一款电子健康应用程序（CAPABLE），为接受免疫检查点抑制剂治疗的黑色素瘤患者提供症状监测、健康干预措施及教育资料：一项探索性干预试验方案

An eHealth App (CAPABLE) Providing Symptom Monitoring, Well-Being Interventions, and Educational Material for Patients With Melanoma Treated With Immune Checkpoint Inhibitors: Protocol for an Exploratory Intervention Trial.

作者信息

Fraterman Itske, Wollersheim Barbara M, Tibollo Valentina, Glaser Savannah Lucia Catherina, Medlock Stephanie, Cornet Ronald, Gabetta Matteo, Gisko Vitali, Barkan Ella, di Flora Nicola, Glasspool David, Kogan Alexandra, Lanzola Giordano, Leizer Roy, Mallo Henk, Ottaviano Manuel, Peleg Mor, van de Poll-Franse Lonneke V, Veggiotti Nicole, Śniatała Konrad, Wilk Szymon, Parimbelli Enea, Quaglini Silvana, Rizzo Mimma, Locati Laura Deborah, Boekhout Annelies, Sacchi Lucia, Wilgenhof Sofie

机构信息

Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands.

Laboratory of Informatics and Systems Engineering for Clinical Research, Istituti Clinici Scientifici Maugeri SpA SB IRCCS, Pavia, Italy.

出版信息

JMIR Res Protoc. 2023 Oct 11;12:e49252. doi: 10.2196/49252.

DOI:10.2196/49252

PMID:37819691

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10600650/

Abstract

BACKGROUND

Since treatment with immune checkpoint inhibitors (ICIs) is becoming standard therapy for patients with high-risk and advanced melanoma, an increasing number of patients experience treatment-related adverse events such as fatigue. Until now, studies have demonstrated the benefits of using eHealth tools to provide either symptom monitoring or interventions to reduce treatment-related symptoms such as fatigue. However, an eHealth tool that facilitates the combination of both symptom monitoring and symptom management in patients with melanoma treated with ICIs is still needed.

OBJECTIVE

In this pilot study, we will explore the use of the CAPABLE (Cancer Patients Better Life Experience) app in providing symptom monitoring, education, and well-being interventions on health-related quality of life (HRQoL) outcomes such as fatigue and physical functioning, as well as patients' acceptance and usability of using CAPABLE.

METHODS

This prospective, exploratory pilot study will examine changes in fatigue over time in 36 patients with stage III or IV melanoma during treatment with ICI using CAPABLE (a smartphone app and multisensory smartwatch). This cohort will be compared to a prospectively collected cohort of patients with melanoma treated with standard ICI therapy. CAPABLE will be used for a minimum of 3 and a maximum of 6 months. The primary endpoint in this study is the change in fatigue between baseline and 3 and 6 months after the start of treatment. Secondary end points include HRQoL outcomes, usability, and feasibility parameters.

RESULTS

Study inclusion started in April 2023 and is currently ongoing.

CONCLUSIONS

This pilot study will explore the effect, usability, and feasibility of CAPABLE in patients with melanoma during treatment with ICI. Adding the CAPABLE system to active treatment is hypothesized to decrease fatigue in patients with high-risk and advanced melanoma during treatment with ICIs compared to a control group receiving standard care. The Medical Ethics Committee NedMec (Amsterdam, The Netherlands) granted ethical approval for this study (reference number 22-981/NL81970.000.22).

TRIAL REGISTRATION

ClinicalTrials.gov NCT05827289; https://clinicaltrials.gov/study/NCT05827289.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49252.

摘要

背景

由于免疫检查点抑制剂（ICI）治疗正成为高危和晚期黑色素瘤患者的标准治疗方法，越来越多的患者出现与治疗相关的不良事件，如疲劳。到目前为止，研究已经证明使用电子健康工具来进行症状监测或采取干预措施以减轻疲劳等与治疗相关的症状是有益的。然而，仍需要一种能够促进对接受ICI治疗的黑色素瘤患者进行症状监测和症状管理相结合的电子健康工具。

目的

在这项试点研究中，我们将探索使用“有能力（癌症患者更美好的生活体验）”应用程序来提供症状监测、教育以及针对与健康相关的生活质量（HRQoL）结果（如疲劳和身体功能）的幸福感干预措施，以及患者对使用“有能力”应用程序的接受度和可用性。

方法

这项前瞻性、探索性试点研究将使用“有能力”（一款智能手机应用程序和多感官智能手表）来检查36例III期或IV期黑色素瘤患者在ICI治疗期间疲劳随时间的变化。该队列将与前瞻性收集的接受标准ICI治疗的黑色素瘤患者队列进行比较。“有能力”应用程序将至少使用3个月，最多使用6个月。本研究的主要终点是治疗开始后基线与3个月和6个月时疲劳的变化。次要终点包括HRQoL结果、可用性和可行性参数。

结果

研究纳入于2023年4月开始，目前正在进行中。

结论

这项试点研究将探索“有能力”应用程序在接受ICI治疗的黑色素瘤患者中的效果、可用性和可行性。与接受标准护理的对照组相比，在积极治疗中添加“有能力”系统被假设可减少高危和晚期黑色素瘤患者在ICI治疗期间的疲劳。荷兰内德梅克医学伦理委员会（阿姆斯特丹，荷兰）批准了本研究的伦理许可（参考编号22 - 981/NL81970.000.22）。