Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer A Randomized Clinical Trial
Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer A Randomized Clinical Trial
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DOI：
10.1001/jama.2022.9265
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发表时间：
2022-06-05
影响因子：
120.7
通讯作者：
Dueck, Amylou C.
中科院分区：
文献类型：
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作者：
Basch, Ethan;Schrag, Deborah;Dueck, Amylou C.
重要性电子系统，促进患者报告的结果（PRO）调查癌症患者可能会发现早期症状，并提示临床医生进行干预。PRO-TECT的次要结局报告（Alliance AFT-39）在52个美国社区肿瘤学实践中进行的随机分组试验，随机接受电子症状监测和PRO调查或常规护理。在2017年10月至2020年3月期间，1191名接受转移性癌症治疗的成年人入选，最后一次随访时间为2021年5月17日。干预在PRO组中，参与者（n = 593）被要求通过基于互联网或自动电话系统完成每周调查，长达1年。严重或恶化的症状触发护理团队警报。对照组（n = 598）接受常规护理。主要结局和指标3个预先设定的次要结局为3个月时的身体功能、症状控制和健康相关生活质量（HRQOL），采用欧洲癌症研究和治疗组织生活质量问卷进行测量（QLQ-C30;范围，0-100分;身体功能的最小临床重要差异[MCID]，2-7分;症状控制或HRQOL未定义MCID）。结果在52个实践中，1191例患者被纳入（平均年龄62.2岁，694 [58.3%]女性）; 1066（89.5%）完成了3个月的随访。与常规治疗相比，PRO组的身体功能QLQ-C30从基线至3个月的平均变化显著改善（PRO为74.27 ~ 75.81分，对照组为73.54 ~ 72.61分，均数差为2.47 [95% CI，0.41-4.53]; P =.02），症状控制（PRO，77.67 - 80.03分;对照组，76.75 - 76.55分;平均差异，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;平均差异，2.43 [95% CI，0.90-3.96]; P = 0.002）。PRO组的患者在身体功能方面的临床获益显著高于常规治疗组（改善≥ 5分者增加7.7%，恶化≥ 5分者减少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），HRQOL（8.5%和4.9%，OR为1.41 [95% CI为1.10-1.81]; P =.006）。结论和相关性在这份关于接受癌症治疗的成年人的随机临床试验的次要结果的报告中，与常规护理相比，使用每周电子PRO调查来监测症状，在3个月时导致身体功能、症状控制和HRQOL的统计学显著改善，在0- 100分量表上平均改善约2.5分。这些发现应在总生存期的主要结局结果出来之前进行临时解释。
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 formetastatic 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 outcomeswere 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.