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. Trial Registration ClinicalTrials.gov Identifier: NCT03249090.

中文翻译：

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电子症状监测对转移性癌症患者报告结果的影响：一项随机临床试验。

重要性 有助于对癌症患者进行患者报告结果 (PRO) 调查的电子系统可以及早发现症状并提示临床医生进行干预。目的 评估癌症治疗期间的电子症状监测是否有益于生活质量结果。设计、设置和参与者 PRO-TECT（联盟 AFT-39）集群随机试验的次要结果报告，该试验在 52 个美国社区肿瘤学实践中随机分配到电子症状监测和 PRO 调查或常规护理。2017 年 10 月至 2020 年 3 月期间，招募了 1191 名接受转移性癌症治疗的成年人，最后一次随访时间为 2021 年 5 月 17 日。干预措施 在 PRO 组中，参与者 (n = 593) 被要求通过互联网完成每周调查。基于或自动电话系统长达 1 年。严重或恶化的症状引发了护理团队的警报。对照组（n = 598）接受常规护理。主要结果和测量 3 项预先指定的次要结果是 3 个月时的身体功能、症状控制和健康相关生活质量 (HRQOL)，由欧洲癌症研究和治疗组织生活质量问卷 (QLQ-C30；范围，0-100 分；最小临床重要差异 [MCID]，身体功能 2-7；没有为症状控制或 HRQOL 定义 MCID）。主要结局（总体生存率）的结果尚未公布。结果 在 52 个诊所中，纳入了 1191 名患者（平均年龄 62.2 岁；694 名女性 [58.3%]）；1066 名（89.5%）完成了 3 个月的随访。与平时的护理相比，PRO 组身体功能从基线到 3 个月的 QLQ-C30 平均变化显着改善（PRO，从 74.27 分到 75.81 分；对照，从 73.54 分到 72.61 分；平均差，2.47 [95% CI，0.41- 4.53]；P = .02）、症状控制（PRO，77.67 至 80.03 分；对照，76.75 至 76.55 分；平均差，2.56 [95% CI，0.95-4.17]；P = .002）和 HRQOL （PRO，从 78.11 到 80.03 分；对照，从 77.00 到 76.50 分；平均差，2.43 [95% CI，0.90-3.96]；P = .002）。与常规的身体功能护理相比，PRO 组的患者获得具有临床意义的益处的几率显着更高（改善 ≥5 分时增加 7.7%，恶化 ≥5 分时减少 6.1%；比值比 [OR]，1.35 [95] % CI，1.08-1.70]；P = .009），症状控制（分别为 8.6% 和 7.5%；OR，1。50 [95% CI，1.15-1.95]；P = .003）和 HRQOL（分别为 8.5% 和 4.9%；OR，1.41 [95% CI，1.10-1.81]；P = .006）。结论和相关性 在这份针对接受癌症治疗的成年人的随机临床试验的次要结果报告中，与常规护理相比，使用每周电子 PRO 调查来监测症状，导致身体功能、症状控制和 HRQOL 方面具有统计学意义的显着改善。 3 个月，平均提高约 2.5 分（从 0 到 100 分）。这些发现应暂时解释为总生存期主要结局的结果。试验注册 ClinicalTrials.gov 标识符：NCT03249090。结论和相关性 在这份针对接受癌症治疗的成年人的随机临床试验的次要结果报告中，与常规护理相比，使用每周电子 PRO 调查来监测症状，导致身体功能、症状控制和 HRQOL 方面具有统计学意义的显着改善。 3 个月，平均提高约 2.5 分（从 0 到 100 分）。这些发现应暂时解释为总生存期主要结局的结果。试验注册 ClinicalTrials.gov 标识符：NCT03249090。结论和相关性 在这份针对接受癌症治疗的成年人的随机临床试验的次要结果报告中，与常规护理相比，使用每周电子 PRO 调查来监测症状，导致身体功能、症状控制和 HRQOL 方面具有统计学意义的显着改善。 3 个月，平均提高约 2.5 分（从 0 到 100 分）。这些发现应暂时解释为总生存期主要结局的结果。试验注册 ClinicalTrials.gov 标识符：NCT03249090。3 个月时的 HRQOL，平均提高约 2.5 分（0 到 100 分制）。这些发现应暂时解释为总生存期主要结局的结果。试验注册 ClinicalTrials.gov 标识符：NCT03249090。3 个月时的 HRQOL，平均提高约 2.5 分（0 到 100 分制）。这些发现应暂时解释为总生存期主要结局的结果。试验注册 ClinicalTrials.gov 标识符：NCT03249090。