Computer and Information Sciences, University of Strathclyde, Glasgow, UK
Computer and Information Sciences, University of Strathclyde, Glasgow, UK.
BMJ. 2021 Jul 21;374:n1647. doi: 10.1136/bmj.n1647.
To evaluate effects of remote monitoring of adjuvant chemotherapy related side effects via the Advanced Symptom Management System (ASyMS) on symptom burden, quality of life, supportive care needs, anxiety, self-efficacy, and work limitations.
Multicentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial.
Twelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK.
829 patients with non-metastatic breast cancer, colorectal cancer, Hodgkin's disease, or non-Hodgkin's lymphoma receiving first line adjuvant chemotherapy or chemotherapy for the first time in five years.
Patients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy.
The primary outcome was symptom burden (Memorial Symptom Assessment Scale; MSAS). Secondary outcomes were health related quality of life (Functional Assessment of Cancer Therapy-General; FACT-G), Supportive Care Needs Survey Short-Form (SCNS-SF34), State-Trait Anxiety Inventory-Revised (STAI-R), Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer), and work limitations questionnaire (WLQ).
For the intervention group, symptom burden remained at pre-chemotherapy treatment levels, whereas controls reported an increase from cycle 1 onwards (least squares absolute mean difference -0.15, 95% confidence interval -0.19 to -0.12; P<0.001; Cohen's D effect size=0.5). Analysis of MSAS sub-domains indicated significant reductions in favour of ASyMS for global distress index (-0.21, -0.27 to -0.16; P<0.001), psychological symptoms (-0.16, -0.23 to -0.10; P<0.001), and physical symptoms (-0.21, -0.26 to -0.17; P<0.001). FACT-G scores were higher in the intervention group across all cycles (mean difference 4.06, 95% confidence interval 2.65 to 5.46; P<0.001), whereas mean scores for STAI-R trait (-1.15, -1.90 to -0.41; P=0.003) and STAI-R state anxiety (-1.13, -2.06 to -0.20; P=0.02) were lower. CASE-Cancer scores were higher in the intervention group (mean difference 0.81, 0.19 to 1.43; P=0.01), and most SCNS-SF34 domains were lower, including sexuality needs (-1.56, -3.11 to -0.01; P<0.05), patient care and support needs (-1.74, -3.31 to -0.16; P=0.03), and physical and daily living needs (-2.8, -5.0 to -0.6; P=0.01). Other SCNS-SF34 domains and WLQ were not significantly different. Safety of ASyMS was satisfactory. Neutropenic events were higher in the intervention group.
Significant reduction in symptom burden supports the use of ASyMS for remote symptom monitoring in cancer care. A "medium" Cohen's effect size of 0.5 showed a sizable, positive clinical effect of ASyMS on patients' symptom experiences. Remote monitoring systems will be vital for future services, particularly with blended models of care delivery arising from the covid-19 pandemic.
Clinicaltrials.gov NCT02356081.
通过先进症状管理系统（ASyMS）评估远程监测辅助化疗相关副作用对症状负担、生活质量、支持性护理需求、焦虑、自我效能和工作限制的影响。
多中心、重复测量、平行组、评估者盲法、分层随机对照试验。
奥地利、希腊、挪威、爱尔兰共和国和英国的 12 家癌症中心。
829 名患有非转移性乳腺癌、结直肠癌、霍奇金病或非霍奇金淋巴瘤的患者，他们正在接受一线辅助化疗或五年内首次化疗。
患者被随机分配到 ASyMS（干预组；n=415）或标准护理（对照组；n=414），共进行六个化疗周期。
主要结局是症状负担（纪念症状评估量表；MSAS）。次要结局是健康相关生活质量（癌症治疗功能评估一般量表；FACT-G）、支持性护理需求调查简表（SCNS-SF34）、状态-特质焦虑量表修订版（STAI-R）、癌症沟通和态度自我效能量表（CASE-Cancer）和工作限制问卷（WLQ）。
对于干预组，症状负担保持在化疗前治疗水平，而对照组则报告从第 1 个周期开始增加（最小二乘绝对平均差异-0.15，95%置信区间-0.19 至-0.12；P<0.001；Cohen's D 效应大小=0.5）。MSAS 子域分析表明，ASyMS 显著降低了整体困扰指数（-0.21，-0.27 至-0.16；P<0.001）、心理症状（-0.16，-0.23 至-0.10；P<0.001）和身体症状（-0.21，-0.26 至-0.17；P<0.001）。在所有周期中，FACT-G 评分在干预组中均较高（平均差异 4.06，95%置信区间 2.65 至 5.46；P<0.001），而 STAI-R 特质焦虑（-1.15，-1.90 至-0.41；P=0.003）和 STAI-R 状态焦虑（-1.13，-2.06 至-0.20；P=0.02）的平均得分较低。CASE-Cancer 评分在干预组中较高（平均差异 0.81，0.19 至 1.43；P=0.01），并且大多数 SCNS-SF34 领域的评分较低，包括性需求（-1.56，-3.11 至-0.01；P<0.05）、患者护理和支持需求（-1.74，-3.31 至-0.16；P=0.03）和身体和日常生活需求（-2.8，-5.0 至-0.6；P=0.01）。其他 SCNS-SF34 领域和 WLQ 没有显著差异。ASyMS 的安全性令人满意。干预组中性粒细胞减少事件较高。
症状负担的显著降低支持使用 ASyMS 进行癌症护理的远程症状监测。0.5 的“中等”Cohen's 效应大小表明 ASyMS 对患者症状体验具有显著的、积极的临床效果。远程监测系统将是未来服务的关键，特别是随着从新冠疫情中出现的混合护理模式的出现。
Clinicaltrials.gov NCT02356081。
