grant

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

Organization 5 POINT APPLocation NEW YORK, UNITED STATESPosted 7 May 2025Deadline 30 Apr 2027
NIHUS FederalResearch GrantFY202521+ years oldAcupressureAddressAdherenceAdoptedAdoptionAdultAdult HumanAffectAfter CareAfter-TreatmentAftercareAgeAmericanAndroidApple watchAroma TherapyAromatherapyCancer CenterCancer SurvivorCancer TreatmentCancersClinicalClinical TrialsCognition TherapyCognitive PsychotherapyCognitive TherapyCognitive treatmentCommunity PracticeComputer Software DevelopmentComputer Software EngineeringComputer softwareControl GroupsDataDecentralizationDiagnosisDistressDoseEducationEducational MainstreamingEducational aspectsEducational process of instructingEffectivenessEmotionalEvaluationExerciseFatigueFeedbackFutureGenderGeographyGoalsHealthHealth Care ProvidersHealth PersonnelHomeIndividualInformaticsInsomniaInsomnia DisorderInstitutionInstructionInsuranceInterventionInterviewIschemic CompressionLack of EnergyLicensingLocationMainstreamingMalignant Neoplasm TherapyMalignant Neoplasm TreatmentMalignant NeoplasmsMalignant TumorMarketingMeasuresMental HealthMental HygieneModelingModificationMonitorMusicNon-pharmacologic TherapyNonpharmacologic InterventionNonpharmacologic TherapyNonpharmacologic approachNonpharmacologic treatmentOutcomeParticipantPatient Self-ReportPatientsPersonsPhaseProviderPsychological HealthQOLQualifyingQuality of lifeQuestionnairesRandomizedRecommendationRelaxationRitual compulsionRitualsSBIRSamplingScienceScientistSelf CareSelf ManagementSelf-ReportSleepSleep DeprivationSleep disturbancesSleeplessnessSmall Business Innovation ResearchSmall Business Innovation Research GrantSoftwareSoftware EngineeringSurvivorsSymptomsTeachingTechniquesTestingTimeUnited StatesVisualWaiting Listsaberrant sleepachievement Mainstream Educationadulthoodagesanti-cancer therapyapplewatchassess effectivenessassessment appassessment applicationassociated symptomcancer therapycancer-directed therapyco-morbid symptomco-occuring symptomcognitive behavior interventioncognitive behavior modificationcognitive behavior therapycognitive behavioral interventioncognitive behavioral modificationcognitive behavioral therapycognitive behavioral treatmentcommercializationcomorbid symptomconcurrent symptomcooccuring symptomcostdata collected in real worlddebilitating symptomdeficient sleepdesigndesigningdetermine effectivenessdisrupted sleepdistractiondisturbed sleepeffectiveness assessmenteffectiveness clinical trialeffectiveness evaluationeffectiveness testingeffectiveness validationethnic diversityethnically diverseevaluate effectivenessexamine effectivenessexperiencefitbitfitnesshealth care personnelhealth care workerhealth providerhealth workforcehomesimpaired sleepimprovedimproved outcomeimprovement on sleepinadequate sleepinstructorinsufficient sleepirregular sleepm-HealthmHealthmalignancymanage symptommedical personnelmindfulnessmobile healthneoplasm/cancernon-drug therapynon-drug treatmentnondrug therapynondrug treatmentpersonal carephysical conditioningphysical healthpost treatmentracial diversityracially diverserandomisationrandomizationrandomly assignedreal world dataresponseskillssleep debtsleep deficiencysleep deficitsleep disruptionsleep dysregulationsleep healthsleep hygienesleep improvementsleep insufficiencysleep losssleep wellnesssleep/wake disruptionsleep/wake disturbancesocialsocial engagementsocial involvementsocial participationsymptom associationsymptom comorbiditysymptom managementtreatment providerusabilityvalidate effectivenesswaitlist
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Full Description

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.

Grant Number: 1R44CA297977-01
NIH Institute/Center: NIH

Principal Investigator: SUSAN BECK

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