Integration of Remote Monitoring Into Palliative Care for Patients With Advanced Cancer Undergoing Phase I Therapies: A Randomized Clinical Trial.

Abstract

Outpatient specialist palliative care (SPC) referral improves patient outcomes; however, it is unclear whether additional remote monitoring (RM) would provide further benefit. This pilot, parallel-group, single-blind, randomized clinical trial examined the within-group effect of monthly SPC alone or with additional weekly RM on symptom burden in patients with advanced cancer undergoing phase I therapies. Eligibility criteria included advanced solid tumor diagnosis and moderate-to-high symptom burden (ie, Edmonton Symptom Assessment System [ESAS] score ≥4/10 for ≥1 symptom and Global Distress Score [GDS] ≥20/90) before starting phase I therapies. Patients were randomly assigned 1:1 to either monthly outpatient SPC visits alone or with additional RM, consisting of weekly phone calls and concurrent electronic ESAS assessments between monthly SPC visits. The primary outcome was within-group change in symptom burden (ESAS-GDS) from baseline to 2 weeks; secondary outcomes included within-group change from baseline in ESAS-GDS and health-related quality of life (HRQOL; measured by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being [FACIT-Sp]) over 12 weeks. Between December 15, 2020, and December 21, 2022, 115 patients consented and 100 were randomly assigned (SPC + RM, n = 57; SPC, n = 43). The mean age (standard deviation) of analyzed patients was 56 (12) years, and 57 (64%) were female. At 2 weeks, SPC + RM had significant within-group improvement in ESAS-GDS (mean change, -5.0 [95% CI, -8.9 to -1.2]; <i>P</i> = .01) and FACIT-Sp (5.6 [95% CI, 1.2 to 10]; <i>P</i> = .01), but SPC alone did not (ESAS-GDS, -2.0 [95% CI, -5.8 to 1.8]; <i>P</i> = .29; FACIT-Sp, -1.1 [95% CI, -7.3 to 5.1]; <i>P</i> = .50). HRQOL improved significantly in SPC + RM compared with SPC at 12 weeks (14 [95% CI, 2.6 to 25]; <i>P</i> = .02). Incorporating RM into SPC may improve symptoms and HRQOL beyond SPC alone for patients with moderate-to-high symptom burden. Our findings are considered preliminary and larger confirmatory trials are needed.