促进癌症相关疲劳自我管理的INGeniouS ONline支持性解决方案的STEpwise计划的有效性和实施：The STEPPING-STONe数字化随机试验

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-06-26 DOI:10.1016/j.cct.2025.107993

Maria Alice Franzoi , Arnaud Pages , Cecile Charles , Marcio Debiasi , Emma Gillanders , Arlindo Ferreira , Fanny Jacques , Sibille Everhard , Guillaume GaryBobo , Cesarine Sambou , François Alla , Amandine Quivy , Sophie Morin , Ines Vaz-Luis

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引用次数: 0

摘要

背景：在整个癌症治疗过程中，疲劳是患者面临的最常见和最令人不安的症状之一，在常规治疗中，它没有得到最佳的解决。开发有效和可扩展的症状管理工具是实现全面和以患者为中心的癌症护理交付的核心未满足需求。本研究旨在评估三种数字辅助模式对癌症相关疲劳（CRF）的有效性，重点是患者赋权和自我管理。方法采用ⅱ型随机临床试验。共有372名被诊断为癌症并自我报告中度至重度CRF的患者将以1:1的比例随机分配到三个干预组之一：教育移动应用程序，带有自我指导的疲劳自我管理程序的教育移动应用程序，或带有疲劳自我管理程序和互动指导的教育移动应用程序。临床试验程序将受益于一个实用的数字化研究在线平台，该平台允许资格筛选、电子同意、随机化和收集患者报告的结果和临床数据。主要终点是EORTC QLQ-C30问卷测量的疲劳评分在基线和项目结束后三个月之间的差异。次要终点包括对疲劳评分的短期和长期影响，包括疲劳子域、自我效能、整体生活质量、健康资源的使用，以及对研究干预和数字化试验程序的详细实施评估。本研究将为CRF数字干预的有效性和实施提供高层次的证据。它还将展示使用技术简化临床试验程序的可行性。试验注册：ClinTrials.gov NCT06505590

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The effectiveness and implementation of a STEpwise program to promote INGeniouS ONline supportive solutions for self-management of cancer-related fatigue: The STEPPING-STONe digitally enabled randomized trial

Background

Fatigue is one of the most common and disturbing symptoms patients face throughout the cancer care continuum, and it is sub optimally addressed in routine care. Developing effective and scalable tools for symptom management is a central unmet need for achieving comprehensive and patient-centric cancer care delivery. This study aims to evaluate the effectiveness of three digital aid modalities for cancer related fatigue (CRF) focusing on patient empowerment and self-management.

Methods

Hybrid type 2 effectiveness-implementation randomized clinical trial. A total of 372 patients diagnosed with cancer and moderate to severe self-reported CRF will be randomized 1:1:1 into one of three intervention arms: educational mobile app, educational mobile app powered with a self-guided fatigue self-management program, or educational mobile app powered with the fatigue self-management program and interactive coaching. Clinical trial procedures will benefit from a pragmatic online platform for digitally enabled research allowing eligibility screening, electronic consent, randomization and collection of patient-reported outcomes and clinical data. The primary endpoint is the difference in fatigue scores measured by the EORTC QLQ-C30 questionnaire between baseline and three months after the end of the program. Secondary endpoints include short and long-term impact on fatigue scores including fatigue subdomains, self-efficacy, overall quality of life, use of health resources, as well a detailed implementation evaluation of both the study intervention and the digitally enabled trial procedures.

Discussion

This study will provide high-level evidence on the effectiveness and implementation of digital interventions for CRF. It will also demonstrate the feasibility of using technology to streamline clinical trial procedures.

Trial Registration: ClinTrials.gov NCT06505590

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.