促进癌症患者的患者报告结果(PRO)调查的电子系统可以早期发现症状并提示临床医生进行干预。
评估癌症治疗过程中的电子症状监测是否对生活质量结果有益。
来自PRO-TECT(AllianceAFT-39)整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PRO调查或常规护理的电子症状监测。在2017年10月至2020年3月期间,纳入了1191名接受转移性癌症治疗的成年人。最后一次随访是2021年5月17日。
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长达1年的每周调查.严重或恶化的症状触发了护理团队警报。对照组(n=598)接受常规护理。
3个预设的次要结局是身体功能,症状控制,以及3个月时与健康相关的生活质量(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],2-7表示身体功能;没有为症状控制或HRQOL定义MCID)。主要结果的结果,总生存率,尚不可用。
在52种做法中,纳入1191例患者(平均年龄,62.2年;694[58.3%]女性);1066(89.5%)完成了3个月的随访。与平时护理相比,PRO组从基线到3个月的QLQ-C30的平均变化显着改善了身体功能(PRO,从74.27点到75.81点;控制,从73.54点到72.61点;平均差,2.47[95%CI,0.41-4.53];P=.02),症状控制(PRO,从77.67点到80.03点;控制,从76.75点到76.55点;平均差,2.56[95%CI,0.95-4.17];P=.002),和HRQOL(PRO,从78.11点到80.03点;控制,从77.00到76.50点;平均差,2.43[95%CI,0.90-3.96];P=.002)。PRO组患者在身体功能方面获得有临床意义的益处的几率明显高于常规护理(改善≥5分的患者增加7.7%,恶化≥5分的患者减少6.1%;比值比[OR],1.35[95%CI,1.08-1.70];P=.009),症状控制(8.6%和7.5%,分别;或,1.50[95%CI,1.15-1.95];P=.003),和HRQOL(8.5%和4.9%,分别;或,1.41[95%CI,1.10-1.81];P=.006)。
在这份关于接受癌症治疗的成人随机临床试验的次要结果报告中,使用每周电子PRO调查来监测症状,与常规护理相比,导致身体功能的统计显着改善,症状控制,和HRQOL在3个月,在0到100分的范围内,平均提高了大约2.5点。这些发现应暂时解释,等待总生存期的主要结果。
ClinicalTrials.gov标识符:NCT03249090。
Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene.
To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes.
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.
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.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT03249090.