KEY TAKEAWAYS
- This phase 0/I study investigated the feasibility of a larger clinical trial to determine the ePVA’s effectiveness in enhancing pain management and Health-Related Quality of Life in HNC patients.
- The study suggested the feasibility of a large clinical trial using digital remote monitoring and showed positive trends in pain management and HRQoL improvement in the cohort.
Patients with head and neck cancer (HNC) often encounter severe symptoms and functional limitations during their cancer treatment. To address this issue, the NYU Electronic Patient Visit Assessment (ePVA) was developed to detect and manage uncontrolled symptoms in HNC patients.
This phase 0/I study, which was randomized and not blinded, aimed to determine the feasibility of conducting a larger randomized clinical trial. The larger trial would assess how effective the ePVA is at improving pain management and Health-Related Quality of Life in individuals with HNC.
The trial involved 32 participants who were randomly assigned to one of two groups: 1) receiving the ePVA intervention or 2) receiving usual care. For those in the intervention group, they completed the ePVA every other week during their radiation therapy (RT) and at weeks 4, 12, and 24 after completing RT. Automated reports containing ePVA data, such as pain reports and patient-reported use of pain medications, were sent to healthcare providers to assist in their clinical decision-making.
Due to the impact of COVID-19, the study team adapted all study procedures to be conducted remotely via telehealth. Potential participants were contacted 5 to 7 days before commencing radiation therapy, and their informed consent was obtained using REDCap e-consent. The study successfully met its recruitment goals by enrolling 32 participants, achieving a recruitment rate of 68%.
The primary reason for potential participants not joining the study was the overwhelming nature of their diagnosis and the start of their treatment. The average age of participants was 60, with the majority being male (69%), of white ethnicity (81%), and non-Hispanic (81%). The distribution of gender, race, cancer stage, and treatment was balanced between the two study groups. Impressively, 88% (28 out of 32) of participants completed 6 out of 7 planned data collection time points, meeting the criteria for feasibility in a large, multi-site randomized clinical trial. On average, participants in the ePVA group showed non-significant trends toward experiencing less pain and slightly improved Health-Related Quality of Life (HRQoL) vs. those receiving usual care.
These findings indicated that it is feasible to conduct a large randomized clinical trial using a digital remote monitoring system. Additionally, there were positive but statistically non-significant trends observed in pain management and HRQoL improvement in this relatively small sample size. However, it’s important to note that the generalizability of these study findings is limited due to the small sample size.
Source: https://ons.confex.com/ons/2023/meetingapp.cgi/Paper/13528
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04502797
Cleave, J.V. Implementing the NYU Electronic Patient Visit Assessment (ePVA) To Improve Patient Outcomes In Head and Neck Cancer.
