Abstract：
BACKGROUND: For patients receiving immune checkpoint inhibitors, early detection of immune-related adverse events (irAEs) is critical for one\'s safety. To this end, a smartphone app (SOFIA) was developed that featured the assessment of electronic patient-reported outcomes (ePROs) focusing on irAEs as well as a set of comprehensive supportive information. Its feasibility and preliminary efficacy were evaluated in a randomized controlled trial (RCT).
METHODS: Patients who received immune checkpoint inhibition therapy were randomly assigned to an intervention group (IG) or a control group (CG; care as usual). During the 12-week intervention period, IG patients used SOFIA to report twice weekly ePROs and receive cancer- and immunotherapy-relevant contents. Before a patient\'s next clinical visit, the physician in charge was given the ePRO reports. The primary objective was to test the feasibility of SOFIA. Furthermore, the preliminary efficacy of SOFIA for health-related quality of life (HRQOL), psychosocial outcomes, and medical data was examined. Clinical outcomes were assessed at baseline (T0), post-intervention (T1), and a 3-month follow-up (T2).
RESULTS: Seventy-one patients were randomized to the IG (n = 34) or the CG (n = 37). SOFIA showed high feasibility and acceptance. At T1, patients in the IG reported significantly better HRQOL and role functioning and less depression, distress, and appetite loss. No significant differences were revealed regarding medical data, the utilization of supportive care services, or survival.
CONCLUSIONS: SOFIA showed high feasibility and acceptance and improved HRQOL and psychosocial outcomes. These results suggest further evaluation of efficacy in a large-scale confirmatory multicenter RCT.
METHODS: Patients who received immune checkpoint inhibition therapy were randomly assigned to an intervention group (IG) or a control group (CG; care as usual). During the 12-week intervention period, IG patients used SOFIA to report twice weekly ePROs and receive cancer- and immunotherapy-relevant contents. Before a patient\'s next clinical visit, the physician in charge was given the ePRO reports. The primary objective was to test the feasibility of SOFIA. Furthermore, the preliminary efficacy of SOFIA for health-related quality of life (HRQOL), psychosocial outcomes, and medical data was examined. Clinical outcomes were assessed at baseline (T0), post-intervention (T1), and a 3-month follow-up (T2).
RESULTS: Seventy-one patients were randomized to the IG (n = 34) or the CG (n = 37). SOFIA showed high feasibility and acceptance. At T1, patients in the IG reported significantly better HRQOL and role functioning and less depression, distress, and appetite loss. No significant differences were revealed regarding medical data, the utilization of supportive care services, or survival.
CONCLUSIONS: SOFIA showed high feasibility and acceptance and improved HRQOL and psychosocial outcomes. These results suggest further evaluation of efficacy in a large-scale confirmatory multicenter RCT.
摘要：
背景：对于接受免疫检查点抑制剂的患者，早期发现免疫相关不良事件(irAEs)对患者的安全性至关重要.为此,我们开发了一款智能手机应用程序(SOFIA),该应用程序的特点是评估电子患者报告的结果(ePROs),重点是irAE以及一套全面的支持信息.在一项随机对照试验（RCT）中评估了其可行性和初步疗效。
方法：将接受免疫检查点抑制治疗的患者随机分为干预组（IG）或对照组（CG；照常治疗）。在12周的干预期间，IG患者使用SOFIA每周报告两次epro，并接受癌症和免疫治疗相关内容。在患者下一次临床就诊之前，主治医师获得了ePRO报告.主要目标是测试SOFIA的可行性。此外，SOFIA对健康相关生活质量（HRQOL）的初步疗效，社会心理结果，并检查了医疗数据。在基线（T0）评估临床结果，干预后（T1），3个月随访（T2）。
结果：71例患者被随机分为IG组（n=34）或CG组（n=37）。SOFIA表现出很高的可行性和接受度。在T1时，IG患者报告的HRQOL和角色功能明显更好，抑郁较少，苦恼,和食欲减退。关于医疗数据没有发现显著差异，支持性护理服务的利用，或生存。
结论：SOFIA显示出很高的可行性和接受度，并改善了HRQOL和心理社会结果。这些结果表明，在大规模验证性多中心RCT中进一步评估疗效。
方法：将接受免疫检查点抑制治疗的患者随机分为干预组（IG）或对照组（CG；照常治疗）。在12周的干预期间，IG患者使用SOFIA每周报告两次epro，并接受癌症和免疫治疗相关内容。在患者下一次临床就诊之前，主治医师获得了ePRO报告.主要目标是测试SOFIA的可行性。此外，SOFIA对健康相关生活质量（HRQOL）的初步疗效，社会心理结果，并检查了医疗数据。在基线（T0）评估临床结果，干预后（T1），3个月随访（T2）。
结果：71例患者被随机分为IG组（n=34）或CG组（n=37）。SOFIA表现出很高的可行性和接受度。在T1时，IG患者报告的HRQOL和角色功能明显更好，抑郁较少，苦恼,和食欲减退。关于医疗数据没有发现显著差异，支持性护理服务的利用，或生存。
结论：SOFIA显示出很高的可行性和接受度，并改善了HRQOL和心理社会结果。这些结果表明，在大规模验证性多中心RCT中进一步评估疗效。
