Digital Therapeutics Research Articles

Digital assessment of cognitive-affective biases related to mental health.

With an increasing societal need for digital therapy solutions for poor mental health, we face a corresponding rise in demand for scientifically validated digital contents. In this study we aimed to lay a sound scientific foundation for the development of brain-based digital therapeutics to assess and monitor cognitive effects of social and emotional bias across diverse populations and age-ranges. First, we developed three computerized cognitive tasks using animated graphics: 1) an emotional flanker task designed to test attentional bias, 2) an emotional go-no-go task to measure bias in memory and executive function, and 3) an emotional social evaluation task to measure sensitivity to social judgments. Then, we confirmed the generalizability of our results in a wide range of samples (children (N = 50), young adults (N = 172), older adults (N = 39), online young adults (N=93), and depression patients (N = 41)) using touchscreen and online computer-based tasks, and devised a spontaneous thought generation task that was strongly associated with, and therefore could potentially serve as an alternative to, self-report scales. Using PCA, we extracted five components that represented different aspects of cognitive-affective function (emotional bias, emotional sensitivity, general accuracy, and general/social attention). Next, a gamified version of the above tasks was developed to test the feasibility of digital cognitive training over a 2-week period. A pilot training study utilizing this application showed decreases in emotional bias in the training group (that were not observed in the control group), which was correlated with a reduction in anxiety symptoms. Using a 2-channel wearable EEG system, we found that frontal alpha and gamma power were associated with both emotional bias and its reduction across the 2-week training period.

Understanding patient perspectives on digital therapeutics and its platform for insomnia: insights from focused group interviews

BackgroundDigital therapeutics (DTx) is a treatment option that uses computer software to provide evidence-based interventions for medical disorders. DTx platforms are digital services that facilitate interactions among stakeholders of DTx treatment within a standardized structure. However, there is still a lack of overall awareness regarding the effectiveness and usage of DTx and DTx platforms. This study aimed to investigate insomnia patients’ recognition, thoughts, feelings, and demands for conventional treatments versus DTx for insomnia.MethodsNine participants, aged 19–50 years, who had experience with professional medical interventions for insomnia, were recruited through purposive sampling. Two online focus group interviews, each lasting 1.5 h, were conducted. The interview questions focused on difficulties encountered during conventional treatment, inadequate recognition of DTx, and concerns and demands regarding DTx and its platform. The data were analyzed using thematic analysis.ResultsThe participants reported subjective difficulties associated with receiving conventional treatment, including concerns about drug side effects and dependence, social stigma, and lack of perceived necessity for treatment. They expressed concerns about DTx, such as cost-effectiveness, evidence on efficacy, and concerns about breach of personal information. Additionally, their demands included convenience of use, reduction in social stigma related to the use of DTx, compatibility of DTx with other healthcare systems, and enhanced communication with healthcare providers when using DTx platforms.ConclusionsThe focus group highlighted the need for increased awareness, demonstrated efficacy, cost-effectiveness, cybersecurity measures, and accessibility of insomnia DTx and its platforms. Tailored approaches considering patient characteristics are crucial for widespread adoption of insomnia DTx and its platforms.

A Digital Platform for Home-Based Exercise Prescription for Older People with Sarcopenia.

Digital therapeutics refers to smartphone applications, software, and wearable devices that provide digital solutions to improve healthcare delivery. We developed a digital platform to support the GYM (Grow Your Muscle) study, an ongoing 48-week randomized, controlled trial on reduction of sarcopenia through a home-based, app-monitored physical exercise intervention. The GYM platform consists of a smartphone application including the exercise program and video tutorials of body-weight exercises, a wearable device to monitor heart rate during training, and a website for downloading training data to remotely monitor the exercise. The aim of this paper is to describe the platform in detail and to discuss the technical issues emerging during the study and those related to usability of the smartphone application through a retrospective survey. The main technical issue concerned the API level 33 upgrade, which did not enable participants using the Android operating systems to use the wearable device. The survey revealed some problems with viewing the video tutorials and with internet or smartphone connection. On the other hand, the smartphone application was reported to be easy to use and helpful to guide home exercising. Despite the issues encountered during the study, this digital-supported physical exercise intervention could provide useful to improve muscle measures of sarcopenia.

