The Effects of Brief and Intensive Therapy for Dysphagia in Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- M. D. Anderson Dysphagia Inventory (MDADI)
研究概览
简要总结
According to data in the literature, patients with head and neck cancer, who undergo combined treatment of radio-chemotherapy, have, to a greater or lesser extent, swallowing changes. Most of the time, these patients undergo traditional speech-language interventions, performed weekly. This project proposes a brief and intensive therapy program for dysphagia, with daily interventions, showing that this therapeutic modality generates benefits in a shorter time interval when compared to traditional therapy. This short service period contributes to the reduction of hospital costs and reduces the total number of interventions, which is beneficial for both the patient and the service that performs the care. The present study was to verify the efficacy of a brief and intensive therapy program for dysphagia in patients with head and neck cancer submitted to radio-chemotherapy treatments, since they present, to a greater or lesser extent, changes of swallowing. This is a randomized clinical trial pilot project that will be developed in an oncology hospital. The population of this study is composed of patients diagnosed with head and neck cancer, over 18 years of age, with indication of combined radiotherapy , referred for speech therapy through the Multidisciplinary Oncology Outpatient Clinic of Santa Rita Hospital (AMOHR).
详细描述
he sample will consist of 20 patients who will be randomized into two groups: 10 in the intervention group with intensive brief therapy and 10 in the control group with traditional weekly therapy. In both groups, instruments related to swallowing assessment and quality of life will be applied before and after speech therapy. The control group will receive speech therapy with weekly frequency, and the intervention group will participate in a brief and intensive therapy program that will take place during five days a week for three weeks, totaling fifteen sessions. The sessions will be of 40 minutes and, in both groups, the patients will receive care of individualized form, according to their needs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients from 18 years of age;
- •Diagnosis of head and neck cancer;
- •Indication of combined treatment of radio-chemotherapy;
排除标准
- •Have performed prior speech and hearing care for at least three months prior to the start of the study;
- •Previous history of other neoplasias and / or neurological diseases, according to the participant's report and information of the medical record;
- •Cognitive deficits and / or changes in the central nervous system that make it difficult to understand commands (illiterate individuals will have scores of at least 20 points, followed by 25 individuals from 1 to 4 years of study, 26.5 to 5 at 8 years, 28 to 9 to 11 years and finally, 29 to 11 years or more of schooling, according to Brucki et al., 2003).
- •Cardiac problems, according to the participant's report and information on the medical chart.
- •Do not attend therapy for more than three sessions.
研究组 & 干预措施
Brief and intensive therapy
exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, daily
干预措施: bried and intensive therapy (Other)
Therapy Weekly
exercises for swallowing (strength and mobility of oral and pharyngeal muscles) controlling the number of series according to each participant, weekly
干预措施: bried and intensive therapy (Other)
结局指标
主要结局
M. D. Anderson Dysphagia Inventory (MDADI)
时间窗: 3 months average
41/5000 quality of life parameter, questionnaire.Questionnaire developed by Chen et al. (2001) and validated by Guedes et al. (2013) With the objective of evaluating the quality of life of patients. consisting of 20 items, involving global, physical, functional and emotional domains, with objective of assessing the impact of dysphagia on the quality of life of patients who underwent treatment of head and neck cancer
次要结局
- Functional Oral Intake Scale(3 months average)
- Deglutition evaluation(3 months average)
- Iowa Oral Performance Instrument (IOPI)(3 months average)
研究者
Fabrício Edler Macagnan
Clinical professor
Federal University of Health Science of Porto Alegre