Department of Hematology and Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
Genitourinary Oncology Department, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.
JCO Clin Cancer Inform. 2024 Jul;8:e2400044. doi: 10.1200/CCI.24.00044.
Patients with advanced renal cell carcinoma (RCC) face significant challenges, stemming both from the complexities of the disease itself and the adverse effects of treatments. This study evaluated the feasibility and acceptability of a mobile health (mHealth) application tailored for education and symptom management of patients with advanced RCC receiving combined immune checkpoint inhibitor and tyrosine kinase inhibitor (ICI-TKI) therapy.
The primary end points were acceptability and feasibility. Acceptability was defined as the proportion of patients approached who consented to participate, setting a benchmark of at least 50% for this metric. Feasibility was gauged by the completion rate of the intervention among the participants; it required at least 50% of participants to fully complete the intervention and at least 70% to finish half of the administered questionnaires. The secondary end points included knowledge assessment and patient-reported outcomes (PROs). PROs were evaluated using validated instruments. To discern the changes between pre- and post-educational module quiz scores, we used the Wilcoxon signed-rank test. Time-course data of PROs were visualized using line plots and then compared using paired t-tests.
From November 2022 to July 2023, 20 of 22 (90%) patients approached for the study consented and enrolled. Of the enrolled patients, 60% completed all questionnaires and knowledge assessments at every time point and 75% completed at least half of the surveys and questionnaires. Significant pre/post differences were noted in two of six quizzes in the knowledge assessment. This study population did not experience a significant change in PRO scores after starting therapy.
The mHealth application designed for education and symptom management in patients with advanced RCC undergoing combination ICI-TKI has proven to be both acceptable and feasible, meeting previous research benchmarks.
晚期肾细胞癌（RCC）患者面临着巨大的挑战，这些挑战不仅源于疾病本身的复杂性，还源于治疗带来的不良反应。本研究评估了一款为接受免疫检查点抑制剂联合酪氨酸激酶抑制剂（ICI-TKI）治疗的晚期 RCC 患者量身定制的移动医疗（mHealth）应用程序用于教育和症状管理的可行性和可接受性。
主要终点是可接受性和可行性。可接受性定义为愿意参与的患者比例，该指标的基准值至少为 50%。可行性通过参与者完成干预的比例来衡量；至少需要 50%的参与者完全完成干预，至少 70%的参与者完成一半以上的问卷。次要终点包括知识评估和患者报告的结果（PROs）。PROs 使用经过验证的工具进行评估。为了辨别教育模块测验前后得分的变化，我们使用了 Wilcoxon 符号秩检验。使用线图可视化 PRO 时间过程数据，然后使用配对 t 检验进行比较。
从 2022 年 11 月至 2023 年 7 月，研究共招募了 22 名患者，其中 20 名（90%）符合条件的患者同意并入组。在入组的患者中，60%的患者在每个时间点完成了所有问卷和知识评估，75%的患者完成了至少一半的调查和问卷。在知识评估的六个测验中，有两个测验的前/后差异显著。在开始治疗后，该研究人群的 PRO 评分没有显著变化。
为接受联合 ICI-TKI 治疗的晚期 RCC 患者设计的用于教育和症状管理的 mHealth 应用程序已被证明是可接受和可行的，达到了先前的研究基准。
