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临床试验/NCT03206242
NCT03206242已完成不适用

Rehabilitation Outcomes in Head and Neck Survivors

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
return to work as measured by interview

研究概览

简要总结

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Patients with advanced stage of the disease need extensive tumor excision with neck dissection. Secondary reconstructive surgeries using free flap could improve the postoperative function or appearance of cancer survivors. Advanced treatments make survival rates increased. Effects of treatment for oral cancer develop shoulder dysfunction, speech, mastication, donor site morbidity and psychological issues. Physical therapy may have benefits for temporomandibular joint function, shoulder pain relief, muscle performance, and oral structures coordination. Return to work in the number of cancer survivors is a realistic outcome. Rehabilitation effects on functional restorations and quality of life for head and neck survivors are needed for further studied.

The purpose of this project is to explore the rehabilitation effects following head and neck reconstructive survivors. The investigators measure temporomandibular joint function, shoulder function, pain monthly. Physical functions, self-reported quality of life, and the status of return to work are measured 3 and 6 months after surgery. This prospective study could help to predict the rehabilitation outcomes and benefits.

详细描述

Head and neck cancer is prevalent in Taiwan, and oral cancer is the most common location. Patients with advanced stage of the disease need extensive tumor excision with neck dissection. Secondary reconstructive surgeries using free flap could improve the postoperative function or appearance of cancer survivors. Oral functions include respiration, speech, mastication, deglutition, and cosmetics. Advanced treatments make survival rates increased, but might develop shoulder dysfunction, speech, mastication, donor site morbidity and psychological issues. The purpose of this project is to explore the effects of rehabilitation following reconstructive surgery in oral cancer survivors.

This study design is an interrupted time-series design. The investigators will recruit 50 subjects one week following reconstructive surgery. The measurements include manual muscle strength, joint range of motion, maximal mouth opening, pain status, hand-to-neck test, hand-to-scapula test, hand-to-opposite-scapula test, 6-minute walking test, timed up & go test, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30, European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35 and return-to-work. These tests were done at the first visit (0 week post-operation), three months and six months after reconstructive surgery respectively. The intervention programs consist of edema control, scar management, pain management, respiration training, oral function training, neck and shoulder function training, donor site mobility training. Continuous variables were analyzed by descriptive statistics. One-way ANOVA was used to compare the difference between measurements. Binary logistic regression was used to predict the factors of return-to-work.

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
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of oral cancer
  • Post-reconstructive surgery
  • Age between 20 to 65 years old
  • Must be able to follow instructions

排除标准

  • Central nervous disease
  • Metastasis

结局指标

主要结局

return to work as measured by interview

时间窗: 1 year

quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30

时间窗: 1 year

physical functions measured by 6-minute walking test

时间窗: 1 year

quality of life as measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-H&N35

时间窗: 1 year

physical functions measured by time up & go test

时间窗: 1 year

次要结局

  • shoulder function measured by function-related tests(1 year)
  • pain measured by Visual Analog Scale(1 year)
  • joint range of motion measured by goniometer(1 year)
  • mouth opening measured by Boley gauge(1 year)
  • muscle strength measured by manual muscle testing(1 year)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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