Decentralized Clinical Trial of Effectiveness of EnergyPoints App to Guide Acupressure Use for Fatigue and Sleep Disturbances in Cancer Survivors

5 Point App, New York NY

Investigators

Abstract

PROJECT SUMMARY The Cancer Moonshot Initiative prioritized improving common, distressing, and debilitating symptoms of cancer and its treatment including fatigue and sleep disturbances, symptoms that negatively impact physical, emotional, and social health of millions of cancer survivors. Most of the 1.9 million Americans diagnosed with cancer in 2024 will suffer from cancer- and treatment-related symptoms; up to 90% receiving treatment experience fatigue; 30% may experience long-lasting fatigue. Sleep disturbances (affecting up to 75% of survivors) contribute to poor health and may exacerbate fatigue. Evidence indicates that acupressure, which is unfamiliar and infrequently used by cancer survivors, can reduce fatigue and improve sleep. 5 Point App, Inc. developed its first mobile health software, EnergyPoints, an activation and educational app that offers an opportunity to increase access to acupressure–a beneficial strategy to help cancer survivors self-manage their symptoms. During our feasibility and usability study, we developed a fully functional app, validated data accuracy and acceptability, debugged programming, and enhanced the original design by adding user- recommended features such as music, visual distraction, aromatherapy, and social engagement. The EnergyPoints app guides implementation of daily acupressure rituals to self-manage fatigue and sleep disturbances. The app connects individual sleep and activity data, synchronized from an Apple Watch/Fitbit, with self-reports of symptoms, allowing users and clinical providers to monitor symptoms and their response to acupressure self-treatment. The long-term goal is to improve clinical outcomes for cancer survivors by mainstreaming acupressure as a safe, affordable self-care technique for managing symptoms. In this Phase II SBIR project, we will enhance the app by allowing users to personalize the acupressure and use enhancements to improve the experience and outcomes. We will conduct a decentralized clinical trial (DCT) in which cancer survivors use the EnergyPoints app at home for 6 weeks. Blocking on treatment status (on and off cancer treatment), we will randomize a national, geographically, racially, and ethnically diverse sample of 180 adult cancer survivors with fatigue to the EnergyPoints-Immediate Group or a Wait-List Control Group. Data includes weekly and daily self-report measures of fatigue, sleep, and quality of life (physical and mental health) and tracker measures of activity and sleep. An exit interview and questionnaire assess app usability, acceptability, and desirability. The aims are to 1) determine the effectiveness of EnergyPoints on clinical outcomes, and 2) identify important intervention dose and enhancement effects (e.g., dose of each ritual, time of pressing, ritual adherence, and use of music). The DCT evidence will support the effectiveness and commercialization of EnergyPoints and guide future improvements. A commercialization plan proposes direct subscriptions, institutional licenses (e.g., cancer centers, community practices), and sponsors to reach nearly 7 million people living with cancer-related fatigue and sleep disturbances in the United States.