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癌症化疗期间实时远程症状监测可有效减轻患者症状负担
2021-07-25 14:53

英国斯凯莱德大学Roma Maguire团队研究了癌症化疗期间实时远程症状监测的效果。相关论文于2021年7月22日发表在《英国医学杂志》上。

为了评估通过先进症状管理系统(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、自我效能感和工作局限性的影响,研究组在奥地利、希腊、挪威、爱尔兰共和国和英国的12家癌症中心进行了一项多中心、重复测量、平行组、评估者盲、分层随机对照试验。

共招募了829例非转移性乳腺癌、结直肠癌、霍奇金病或非霍奇金淋巴瘤患者,5年来首次接受一线辅助化疗或化疗。将其随机分为两组,其中415例接受ASyMS治疗(干预组),414例接受标准治疗(对照组),均接受6个化疗周期以上。

主要结局为症状负担(记忆性症状评估量表;MSAS)。次要结局为健康相关生活质量(癌症综合治疗功能评估;FACT-G)、支持性护理需求调查简表(SCNS-SF34)、修订的状态-特质焦虑量表(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)。

干预组的症状负担维持在化疗前水平,而对照组从第1周期开始出现增加,组间差异显著。对MSAS子域的分析表明,两组间总体症状困扰指数、心理症状、躯体症状的差异均显著。

在所有周期中,与对照组相比,干预组的FACT-G评分均较高,而STAI-R特征的平均得分和STAI-R状态焦虑均较低。与对照组相比,干预组CASE Cancer评分较高,但大多数SCNS-SF34子域评分较低,包括性需求、患者的护理和支持需求及身体和日常生活需要。两组间其他SCNS-SF34子域和WLQ无显著差异。ASyMS的安全性令人满意。干预组中性粒细胞减少的发生率较高。

研究结果表明,症状负担的显著减轻支持在癌症护理中使用ASyMS进行远程症状监测。“中等”的科恩效应值为0.5,表明ASyMS对患者的症状体验具有相当大的、积极的临床效应。

附:英文原文

Title: Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART)

Author: Roma Maguire, Lisa McCann, Grigorios Kotronoulas, Nora Kearney, Emma Ream, Jo Armes, Elisabeth Patiraki, Eileen Furlong, Patricia Fox, Alexander Gaiger, Paul McCrone, Geir Berg, Christine Miaskowkski, Antonella Cardone, Dawn Orr, Adrian Flowerday, Stylianos Katsaragakis, Andrew Darley, Simone Lubowitzki, Jenny Harris, Simon Skene, Morven Miller, Margaret Moore, Liane Lewis, Nicosha DeSouza, Peter T Donnan

Issue&Volume: 2021/07/22

Abstract:

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.

DOI: 10.1136/bmj.n1647

Source: https://www.bmj.com/content/374/bmj.n1647

BMJ-British Medical Journal:《英国医学杂志》,创刊于1840年。隶属于BMJ出版集团,最新IF:93.333
官方网址:http://www.bmj.com/
投稿链接:https://mc.manuscriptcentral.com/bmj


本期文章:《英国医学杂志》:Online/在线发表

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