Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55455
- Masonic Cancer Center, University of Minnesota
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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- Voluntary written informed consent with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care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
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Patients Treated with Laryngectomy
Patients initially treated with laryngectomy and followed for 12 months after receiving this treatment.
|
|
Patients Treated with Chemoradiation
Patients treated initially with chemoradiation and followed for 12 months after receiving treatment.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Swallowing Function Scores
大体时间：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.
|
12 months after Treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
General Quality of Life
大体时间：PreTreatment, 6 Months and 12 Months After Treatment
|
The SF-12 Quality of Life questionnaire will be used to assess general health status.
The SF-12 contains one or two items that measure each of eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS).
|
PreTreatment, 6 Months and 12 Months After Treatment
|
|
Speech Assessment
大体时间：PreTreatment, 6 Months and 12 Months After Treatment
|
Speech analysis will focus primarily on speech intelligibilty and acceptability to both clinicians and naive listeners, and less on voice quality per se using the Voice Handicap Index.
The Voice Handicap Index (VHI) measures the influence of voice problems on a patient's quality of life.
|
PreTreatment, 6 Months and 12 Months After Treatment
|
|
Head and Neck Quality of Life
大体时间：PreTreatment, 6 Months and 12 Month After Treatment
|
The University of Washington Quality of Life Assessment Questionnaire will be administered.
This questionnaire is specifically designed to capture head and neck cancer-specific function.
|
PreTreatment, 6 Months and 12 Month After Treatment
|
合作者和调查者
合作者
调查人员
- 首席研究员：Bevan Yueh, MD, MPH、Masonic Cancer Center, University of Minnesota
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.