BackgroundFor 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).MethodsPatients 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).ResultsSeventy‐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.ConclusionsSOFIA 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.

中文翻译：

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用于管理癌症患者免疫治疗症状的电子健康干预 (SOFIA)：随机对照试点试验的结果

背景对于接受免疫检查点抑制剂的患者来说，早期检测免疫相关不良事件（irAE）对于患者的安全至关重要。为此，开发了一款智能手机应用程序 (SOFIA)，其特点是评估电子患者报告结果 (ePRO)，重点关注 irAE 以及一组全面的支持信息。通过随机对照试验（RCT）评估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；照常护理）。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。在患者下次临床就诊之前，负责的医生会收到 ePRO 报告。主要目标是测试 SOFIA 的可行性。此外，还检查了 SOFIA 对健康相关生活质量 (HRQOL)、心理社会结果和医疗数据的初步功效。在基线 (T0)、干预后 (T1) 和 3 个月随访 (T2) 时评估临床结果。 结果 71 名患者被随机分配至 IG 组（n= 34) 或 CG (n= 37）。 SOFIA表现出很高的可行性和接受度。在 T1 时，IG 患者的 HRQOL 和角色功能显着改善，抑郁、痛苦和食欲不振也减少。在医疗数据、支持性护理服务的利用或生存方面没有显着差异。结论SOFIA 显示出较高的可行性和接受度，并改善了 HRQOL 和心理社会结果。这些结果表明需要进一步评估大规模验证性多中心随机对照试验的疗效。