Brief Review and Primer of Key Terminology for Artificial Intelligence and Machine Learning in Hypertension.

Recent breakthroughs in artificial intelligence (AI) have caught the attention of many fields, including health care. The vision for AI is that a computer model can process information and provide output that is indistinguishable from that of a human and, in specific repetitive tasks, outperform a human's capability. The 2 critical underlying technologies in AI are used for supervised and unsupervised machine learning. Machine learning uses neural networks and deep learning modeled after the human brain from structured or unstructured data sets to learn, make decisions, and continuously improve the model. Natural language processing, used for supervised learning, is understanding, interpreting, and generating information using human language in chatbots and generative and conversational AI. These breakthroughs result from increased computing power and access to large data sets, setting the stage for releasing large language models, such as ChatGPT and others, and new imaging models using computer vision. Hypertension management involves using blood pressure and other biometric data from connected devices and generative AI to communicate with patients and health care professionals. AI can potentially improve hypertension diagnosis and treatment through remote patient monitoring and digital therapeutics.

Digital Healthcare Innovations and Idea Management

The aim of the paper is to analyse the global demand development and funding of digital healthcare innovations and also characterise idea management trends in the digital healthcare context. Web-based idea management systems (IMS) fall in line with the growing importance of information communication technologies, the spread of open innovation and co-innovation, etc. Especially systems, which are based on the Internet during COVID-19 have become important tools in all sectors. Plus, over the last few years the changes related to digital healthcare have taken place and now in this context the questions have been raised. How could they be linked with a web-based IMS? What are digital healthcare innovation demands and funding trends? The changes in search habits for health information over the last three years have become statistically significant. The growth of funding volumes has followed these changes because both digital health care and digital therapeutics have increased much faster during pandemic times than before. The growth in 2020 compared to 2019 reached 53.9%, but in 2021 compared to 2020 it even accounted 74.7%. The Asian region and Europe have also seen a sharp increase in the leverage over the past two years, but pre-pandemic levels were significantly lower than in the United States. Average annual volumes of investments in digital health have increased by about 4.2 Bn$ per year in the USA, by about 1.2 Bn$ per year in Asia, by about 0.83 Bn$ per year in Europe and by about 0.15 Bn$ per year in other regions. Such demand and funding could boost new innovations in healthcare with web-based idea management systems by internal, external, and mixed approaches in organisations with active and passive IMS. Plus, IMS could become a tool to create innovations in product or organisational innovation.

Redesigning Pharmacy to Improve Public Health Outcomes: Expanding Retail Spaces for Digital Therapeutics to Replace Consumer Products That Increase Mortality and Morbidity Risks.

United States healthcare outcomes, including avoidable mortality rates, are among the worst of high-income countries despite the highest healthcare spending per capita. While community pharmacies contribute to chronic disease management and preventive medicine, they also offer consumer products that increase mortality risks and the prevalence of cardiovascular diseases, diabetes, cancer, and depression. To resolve these contradictions, our perspective article describes opportunities for major pharmacy chains (e.g., CVS Pharmacy and Walgreens) to introduce digital health aisles dedicated to prescription and over-the-counter digital therapeutics (DTx), together with mobile apps and wearables that support disease self-management, wellness, and well-being. We provide an evidence-based rationale for digital health aisles to replace spaces devoted to sugar-sweetened beverages and other unhealthy commodities (alcohol, tobacco) that may increase risks for premature death. We discuss how digital health aisles can serve as marketing and patient education resources, informing customers about commercially available DTx and other technologies that support healthy lifestyles. Since pharmacy practice requires symbiotic balancing between profit margins and patient-centered, value-based care, replacing health-harming products with health-promoting technologies could positively impact prevention of chronic diseases, as well as the physical and mental health of patients and caregivers who visit neighborhood pharmacies in order to pick up medicines.

