美国北卡罗莱纳大学Ethan Basch团队研究了电子症状监测对转移性癌症患者报告结果的影响。相关论文于2022年6月5日发表在《美国医学会杂志》上。

帮助癌症患者调查患者报告结果（PRO）的电子系统可以早期发现症状，并提示临床医生进行干预。

为了评估癌症治疗过程中的电子症状监测是否有助于提高患者的生活质量，研究组采用52个美国社区肿瘤学实践中进行的PRO-TECT（Alliance AFT-39）群集随机试验的次要结果报告，该试验采用PRO调查或常规护理进行电子症状监测。2017年10月至2020年3月，共有1191名接受转移性癌症治疗的成年人入组，最后一次随访时间为2021年5月17日。

PRO组593名参与者被要求通过基于互联网或自动电话系统完成为期1年的每周调查，严重或恶化的症状将引发护理团队警报；对照组598名参与者接受常规护理。根据欧洲癌症研究与治疗组织的生活质量问卷（QLQ-C30；范围0-100分；身体功能最小临床重要差异[MCID]为2-7分），3个月时的身体功能、症状控制和健康相关生活质量（HRQOL）为3个预先指定的次要结局。关于主要结局，即总生存期的结果尚不可用。

在52个临床实践中，1191例参与者的平均年龄为62.2岁，女性694例，占58.3%；1066例（89.5%）完成了3个月的随访。PRO组从基线检查到3个月时QLQ-C30的身体功能评分从74.27分平均提高到75.81分，对照组从73.54分降低至72.61分；PRO组症状控制评分从77.67分提高到80.03分，对照组从76.75分降至76.55分；PRO组HRQOL评分从78.11分提高到80.03分，对照组从77.00分降至76.50分，组间差异均显著。PRO组患者在身体功能（≥5分的改善多7.7%，≥5分的恶化少6.1%，比值比[OR]为1.35）、症状控制（分别为8.6%和7.5%，OR为1.50）和HRQOL（分别为8.5%和4.9%，OR为1.41）方面获得临床意义益处的几率明显高于常规护理组。

综上，在这份关于接受癌症治疗的成年人随机临床试验次要结局的报告中，与常规护理相比，使用每周电子PRO调查来监测症状，患者3个月时身体功能、症状控制和HRQOL在统计学上显著改善，在0到100分的量表上平均改善约2.5分。

附：英文原文

Title: Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer: A Randomized Clinical Trial

Author: Ethan Basch, Deborah Schrag, Sydney Henson, Jennifer Jansen, Brenda Ginos, Angela M. Stover, Philip Carr, Patricia A. Spears, Mattias Jonsson, Allison M. Deal, Antonia V. Bennett, Gita Thanarajasingam, Lauren J. Rogak, Bryce B. Reeve, Claire Snyder, Deborah Bruner, David Cella, Lisa A. Kottschade, Jane Perlmutter, Cindy Geoghegan, Cleo A. Samuel-Ryals, Barbara Given, Gina L. Mazza, Robert Miller, Jon F. Strasser, Dylan M. Zylla, Anna Weiss, Victoria S. Blinder, Amylou C. Dueck

Issue&Volume: 2022-06-05

Abstract:

Importance  Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene.

Objective  To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes.

Design, Setting, and Participants  Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021.

Interventions  In the PRO group, participants (n=593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n=598) received usual care.

Main Outcomes and Measures  The 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available.

Results  Among 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P=.02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P=.002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P=.002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P=.009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P=.003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P=.006).

Conclusions and Relevance  In this report of secondary outcomes from a randomized clinical trial of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQOL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of overall survival.

DOI: 10.1001/jama.2022.9265

Source: https://jamanetwork.com/journals/jama/fullarticle/2793279