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
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
- 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)
