跳至主要内容
临床试验/NCT01844557
NCT01844557Unknown不适用

Testing Accountability in Patient Adherence

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
225
试验地点
1
主要终点
Adherence to Swallowing Exercises

研究概览

简要总结

The goal of this research study is to look for factors that influence whether or not head and neck cancer patients follow the swallowing exercises that they are asked to perform while receiving radiation treatment.

详细描述

Head and neck cancer patients who receive radiation are at risk for permanent swallowing disorders. Because of these potential problems, swallowing exercises are an important part of recovery. Researchers want to learn what factors affect how well patients follow the swallowing schedule they are given, and what can be done to make it consistent.

If you agree to take part in this study, you will have the following procedures performed.

Videotaped Swallowing Exercise:

Researchers will ask you to perform 3 swallowing exercises while being recorded by a video camera. The length of the taping session will be 3 minutes. Afterward, you will fill out 3 questionnaires. The questionnaires will take about 10 minutes to complete.

Length of Study:

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

入选标准

  • Are dispositioned to receive radiation with curative intent for nasopharyngeal, oropharyngeal, hypopharyngeal, laryngeal, 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 and read English
  • Oriented to time, person, and place
  • 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
  • Have a history of previous head and neck surgery (excluding biopsy and/or tonsillectomy and/or tracheotomy)
  • Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia due to underlying neurogenic disorder)

结局指标

主要结局

Adherence to Swallowing Exercises

时间窗: 1 day

Purpose of experiment is to determine whether an accountability manipulation and whether human vs technological monitoring result in higher patient adherence. Main outcome measure is perseverance of effort which will be number of repetitions within one minute interval for each exercise.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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