Cancer Care Recipient, Observational Study
Conditions
Brief summary
The proposed study aims to optimize and validate the Veris Cancer Care Platform for the needs of medically underserved cancer patients receiving outpatient cancer therapy. The Veris Health platform is a remote patient monitoring and communication system designed to bridge the gap between clinical visits and provide oncology care teams with objective data during high-risk periods. This study will specifically focus on optimizing the Veris Health platform for patients with language barriers, limited access to technology, and socioeconomic disparities. By incorporating user-centered design and working closely with community health centers, the research team will ensure that the platform is culturally and linguistically appropriate, easy to use, and accessible for all patients. The study will use a mixed-methods approach to validate the effectiveness of the optimized platform, including quantitative data analysis and qualitative interviews with patients and healthcare providers. The goal is to demonstrate the potential for the Veris Health platform to improve outcomes for vulnerable populations by reducing hospitalizations, emergency department visits, and the economic burden of cancer care.
Interventions
OTHERVeris Health Inc. Application
Veris Health offers at-home devices to monitor multiple physiological parameters, including temperature, heart rate, oxygen saturation, blood pressure, weight, and activity (step count). Patients are provided with a home cellular hub that is already paired to peripheral devices via Bluetooth. The hub communicates with all devices and the local cellular network out-of-the-box, and data is automatically sent via cellular network to the Veris Health backend database, making it easy for patients to use the system. Patients are responsible for taking their vital sign measurements daily. The devices automatically send the measurement data to the Veris Health HIPAA compliant, secure cloud server via the preconnected cellular hub.
Sponsors
VERIS HEALTH INC
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \> 18 years old * Diagnosis of cancer * ECOG Performance Status of 0-2 * Undergoing or initiating systemic anticancer therapy * Able to utilize and interact with a mobile application and in-home devices for physiological monitoring. Have at least one of the following barriers to healthcare access: Spanish as primary language, uninsured, insured with Medicaid, dual eligible for Medicare and Medicaid
Exclusion criteria
-N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability of the Veris Health Cancer Care Platform | 5 Months | Usability of the Veris Health Cancer Care platform as assessed by the Software Usability Measurement Inventory (SUMI) among patients, caretakers, and healthcare teams. Measure: SUMI total and domain scores Time Frame: During study participation |
| Product Design Usability and Acceptability | 5 Months | Ease of use, accessibility, and acceptability of the Veris Health Cancer Care platform based on A/B testing of product design features. Measure: Comparative usability metrics (e.g., task completion success, user preference) Time Frame: During study participation |
| User Needs and Preferences | 5 Months | User-identified needs, preferences, and barriers to use of the Veris Health Cancer Care platform. Measure: Qualitative themes derived from user interviews and focus groups Time Frame: During study participation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life (HRQL) | 5 Months | Change in health-related quality of life among participants using the Veris Health Cancer Care platform. Measure: EQ-5D Index score |
| Symptom Burden of Cancer Treatment Side Effects | 5 Months | Frequency and severity of cancer treatment-related symptoms, including nausea, diarrhea, and infection. Measure: Patient-reported symptom frequency and severity scores |
| Cancer Treatment Adherence and Duration | 5 months | Adherence to prescribed cancer therapy and treatment duration. Measure: Rates of dose reductions, early treatment discontinuation, and treatment duration |
Countries
United States
Contacts
CONTACTBrian deGuzman MD COO
Outcome results
None listed