Digital Therapeutics in Hearing Healthcare: Evidence-Based Review.

Digital therapeutics (DTx) in hearing research have emerged as a new category of therapies providing evidence-based intervention via digital means, such as software, smartphone apps, or websites. However, although relatively new, they are not well-established. In this article, we review DTx technologies in hearing research fields, focusing on three categories: prevention and diagnosis, aid (assistance), and cure (digital medicine). We observe that most DTx systems require interactions with users (or patients) without the direct support of clinical professionals to obtain or collect medical evidence; this makes training (or education) features crucial to the therapy's success. In this view, this article discusses the education or training functions of the current DTx and their contribution and purposes. The impact of emerging artificial intelligence (AI) on DTx in hearing research is being explored, and the future of DTx concerning AI integration is being discussed. We believe that this work will contribute to a better understanding of the current and future DTx technological advancements and, in particular, shed light on the field of hearing research.

Use of cortical hemodynamic responses in digital therapeutics for upper limb rehabilitation in patients with stroke

BackgroundStroke causes long-term disabilities, highlighting the need for innovative rehabilitation strategies for reducing residual impairments. This study explored the potential of functional near-infrared spectroscopy (fNIRS) for monitoring cortical activation during rehabilitation using digital therapeutics.MethodsThis cross-sectional study included 18 patients with chronic stroke, of whom 13 were men. The mean age of the patients was 67.0 ± 7.1 years. Motor function was evaluated through various tests, including the Fugl–Meyer assessment for upper extremity (FMA-UE), grip and pinch strength test, and box and block test. All the patients completed the digital rehabilitation program (MotoCog®, Cybermedic Co., Ltd., Republic of Korea) while being monitored using fNIRS (NIRScout®, NIRx Inc., Germany). Statistical parametric mapping (SPM) was employed to analyze the cortical activation patterns from the fNIRS data. Furthermore, the K-nearest neighbor (K-NN) algorithm was used to analyze task performance and fNIRS data to classify the severity of motor impairment.ResultsThe participants showed diverse task performances in the digital rehabilitation program, demonstrating distinct patterns of cortical activation that correlated with different motor function levels. Significant activation was observed in the ipsilesional primary motor area (M1), primary somatosensory area (S1), and contralateral prefrontal cortex. The activation patterns varied according to the FMA-UE scores. Positive correlations were observed between the FMA-UE scores and SPM t-values in the ipsilesional M1, whereas negative correlations were observed in the ipsilesional S1, frontal lobe, and parietal lobe. The incorporation of cortical hemodynamic responses with task scores in a digital rehabilitation program substantially improves the accuracy of the K-NN algorithm in classifying upper limb functional levels in patients with stroke. The accuracy for tasks, such as the gas stove-operation task, increased from 44.4% using only task scores to 83.3% when these scores were combined with oxy-Hb t-values from the ipsilesional M1.ConclusionsThe results advocated the development of tailored digital rehabilitation strategies by combining the behavioral and cerebral hemodynamic data of patients with stroke. This approach aligns with the evolving paradigm of personalized rehabilitation in stroke recovery, highlighting the need for further extensive research to optimize rehabilitation outcomes.

Longitudinal gut microbial signals are associated with weight loss: insights from a digital therapeutics program.

