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Digital therapeutics in Oncology: findings, barriers and prospects. A narrative review

ABSTRACT
Digital therapeutics (DTx) have been defined as technologies that “offer therapeutic interventions driven by high-quality software programs, based on scientific evidence obtained through methodologically rigorous confirmatory clinical investigation, to prevent, manage and treat a broad spectrum of physical, mental and behavioural conditions”. DTx products are on the market in a number of countries or under development for a broad range of physical and behavioral conditions, including oncology treatment management. The aim of this narrative review is to provide an update on findings available for DTx, specifically developed for the treatment of patients with cancer. A search was conducted using the following databases: PubMed, Google Scholar, Clinicaltrials.gov and Deutsches Register Klinischer Studien, as well as some websites specifically concerned with DTx. The products included in this review had to rely on at least one randomized controlled trial (already published or ongoing); or to be in the active phase of development for oncological indications, as documented by registered ongoing clinical trials and declared by the developer (“candidate DTx”). A total of nine DTx have been selected for this review, eight of them validated by Regulatory Authorities. The mechanism of action of DTx in oncological indications is mainly linked to cognitive behavioral stress management or management of symptoms and adverse events from anti-cancer treatments. In the majority of cases, quality of life, control of fatigue and physical activity/performance status were the primary endpoints of the studies. Survival was assessed in 3 studies, showing significant benefit in cancer patients using DTx. Data available in the literature seem to indicate the prospect of a useful role for DTx in addressing many unmet needs that characterize the current management of cancer patients. The success of this path is linked to a series of significant aspects: need for more clinical research and evidence of clinical benefit on relevant outcomes; greater improved familiarity of physicians with these technologies, regulatory systems ready to evaluate the products, possibly also for reimbursement; and access to technology, together with improved digital literacy, for patients and caregivers.

IMPACT STATEMENT
Digital therapeutics are evidence-based devices aimed at interacting with the patient, and offer potential benefits for patients with cancer (reduced symptom distress, improved medication adherence, adverse event management, quality of life and survival).

Table of Content: Vol. 2 (No. 1) 2022 March

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