication monitoring) and pharmacological measures (validated biomarkers of drug metabolites). Findings will make significant conceptual contributions through examining how the MedSupport intervention works to pave the way for future intervention optimization. Findings will have significant translational impact through examining implementation effectiveness to enhance future dissemination of the MedSupport intervention. Upon completion of this research, we will have an innovative, low-cost, and scalable intervention to enhance home-based medication adherence in pediatric cancer that is ready to be translated to clinical practice. While this study focuses on pediatric ALL, the MedSupport intervention has potential for high impact in numerous pediatric diseases.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $612,506 )
2025	2025	HEALTH RESEARCH, INC.	665 ELM ST	BUFFALO	NY	14203	ERIE	USA	Cancer Cause and Prevention Research	000	2	3/28/2025	NON-COMPETING CONTINUATION	$612,506
														Subtotal = $612,506

Issue Date FY: 2024 ( Subtotal = $754,264 )
2024	2024	HEALTH RESEARCH, INC.	665 ELM ST	BUFFALO	NY	14203	ERIE	USA	Cancer Cause and Prevention Research	000	1	3/15/2024	NEW	$754,264
														Subtotal = $754,264

Grand Total All Awards = $1,366,770

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MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication

Award Number: R01CA283501

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2024

PERIOD OF PERFORMANCE END DATE: 03/31/2029

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