Adherence to Swallowing Exercises in Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 485
- 试验地点
- 1
- 主要终点
- Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises)
研究概览
简要总结
The goal of this research study is to help patients complete the swallowing and dental care exercises they are supposed to perform during radiation treatment.
详细描述
If you agree to take part in this study, you will be taught ways to cope with the side effects of radiation as a way to help you do your swallowing exercises during radiation treatment. To find out if the swallowing exercises are being performed, researchers will compare 2 groups of participants.
Study Groups:
You will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups, the Study Program Group or the Usual Care Group. You will have an equal chance of being in either group.
As a part of standard of care, a speech pathologist will teach you how to perform swallowing exercises.
If you are assigned to the Study Program Group, you will complete the following:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Men and women are eligible if they a) are predispositioned to receive radiation treatment for oropharyngeal, laryngeal, hypopharyngeal, nasopharyngeal, or an unknown primary cancer with cervical metastases,
- •are stage II-IVB for oropharyngeal and laryngeal
- •are stage I-IVB for hypopharyngeal and nasopharyngeal
- •at least 18 years of age,
- •speak English,
- •are oriented to time, person, and place,
- •and have a Zubrod performance status of 0 to 2.
排除标准
- •have other cancer diagnoses, except non-melanoma skin cancer,
- •had treatment for previous H & N cancer or radiation to the head and neck, or
- •history of previous head and neck surgery (excluding biopsy, tonsillectomy, tracheotomy or selective neck dissection),
- •history of current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g. dysphagia due to underlying neurogenic disorder)
结局指标
主要结局
Categorized Adherence Score (e.g., not adherence at all, somewhat adherent, and adherent to all exercises)
时间窗: Day 1, 10 Weeks, and at 12 Months
次要结局
未报告次要终点