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临床试验/NCT04126226
NCT04126226已完成不适用

Quality of Life in Patients Treated for Tongue and/or Jaw Neoplasia Before and After Speech Therapy: a Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Changes in Quality of Life Scores related to swallowing

研究概览

简要总结

This study aims to verify the impact of four speech therapy sessions on the Quality of Life of patients treated for malignant tongue and/or jaw cancer, using as measure specific questionnaires of speech and swallowing.

The hypothesis is that after treatment with exercises and speech therapy guidance, patients will present better indicators on Quality of Life related to speech and swallowing.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Over 18 Years
  • Tongue and/or Jaw Neoplasm
  • Submitted to surgical treatment

排除标准

  • Under 18 Years
  • Cognitive impairment or deficits in language comprehension
  • Previous speech therapy intervention
  • Recurrence or active disease
  • Death during the intervention

研究组 & 干预措施

Study group

Experimental

干预措施: Speech-language guidance (Other)

Study group

Experimental

干预措施: Speech therapy exercises for swallowing (Other)

Study group

Experimental

干预措施: Speech therapy exercises for speech (Other)

Control Group

No Intervention

结局指标

主要结局

Changes in Quality of Life Scores related to swallowing

时间窗: 1 month

To measure the changes in Quality of Life related to swallowing it was used the questionnaire Dysphagia Handicap Index (DHI)

Changes in Quality of Life Scores related to speech

时间窗: 1 month

To measure the changes in Quality of Life related to speech it was used the questionnaire Speech Handicap Index (SHI)

次要结局

  • Changes in Speech Intelligibility Classification(1 month)
  • Changes in Dysphagia Classification(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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