PRO-WAVE1: Monitoring Patient Reported Outcomes (PROs) in Prostate Cancer Through Wave Health: A Novel ePRO Health Platform
Author(s)
Lashey M1, Gurruchaga I2, Gómez Mediavilla B3, Linares-Espinos E4, Cacho Lavin D3, Congregado Ruiz B5, Rivero Belenchon I5, Hernandez A6, Lainez N2, Sancho G7, Buchser D8, Sanguedolce F9, Esteban B10, Basterretxea L6, Duran I3
1Treatment Technologies & Insights, LA, CA, USA, 2Navarra University Hospital, Pamplona, Navarre, Spain, 3Hospital Universitario Marqués de Valdecilla, Santander, Spain, 4University Hospital La Paz and Lyx Institute of Urology, Madrid, Spain, 5University Hospital Virgen del Rocío, Seville, Seville, Spain, 6Donostialdea ESI/OSI Donostialdea, Donostia, Unibertsitate Ospitalea/Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain, 7Hospital de la Santa Creu i Sant Pau, Barcelona, Barcelona, Spain, 8Hospital Universitario Cruces; Biobizkaia, Basque Health Research, Barakaldo, Bizkaia, Spain, 9Fundació Puigvert, Barcelona, Barcelona, Spain, 10Donostialdea ESI/OSI Donostialdea, Donostia, Unibertsitate Ospitalea/Hospital Universitario Donostia, SAN SEBASTIAN, Spain
OBJECTIVES: It is well established that the monitoring and evaluation of PROs in cancer patients has a positive impact on quality of life and overall survival [Basch E., JAMA 2017]. In parallel, the widespread use of smart phones in the general population has increased significantly over recent years [Statista, 2023], representing a unique opportunity to operationalize ePROs. PRO-WAVE1 aims to determine the acceptability, engagement and satisfaction of the Wave Health patient app and HCP portal, enhanced for prostate cancer.
METHODS: 98 patients across 8 sites in Spain enrolled in the study, and 82 of those patients engaged with the Wave Health App over a 13-week period. Patients completed validated ePRO questionnaires (generating 93.3% compliance – the primary endpoint) consisting of: a weekly symptom review (WSR) using PRO-CTCAE symptoms, FACT-P (4 times) and CHLT-30-Dkspa (2 times). Exploratory objectives include analyzing patient-reported symptom data and evaluating correlations between symptom severity and quality of life.
RESULTS: PRO-CTCAE symptom data analytics indicated that the most commonly patient reported symptoms with mild severity or higher throughout the 12-week period were Weakness (72%), Fatigue (71%), and Sad Feelings (54%). To better understand the relationship between symptom severity and quality of life (QoL), linear mixed-effects models were trained on CTCAE data to predict FACT-P subscores and account for within-subject correlation.
- Weakness (p = 5.21e-6), Pain (p=6.68e-5), and Fatigue (p=2.19e-4) were the strongest predictors of diminished physical well-being (PWB)
- Sad Feelings (p = 1.57e-4), Constipation (p = 9.55e-4), and Anxiety (p=0.0109) were the strongest predictors of diminished emotional well-being (EWB)
- Sad Feelings (p = 1.30e-3), Pain (p = 5.79e-3), and Constipation (p=5.83e-3) were the strongest predictors of diminished total FACT-P score.
CONCLUSIONS: The Wave Health ePRO platform allowed for high level symptom reporting analytics to help patients and HCPs understand which symptoms may strongly relate to patients’ physical, emotional, and overall wellbeing.
Conference/Value in Health Info
Value in Health, Volume 27, Issue 12, S2 (December 2024)
Code
CO25
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology