Adherence to Swallowing Rehabilitation Exercises in Head and Neck Cancer

描述（由申请人提供）：接受大野放射治疗的头颈部癌症患者发生永久性吞咽障碍的风险较高。为了防止这种情况，患者可以进行运动练习，加强舌头和增加口咽结构的运动范围。然而，吞咽困难患者的吞咽练习依从性较低;我们的初步数据表明，只有9.5%的参与者在放疗期间坚持吞咽练习（n=97）。我们的干预试点干预，CIPE（n=16）表明，它是高度有效和可行的。确定关键介质和主持人坚持吞咽练习将是有价值的头颈部癌症患者。主要目的目的1）比较自我调节干预与增强型口腔护理对照组在增加接受放射治疗的头颈部癌症患者样本中对处方吞咽练习的依从性方面的功效。目的1a）在6周和12个月随访时，评价拟议干预措施对自我报告吞咽练习依从性的调节作用。要测试的介质将感知疾病，应对程序和评估的应对程序。目的1b）确定抑郁、疼痛、疲劳和社会支持是否会在6周随访或12个月随访或两者时调节干预对依从性的影响。目的2a）通过采用OPSE评分的金标准放射学改良钡剂吞咽（MBS）评估，测试CTEE干预对解剖吞咽功能的影响。目的2b）测试通过MDADI和PSS-HN评估的EAE干预对自我报告的吞咽功能的影响。研究设计：从M. D.安德森和林登贝恩斯约翰逊社区医院，主要服务于少数民族，低收入患者，将被随机分为两组之一：1）加强口腔护理加上关于吞咽练习重要性的信息手册，和2）自我调节，一种基于自我调节理论的干预措施，为粘膜炎，口干，疲劳，恶心和吞咽困难提供客观和动机性的应对策略。评估时间点为进入研究的基线、放射治疗结束后6周和放射治疗后12个月。为了测量干预对吞咽解剖功能的影响，将在基线和12个月随访时通过改良钡剂吞咽测量100名参与者的子样本。总结：由此产生的纵向数据将产生重要的信息，坚持吞咽练习及其关系的解剖吞咽功能的理论框架内。公共卫生相关性：确定关键因素和成功的策略，坚持吞咽练习将是有价值的头颈癌患者，谁是在风险的永久性吞咽障碍。该项目还将提供关于依从性干预是否可以增加依从性和改善解剖功能的有用信息，如黄金标准视频透视评估所评估的。

DESCRIPTION (provided by applicant): Head and neck cancer patients who are treated with large-field radiation are at high risk to develop permanent swallowing disorders. To prevent this, patients can perform motor exercises that strengthen the tongue and increase range of motion in oropharyngeal structures. However, adherence to swallowing exercises is low in dysphagic patients; our preliminary data indicated that just 9.5% of the participants were adherent to swallowing exercises during radiation (n=97). Our intervention pilot intervention, PREPARE (n=16) indicates that it is highly effective and feasible. Identifying key mediators and moderators in adherence to swallowing exercises would be valuable to head and neck cancer patients. Primary Aims Aim1) To compare the efficacy of a Self- Regulation intervention with an Enhanced Usual Care control group in increasing adherence to prescribed swallowing exercises in a sample of irradiated head and neck cancer patients. Aim1a) To evaluate the mediators of the proposed intervention on adherence to self-reported swallowing exercises at 6 week and twelve month follow-up. The mediators to be tested will be perception of illness, coping procedures and appraisal of coping procedures. Aim1b) To determine whether depression, pain, fatigue and social support moderate the impact of the intervention on adherence at 6 week follow-up or 12 month follow-up or both. Aim 2a) To test the impact of the PREPARE intervention on anatomic swallowing function as assessed by gold-standard radiographic Modified Barium Swallow (MBS), which is scored with the OPSE. Aim 2b) To test the impact of the PREPARE intervention on self-reported swallowing function as assessed by the MDADI and the PSS-HN. Study design: 288 patients recruited from M. D. Anderson and Lyndon Baines Johnson Community hospital, which serves primarily minority, low-income patients, will be randomized into one of two groups: 1) Enhanced Usual care plus an informational brochure about the importance of swallowing exercises, and 2) PREPARE, an intervention based on the Theory of Self-Regulation delivering objective and motivational coping strategies for mucositis, xerostomia, fatigue, nausea and dysphagia. Assessment timepoints are at baseline entry into the study, 6 weeks after the end of radiation therapy, and 12 months post-radiation. To measure the impact of the intervention on swallowing anatomic function, a subsample of 100 participants will be measured by modified barium swallow at baseline and at 12 month follow-up. Summary: The resulting longitudinal data will yield important information about adherence to swallowing exercises and its relationship to anatomic swallowing function within a theoretical framework. PUBLIC HEALTH RELEVANCE: Identifying key factors and successful strategies in adherence to swallowing exercises would be valuable to head and neck cancer patients, who are at risk for permanent swallowing disorders. This project will also provide useful information on whether an adherence intervention can increase adherence and improve anatomic function as assessed by gold-standard videofluoroscopic assessment.