Adherence to Swallowing Rehabilitation Exercises in Head and Neck Cancer

描述（由申请人提供）：接受大视场辐射治疗的头颈癌患者发生永久性吞咽障碍的风险很高。为了防止这种情况，患者可以进行运动锻炼，增强舌头的力量，增加口咽结构的活动范围。然而，吞咽困难患者坚持吞咽练习的比例很低；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，PREPARE （n=16）表明它是非常有效和可行的。确定坚持吞咽练习的关键调节因素和调节因素对头颈癌患者有价值。主要目的1)比较自我调节干预组与强化常规护理对照组在提高放疗头颈癌患者对处方吞咽练习的依从性方面的疗效。目的1a)在6周和12个月的随访中评估拟议干预对自述吞咽练习依从性的中介作用。需要测试的中介包括疾病感知、应对程序和应对程序的评价。目的1b)确定抑郁、疼痛、疲劳和社会支持是否在6周或12个月随访时调节干预对依从性的影响。目的2a)测试PREPARE干预对解剖吞咽功能的影响，通过金标准放射照相改良钡吞咽（MBS）评估，并以OPSE评分。目的2b)测试PREPARE干预对MDADI和PSS-HN评估的自我报告吞咽功能的影响。研究设计：从m.d. Anderson和Lyndon Baines Johnson社区医院招募288名患者，主要服务于少数民族和低收入患者，将被随机分为两组：1)增强常规护理加关于吞咽运动重要性的信息手册；2)PREPARE，一种基于自我调节理论的干预，提供针对粘膜炎、口干、疲劳、恶心和吞咽困难的客观和动机应对策略。评估时间点为基线入组、放疗结束后6周和放疗后12个月。为了测量干预对吞咽解剖功能的影响，100名参与者的子样本将在基线和12个月的随访中通过改良钡吞咽来测量。总结：由此产生的纵向数据将在理论框架内提供关于坚持吞咽练习及其与解剖吞咽功能关系的重要信息。公共卫生相关性：确定坚持吞咽练习的关键因素和成功策略对有永久性吞咽障碍风险的头颈癌患者很有价值。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.