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临床试验/CTRI/2019/09/021057
CTRI/2019/09/021057尚未招募3 期

Pilot project to evaluate impact of a patient counselling and rehabilitation programme on treatment outcomes and quality of life in head and neck cancer patients receiving chemoradiotherapy

AMERICAN SOCIETY OF CLINICAL ONCOLOGY1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2019年9月13日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
170
试验地点
1
主要终点
To evaluate the impact of a structured counseling and rehabilitation programme on the quality of life of patients

研究概览

简要总结

The purpose of this research is to evaluate a dedicated & comprehensive supportive care and rehabilitation programme for patients with locally advanced head and neck cancers receiving chemoradiotherapy. Our hypothesis is based on the assumption that  integrating counseling and rehabilitation services with the  treatment will improve patient compliance and tolerance to chemoradiotherapy and will positively impact the treatment outcomes and quality of life of the  patients. Dedicated faculty will monitor the patients during the project and provide counseling on hygeine , nutrition, home made diets and   swallowing therapy to prevent dysphagia. The aims and objectives of this study are as below

1.     To evaluate theimpact of a structured counseling and rehabilitation programme on the qualityof life of patients

  1. To evaluate theimpact of a structured counseling and rehabilitation program onchemoradiotherapy related treatment toxicity 3.    To evaluate theimpact of a structured counseling and rehabilitation programme on patientscompliance to treatment

Majority of our patients come from the economically weaker sections of society and are unaware of and also unable to afford dedicated supportive services.The research is designed to fill this lacunae in our patient care system for such patients.

Head and neck cancers is emerging as a important public health problem in our country with a huge burden of disease( 30% cancers in males and 4.8-15% cancers in females). The results of this study will help us improve our treatment protocols  keeping in mind the specific requirements of our  Indian patients and we propose  to provide counselling and rehabilitation services routinely to our patients in the near future by using the results of this pilot project to guide us.

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研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
16.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Adult patients presenting with stage III-IVB head and neck cancers having a histopathological proof and with primaries in oral cavity, oropharynx and hypopharynx will be included in the analysis.

排除标准

  • All post operative patients and those who have undergone prior chemoradiotherapy to head and neck will be excluded from the analysis.

结局指标

主要结局

To evaluate the impact of a structured counseling and rehabilitation programme on the quality of life of patients

时间窗: ONE YEAR

次要结局

  • 1.To evaluate the impact of a structured counseling and rehabilitation programme on chemoradiotherapy related treatment toxicity(2.To evaluate the impact of a structured counseling and rehabilitation programme on patients compliance to treatment)

研究者

申办方类型
Other [ACADEMIC AND RESEARCH ORGANIZATION]

研究点 (1)

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