Fraterman Itske, Sacchi Lucia, Mallo Henk, Tibollo Valentina, Glaser Savannah Lucia Catherina, Medlock Stephanie, Cornet Ronald, Gabetta Matteo, Hisko Vitali, Khadakou Vadzim, Barkan Ella, Del Campo Laura, Glasspool David, Kogan Alexandra, Lanzola Giordano, Leizer Roy, Ottaviano Manuel, Peleg Mor, Śniatała Konrad, Lisowska Aneta, Wilk Szymon, Parimbelli Enea, Quaglini Silvana, Rizzo Mimma, Locati Laura Deborah, Boekhout Annelies, van de Poll-Franse Lonneke V, Wilgenhof Sofie
Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam, 1066CX, Netherlands, 31 0621885919.
Department of Electric, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.
JMIR Cancer. 2025 Jan 30;11:e58938. doi: 10.2196/58938.
Patients with melanoma receiving immunotherapy with immune-checkpoint inhibitors often experience immune-related adverse events, cancer-related fatigue, and emotional distress, affecting health-related quality of life (HRQoL) and clinical outcome to immunotherapy. eHealth tools can aid patients with cancer in addressing issues, such as adverse events and psychosocial well-being, from various perspectives.
This study aimed to explore the effect of the Cancer Patients Better Life Experience (CAPABLE) system, accessed through a mobile app, on HRQoL compared with a matched historical control group receiving standard care. CAPABLE is an extensively tested eHealth app, including educational material, remote symptom monitoring, and well-being interventions.
This prospective pilot study compared an exploratory cohort that received the CAPABLE smartphone app and a multisensory smartwatch for 6 months (intervention) to a 2:1 individually matched historical prospective control group. HRQoL data were measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 at baseline (T0), 3 months (T1), and 6 months (T2) after start of treatment. Mixed effects linear regression models were used to compare HRQoL between the 2 groups over time.
From the 59 eligible patients for the CAPABLE intervention, 31 (53%) signed informed consent to participate. Baseline HRQoL was on average 10 points higher in the intervention group compared with controls, although equally matched on baseline and clinical characteristics. When correcting for sex, age, disease stage, and baseline scores, an adjusted difference in fatigue of -5.09 (95% CI -15.20 to 5.02, P=.32) at month 3 was found. No significant nor clinically relevant adjusted differences on other HRQoL domains over time were found. However, information satisfaction was significantly higher in the CAPABLE group (β=8.71, 95% CI 1.54-15.88, P=.02).
The intervention showed a limited effect on HRQoL, although there was a small improvement in fatigue at 3 months, as well as information satisfaction. When aiming at personalized patient and survivorship care, further optimization and prospective investigation of eHealth tools is warranted.
接受免疫检查点抑制剂免疫治疗的黑色素瘤患者经常经历免疫相关不良事件、癌症相关疲劳和情绪困扰，影响与健康相关的生活质量（HRQoL）以及免疫治疗的临床结局。电子健康工具可以从多个角度帮助癌症患者解决诸如不良事件和心理社会福祉等问题。
本研究旨在探讨通过移动应用程序访问的癌症患者美好生活体验（CAPABLE）系统与接受标准护理的匹配历史对照组相比，对HRQoL的影响。CAPABLE是一款经过广泛测试的电子健康应用程序，包括教育材料、远程症状监测和福祉干预措施。
这项前瞻性试点研究将接受CAPABLE智能手机应用程序和多感官智能手表6个月的探索性队列（干预组）与2:1个体匹配的历史前瞻性对照组进行比较。在治疗开始后的基线（T0）、3个月（T1）和6个月（T2），使用欧洲癌症研究与治疗组织生活质量问卷核心30来测量HRQoL数据。使用混合效应线性回归模型比较两组随时间的HRQoL。
在59名符合CAPABLE干预条件的患者中，31名（53%）签署了知情同意书参与研究。尽管干预组和对照组在基线和临床特征方面匹配，但干预组的基线HRQoL平均比对照组高10分。在对性别、年龄、疾病阶段和基线分数进行校正后，发现第3个月时疲劳的调整差异为-5.09（95%CI -15.20至5.02，P = 0.32）。随着时间的推移，在其他HRQoL领域未发现显著或具有临床相关性的调整差异。然而，CAPABLE组的信息满意度显著更高（β = 8.71，95%CI 1.54 - 15.88，P = 0.02）。
该干预措施对HRQoL的影响有限，尽管在3个月时疲劳有小幅改善，信息满意度也有所提高。在旨在实现个性化患者和生存护理时，有必要对电子健康工具进行进一步优化和前瞻性研究。
