Continuous Remote Activity Monitoring In Head And Neck Cancer Patients Receiving Radiotherapy: An Initial Report On Patient Compliance And Utility From A Phase I Trial

Abstract

The treatment of locally advanced head and neck cancer (HNC) requires multi-modality treatment and is associated with significant treatment-related toxicity. This results in burden to both patients and the healthcare system in the form of unplanned interventions. Remote activity monitoring (RAM) has been suggested to be a complementary means of identifying patients at risk, potentially providing a window for timely intervention. While previous reports have evaluated brief periods of RAM in HNC, the role of continuous RAM in HNC patients is not well defined. We evaluated the feasibility and utility of RAM in HNC patients undergoing radiotherapy (RT) or chemoradiotherapy (CRT). IRB approval was obtained (ClinicalTrials.gov Identifier: NCT03489252). Patients 18 years and older with HNC requiring RT per multi-disciplinary discussion were screened. Enrollees were provided a Fitbit Charge 3 at CT simulation (sim), instructed on use, and provided online accounts. Patients were advised to wear devices 22+ hours per day from sim to the final day of RT. Sim and treatment plans were designed by the treating radiation oncologist, with weekly on-treatment visits and standard monitoring. Clinical, treatment, and step count data were collected prospectively and recorded. The primary endpoint was RAM compliance defined as wearing the device 19+ hours daily for 80% of protocol days. Secondary endpoints included changes in daily steps and correlations between daily steps with significant treatment-related events (STRE) including feeding tube placement, emergency room (ER) visits, and hospitalizations. 21 patients were screened and 16 were enrolled in 2019. 82% had a diagnosis of oral cavity or oropharynx cancer. Patients were 39 – 78 years of age, Caucasian (100%), male (88%) smokers (69%), with a KPS of 90 (70 – 100). 69% received postoperative RT and 63% received CRT. As defined per protocol, 44% of patients were found to be compliant with RAM devices, with the remainder of patients wearing their devices a median of 53% (0% - 76%) of protocol days. 50% of patients had a STRE including feeding tube placement (38%), hospitalization (13%), and ER visits (6%). One patient expired due to sepsis after their first week of treatment. Median daily step count at baseline was 4966 (1494 - 11652), with an average drop in daily step count of -13% after 4 weeks of RT for all patients. When evaluating patients with STREs, daily step counts the week before their event (median week 4) decreased by -15% while patients without STREs had an average decrease of -5% at week 4 of treatment. Continuous RAM in HNC receiving RT is feasible in select patients, and may provide meaningful information for patients at risk of STREs. Additional studies evaluating patient reported outcomes with RAM are in development.