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

化疗可损害神经系统结构导致化疗所致外周 神经病(CIPN)，损害数百万癌症幸存者的生活质量和日常功能。约30% 的受者在化疗结束后长期生活在CIPN中。传统护理是有症状的 包括抗抑郁药、抗惊厥药、镇痛剂、维生素补充剂和局部凝胶来管理 症状。虽然没有FDA批准的治疗方法，但有证据表明，特定的手动疗法 技术可以减轻CIPN的症状。也有证据表明，照顾者可以安全有效地学习 通过多媒体教学在护理中使用的手动治疗技术。然而，目前还没有 护理员教育产品，教授与CIPN有关的具体技术和安全预防措施。 该项目将开发一款移动健康(MHealth)应用程序，以增强照顾者的知识、技能、 支持亲人的自我效能感和动机通过使用简单的手工技术 对CIPN的具体理解和安全注意事项。该项目将采用以人为中心的设计 形成性研究中的一种方法，为最终的照顾者开发“最低生存产品(MVP)” 移动健康应用程序。以用户为中心、与护理人员焦点小组一起的迭代流程将指导 MVP然后将通过Think-Aloud协议评估其可行性。具体目标如下： 目标1.开发最初的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 教育内容将在应用程序中亮相，然后通过患者焦点小组的反馈进行优化。由此产生的 最初的应用程序设计将包含易于导航、可用性、实用性和参与性的原则。 目标2.通过质量反馈的迭代过程改进APP设计。最初的应用程序 设计将通过三轮护理人员焦点小组进行处理和修改，以获得定性反馈 和精致。将在每一轮之后对答复进行定性分析，并应用于生产 通过第三轮的修订版本，产生了MVP原型。 目的3.评估最低可行产品(MVP)的可用性。护理者将体验MVP 通过与设计团队的互动思考-有声会议制作原型，并进行定性记录 分析。之后将进行汇报，并提出关于设计、相关性和 意图使用。量化数据将评估系统的可用性，以及感知的相关性和对护理的影响。 可行性标准将是可用性分数和用户对感知价值和使用意图的评级，用于护理。 如果第一阶段成功，应用程序将在第二阶段完成，随后将进行大型RCT评估 CIPN患者和照顾者的使用结果。最终对公共健康的好处包括改善 CIPN患者的生活质量和功能幸福感，减轻照顾者负担，以及 减少与CIPN相关的医疗成本和生产力损失带来的经济负担。

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.