The gut microbiome's influence on weight management has gained significant interest for its potential to support better obesity therapeutics. Patient stratification leading to personalized nutritional intervention has shown benefits over one-size-fit-all diets. However, the efficacy and impact on the gut's microbiome of personalizing weight loss diets based on individual factors remains under-investigated. This study assessed the impact of Digbi Health's personalized dietary and lifestyle program on weight loss and the gut microbiome end-points in 103 individuals. Participants' weight loss patterns and gut microbiome profiles were analyzed from baseline to follow-up samples. Specific microbial genera, functional pathways, and communities associated with BMI changes and the program's effectiveness were identified. 80% of participants achieved weight loss. Analysis of the gut microbiome identified genera and functional pathways associated with a reduction in BMI, including Akkermansia, Christensenella, Oscillospiraceae, Alistipes, and Sutterella, short-chain fatty acid production, and degradation of simple sugars like arabinose, sucrose, and melibiose. Network analysis identified a microbiome community associated with BMI, which includes multiple taxa known for associations with BMI and obesity. The personalized dietary and lifestyle program positively impacted the gut microbiome and demonstrated significant associations between gut microbial changes and weight loss. These findings support the use of the gut microbiome as an endpoint in weight loss interventions, highlighting potential microbiome biomarkers for further research.

Digital therapeutics as an emerging new therapy for diabetes mellitus: potentials and concerns.

The global burden of controlling and managing diabetes mellitus (DM) is a significant challenge. Despite the advancements in conventional DM therapy, there remain hurdles to overcome, such as enhancing medication adherence and improving patient prognosis. Digital therapeutics (DTx), an innovative digital application, has been proposed to augment the traditional disease management workflow, particularly in managing chronic diseases like DM. Several studies have explored DTx, yielding promising results. However, certain concerns about this innovation persist. In this review, we aim to encapsulate the potential of DTx and its applications in DM management, thereby providing a comprehensive overview of this technique for public health policymakers.

디지털 의료기기의 등장에 따른 법적 문제와 법제 개선에 관한 연구

This study aims to review and improve the current legal issues related to the emergence of Digital Therapeutics. First, we reviewed the scope of the Game Industry Promotion Act (Game Industry Act) and what regulations are made under the Game Industry Act. In particular, the scope of application of the Game Industry Act is the same as whether or not a game falls under Article 2(1) of the Game Industry Act, and we found that the concept of a game is used in a broad sense both in literature and in practice. In other words, there have been precedents in which content in the field of education and video, which has not traditionally been considered a game, that uses VR technology or has a game nature, has been considered a game under the Game Industry Act. In addition, after reviewing the concept of Digital Therapeutics and examining related laws such as the Digital Medical Products Act, we found that some of the Digital Therapeutics use VR technology or take the form of a game, so there is room for them to fall under the Game Industry Act, but there is no discussion of game products in the legal discussions related to Digital Therapeutics. Therefore, in order to ensure that Digital Therapeutics with game characteristics are appropriately regulated in the Korean legal system, it is necessary to introduce a new concept of 'Digital Therapeutics game product' in the Digital Medical Products Act, establish a classification system that considers the characteristics of both Digital Therapeutics and game products, and provide special provisions. In addition, it suggests that improvements should be made to medical treatment benefits and telemedicine related to digital medical device games.

Digital Therapeutics and Decentralized Clinical Trials Optimization in An Era of Increasing Complexities

Digital Therapeutics and Decentralized Clinical Trials Optimization in An Era of Increasing Complexities

A Study on the UX Design of Digital Therapeutics(DTx) Based on Cognitive Behavioral Therapy in Patients with Eating Disorders aged 10 to 30

A Study on the UX Design of Digital Therapeutics(DTx) Based on Cognitive Behavioral Therapy in Patients with Eating Disorders aged 10 to 30

A Review of Current Digital Mental Health Care Applications for Anxiety Symptoms and Future Prospects.

