— Patient Reported Outcome pilot to examine the symptom experience of long-term Immunotherapy patients to better understand chronic effects of treatment —
— With drug approvals increasing every year, and clinical trials over-representing patients with better health and fewer comorbidities, critical pilot to examine real-world patient experiences —
LOS ANGELES, October 26, 2021 – Nearly half of all adult advanced-cancer patients are candidates for treatment with immune checkpoint inhibitors (ICIs). Immunotherapy triggers the body’s immune system to fight cancer cells but can also precipitate a host of side effects ranging from mild to life threatening, driving a wide variety of symptoms that can adversely impact patient quality of life and day-to-day functioning.
Wave Health app, ranked the #1 rated PRO application for oncology patients in 2020 by Cedars-Sinai, today announced a pioneering new study to enable an innovative approach to monitor real-world immunotherapy symptoms and side effects that could shorten the cycle for patients and physicians to understand how it really feels to be on their medications.
“In the past 10 years, there have been approximately 40 new drug approvals every year. Unfortunately, there is often limited data on side effects, tolerability and quality of life at the time of approval,” said Treatment Technologies & Insights CEO Matt Lashey. “TTI’s technology changes that by transforming reported data into actionable intelligence.”
TTI lead engineer Armando Monroy added: “The study’s app provides an AI-driven ePRO solution within the infrastructure of Wave Health’s current system. Specifically, the technology allows SCCA participants, using either iPhone or Android versions of the app, to securely track and share profile information, symptom occurrences and other relevant activity and experience information – to generate personal insight for treatment understanding and ultimately care team management.”
For the 3-month study, with a rolling enrollment of approximately 50 patients, app users complete symptom assessments using the National Cancer Institute’s “Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events” (PRO-CTCAE). These instruments measure symptom toxicity in clinical trials and consist of 78 discrete symptoms. The appasks subjects to report on a subset of these symptoms of specific interest to the SCCA study.
Additionally, TTI has implemented a new HRQoL weekly series of surveys using the PROMIS-29-item questionnaire to assess health-related quality of life across various domains of interest to the study. Monroy explains: “Subjects are asked additional PROMIS short form items as a follow up to the subset of PRO-CTCAEs they earlier reported as having experienced at a ‘moderate,’ ‘severe’ or ‘very severe’ level in the last 7 days. This lays tremendous new groundwork for future interventional studies on adverse event prevention and management by demonstrating patient-level impact.”
Treatment Technologies & Insights, parent company of Wave Health, is a digital health company offering cloud-based services to systematically monitor, manage and learn from patient reported outcomes – occurring outside the clinical setting. TTI’s mission is to transform healthcare by equipping every patient and healthcare ecosystem with life-changing patient intelligence.
Through unique patient engagement and AI-driven insights, TTI’s patient-centric solutions, including apps, a provider-facing care portal, and research databases, help elevate patient health literacy, decrease population health disparities and create opportunity for intervention to benefit patients, caregivers, providers, payors, and pharmaceutical companies. TTI started first in cancer, from a personal experience, and now serves all chronic conditions.
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SOURCE: Treatment Technologies & Insights, Inc.