Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 1
- 主要终点
- Swallowing Function Scores
研究概览
简要总结
The purpose of this prospective, multi-institutional, observational cohort study is to determine if an initial surgical approach leads to better function and quality of life than primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal cancers.
详细描述
At the time of registration patients will be categorized into 2 groups based on the initial treatment plan as either chemoradiation-based or surgically-based (laryngectomy). Treatment will be assigned by the patient's physician, it will not be assigned by the study.
Patients will be asked to complete a series of 4 questionnaires addressing swallowing function, generic health status, head and neck cancer-specific quality of life, and self-reported speech function at 3 time points (baseline, 6 months and 12 months after the end of treatment). The treating physician will provide basic clinical information at these same time points. In centers where swallowing and voice assessments are done as part of standard of care, data from these studies will also be provided.
Study entry is open to all adults regardless of gender or ethnic background. Specific information regarding the definitive treatment (surgery or chemoradiation) will be provided to the patient by the treating physician as part of the routine standard of care. Any treatment related side effects, as well as the duration of therapy and follow-up will be managed by the treating physician. Participation in this study will have no effect on the initial treatment decisions or the course of care.
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
- •Willingness and ability to complete self-administered follow-up questionnaires over the course of one year as determined by a member of the research team
- •Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- •Must be at least 18 years of age
排除标准
- •Require a resection that would involve more than the standard laryngectomy (total pharyngectomy, esophagectomy)
- •Undergo partial laryngectomy, when open or endoscopic
- •Have previously altered anatomy of the upper aerodigestive tract
- •Have pre-existing dysphagia unrelated to the tumor, or neurologic disorders that could affect swallowing (Parkinson's, cerebrovascular accidents)
- •Have prior malignant disease of the upper aerodigestive tract
- •Have prior radiation therapy to the head and neck region
- •Metastatic disease
- •Unable to complete self-administered questionnaires written in simple English for cognitive, psychiatric, or other reasons that in the opinion of the enrolling investigator is likely to interfere with participation in this clinical study.
结局指标
主要结局
Swallowing Function Scores
时间窗: 12 months after Treatment
The primary outcome will be self-reported swallowing function (M.D. Anderson Dysphagia Inventory questionnaire - MDADI) 12 months after treatment. Analysis will compare MDADI scores of patients treated initially with laryngectomy vs. those of patients treated initially with chemoradiation.
次要结局
- General Quality of Life(PreTreatment, 6 Months and 12 Months After Treatment)
- Speech Assessment(PreTreatment, 6 Months and 12 Months After Treatment)
- Head and Neck Quality of Life(PreTreatment, 6 Months and 12 Month After Treatment)