Since the impact of the coronavirus disease-2019 pandemic, the need for efficiency in medical services has become more urgent than ever. The digital treatment market is rapidly growing worldwide and digital therapeutics (DTx), a major part of the digital medical services, is also emerging as a new paradigm for treatment, with its industry growing rapidly as well. Increasing research is done on the effectiveness of mobile DTx in improving mental health conditions such as insomnia, panic, and depression. This review paper investigates 1) the functions and characteristics of mobile digital mental health care applications for the treatment of anxiety symptoms, 2) extracts common attributes of the applications, and 3) compares them with existing traditional treatment mechanisms. Among the 20,000 mental health management applications that have been developed so far, 8 applications that are relatively widely used were selected and reviewed. Check-in, self-help tips, quick relief, journal, courses for practice are common features of the digital mental health care applications for anxiety and are also widely used feature in the cognitive behavioral therapy. Based on this review, we have proposed the essential elements and directions for the development of a Korean digital mental health care applications for anxiety disorders.

Feasibility and Acceptability Evaluation of a Digital Therapeutic Program for Improving Cancer Prevention: A Quasi-experimental Pre-post Interventional Pilot Study.

Previous studies have proved that healthy behaviors hinder the onset and progression of tumors. Digital therapeutics (DTx), playing a pivotal role in facilitating behavioral adjustments through educational interventions, lifestyle support, and symptom monitoring, contribute to the goal of tumor prevention. We aim to optimize the evaluation of the feasibility and acceptability of DTx for cancer prevention. This involves assessing AITI's daily activity rates and user feedback, and comparing changes in behavioral habits and differences in SF-36 before and after the intervention. In a 4-week trial with 57 participants engaging actively, we found both the average daily activity rate and 4-week retention rate at 35 (61.4%). The USE Questionnaire scores (validity, ease of use, acquisition, and satisfaction) ranged from 68.06 to 83.10, indicating AITI's user-friendliness and acceptability. Furthermore, positive habit changes were noted among participants in exercise and diet (p < 0.0001), suggesting the effectiveness of the DTx approach in modifying behavioral habits related to physical activity and nutrition. This pilot study underscores the potential of DTx in advancing cancer prevention. However, larger and longer studies are needed to comprehensively assess its impact.

Elderly patients' reactions to gamification-based digital therapeutics (DTx): The relevance of socialization tendency seeking

The acceptance of new technologies by elderly individuals has been long debated in literature, showing barriers in their adoption. However, recent technology features such as gamification have been promising a great deal of impact on their intention to use new technology-based solutions. Particularly in the healthcare sector, gamification has been suggested to increase elderly individuals' intention to use digital therapeutics. However, in the attempt to incentivize the adoption of these new technological innovations, the importance of socialization has been advanced as a further reinforcement mechanism by improving the social interactions of elderly patients thanks to the connections with young or expert people. In this paper, we aim to investigate whether the use of gamification affects elderly patients' intention to use new digital therapeutics (DTx) trying to shed lights on the importance of socialization as a winning strategy to boost their adoption. Through an explorative research design, we conducted a study among a selected group of 168 elderly participants. Our findings reveal that these patients' perceived ease of use gamification-based digital therapeutics positively affects their intention to use, via the perceived usefulness of such new technological features. More importantly, we find that this effect increases in magnitude as elderly patients' socialization tendency seeking increases, revealing the importance of socialization-oriented strategies in stimulating elderly's positive reactions to technological tools. This results in a higher willingness to adopt new digital healthcare therapeutics. Implications for both theory and practices emerge from this research.

The Effectiveness of Virtual Reality-Based Training on Cognitive, Social, and Physical Functioning in High-Functioning Older Adults (CoSoPhy FX): 2-Arm, Parallel-Group Randomized Controlled Trial.

