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临床试验/NCT04269148
NCT04269148Unknown不适用

Validity and Reliability of the Turkish Version of the McMaster University Head and Neck Radiotherapy Questionnaire

Izmir Bakircay University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年3月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
McMaster University Head and Neck Radiotherapy Questionnaire

研究概览

简要总结

More than half of the patients with head and neck cancer are locally advanced patients. Radiotherapy is the primary treatment option for many patients with stage III and stage IV diagnosed with head and neck cancer. Radiation often causes tissue reactions by increasing local symptoms of the tumor and adding new symptoms to them. The acute effects of radiation are pain and burns associated with mucosal irritations and skin irritations, the root smell of the necrotic tumor and damaged normal tissues, dry skin, skin irritation, pain and dryness of mucosal membranes, decreased appetite, loss of chewing and swallowing skills, and hoarseness. The aim of this study is to make the validity, reliability and cultural adaptation of McMaster University Head and Neck Radiotherapy Inventory in Turkish.

详细描述

Although there are various surveys in the literature that evaluate the quality of life of head and neck cancer patients, apart from the "McMaster University Head and Neck Radiotherapy Questionnaire", there is no other questionnaire designed specifically for local advanced stage III and stage IV head and neck cancer and treatment of specific morbidity at a certain time. Patients in these stages often have difficulties in oral communication, nutritional disorders and loss of chewing and swallowing skills leading to dehydration, bad mouth odors, appearance problems affecting social and family life, and often significant morbidity including severe pain symptoms.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Voluntarily accepting to participate in the study
  • Patients whose native language is Turkish
  • Undergoing or receiving radiotherapy treatment
  • At least 3 weeks have passed since the beginning of radiotherapy

排除标准

  • The patient does not have sufficient functions of bone marrow, liver and kidney
  • To have scored less than 70 from Karnofsky Performance Scale

结局指标

主要结局

McMaster University Head and Neck Radiotherapy Questionnaire

时间窗: At baseline

McMaster University Head and Neck Radiotherapy Questionnaire: This questionnaire includes 22 questions covering signs and symptoms related to 6 categories: oral cavity, throat, skin, digestive system, energy and psychosocial. n each category, there are at least 3 questions related to that category. There are 7 possible answer options in each question using Likert scale. High scores obtained according to the scoring system used indicate low toxicity. The final score of the survey is expressed as the average of the scores from 22 questions. In addition, the independent scores of each category are the average of the scores from the questions belonging to that category \[1\].

次要结局

  • The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4(At baseline)

研究者

发起方
Izmir Bakircay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kadirhan Ozdemir, PT, PhD.

Head of Geriatric Rehabilitation Department

Izmir Bakircay University

研究点 (1)

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