Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in OP HNC

呼吸吞咽训练对 OP HNC 难治性吞咽困难的临床影响

• 批准号: 10084171
• 负责人: BONNIE J MARTIN-HARRIS
• 金额: --
• 依托单位: EDWARD HINES JR VA HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10084171
• 关键词: Ablation; Adherence; Adjuvant; Area; Aspiration Pneumonia; Barium swallow; Behavioral; Big Data; Chronic; Clinic; Clinical; Clinical assessments; Computer Analysis; Computer software; Crossover Design; Data; Databases; Deglutition; Deglutition Disorders; Development; Diet; Disease; Eating; Educational Intervention; Elements; Enteral Feeding; Event; Food; Future; General Population; Generations; Goals; Head and Neck Cancer; Health; Health care facility; Home; Impairment; Incidence; Infection; Ingestion; Intake; Intervention; Knowledge; Laboratories; Larynx; Learning; Life; Liquid substance; Maintenance; Malignant Neoplasms; Measurement; Measures; Mechanics; Medical; Methods; Modeling; Motor; Operative Surgical Procedures; Oral; Oropharyngeal; Outcome; Outcome Measure; Patient Care; Patients; Pattern; Penetration; Personal Satisfaction; Pharyngeal structure; Phase; Physiological; Physiology; Public Health Informatics; Quality of life; Randomized; Refractory; Rehabilitation therapy; Reporting; Reproducibility; Research; Resistance; Respiration; Risk; Science; Services; Site; Standardization; System; Testing; Texture; Toxic effect; Training; Translations; Veterans; active method; arm; cancer care; cancer therapy; care burden; care coordination; clinical application; clinical efficacy; clinical practice; clinical translation; clinically relevant; compliance behavior; cost; design; drinking; feasibility testing; functional improvement; functional outcomes; improved; innovation; intervention effect; mobile computing; novel; patient population; primary outcome; programs; prototype; recruit; rehabilitative care; respiratory; response; secondary endpoint; standard of care; tongue root; treatment arm

Despite important advancements in medical and surgical cancer treatments that prolong survival, veterans with oropharyngeal head and neck cancer (OP HNC) are faced with chronic, intractable dysphagia resulting in persistent drastic alterations in diet, the need for feeding tubes, and increased risk for aspiration pneumonia – a life threatening infection. We must devote research and clinical efforts to mitigate these devastating impairments because currently our rehabilitative intervention options are severely limited. As such, and in keeping with the VHA’s Blueprint for Excellence Transformative Actions, the need for the development of effective swallowing interventions that show potential for rapid translation to clinical practice is imperative. Respiratory-swallow coordination is an essential element of airway protection during swallowing and facilitates many key aspects of swallowing physiology. This key coordinative event is significantly disrupted in patients who are dysphagic following medical and surgical treatments for OP HNC. [Our preliminary trial tested an innovative swallowing treatment approach developed in our clinical laboratory, respiratory-swallow training (RST), that targets respiratory-swallow coordination directly and resulted in compelling improvements in physiologic swallowing outcomes in veterans suffering from dysphagia that persisted long after traditional behavioral swallowing intervention(s). The goal of this proposed trial is to extend our preliminary study using a rigorous, randomized cross over design and determine the impact and durability of RST on clinical outcomes essential for eating, drinking, health, and quality-of-life in veterans with OP HNC. As such, positive results from the proposed trial have high significance and clinical relevance for veterans’ health and well-being.] A total of 88 subjects will be recruited and randomly assigned 1:1 to either RST (intervention arm) or no active treatment (control arm), which is considered standard of care in this patient population. Data obtained will be used to evaluate clinical efficacy and durability. Data obtained from [an additional 11] subjects randomized to RST + home practice (HP) will be used to assess the feasibility of adjuvant HP program and to obtain preliminary data on its added impact on efficacy and response durability. The primary efficacy endpoint is Functional Oral Intake Scale level, and the secondary endpoint will be respiratory-swallow phase patterning. We will also elaborate on the impact of RST by detailing the physiological, airway protective, and morphometric changes that occur. We will use reproducible, reliable, and validated metrics that include the Modified Barium Swallow Impairment Profile, Penetration-Aspiration Scale, and Computational Analysis of Swallowing Mechanics to distinguish the mechanistic effects of RST. Further, adherence to a novel HP component using self-guided practice will be introduced and tested for feasibility and contribution to the degree and durability of the RST intervention effect. Our overarching goal is to provide two parallel tracks of knowledge generation: 1) provide immediate clinical translation of experimental findings to improve the lives of veterans, and 2) drive model generation on fundamental mechanisms of motor coordination. Basic knowledge will drive clinical application and vice-a- versa. As such, this is an ideal experimental and clinical context that will fuel knowledge generation in this highly significant area of science and clinical practice.

尽管在医学和外科癌症治疗方面取得了重大进步，这延长了生存期，但退伍军人 口咽头和颈癌（OP HNC）面临着慢性，棘手的吞咽困难，导致 饮食的持续急剧改变，进食管的需求以及增加肺炎的风险增加 - 威胁生命的感染。我们必须投入研究和临床努力来减轻这些毁灭性的 损害是因为目前我们的康复干预选择受到严重限制。因此，在 与VHA的蓝图保持卓越的变革行动，需要发展 有效的吞咽干预措施表明了快速转化为临床实践的潜力。 呼吸道戒烟协调是吞咽和促进气道保护的重要因素 吞咽生理学的许多关键方面。此关键协调事件在患者中受到了显着破坏 在医学和外科手术治疗后，他们吞咽困难。 [我们的初步试验测试了 创新的吞咽治疗方法在我们的临床实验室中开发 （rst），以直接针对呼吸道含量配位，并导致令人信服的改善 在传统之后很长一段时间以来，患有吞咽困难的退伍军人的生理吞咽结果 行为吞咽干预。该拟议试验的目的是使用A扩展我们的初步研究 严格的，随机的交叉设计，并确定RST对临床结果的影响和耐用性 使用OP HNC的退伍军人在饮食，饮水，健康和生活质量的必要条件下必不可少。因此，来自 拟议的试验对退伍军人的健康和福祉具有很高的意义和临床相关性。] 总共将招募88名受试者，并随机分配1：1的第一个（干预组）或没有主动 治疗（对照组），该治疗被认为是该患者人群的护理标准。获得的数据将是 用于评估临床效率和耐用性。从[另外11个]受试者获取的数据随机分配给 RST +家庭实践（HP）将用于评估调整HP计划的可行性并获得 有关其对效率和响应耐用性的附加影响的初步数据。主要效率端点是 功能性口服量表水平和次要终点将是呼吸量含量的相位图案。 我们还将通过详细说明生理，气道保护和形态计量学来详细说明RST的影响 发生的变化。我们将使用可复制，可靠和经过验证的指标，包括修改的钡 吞咽损伤概况，吸气量表和吞咽的计算分析 区分RST的力学效应的力学。此外，使用使用新型的HP组件的粘附 将引入和测试自我引导的实践，以实现可行性和贡献 第一个干预效果。 我们的总体目标是提供两个平行的知识生成轨道：1）立即提供临床 实验发现的翻译以改善退伍军人的生活，2）开发模型 运动协调的基本机制。基础知识将推动临床应用和副副作用 - Versa。因此，这是理想的实验和临床环境，它将在此推动知识的产生 非常重要的科学和临床实践领域。