Virtual reality (VR) has emerged as a promising technology for enhancing the health care of older individuals, particularly in the domains of cognition, physical activity, and social engagement. However, existing VR products and services have limited availability and affordability; hence, there is a need for a scientifically validated and personalized VR service to be used by older adults in their homes, which can improve their overall physical, cognitive, and social well-being. The main purpose of the CoSoPhy FX (Cognitive, Social, and Physical Effects) study was to analyze the effects of a VR-based digital therapeutics app on the cognitive, social, and physical performance abilities of healthy (high-functioning) older adults. This paper presents the study protocol and the results from the recruitment phase. A group of 188 healthy older adults aged 65-85 years, recruited at the Medical University of Lodz, Poland, were randomly allocated to the experimental group (VR dual-task training program) or to the control group (using a VR headset app showing nature videos). A total of 3 cognitive exercises were performed in various 360° nature environments delivered via a VR head-mounted display; the participants listened to their preferred music genre. Each patient received 3 sessions of 12 minutes per week for 12 weeks, totaling a minimum of 36 sessions per participant. Attention and working memory (Central Nervous System Vital Signs computerized cognitive battery) were used as primary outcomes, while other cognitive domains in the Central Nervous System Vital Signs battery, quality of life (World Health Organization-5 Well-Being Index), health-related quality of life (EQ-5D-5L), and anxiety (General Anxiety Disorder 7-item questionnaire) were the secondary outcomes. The group-by-time interaction was determined using linear mixed models with participants' individual slopes. In total, 122 (39%) of the initial 310 participants failed to meet the inclusion criteria, resulting in a recruitment rate of 61% (188/310). Among the participants, 68 successfully completed the intervention and 62 completed the control treatment. The data are currently being analyzed, and we plan to publish the results by the end of September 2024. VR interventions have significant potential among healthy older individuals. VR can address various aspects of well-being by stimulating cognitive functions, promoting physical activity, and facilitating social interaction. However, challenges such as physical discomfort, technology acceptance, safety concerns, and cost must be considered when implementing them for older adults. Further research is needed to determine the long-term effects of VR-based interventions, optimal intervention designs, and the specific populations that would benefit most. ClinicalTrials.gov NCT05369897; https://clinicaltrials.gov/study/NCT05369897. DERR1-10.2196/53261.

Effect of Digital Therapeutics on Range of Motion, Flexibility, Dynamic Balance, Satisfaction, and Adherence: A Randomized Controlled Trial

This study investigated the effect of digital therapeutics on ROM, flexibility, dynamic balance, satisfaction, and adherence. A sample of 34 volunteers was randomly assigned into a Digital Therapeutic Group (DTG) (n = 17) and a Non-Digital Therapeutic Group (NDG) (n = 17). The groups performed four calf muscle stretches and two hamstring stretches for 4 weeks. Flexibility and balance were evaluated to assess the effectiveness of the exercise program. A survey was conducted to assess subjects’ satisfaction, and exercise performance record papers and video records were assessed for exercise adherence. The paired t-test was used to compare the two populations before and after the program. The independent t-test was used to compare the change scores between groups. In the pre- and post-comparison within each group, the DTG group showed significant differences in all items except the dorsiflexion range of motion (ROM) (p &lt; 0.05). The left straight leg raise (SLR) was significantly different (p &lt; 0.05), and there was a significant difference in exercise satisfaction and participation between the two groups (p &lt; 0.05). DTG showed improved flexibility, dynamic balance, and higher exercise satisfaction and adherence than NDG. The application, providing lower extremity stretching, can improve dorsiflexion ROM, flexibility of the lower extremity, dynamic balance, exercise satisfaction, and exercise adherence.

DTx-based cardio-oncology rehabilitation for lung cancer survivors: A randomized controlled trial.

