Effect of Integrative Yoga Program on Quality of Life, Mental Health, Prakriti, and Treatment-related Symptoms in Breast Cancer Patients Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- EORTC 42 (Quality of life),
研究概览
简要总结
This study will evaluate whether yoga can improve quality of life, mental health, sleep, and fatigue in women with non-metastatic breast cancer receiving radiotherapy. About 128 participants aged 18–65 years will be randomly assigned to two groups. One group will continue standard cancer treatment along with a guided yoga program (45 minutes, five times a week for 12 weeks), while the other group will receive only standard treatment. The study will also explore whether Ayurvedic body type (Prakriti) influences the benefits of yoga.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Subjects with a confirmed diagnosis of Breast cancer patients, stage I to III, scheduled to undergo radiotherapy, ECOG-PS: 0 to 2 or KPS score more than 70, who are willing to give consent and participate in the 12-week intervention study protocol for hybrid-online and offline mode.
排除标准
- •Subjects with Stage IV breast cancer with Metastasis, Patient planned for Brachytherapy, Neo-adjuvant Chemo with radiotherapy, currently doing another form of structured yoga, Severe medical co-morbidities, inability to perform yoga, Pregnant women, those who are on medication for severe psychotic diseases, Severe immobility due to arthritis, vision, and hearing impairment.
结局指标
主要结局
EORTC 42 (Quality of life),
时间窗: Timepoints: | T1=Baseline (prior to start of radiation therapy) | T2= End of radiation therapy (approx. 6 weeks from baseline) | T3= 12 weeks from baseline | EORTC 42:T1.T2,T3, | HADS:T1.T2,T3, | PSS:T1,T2,T3, | PSQI:T1T2T3, | symptoms(VAS Score): T1,T2,T3, | Prakruti -vikruti Priksha: T1,T2 | Nadipariksha: daily between T1 and T2
HADS (Anxiety and Depression Score),
时间窗: Timepoints: | T1=Baseline (prior to start of radiation therapy) | T2= End of radiation therapy (approx. 6 weeks from baseline) | T3= 12 weeks from baseline | EORTC 42:T1.T2,T3, | HADS:T1.T2,T3, | PSS:T1,T2,T3, | PSQI:T1T2T3, | symptoms(VAS Score): T1,T2,T3, | Prakruti -vikruti Priksha: T1,T2 | Nadipariksha: daily between T1 and T2
PSS (Perceived Stress score),
时间窗: Timepoints: | T1=Baseline (prior to start of radiation therapy) | T2= End of radiation therapy (approx. 6 weeks from baseline) | T3= 12 weeks from baseline | EORTC 42:T1.T2,T3, | HADS:T1.T2,T3, | PSS:T1,T2,T3, | PSQI:T1T2T3, | symptoms(VAS Score): T1,T2,T3, | Prakruti -vikruti Priksha: T1,T2 | Nadipariksha: daily between T1 and T2
PSQI (Pittsburgh Sleep Quality score),
时间窗: Timepoints: | T1=Baseline (prior to start of radiation therapy) | T2= End of radiation therapy (approx. 6 weeks from baseline) | T3= 12 weeks from baseline | EORTC 42:T1.T2,T3, | HADS:T1.T2,T3, | PSS:T1,T2,T3, | PSQI:T1T2T3, | symptoms(VAS Score): T1,T2,T3, | Prakruti -vikruti Priksha: T1,T2 | Nadipariksha: daily between T1 and T2
treatment-related symptoms(VAS Score),
时间窗: Timepoints: | T1=Baseline (prior to start of radiation therapy) | T2= End of radiation therapy (approx. 6 weeks from baseline) | T3= 12 weeks from baseline | EORTC 42:T1.T2,T3, | HADS:T1.T2,T3, | PSS:T1,T2,T3, | PSQI:T1T2T3, | symptoms(VAS Score): T1,T2,T3, | Prakruti -vikruti Priksha: T1,T2 | Nadipariksha: daily between T1 and T2
Prakruti -vikruti questionnaire,
时间窗: Timepoints: | T1=Baseline (prior to start of radiation therapy) | T2= End of radiation therapy (approx. 6 weeks from baseline) | T3= 12 weeks from baseline | EORTC 42:T1.T2,T3, | HADS:T1.T2,T3, | PSS:T1,T2,T3, | PSQI:T1T2T3, | symptoms(VAS Score): T1,T2,T3, | Prakruti -vikruti Priksha: T1,T2 | Nadipariksha: daily between T1 and T2
Nadipariksha score
时间窗: Timepoints: | T1=Baseline (prior to start of radiation therapy) | T2= End of radiation therapy (approx. 6 weeks from baseline) | T3= 12 weeks from baseline | EORTC 42:T1.T2,T3, | HADS:T1.T2,T3, | PSS:T1,T2,T3, | PSQI:T1T2T3, | symptoms(VAS Score): T1,T2,T3, | Prakruti -vikruti Priksha: T1,T2 | Nadipariksha: daily between T1 and T2
次要结局
- Hear Rate Variability (HRV )(T1,T2)
研究者
Dr Sunita Chaudhari
Dr.Vishwanath Karad MIT World Peace University