The Impact of integrative yoga intervention on quality of life, cognitive function, symptom management and fear of recurrence in head and neck cancer patients during chemo radiation : A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Quality of life : FACT-Q and PROMIS measures will be used to asses physical , emotional , social and spiritual well being.
研究概览
简要总结
This study aims to evaluate the efficacy of a structured yoga program in improving Qualiity of life , Cognitive function , symptom management and Fear of recurrence of the disease in Head and Nech cancer patients undergoing chemoradiation compared to standard care control group. We further aim to explore potential biological mechanisms underlying these effects by measuring cortisol level , BDNF ( Brain derived neurotropic factor ) expression and Neurocognitive functioning in HNC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of HNC
- •Scheduled to receive chemo radiation therapy
- •Medically stable
- •Able to provide informed consent and participate yoga sessions safely
- •Free from significant psychological or neurological disturbances that interfere with participation.
- •No recent physical amputation
- •Willing to adhere to the research process.
排除标准
- •Metastatic disease.
- •Prior history of psychiatric disturbances or musculoskeletal conditions.
- •Active uncontrolled psychiatric illness
- •Inability to participate in physical activity safely ( i.e., Patient with tracheostomy and recent physical amputation).
- •HPV negative larynx cancer (considered radio sensitive and may require different treatment approach).
- •Stage 4b HNC.
结局指标
主要结局
1. Quality of life : FACT-Q and PROMIS measures will be used to asses physical , emotional , social and spiritual well being.
时间窗: Pre intervention , Post intervention and 4 week follow up
2. Blood and bio markers - Corisol level and BDNF expression
时间窗: Pre intervention , Post intervention and 4 week follow up
次要结局
- 1.Cognitive function measures which evaluates memory , attention and processing speed.(2. Pain , sleep quality and fatigue would be evaluated.)
研究者
Akshaya K
Sri Ramachandra Institute of Higher Education and Research