Effect of activity monitoring on quality of life in patients with gastrointestinal cancer undergoing chemoradiation.

Abstract

e18671 Background: Patients undergoing concurrent radiation therapy and systemic therapy often experience significant toxicities, which can adversely affect their quality of life. We sought to determine if activity monitoring and early outpatient intervention could lead to improved quality of life (QoL) in patients with gastrointestinal malignancies undergoing chemoradiotherapy. Methods: In this prospective randomized trial, patients with gastrointestinal malignancies undergoing concurrent chemoradiotherapy were randomized to activity monitoring versus standard of care (observation). Each group was provided a commercially available fitness tracker but only the intervention group was actively monitored. If a patient in the intervention arm had a 20% decrease in step count or 20% increase in heart rate from their baseline, a triage visit was triggered to further evaluate and manage symptoms. In the observation group, step count and heart rate were recorded but no triage visit was triggered. All patients had weekly on treatment visits and access to standard communication methods for symptom management during and after-hour business hours. The primary endpoint was the rate of completed triage visits. QoL was a secondary endpoint and was collected from both arms at radiation simulation (baseline) and weekly during treatment using the EORTC QLQ-C30 (v.3). The mixed model for repeated measures was used for longitudinal analysis of global health status (GHS) and overall QoL scores (range 1-7) to determine the impact of intervention and time on QoL. Results: A total of 40 patients were evaluable in this study: 22 in the intervention group and 18 in the observation group. The primary endpoint was met with an increased rate of triage visits in the active monitoring group compared to the observation group (86.4% vs 39.9%, OR 9.95, 95% CI 2.12 -46.56, p = 0.015). EORTC QLQ-C30 questionnaires were completed by 97.5% of patients. The baseline QoL scores were similar in both arms (mean GHS 5.06 vs 5.50, p = 0.28 and mean QoL 4.98 vs 5.73, p = 0.09 in observation vs intervention group, respectively). There was a trend towards improved mean GHS, and QoL scores in the intervention group at all timepoints, although it did not reach statistical significance. Overall, GHS and QoL scores deteriorated from week 1 to week 6 during treatment in both groups (mean QoL 5.06 to 4.46, p = 0.16 in observation; mean QoL 5.55 to 5.03, p = 0.16 in intervention group). Conclusions: This study supports the feasibility of using activity monitor to actively track step count and heart rate to successfully trigger triage visits for patients at high risk for toxicity. Early outpatient intervention with the use of activity monitoring may improve quality of life in patients undergoing chemoradiotherapy.