PRANAYAMA BASED MOBILE APP FOR BREAST CANCER SURVIVORSHIP: I-CORPS SUPPLEMENT

项目总结 癌症仍然是美国第二大死亡原因。令人鼓舞的是，最近早期癌症的改善 诊疗使癌症患者的存活率显著提高。作为癌症 成为一种慢性但可控的疾病，对成千上万的幸存者来说，长期的生理和心理上的 治疗方案的副作用变得越来越明显，这些问题对无病的影响也是如此 或总体存活率。作为这种不断变化的格局的结果，生存护理计划和方法 融入非药理学的生活方式和身心干预正变得越来越重要 患者治疗路径的组成部分。在这方面，瑜伽呼吸等综合方法 (YB)，一种自愿调节呼吸的技术的集合，已经成为一种有效的补充 癌症患者的治疗。YB可以通过迷走神经和迷走神经诱导强烈的松弛反应 副交感神经刺激。YB很容易使用移动应用程序等虚拟工具进行练习，特别是在 新冠肺炎大流行的当前情景和社会疏远。在本申请中，PranaScience寻求 为YB开发一款新的群视频应用程序，该应用程序针对被禁的YB节目的家庭交付进行了优化 这在促进同伴支持和缓解与以下方面相关的症状方面最有效 癌症治疗和生存。这一干预基于令人信服的初步数据，由 这项建议的PI表明，特定的YB运动导致相关蛋白质水平的变化 与肿瘤抑制、免疫调节、神经调节、应激反应/炎症以及 在癌症幸存者和其他患者/普通人群中进行的试点研究表明，参与者是 对YB干预感兴趣，并在YB治疗后感受到幸福感的改善。在此第一阶段STTR中， PranaScience(1)和(2)合作伙伴构建了文化中立的团体视频YB应用程序的第一个生产版本 与南卡罗来纳医科大学(MUSC)合作，在乳腺癌幸存者中试行YB应用程序，以 评估应用程序支持症状管理的依从性、可行性和可接受性。应用程序使用数据 被收集并用于评估对计划的遵守情况，症状管理的可接受性将是 在基线和实施12周后使用一系列已定义的生物行为测量进行评估 句号。探索性唾液和指甲生物标记物分析侧重于肿瘤抑制物、炎症性 细胞因子、蛋白质组水平改变和应激激素将在基线和第12周进行。 对研究参与者的有组织的焦点小组访谈将用于评估技术认知/计划 可行性，并将为未来的设计优化提供信息。来自i-Corps补充工作的信息将是 用于精炼APP，为二期大规模评估做准备，并用于商业化目的 通过客户发现访谈。

PROJECT SUMMARY Cancer remains the second leading cause of deaths in the U.S. Encouragingly, recent improvements in early diagnosis and treatment has led to significant increases in the survival rate of cancer patients. As cancer becomes a chronic but manageable disease for thousands of survivors, the long-term physical and psychological side effects of treatment protocols is becoming more apparent, as is the impact of these issues on disease-free or overall survival. As a result of this changing landscape, survivorship care programs and approaches that incorporate non-pharmacological lifestyle and mind-body interventions are becoming increasingly critical components of the patient treatment pathway. In this regard, integrative approaches such as yogic breathing (YB), a collection of techniques to voluntarily regulate breathing, have emerged as an effective complementary therapy for cancer patients. YB is well-established to induce strong relaxation responses via vagal and parasympathetic stimulation. YB is easy to practice using virtual tools such as mobile apps especially during the current scenario of COVID-19 pandemic and social distancing. In this application, PranaScience seeks to develop a novel group video app for YB that is optimized for home-based delivery of a proscribed YB program that is maximally effective in promoting peer support, and relieving symptomatic conditions associated with cancer treatment and survivorship. This intervention is based on compelling preliminary data generated by the PI of this proposal demonstrating that specific YB exercises induce alterations in the levels of proteins associated with tumor suppression, immune regulation, neuromodulation, and stress response/ inflammation, as well as pilot studies performed in cancer survivors and other patient/general populations indicating that participants are interested in a YB intervention and perceive improvements in well-being after YB sessions. In this Phase I STTR, PranaScience (1) has built a first production version of a culturally neutral group video YB app and (2) partners with the Medical University of South Carolina (MUSC) to pilot test the YB app in breast cancer survivors to evaluate adherence, feasibility, and acceptability of the app to support symptom management. App usage data is collected and used to evaluate adherence to the program, and acceptability for symptom management will be evaluated using a series of defined biobehavioral measures at baseline and following a 12-week implementation period. Exploratory salivary and fingernail biomarker analysis focused on tumor suppressors, inflammatory cytokines, proteome level alterations, and stress hormones will be performed at baseline and at week 12. Structured, focus group interviews of study participants will be used to assess technology perception/ program feasibility and will inform future design optimizations. Information from the I-Corps supplemental work will be used to refine app in preparation for large-scale evaluation in Phase II, and for commercialization purposes through customer discovery interviews.