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.

尽管在延长生存期的医学和外科癌症治疗方面取得了重要进展，但退伍军人 口咽头颈癌 (OP HNC) 面临慢性、顽固性吞咽困难，导致 饮食持续剧烈改变、需要饲管以及吸入性肺炎的风险增加 – 我们必须投入研究和临床努力来减轻这些毁灭性的感染。 因为目前我们的康复干预选择非常有限。 与 VHA 的卓越变革行动蓝图保持一致，需要开发 有效的吞咽干预措施必须具有快速转化为临床实践的潜力。 呼吸-吞咽协调是吞咽过程中气道保护的重要组成部分，有助于 吞咽生理学的许多关键方面在患者中都受到显着干扰。 OP HNC 接受药物和手术治疗后出现吞咽困难的人 [我们的初步试验测试了一项研究。 我们的临床实验室开发了创新的吞咽治疗方法，呼吸吞咽训练 （RST），直接针对呼吸-吞咽协调，并导致令人信服的改善 患有吞咽困难的退伍军人的生理吞咽结果在传统方法之后持续很长时间 这项拟议试验的目标是使用吞咽行为干预来扩展我们的初步研究。 严格的随机交叉设计，确定 RST 对临床结果的影响和持久性 对于患有 OP HNC 的退伍军人来说，饮食、健康和生活质量至关重要。 拟议的试验对退伍军人的健康和福祉具有重要意义和临床相关性。] 将招募总共 88 名受试者，并按 1:1 随机分配至 RST（干预组）或无活性组 治疗（对照组），这被认为是该患者群体的护理标准，所获得的数据将是。 用于评估从[另外 11] 名随机分组的受试者获得的数据。 RST+家庭实践（HP）将用于评估辅助HP计划的可行性并获得 关于其对疗效和反应持久性的额外影响的初步数据是主要疗效终点。 功能性口服摄入量表水平，次要终点是呼吸-吞咽阶段模式。 我们还将通过详细说明 RST 的生理、气道保护和形态测量的影响 我们将使用可重复、可靠且经过验证的指标，其中包括改良钡。 吞咽损伤概况、刺入-误吸量表和吞咽计算分析 区分 RST 机械效应的机制此外，坚持使用新型 HP 组件。 将引入并测试自我指导实践的可行性以及对程度和持久性的贡献 RST干预效果。 我们的总体目标是提供知识生成的两个平行轨道：1）提供即时临床 转化实验结果以改善退伍军人的生活，2）推动模型生成 运动协调的基本机制。基础知识将推动临床应用和副- 因此，这是一个理想的实验和临床背景，将促进这方面的知识生成。 非常重要的科学和临床实践领域。