Objective 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. Design Multicentre, repeated measures, parallel group, evaluator masked, stratified randomised controlled trial. Setting Twelve cancer centres in Austria, Greece, Norway, Republic of Ireland, and UK. Participants 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. Intervention Patients were randomised to ASyMS (intervention; n=415) or standard care (control; n=414) over six cycles of chemotherapy. Main outcome measures 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). Results 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. Conclusions 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. Trial registration Clinicaltrials.gov [NCT02356081][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02356081&atom=%2Fbmj%2F374%2Fbmj.n1647.atom

中文翻译：

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癌症化疗期间的实时远程症状监测：欧洲多中心随机对照试验 (eSMART)

目的 评估通过高级症状管理系统 (ASyMS) 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。设计多中心、重复测量、平行组、评估者掩蔽、分层随机对照试验。在奥地利、希腊、挪威、爱尔兰共和国和英国设立 12 个癌症中心。参与者 829 名非转移性乳腺癌、结直肠癌、霍奇金病或非霍奇金淋巴瘤患者五年来首次接受一线辅助化疗或化疗。干预 在六个化疗周期内，患者被随机分配到 ASyMS（干预；n=415）或标准治疗（对照；n=414）。主要结果测量主要结果是症状负担（纪念症状评估量表；MSAS）。次要结果是与健康相关的生活质量（癌症治疗的功能评估 - 一般；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)、沟通和癌症态度自我效能量表 (CASE-Cancer) 和工作限制问卷 (WLQ)。结果 对于干预组，症状负担保持在化疗前治疗水平，而对照组报告从第 1 个周期开始增加（最小二乘绝对均值差 -0.15，95% 置信区间 -0.19 至 -0.12；P<0.001；Cohen's D效果大小=0.5）。对 MSAS 子域的分析表明，ASyMS 的全球遇险指数显着减少（-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，干预组的 FACT-G 得分较高（平均差异 4.06，95% 置信区间 2.65 至 5.46；P<0.001），而 STAI-R 性状的平均得分（-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）较低。干预组的 CASE-Cancer 评分较高（平均差异 0.81、0.19 至 1.43；P=0.01），大多数 SCNS-SF34 域较低，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），以及身体和日常生活需求（-2.8，-5.0 至 -0.6；P=0.01）。其他 SCNS-SF34 域和 WLQ 没有显着差异。ASyMS 的安全性令人满意。干预组的中性粒细胞减少事件发生率较高。结论 症状负担的显着减少支持在癌症护理中使用 ASyMS 进行远程症状监测。0.5 的“中等”Cohen 效应大小显示了 ASyMS 对患者症状体验的相当大的、积极的临床效果。远程监控系统对于未来的服务至关重要，尤其是对于因 covid-19 大流行而产生的混合护理模式。试验注册 Clinicaltrials.gov [NCT02356081][1]。[1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02356081&atom=%2Fbmj%2F374%2Fbmj.n1647.atom ASyMS 对患者症状体验的积极临床效果。远程监控系统对于未来的服务至关重要，尤其是对于因 covid-19 大流行而产生的混合护理模式。试验注册 Clinicaltrials.gov [NCT02356081][1]。[1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02356081&atom=%2Fbmj%2F374%2Fbmj.n1647.atom ASyMS 对患者症状体验的积极临床效果。远程监控系统对于未来的服务至关重要，尤其是对于因 covid-19 大流行而产生的混合护理模式。试验注册 Clinicaltrials.gov [NCT02356081][1]。[1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02356081&atom=%2Fbmj%2F374%2Fbmj.n1647.atom