Creation of an mHealth Infrastructure to Support the Development and Delivery of mHealth Interventions: Protocol for Demonstration Projects Addressing Smoking Cessation in Cancer Care

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Abstract
Background: Cancer remains a leading cause of morbidity worldwide. To reduce this burden, scalable, effective approaches are needed to address modifiable risk factors for cancer and support behavioral self-management. With smartphone ownership now nearly ubiquitous, mobile health (mHealth) interventions offer a powerful means to extend the reach, accessibility, and sustainability of evidence-based treatments for a variety of modifiable risk factors (eg, excessive alcohol use, physical inactivity, poor diet, and smoking). Moreover, the flexibility of mHealth platforms enables efficient delivery of novel interventions, supports innovative study designs, and facilitates real-time data collection to advance public health research. Objective: Despite the great potential of mHealth interventions, developing high-quality mHealth tools is complex, time-consuming, and resource-intensive. To address these challenges, we are developing a coordinated, accessible, research-grade infrastructure for mHealth app development, testing, and dissemination. Methods: The mHealth Florida infrastructure (mFLi) will provide a comprehensive, low-code software platform that enables researchers to build apps compatible with major mobile operating systems, namely, Apple iOS and Google Android. Through a modular interface, users will select from a menu of prebuilt features to tailor functionality to specific study needs. The platform will include 3 integrated environments (development, testing, and production), allowing researchers to prototype, evaluate, and deploy mHealth interventions. This infrastructure will be developed and maintained by a multidisciplinary team, ensuring that the platform is technically robust and usable and adheres to institutional and regulatory standards. To demonstrate the platform’s functionality, utility, and adaptability, a multisite study comprising three initial projects focused on smoking cessation among patients with cancer is being conducted: (1) participant screening and enrollment, (2) randomization and treatment delivery, and (3) data processing using machine learning methods with on-device and cloud-based approaches. Results: This study was funded in May 2023, and ethics approval was obtained from all involved sites’ institutional review boards between February 2024 and October 2025. Recruitment began in March 2025 and enrollment is ongoing. As of January 2026, 41% (37/90) of the target sample have been enrolled and 21% (19/90) have completed their 6-month assessment. Data collection will be completed once the final participant completes their 6-month assessment (expected May 2027), with analyses commencing thereafter. Study findings are anticipated to be published in a peer-reviewed journal in 2027. Conclusions: Collectively, these projects will illustrate how mFLi can streamline app development, facilitate rapid translation of research into practice, and reduce barriers for researchers and developers. Ultimately, mFLi is designed to accelerate innovation in mHealth research, enhance access to behavioral interventions, and improve health outcomes among diverse populations. Trial Registration: ClinicalTrials.gov NCT06909357; https://clinicaltrials.gov/study/NCT06909357 International Registered Report Identifier (IRRID): PRR1-10.2196/92288

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