Adherence to Swallowing Rehabilitation Exercises in Head and Neck Cancer

描述(申请人提供)：接受大范围放射治疗的头颈部癌症患者患永久性吞咽障碍的风险很高。为了防止这种情况，患者可以进行运动练习，以加强舌头和增加口咽结构的活动范围。然而，吞咽困难患者对吞咽练习的依从性很低；我们的初步数据显示，只有9.5%的参与者在放射治疗期间坚持吞咽练习(n=97)。我们的干预试点干预，Prepare(n=16)表明它是高度有效和可行的。对于头颈部癌症患者来说，确定坚持吞咽练习的关键介质和调节剂将是很有价值的。主要目的1)比较自我调节干预和增强型日常护理对照组在提高接受放射治疗的头颈癌患者对处方吞咽训练的依从性方面的有效性。目的：在6周和12个月的随访中，评估建议的干预措施对坚持自我报告吞咽练习的调节作用。接受测试的中介者将是疾病感知、应对程序和应对程序的评估。目的确定抑郁、疼痛、疲劳和社会支持是否在6周或12个月随访时缓和干预对依从性的影响，或两者兼而有之。目的2a)以OPSE评分为金标准的X线改良吞钡评分(MBS)，检测预备性干预对解剖吞咽功能的影响。目的2b)测试干预措施对MDADI和PSS-HN评估的自述吞咽功能的影响。研究设计：从M.D.安德森和林登·贝恩斯·约翰逊社区医院招募的288名患者将被随机分为两组：1)加强日常护理，外加一本关于吞咽运动重要性的宣传手册；2)准备，这是一种基于自我调节理论的干预措施，提供针对粘膜炎、口干、疲劳、恶心和吞咽困难的客观和激励性应对策略。评估时间点是在研究开始时的基线、放射治疗结束后6周和放射治疗后12个月。为了衡量干预对吞咽解剖功能的影响，100名参与者将在基线和12个月的随访时用改良的吞钡方法进行测量。摘要：所产生的纵向数据将在理论框架内提供有关坚持吞咽练习及其与解剖吞咽功能的关系的重要信息。公共卫生相关性：确定坚持吞咽练习的关键因素和成功的策略对于面临永久性吞咽障碍风险的头颈部癌症患者将是有价值的。该项目还将提供有用的信息，说明依从性干预是否可以增加依从性并改善金标准视频透视评估所评估的解剖功能。

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.