A prospective pilot study to assess the effect of MUSIc therapy on quality of life of Cancer patients undergoing Chemotherapy in Oncology day care - (MUSICC)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
| Background and Rationale |
People who have cancer may find the physical, emotional, and social effects of the disease to be stressful. Distress has become increasingly recognized as a factor that can reduce the quality of life of cancer patients. Those who are unable to manage their stress may have a poorer quality of life after cancer treatment. In contrast, people who are able to use effective coping strategies to deal with stress have been shown to have lower levels of depression, anxiety, and symptoms related to cancer and its treatment.
Music therapy has been extensively used for various conditions related to the mind. However, music preference is very subjective and often rendering music by a performer can be cumbersome, the publicly available music is not designed to cater to the specific needs of the listener or do not have the required calming and therapeutic benefits. Music by ‘echo care’ are engineered at frequencies to render calming effect, improve sleep, elevate mood and reduce stress & anxiety as the case may be. This study is to observe the health benefits of music on the quality of life of the patients.
|General aim
The aim of this study is to observe the effects of music therapy and standard care in patients with measured using the EORTC QLQ C30 scale, FACT G7 & HADS before and after the application of music/sound therapy
|Primary objective (endpoint)
To evaluate the impact of Music therapy “ on the Quality of life during chemotherapy. .
|Secondary objectives (endpoints)
To evaluate the benefits of non-pharmacological, non-invasive, based intervention using echocare music therapy on the anxiety levels and physiological parameters like blood pressure when patients undergo music therapy at start of chemotherapy, during chemotherapy and at the completion of chemotherapy
|Design
The study will be conducted at Apollo Proton Cancer Centre at Chennai, India location. A sample size of 50 cancer patients undergoing chemotherapy in the day-care will be part of the study. The age range for this study will be 18 and above. The duration of this study will be for 2 to 3 months.
Patient qualification for the study will be done by the attending consultant. The patients will be identified based on their fitment for music therapy which includes physical condition, patient & attendant’s consent and their English language comprehension.
|Population
All Genders above the age of 18 undergoing cancer treatment at Apollo proton Chemotherapy Day Care centre
|Statistical considerations
To be filled by Dr Pankaj
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with a confirmed diagnosis of cancer undergoing chemotherapy in the daycare facility
- •Patients aged >18 years
- •Patients who are about to start chemotherapy (both curative, palliative intent)
- •Physical condition ( minimum performance status of ECOG 3)
- •Patients with acceptable English comprehension.
排除标准
- •Patients who have already started chemotherapy
- •Lack of English comprehension as the tools of assessment are validated only in English in the digital platform.
结局指标
主要结局
Quality of life
时间窗: 0,3,6 weeks
次要结局
- predefined health parameters like blood pressure(0, 3, 6 weeks)