12024 Background: Cardio-oncology rehabilitation holds significant importance for lung cancer survivors, particularly those diagnosed at an early stage requiring lobectomy, where the maximal oxygen uptake peak (VO2PEAK) stands out as a robust prognositic predictor. Home-based cardiac telerehabilitation serves as a substitute for traditional center-based rehabilitation, demonstrating higher participation and completion rates. Despite the potential benefits, wearable devices and mobile apps, which offer tailored video guides, real-time monitoring, individualized safety alerts, and exercise-specific feedback, have not gained widespread adoption in clinical practice. Here, we present findings on the efficacy, safety, and compliance of a 3-month cardio-oncology rehabilitation program based on digital therapeutics (DTx) for lung cancer survivors. Methods: Early-stage lung cancer survivors post-lobectomy, not requiring radiotherapy or chemotherapy, were randomly assigned to receive cardiac telerehabilitation or usual care for 5 months. For pts in the telerehabilitation group, exercise prescriptions with video guides and real-time HR monitoring were implemented using the R Plus Health APP, a software as medical device approved by CFDA for remote cardiac rehab. The AI-driven prescriptions were generated based on CPET, modified by physiologists, and dynamically optimized according to feedback. Pts in the usual care group received routine instructions. Outcome measurements included VO2PEAK (primary outcome), FEV1, DLCO, cardiac function, safety, compliance, and scales assessing symptoms (MDASI), psychology (HADS), sleep (PSQI), fatigue (MSFI-SF), and quality of life (QLQ-C30). Results: 40 of 47 (85%) pts completed the trial (22 in the telerehabilitation group and 18 in the usual care group). Pts in the telerehabilitation group engaged in exercise an average of 3.3 times per week. The average exercise duration was 151.4 min per week, with an average effective exercise duration (when the required heart rate was reached) of 92.3 min per week. The average prescription compliance rate (effective exercise duration/lower limit of prescription duration) was 101.2%. Cardiac telerehabilitation was associated with a higher average VO2PEAK improvement (3.660±3.232 vs 1.088±3.230 mL/Kg/min, p=0.023), better alleviation of affective interference (-0.883±1.500 vs 0.208±1.222, p=0.048), higher quality of life improvement (16.250±23.017 vs 1.042±13.903, p=0.027), fatigue (-0.889±15.960 vs 1.389±12.087, p=0.024), daytime dysfunction (-0.550±0.686 vs 0.000±0.516, p=0.015), and more anxiety relief (-0.314±0.444 vs -0.054±0.295, p=0.048) compared with usual care. Other efficacy outcomes did not show significant differences between the two groups. No exercise-related adverse events occurred during the intervention. Conclusions: DTx-based cardio-oncology rehabilitation demonstrated improvements in cardiorespiratory fitness and reductions in affective interference and anxiety among lung cancer survivors, indicating high compliance and safety. Clinical trial information: ChiCTR2200064000.

A Digital Therapeutic Application (ePAL) to Manage Pain in Patients With Advanced Cancer: A Randomized Controlled Trial

BackgroundPatients with advanced cancer often experience immense cancer pain that negatively impacts their quality of life. Interventions to address cancer-related pain are limited. MethodsWe conducted a randomized trial of a digital therapeutic app (ePAL) for patients with advanced cancer receiving care in a specialty palliative care clinic at a tertiary care hospital. Patients were randomized to ePAL or usual care. ePAL included 1) active pain monitoring; 2) artificial intelligence algorithm to triage patient symptoms; and 3) patient education to address barriers to pain management. Participants were instructed to use ePAL over eight weeks. Patient-reported pain symptoms were assessed at baseline, Week-4, and Week-8 (primary endpoint) using the Brief Pain Inventory. Secondary outcomes include pain-related hospitalizations by Week-8. ResultsWe enrolled 112 patients who were randomly assigned to ePAL (N = 56) or usual care (N = 56). Patients utilized ePAL on average 2.1 times per week to report pain symptoms, and 47.6% reported their pain at least once per week over eight weeks. Patients randomized to ePAL reported lower pain scores at Week-4 (mean: 3.16 vs. 4.28, P = 0.010) and week-8 (mean:2.99 vs. 4.05, P = 0.017), compared to those receiving usual care. Participants randomized to ePAL were less likely to experience a pain-related hospitalization compared to those in the usual care group (7.1% vs. 23.2% P = 0.018) ConclusionsePAL was associated with lower patient-reported pain and fewer pain-related hospitalizations compared to usual care in patients with advanced cancer. This study demonstrates the promise of digital therapeutics for improving patients’ symptoms while reducing burdensome hospitalizations.