Grant Number:	1R01CA291977-01 Interpret this number
Primary Investigator:	Linder, Lauri
Organization:	University Of Utah
Project Title:	Mhealth Intervention to Support Symptom Communication for Children with Cancer
Fiscal Year:	2024

PROJECT SUMMARY Inadequately managed symptoms caused by their disease and its treatment result in unnecessary suffering for children with cancer that interferes with their quality of life and may impact survival. Communication that emphasizes the child’s self-report and is actionable by the child’s parents and the clinical team is key to effective symptom management. The early cancer treatment period (ECTP) is a key time to implement interventions targeting symptom-related communication. Digital health tools, including mobile health (mHealth) apps are emerging as proposed solutions to support health-related communication between patients and clinicians. The Office of the National Coordinator for Health Information Technology prioritizes the routine use of patient-generated health data (PGHD), data recorded by patients that complement clinical data, in clinical care. Achieving the larger goal of integrating PGHD from mHealth apps into clinical care requires attention to data security, interoperability standards for data exchange, and representation of data within the electronic health record (EHR). Integrating PGHD in clinical care also requires attention to facilitators and barriers such as patient/family adherence to reporting, accessibility of PGHD in the EHR, and clinician engagement. Our interprofessional team engaged school-age children (6-12 years) with cancer, parents, and clinicians to co- design Color Me Healthy, a child-centric app that provides an evidence-based structure for children to report eleven common symptoms, and demonstrated its feasibility and acceptability. Our next critical step to advance Color Me Healthy to scalable implementation is to develop and evaluate a clinician-facing app that is interoperable with electronic health record (EHR) systems to integrate review and discussion of children’s data as part of the clinical workflow. The project will be conducted as an early phase Behavioral Intervention Development Trial to define and refine key components of implementing Color Me Healthy during the ECTP with attention to underlying mechanisms of the intervention and to identify and address facilitators and barriers from perspectives of children, parents, and clinicians. During Aim 1, we will employ user-centered design methods to develop a Web-based, clinician-facing version of the Color Me Healthy app for EHR integration as a SMART on FHIR app. Aim 2 will allow us to optimize implementation of Color Me Healthy as an implementable communications-support intervention in the clinical setting during the ECTP by engaging children, parents, and clinicians to define and refine key components of the intervention. During Aim 3, we will conduct a single-site repeated measures trial to evaluate the efficacy of implementing Color Me Healthy in the ECTP to improve symptom communication. The immediate expected outcome is successful implementation of an interoperable, scalable SMART® on FHIR app to improve symptom communication during the ECTP. The proposed work will build a chain of evidence to meet our long-term goal to deliver timely, evidence-based care to alleviate symptoms and promote quality of life for children with cancer.





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