mHealth app for caregiver instruction in manual therapy for chemotherapy-induced peripheral neuropathy

化疗可损伤神经系统结构，导致化疗诱导的外周血淋巴细胞减少。 神经病变（CIPN）损害了数百万癌症幸存者的生活质量和日常功能。约30% 的接受者在完成化疗后长期患有CIPN。常规治疗是对症治疗 包括抗抑郁药、抗惊厥药、止痛药、维生素补充剂和局部凝胶， 症状虽然没有FDA批准的治疗方法，但有证据表明， 技术可以减少CIPN的症状。也有证据表明，照顾者可以学习安全有效 通过多媒体教学，使用手动治疗技术。然而，目前没有 护理人员教育产品，教导与CIPN有关的特定技术和安全预防措施。 该项目将开发一个移动的健康（mHealth）应用程序，使护理人员能够获得知识，技能， 自我效能和动机，以支持亲人与CIPN通过使用简单的手动技术的基础上， 对CIPN的具体理解和安全注意事项。该项目将采用以人为本的设计 形成性研究的方法，为最终的护理人员开发“最低可行产品（MVP）” 一个以用户为中心的，与护理人员焦点小组的迭代过程将指导 MVP，然后将通过一个大声思考方案评估其可行性。具体目标如下： 目标1。开发以用户为中心的应用程序设计。我们将制定核心的初步要求 应用程序中包含的教育内容，然后根据患者焦点小组的反馈进行完善。所得 最初的应用程序设计将纳入易于导航、可用性、实用性和参与性的原则。 目标二。通过定性反馈的迭代过程优化应用程序设计。最初的APP 设计将通过三轮护理人员焦点小组进行处理和修订，以获得定性反馈 和精致。每轮调查结束后，将对答复进行定性分析，并用于产生 通过第三轮的修订版本，产生了MVP原型。 目标3：评估最小可行产品（MVP）的可用性。护理人员将体验MVP 通过与设计团队的互动式“大声思考”会议制作原型， 分析.随后将进行汇报，提出关于设计、相关性和 意图使用。定量数据将评估系统的可用性，以及感知的相关性和对系统的影响。 可行性标准将是可用性评分和用户对感知价值的评分以及在测试中的“使用意图”。 如果第一阶段成功，应用程序将在第二阶段完成，然后进行大型RCT评估 CIPN患者和护理人员的使用结果。最终的公共卫生效益包括改善 CIPN患者人群的生活质量和功能健康，减轻照顾者负担，以及 减少了医疗费用的经济负担和与CIPN相关的生产力损失。

Chemotherapy can damage nervous system structures leading to chemotherapy-induced peripheral neuropathy (CIPN) which impairs quality of life and daily functioning for millions of cancer survivors. Some 30% of recipients live with CIPN chronically beyond completion of chemotherapy. Conventional care is symptomatic including antidepressants, anticonvulsants, analgesics, vitamin supplements and topical gels to manage symptoms. While there are no FDA-approved treatments, evidence indicates that specific manual therapy techniques can reduce symptoms of CIPN. There is also evidence that caregivers can learn safe and effective manual therapy techniques for use in caregiving through multimedia instruction. However, there currently is no caregiver education product teaching specific techniques and safety precautions pertaining to CIPN. This project will develop a mobile health (mHealth) app to empower caregivers with knowledge, skills, self-efficacy and motivation to support loved ones with CIPN by use of simple manual techniques based on specific understanding and safety precautions for CIPN. The project will use a human-centered design approach in formative research to develop a “minimum viable product (MVP)” for the eventual caregiver mHealth app. A user-centered, iterative process with caregiver focus groups will guide development of the MVP which will then be assessed for feasibility through a Think-Aloud protocol. Specific Aims are as follows: Aim 1. Develop initial user-centered app design. We will develop preliminary requirements for core educational content to be featured in the app, then refine this with patient focus group feedback. The resulting initial app design will incorporate principles of ease of navigation, usability, utility, and engagement. Aim 2. Refine app design through an iterative process of qualitative feedback. The initial app design will be processed and revised through three rounds of caregiver focus groups for qualitative feedback and refinement. Qualitative analysis of responses after each round will be conducted, and applied to produce revised versions through round 3, resulting in the MVP prototype. Aim 3. Evaluate usability of a minimum viable product (MVP). Caregivers will experience the MVP prototype through an interactive Think-Aloud session with the design team that is recorded for qualitative analysis. This will be followed by debriefing with structured interview questions about design, relevance and intent to use. Quantitative data will assess system usability, and perceived relevance and impact on caregiving. Feasibility criteria will be usability scores and user ratings of perceived value and “intent to use” in caregiving. If Phase I is successful the app will be completed in Phase II followed by a large RCT to assess outcomes of use for both CIPN sufferers and caregivers. Eventual public health benefits include improved quality of life and functional well-being for the population of CIPN sufferers, reduced caregiver burden, and reduced economic burden from medical costs and lost productivity associated with CIPN.