JCO oncology practice · 2025
Integration of Remote Monitoring Into Palliative Care for Patients With Advanced Cancer Undergoing Phase I Therapies: A Randomized Clinical Trial.
СтатьяРандомизированное исследованиеКлиническое исследование I фазыНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Hui David, Subbiah Ishwaria M, Hong David, Stanton Penny, Ellefson Jennifer, Hosain Monawar, Becerra Josue, de la Cruz Vera, Ontai Amy, Haider Ali, Huang Ethan, Shete Sanjay, Bruera Eduardo
Аннотация
PURPOSE: 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.
METHODS: 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.
RESULTS: 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]; P = .01) and FACIT-Sp (5.6 [95% CI, 1.2 to 10]; P = .01), but SPC alone did not (ESAS-GDS, -2.0 [95% CI, -5.8 to 1.8]; P = .29; FACIT-Sp, -1.1 [95% CI, -7.3 to 5.1]; P = .50). HRQOL improved significantly in SPC + RM compared with SPC at 12 weeks (14 [95% CI, 2.6 to 25]; P = .02).
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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]; P = .01) and FACIT-Sp (5.6 [95% CI, 1.2 to 10]; P = .01), but SPC alone did not (ESAS-GDS, -2.0 [95% CI, -5.8 to 1.8]; P = .29; FACIT-Sp, -1.1 [95% CI, -7.3 to 5.1]; P = .50). HRQOL improved significantly in SPC + RM compared with SPC at 12 weeks (14 [95% CI, 2.6 to 25]; P = .02).
CONCLUSION: 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.