PRANAYAMA BASED GROUP VIDEO APP FOR CANCER SURVIVORSHIP. Phase I. Breast Cancer Pilot

基于调息的癌症幸存者团体视频应用程序。

• 批准号: 10156943
• 负责人: SUNDARAVADIVEL BALASUBRAMANIAN
• 金额: $ 38.87万
• 依托单位: PRANASCIENCE INSTITUTE LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-01 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10156943
• 关键词: Adherence; American Cancer Society; Antineoplastic Protocols; Anxiety; Behavioral; Biological Markers; Breast Cancer survivor; Breathing; Breathing Exercises; Cancer Intervention; Cancer Patient; Cancer Survivor; Cancer Survivorship; Caregivers; Caring; Cause of Death; Chronic; Chronic Care; Cognitive; Collaborations; Collection; Communities; Complementary therapies; Computer software; Control Groups; Custom; Data; Development; Disease; Disease Management; Early Diagnosis; Early treatment; Equipment and supply inventories; Evaluation; Evidence based intervention; Fibrinogen; Frequencies; Future; Gene Expression; Goals; Group Practice; Health; Home; Hormones; Individual; Inflammation; Inflammatory; Institutes; Integrative Medicine; Intervention; Interview; Length; Life; Life Style; Link; Malignant Neoplasms; Measures; Medical; Meditation; Mental Depression; Metabolism; Methods; Mind-Body Intervention; Modality; Online Systems; Outcome; Participant; Pathway interactions; Patient Self-Report; Patients; Perception; Personal Satisfaction; Phase; Pilot Projects; Preparation; Production; Program Acceptability; Proteins; Proteome; Psychological Side Effects; Quality of life; Radiation therapy; Randomized; Recovery; Rehabilitation therapy; Relaxation; Resources; Risk; Saliva; Salivary; Secondary to; Series; Sleep disturbances; Small Business Technology Transfer Research; South Carolina; Stress; Structure; Structure of nail of finger; Supportive care; Surveys; Survival Rate; Survivors; Symptoms; System; Techniques; Technology; Testing; Time; Treatment Protocols; Treatment Side Effects; Tumor Suppression; Tumor Suppressor Proteins; Universities; Visit; Visual; Visual Aid; Work; Yoga; attentional control; base; biobehavior; biological adaptation to stress; biomarker panel; cancer site; cancer survival; cancer therapy; cancer type; cohort; cost; cytokine; design; ethnic minority population; evidence base; healthy lifestyle; healthy volunteer; immunoregulation; improved; instructor; interest; malignant breast neoplasm; mobile application; neuroregulation; novel; peer; peer support; perceived stress; pranayama; programs; racial minority; reduce symptoms; response; rural area; satisfaction; side effect; survivorship; symptom management; targeted biomarker; tool; tumor; usability

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, aspects of meditation and yoga such as yogic breathing (YB), a collection of techniques to voluntarily regulate breathing, has emerged as an effective complementary therapy for cancer patients. YB is well-established to induce strong relaxation responses via vagal and parasympathetic stimulation. 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 reducing symptomatic conditions associated with cancer treatment and survival. This intervention is based on compelling preliminary studies conducted 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 collaboration with the Medical University of South Carolina (MUSC) indicating that cancer survivors are interested in a YB intervention and perceive improvements in well-being after YB sessions. In this Phase I STTR, PranaScience will (1) build a first production version of a group video YB app and (2) partner with 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 will be 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, focused interviews of study participants will be used to assess technology perception/ program feasibility and will inform future design optimizations. Findings from this Phase I program will be synthesized to refine the group video YB app in preparation for large-scale evaluation in Phase II, ultimately resulting in a scalable, low-cost resource that accelerates recovery from treatment and supports sustainable health in all-site cancer survivors, with a promise for adaptation to other chronic care settings.

项目摘要 癌症仍然是美国第二大死亡原因。 诊断和治疗已导致癌症患者的存活率显著提高。如癌症 对于成千上万的幸存者来说，这是一种慢性但可控制的疾病， 治疗方案的副作用越来越明显，这些问题对无病 或总体生存率。由于这种不断变化的景观，生存护理计划和方法， 结合非药物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，冥想和瑜伽的方面，如瑜伽， 呼吸（YB），一系列自愿调节呼吸的技术，已经成为一种有效的方法。 癌症患者的辅助治疗。YB是公认的诱导强松弛反应，通过 迷走神经和副交感神经刺激。在该应用程序中，PranaScience寻求开发一种新颖的群组视频 YB的应用程序，该应用程序针对基于家庭的被禁YB程序的交付进行了优化，该程序在以下方面最有效： 减少与癌症治疗和存活相关的症状性病症。这次干预是基于 由PI对该提案进行的令人信服的初步研究表明，特定的YB演习 诱导与肿瘤抑制，免疫调节， 神经调节和应激反应/炎症，以及与 南卡罗来纳州医科大学（MUSC）表示癌症幸存者对YB干预感兴趣 并在YB会议后感知幸福感的改善。在第一阶段STTR中，PranaScience将（1）建立一个 YB群组视频应用程序的第一个生产版本，以及（2）与MUSC合作，在乳房中对YB应用程序进行试点测试 癌症幸存者评估应用程序支持症状的依从性、可行性和可接受性 管理将收集应用程序使用数据，并用于评估对计划的依从性和可接受性 将使用一系列定义的基线生物行为指标评估症状管理， 在为期12周的实施期之后。探索性唾液和指甲生物标志物分析的重点是 肿瘤抑制因子、炎性细胞因子、蛋白质组水平改变和应激激素将进行 在基线和第12周。将使用对研究参与者的结构化、重点访谈来评估技术 感知/方案可行性，并将为未来的设计优化提供信息。第一阶段项目的结果 将被合成以完善YB群组视频应用程序，为第二阶段的大规模评估做准备， 最终形成一种可扩展的低成本资源，可加速治疗后的恢复， 所有癌症幸存者的可持续健康，并有望适应其他慢性病护理环境。