Basch Ethan, Schrag Deborah, Jansen Jennifer, Henson Sydney, Ginos Brenda, Stover Angela M, Carr Philip, Spears Patricia A, Jonsson Mattias, Deal Allison M, Bennett Antonia V, Thanarajasingam Gita, Rogak Lauren, Reeve Bryce B, Snyder Claire, Bruner Deborah, Cella David, Kottschade Lisa A, Perlmutter Jane, Geoghegan Cindy, Given Barbara, Mazza Gina L, Miller Robert, Strasser Jon F, Zylla Dylan M, Weiss Anna, Blinder Victoria S, Wolf Anna P, Dueck Amylou C
University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Memorial Sloan Kettering Cancer Center, Department of Medicine, New York, NY, USA.
Nat Med. 2025 Apr;31(4):1225-1232. doi: 10.1038/s41591-025-03507-y. Epub 2025 Feb 7.
Symptoms are often underdetected during cancer treatment. To determine if symptom monitoring with electronic patient-reported outcomes (PROs) improves clinical outcomes, we conducted a cluster-randomized trial in which 52 oncology practices were assigned to PRO or usual care. At PRO practices, patients with metastatic cancer were invited to complete weekly symptom surveys. Severe or worsening symptoms generated alerts to the care team. The primary outcome was overall survival, and secondary outcomes included emergency visits, time to deterioration of physical function, symptoms, health-related quality of life (HRQL) and patient satisfaction with PRO. Among 1,191 enrolled patients, there was no difference in survival (hazard ratio (HR) 0.99 (95% confidence interval (CI), 0.83-1.17); P = 0.86). Time to first emergency visit was significantly prolonged with PRO compared to usual care (HR 0.84 ((95% CI, 0.71-0.98); P = 0.03), with a 6.1% reduction in the cumulative incidence of emergency visits and fewer mean visits at 12 months with PRO (1.02 versus 1.30; P < 0.001). Benefits also significantly favored PRO for delayed deterioration of physical function (median 12.6 versus 8.5 months, HR 0.73; P = 0.002), symptoms (12.7 versus 9.9, HR 0.69; P < 0.001) and HRQL (15.6 versus 12.2, HR 0.72; P = 0.001), which remained significant when considering deaths in analyses. Most patients felt that PRO improved discussions with the care team (77.0% (188/244)), made them feel more in control of their care (84.0% (205/244)) and would recommend it to other patients (91.4% (223/244)). Patients completed 91.5% (20,565/22,486) of expected weekly symptom surveys. These findings demonstrate that symptom monitoring with PRO meaningfully improves clinical outcomes, the patient experience and utilization of services and should be included as a standard part of quality cancer clinical care. Future studies of PRO in clinical care should focus on these outcomes rather than mortality as primary endpoints. ClinicalTrials.gov registration: NCT03249090.
在癌症治疗期间，症状常常未被充分检测到。为了确定使用电子患者报告结局（PROs）进行症状监测是否能改善临床结局，我们开展了一项整群随机试验，将52个肿瘤医疗实践机构分为PRO组或常规治疗组。在采用PRO的机构中，转移性癌症患者被邀请每周完成症状调查。严重或症状恶化会向医疗团队发出警报。主要结局是总生存期，次要结局包括急诊就诊、身体功能恶化时间、症状、健康相关生活质量（HRQL）以及患者对PRO的满意度。在1191名入组患者中，生存期无差异（风险比（HR）0.99（95%置信区间（CI），0.83 - 1.17）；P = 0.86）。与常规治疗相比，采用PRO显著延长了首次急诊就诊时间（HR 0.84（95% CI，0.71 - 0.98）；P = 0.03），PRO组急诊就诊的累积发生率降低了6.1%，且在12个月时的平均就诊次数更少（1.02对1.30；P < 0.001）。在身体功能延迟恶化方面（中位数12.6个月对8.5个月，HR 0.73；P = 0.002）、症状方面（12.7对9.9，HR 0.69；P < 0.001）以及HRQL方面（15.6对12.2，HR 0.72；P = 0.001），PRO组也显著更具优势，在分析中考虑死亡情况时这些优势依然显著。大多数患者认为PRO改善了与医疗团队的沟通（77.0%（188/244）），让他们感觉对自己的治疗更有掌控力（84.0%（205/244）），并会向其他患者推荐（91.4%（223/244））。患者完成了预期每周症状调查的91.5%（20,565/22,486）。这些发现表明，使用PRO进行症状监测能显著改善临床结局、患者体验及服务利用情况，应作为优质癌症临床护理的标准组成部分。未来关于PRO在临床护理中的研究应关注这些结局而非将死亡率作为主要终点。ClinicalTrials.gov注册号：NCT03249090。
