Impact of health symptoms on health -related quality of life of patients with breast cancer undergoing chemotherapy with a view to develop an e-pamphlet for symptoms alleviation, in a selected tertiary hospital in India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Symptoms alleviation and improve quality of life of Ca breast patient receiving chemotherapy which will be measure by EORTC c-30 and EORTC BR 45
研究概览
简要总结
The ultimate aim of the study is to explore the impact of symptoms on quality of life of patients with breast cancer undergoing chemotherapy and develop a e-pamphlet and to find out its effect on symptoms alleviation and quality of life. Structured Interview Schedule on demographic variables, EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Standardized tool on Quality of life of Cancer patient) and EORTC QLQ BR 45 (Breast Cancer module is a supplementary questionnaire with QLQ-30) will be used to assess quality of patient receiving chemotherapy.
It will be randomized control trial. Total sample size 126. In phase I, 12 sample will be taken to find out symptoms and based on result e-pamphlet will be develop. Control arm will receive normal health education and a booklet on “Managing Chemotherapy side effects†and experimental group will receive both health education, booklet and e-pamphlet on 1st cycle of chemotherapy. But experimental group will be reinforced to check e-pamphlet on 2nd and 5th cycle of chemotherapy.
Base line data will be collected on 1st cycle and then 4th and last data will be collected after 7th cycle.
So by this study we will be able to find out 1. Symptoms experienced by breast cancer patient during chemotherapy, 2. Effect of symptoms on quality of life (QoL), 3. E-pamphlet will have any effect on health symptoms and QoL or not and 4. there is any association between selected demographic criteria and symptoms and QoL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients receiving chemotherapy regimens and willing to participate Patients without evidence of psychosis, dementia and able to complete Not suffering as a secondary cancer.
排除标准
- •Women who are unwilling or unable to consent and unable to complete the questionnaire and unable to use smart phone.
- •ï‚· Patient who does not follow instructions and cannot speak in English, Bengali or Hindi.
- •ï‚· Severely ill, foreign patients, or those not completing treatment at Tata Medical Center.
结局指标
主要结局
Symptoms alleviation and improve quality of life of Ca breast patient receiving chemotherapy which will be measure by EORTC c-30 and EORTC BR 45
时间窗: finishing 7cycle of chemotherapy
次要结局
- quality of life of patient will improve(Health Symptoms & Quality of life will be checked base line before starting of chemotherapy, cycle 4 & cycle 8)
研究者
Sriparna Giri
Tata Medical Center