BACKGROUND There are a growing number of mHealth tools for breast cancer patients but a lack of scientific evidence for their effects. Recent studies have shown a mix of positive and negative impacts on users. Here we will assess the impact of OWise Breast Cancer, a mobile application for self-monitoring symptoms and managing care, on the process of self-management. METHODS This randomized controlled trial with early stage breast cancer patients will assess the effect of OWise use on patient activation at 3 months from diagnosis measured by the PAM-13 questionnaire. We will also assess differences in changes in health-related quality of life, psychological distress, health status, and National Health Service (NHS) health resource utilization over the first year from diagnosis. Participants will be randomly allocated (1:1) to standard care or standard care plus OWise. Participants will complete questionnaires before starting anti-cancer treatment and at 3, 6, and 12 months from diagnosis. Clinical and patient-reported outcome data will be linked to health resource utilization data from Discover, an integrated care record of primary, secondary, and social care in North West London. We will measure contamination in the control group and adjust the sample size to mitigate the dilution of effect estimates. A per-protocol analysis will be conducted as a sensitivity analysis to assess robustness of the primary results. DISCUSSION This study aims to generate evidence for the effectiveness of OWise at improving patient activation for women with early-stage breast cancer. The results will show the impact of using the tool at the patient level and the NHS health system level. The outcomes of the study will have implications for the application of OWise across the NHS for breast cancer patients and expansion into other tumor types. Assessing publicly available mHealth tools poses a challenge to trialists due to the risk of contamination. Here we apply various methods to measure, mitigate, and assess the effects of contamination. TRIAL REGISTRATION The study was registered at clincaltrials.gov (NCT03866655) on 7 March 2019.

中文翻译：

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评估支持乳腺癌患者的数字工具：随机对照试验方案（ADAPT）。

背景技术用于乳腺癌患者的mHealth工具越来越多，但是缺乏有关其效果的科学证据。最近的研究表明，对用户的正面和负面影响混合在一起。在这里，我们将评估OWise乳腺癌（一种用于自我监测症状和管理护理的移动应用程序）对自我管理过程的影响。方法这项针对早期乳腺癌患者的随机对照试验将评估PAM-13问卷诊断后3个月使用OWise对患者激活的影响。从诊断开始的第一年，我们还将评估与健康相关的生活质量，心理困扰，健康状况以及国家卫生服务（NHS）卫生资源利用方面的变化差异。参与者将被随机分配（1：1）接受标准护理或标准护理加OWise。参加者将在开始抗癌治疗之前以及诊断后的3、6和12个月完成调查表。临床和患者报告的结局数据将与Discover的卫生资源利用数据相关联，Discover是伦敦西北部地区初级，二级和社会护理的综合护理记录。我们将测量对照组中的污染并调整样本量以减轻效果估计值的稀释。进行基于协议的分析作为敏感性分析，以评估主要结果的稳健性。讨论本研究旨在为OWise改善早期乳腺癌女性患者激活的有效性提供证据。结果将显示在患者级别和NHS卫生系统级别使用该工具的影响。该研究的结果将对OWise在乳腺癌患者中在NHS中的应用以及扩展为其他肿瘤类型具有影响。由于存在污染的风险，评估可公开获得的移动医疗工具对审判人员构成了挑战。在这里，我们采用了各种方法来测量，减轻和评估污染的影响。试验注册该研究已于2019年3月7日在clincaltrials.gov（NCT03866655）上进行了注册。在这里，我们采用了各种方法来测量，减轻和评估污染的影响。试验注册该研究已于2019年3月7日在clincaltrials.gov（NCT03866655）上进行了注册。在这里，我们采用了各种方法来测量，减轻和评估污染的影响。试验注册该研究已于2019年3月7日在clincaltrials.gov（NCT03866655）上进行了注册。