This Project Grant award from the National Cancer Institute (CFDA 93.393 - Cancer Cause and Prevention Research) provides $1,019,587.00 to 5 Point App, Inc. to conduct a decentralized clinical trial evaluating the effectiveness of the EnergyPoints mobile app for guiding acupressure use to manage fatigue and sleep disturbances in cancer survivors. The 2-year project aims to: 1) determine the app's effectiveness on clinical outcomes like fatigue, sleep, and quality of life, and 2) identify optimal...
This Project Grant award from the National Cancer Institute (CFDA 93.395 Cancer Treatment Research) provides $638,326 to the H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc. to adapt and evaluate a cognitive behavioral therapy for fatigue (CBTF) intervention called "ENERGIZE-MBC" for women with metastatic breast cancer treated with CDK4/6 inhibitors. The project aims to: 1) adapt CBTF to the needs of this patient population, 2) refine and finalize a web-based platform...
This $656,014 Project Grant award from the National Cancer Institute (CFDA 93.393 - Cancer Cause and Prevention Research) will fund a randomized clinical trial at The Ohio State University to evaluate the effectiveness of a telemedicine-mHealth symptom management intervention, called FOCUS, for advanced cancer patients in underserved rural communities. The FOCUS intervention aims to improve a symptom cluster including sleep difficulties, anxiety, depression, and fatigue, and enhance functional...
This Project Grant award from the National Cancer Institute (NCI), under the Cancer Research Manpower (CFDA 93.398) program, supports a study titled "Examining Physical Activity Promotion Intervention Outcomes, Barriers and Facilitators in Breast Cancer Survivors with Fatigue." The $174,752 award, effective September 1, 2024 through March 31, 2026, will be conducted by Northwestern University. The study aims to explore the effects of different physical activity promotion intervention...
The National Heart, Lung, and Blood Institute (NHLBI) awarded a $1,602,357 Project Grant under the Cardiovascular Diseases Research program (CFDA 93.837) to KDH Research & Communication, Inc., a woman-owned small business located in Atlanta, GA. The grant funds the development and evaluation of the "Personalized Approach to Habits-Sleep" (PATH-S) mobile app, which aims to improve sleep duration and asthma symptoms for Black teenagers aged 14-17 with asthma. The PATH-S app will...
This federal Project Grant award, in the amount of $594,734, was provided by the National Cancer Institute (NCI) under the Cancer Treatment Research program (CFDA 93.395) to investigate the effects of a telehealth exercise program for rural cancer survivors experiencing cancer-related fatigue. The primary objectives are to evaluate the efficacy of the "BFITBWell Telehealth Program" for improving cancer-related fatigue in rural breast and prostate cancer survivors, and to examine the...
This Project Grant award from the National Institute on Drug Abuse (NIDA) under the Drug Abuse and Addiction Research Programs (CFDA 93.279) aims to develop and test a mobile health system prototype for early prediction of chemotherapy-induced peripheral neuropathy (CIPN). The $403,240 award to Newventureiq LLC will fund the development of the "Allo-Cold" mobile app, which will use a patient-reported data collection approach to quantify cold hypersensitivity as an early biomarker for...
This Project Grant award from the National Center for Complementary and Integrative Health (NCCIH), under the federal Research and Training in Complementary and Integrative Health grant program (CFDA 93.213), will fund the development and pilot testing of a novel, daily, digitally delivered mindfulness-based intervention for depressive symptoms in post-treatment cancer patients. The $165,240 award, granted to the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University,...
This Project Grant award from the National Center for Complementary and Integrative Health (NCCIH), under the Research and Training in Complementary and Integrative Health program (CFDA 93.213), will fund the development and evaluation of the AirPen, a novel device designed to facilitate diaphragmatic breathing interventions for stress management among college students. The $294,312 award will support the following key objectives over the 1-year project period: Refine the AirPen intervention...
This Project Grant award from the National Cancer Institute (CFDA 93.395 - Cancer Treatment Research) provides $752,588 to the University of Maryland, Baltimore to conduct a 12-week randomized controlled trial studying the effects of time-restricted eating on cancer-related fatigue among survivors of hematological malignancies. The study will recruit 96 participants and assess patient-reported fatigue, circadian activity rhythms, and glucose metabolism. The project aims to provide initial...
