Does the Use of Clinician Directed Prophylactic Swallowing Therapy in Patients Undergoing Definitive Chemoradiation for Head and Neck Cancer Improve Swallowing Function Outcomes?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in swallowing status
研究概览
简要总结
Clinician directed prophylactic swallowing therapy will improve immediate (four weeks +/- two weeks) and short-term (26 weeks +/- four weeks) post-treatment swallowing function and quality of life versus patient directed home exercises.
The purpose of this prospective, interventional, pilot investigation is to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes and quality of life in the immediate and short-term basis compared to patients receiving standard of care patient directed independent home swallowing therapy. Patient compliance with home exercises programs is reportedly inconsistent. Patients may experience changes in their physical functioning and overall well-being that may impact their ability to follow-through with independent home therapy. Clinician directed swallowing therapy allows for ongoing assessment of changes that may warrant modifying the therapy program in terms of intensity of exercises and/or expectations. This facilitates individualizing the patient's therapy plan to maximize their function and ability to achieve goals. It is anticipated that individualizing swallowing therapy through weekly session will result in improved swallowing function.
详细描述
This is a single-site, two-arm, 1:1 randomized, prospective, interventional, pilot study to determine whether clinician directed swallowing therapy will improve patient swallowing function outcomes when compared to patient-directed home-based swallowing therapy.
The investigators anticipate at least 40 subjects will need to be enrolled/consented in order to obtain the accrual goal of 15 evaluable subjects for each group for a total of 30 participants.
All subjects in each group will receive a face-to-face education session with a speech pathologist to review a recommended program of swallowing exercises prior to initiation of chemoradiation at their baseline (pre-treatment evaluation session).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of head and neck cancer (sites: oropharynx: human papillomavirus (HPV) related and non HPV related tonsil and base of tongue)
- •Scheduled to undergo definitive chemoradiation therapy
- •At least 18 years of age or older
- •Subject must have the ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Surgical management in addition to chemoradiation therapy;
- •Cancer of the sinus, brain, or parotid;
- •Prior treatment for head and neck cancer;
- •Receiving chemoradiation treatment at an outside institution (i.e., non-University of Miami (UM) clinic);
- •Prior history of dysphagia unrelated to the current diagnosis of head and neck cancer;
- •Prior neurologic disorder (i.e., Cerebrovascular accident (CVA), Traumatic brain injury (TBI), dementia) or current degenerative neuromuscular disease;
- •History of prior c-spine surgery;
- •History of prior vocal fold immobility
结局指标
主要结局
Change in swallowing status
时间窗: Baseline, Up to 6 weeks
Swallowing status will be measured using Functional Oral Intake Scale (FOIS). FOIS has a range from 0 (most restrictive) to 7 (least restrictive).
次要结局
- Change in swallowing status as measured by FOIS(Baseline, Up to 30 weeks)
- Change in quality of life as measured by PSS-HN(Baseline to 6 weeks, Baseline to 30 weeks)
- Change in quality of life as measured by EAT-10(Baseline to 6 weeks, Baseline to 30 weeks)
- Change in quality of life as measured by UW-QOL(Baseline to 6 weeks, Baseline to 30 weeks)
- Proportion of patients requiring further swallowing therapy(Baseline to 6 weeks, Baseline to 30 weeks)
- Change in Pharyngeal Swallowing Efficiency and Safety as measured by DIGEST Safety Grade(Baseline to 6 weeks, Baseline to 30 weeks)
研究者
Donna S. Lundy
Professor
University of Miami