A NEW MULTI-FUNCTIONAL AND CONNECTED MOBILE APP GUIDING ACUPRESSURE USE FOR SELF-MANAGEMENT AND MONITORING OF CANCER RELATED FATIGUE AND SLEEP DISTURBANCES - PROJECT SUMMARY FATIGUE AND SLEEP DISTURBANCES, COMMON, DISTRESSING, AND DEBILITATING SYMPTOMS OF CANCER AND ITS TREATMENT, NEGATIVELY IMPACT PHYSICAL, EMOTIONAL, AND SOCIAL HEALTH OF MILLIONS OF CANCER PATIENTS. MOST OF THE 1.7 MILLION AMERICANS DIAGNOSED WITH CANCER IN 2020 WILL SUFFER 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 PATIENTS) CONTRIBUTE TO POOR HEALTH AND MAY EXACERBATE FATIGUE. MOUNTING EVIDENCE INDICATES THAT ACUPRESSURE, WHICH IS UNFAMILIAR AND INFREQUENTLY USED BY CANCER SURVIVORS, CAN REDUCE FATIGUE AND IMPROVE SLEEP. 5 POINT APP, INC. IS DEVELOPING ITS FIRST MOBILE HEALTH (MHEALTH) SOFTWARE, ENERGYPOINTS, A PATIENT ACTIVATION AND EDUCATIONAL APP THAT OFFERS AN OPPORTUNITY TO MAINSTREAM ACUPRESSURE-A BENEFICIAL STRATEGY TO HELP CANCER PATIENTS SELF-MANAGE THEIR SYMPTOMS. THE ENERGYPOINTS APP WILL MOTIVATE AND GUIDE CANCER PATIENTS TO IMPLEMENT DAILY ACUPRESSURE PROTOCOLS TO SELF-MANAGE FATIGUE AND SLEEP DISTURBANCES. THE APP WILL CONNECT INDIVIDUAL SLEEP AND ACTIVITY DATA SYNCED FROM AN APPLE WATCH/FITBIT WITH SELF-REPORTS OF SYMPTOMS, ALLOWING PATIENTS AND CLINICAL PROVIDERS TO MONITOR SYMPTOM RESPONSE TO ACUPRESSURE SELF-TREATMENT. THE LONG- TERM GOAL IS TO IMPROVE QUALITY OF LIFE FOR CANCER PATIENTS SUFFERING FROM FATIGUE AND SLEEP DISTURBANCES USING ACUPRESSURE AS A SAFE, UNIVERSALLY AFFORDABLE SELF-CARE TECHNIQUE. THE TEAM WILL FIRST DEVELOP A FULLY FUNCTIONAL PROTOTYPE APP, VALIDATING DATA ACCURACY AND DEBUGGING PROGRAMMING. SPECIFIC AIM 1 IS TO CONFIRM CANCER PATIENTS CAN ACCURATELY AND CONSISTENTLY SELF-ADMINISTER TWO ACUPRESSURE PROTOCOLS USING THE APP. SPECIFIC AIM 2 IS TO ASSESS THE USABILITY OF THE APP AND THE FITNESS TRACKER. USING AN INTEGRATED AGILE, USER-CENTERED APPROACH, 20 PATIENTS WITH CANCER WHO ARE EXPERIENCING FATIGUE WILL USE THE APP TO SELF-ADMINISTER ACUPRESSURE (TWICE DAILY FOR 1 WEEK) WHILE WEARING A FITNESS TRACKER. USER PERFORMANCE VIDEO-RECORDINGS, AND FEEDBACK VIA TALK-ALOUD SESSION, DEBRIEFING, AND EXIT INTERVIEW, WILL BE USED TO IMPROVE ALL PROTOTYPE APP FEATURES IN SPRINTS. RESULTS WILL PROVIDE EVIDENCE OF FEASIBILITY AND USABILITY: SPECIFICALLY, THE ENERGYPOINTS PROTOTYPE APP CAN TEACH AND GUIDE CANCER PATIENTS TO PERFORM ACUPRESSURE AS DIRECTED, IS ACCEPTABLE, AND CAN CONNECT AND ACCURATELY SHARE IMPORTANT HEALTH DATA FROM A FITNESS TRACKER. IN A SUBSEQUENT PHASE 2 SBIR APPLICATION, A CLINICAL TRIAL IS PLANNED TO EXAMINE EFFICACY OF THE APP IN IMPROVING FATIGUE AND SLEEP IN A SAMPLE OF CANCER PATIENTS. ADDITIONALLY, ENERGYPOINTS APP FEATURES WILL BE EXTENDED BY ADDING: 1) USE OF ESSENTIAL OILS; 2) TAILORED ACUPRESSURE DELIVERY; 3) CLINICAL MONITORING TO INTEGRATE WITH CANCER CARE; 4) SOCIAL CONNECTION FEATURES, 5) ADDITIONAL MEASURES (E.G. PAIN, DEPRESSION, ACTIVATION) AND 6) COMPATIBILITY WITH OTHER TRACKERS (E.G. AMAZON HALO). POTENTIAL USERS INCLUDE MILLIONS OF CANCER PATIENTS BEFORE AND AFTER TREATMENT. THE INITIAL COMMERCIALIZATION STRATEGY INCLUDES MULTIPLE REVENUE STREAMS AND MARKETING DIRECTED TOWARDS PATIENTS, CAREGIVERS, PRACTITIONERS, CANCER CENTERS, HOSPITALS, MEDICAL PRACTICES, AND CORPORATE SPONSORS.