Effect of Yoga Program on Quality of Life in Women With Breast Cancer Receiving Endocrine Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
研究概览
简要总结
The goal of this randomized controlled trial is to evaluate the effect of a yoga program on improving the quality of life, reducing joint pain, and alleviating vasomotor symptoms (night sweats, hot flashes) in women with breast cancer undergoing endocrine therapy.
The main questions it aims to answer are:
Does the yoga program significantly improve the quality of life in women with breast cancer undergoing endocrine therapy? Is the yoga program effective in reducing joint pain in women with breast cancer? Does the yoga program reduce the severity of night sweats and hot flashes in women with breast cancer? Researchers will compare the intervention group, which will receive the yoga program, to the control group, which will continue with their physician-recommended routine exercise, to see if there is a difference in these outcomes.
Participants will: Participants will consist of women with breast cancer undergoing endocrine therapy, with 34 in the yoga (intervention) group and 34 in the control group.
Complete the;Patient Assessment Form; and the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) scale.
The intervention group will participate in a 70-minute yoga program, delivered online via a digital platform, four days a week for six weeks, led by an instructor.
The control group will not receive any intervention and will continue with their physician-recommended routine exercise.
详细描述
The goal of this randomized controlled trial is to evaluate the effect of a yoga program on improving the quality of life, reducing joint pain, and alleviating vasomotor symptoms (such as night sweats and hot flashes) in women with breast cancer undergoing endocrine therapy. The participants will be divided into two groups: 34 women in the yoga (intervention) group and 34 women in the control group.
Hypotheses:
H1: The yoga program will significantly improve the quality of life in women with breast cancer undergoing endocrine therapy.
Population:
The study population consists of women who have completed surgical treatment in oncology units, have completed chemotherapy or radiation therapy, and have recently started adjuvant endocrine therapy. The sample size, calculated using G power with an effect size of 0.5, a 5% error margin, and 80% power, includes 68 participants (34 in the intervention group and 34 in the control group), taking into account possible data losses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being over 18 years of age,
- •Having the ability to read, write, and speak Turkish,
- •Having a diagnosis of breast cancer,
- •Having completed surgical treatment,
- •Having completed chemotherapy or radiation therapy,
- •Recently starting endocrine therapy,
- •Having a Body Mass Index (BMI) below 35.
排除标准
- •Being over 70 years of age,
- •Having a diagnosis of metastatic disease,
- •Previous participation in yoga or similar exercises,
- •Having a physical disability that prevents practicing yoga,
- •Having a condition that causes shortness of breath (e.g., COPD),
- •Having another chronic heart or lung disease that prevents yoga practice,
- •Having a serious psychiatric illness or cognitive impairment.
研究组 & 干预措施
Yoga (intervention) Group
A yoga program will be conducted with 34 women undergoing endocrine therapy, experiencing joint pain or vasomotor symptoms, who are randomly assigned to the intervention group. The program will be delivered online via a digital platform for 6 weeks, 70 minutes per session, 4 days a week, with an instructor. An introductory session will provide information on yoga philosophy and program details. Each session will start with breathing exercises (pranayama), followed by yoga postures (asanas), and end with meditation. Participants will receive a yoga guide and necessary equipment (yoga mats, blocks) before starting. The FACT-ES Endocrine Symptoms Subscale will be re-administered in the second week. After each session, participants will report any adverse effects via digital communication. One month after the program, participants will be asked if they continued yoga at home, and reasons for discontinuation will be recorded.
干预措施: Yoga (intervention) group (Other)
Control Group
No intervention will be applied to individuals in this group, and they will continue with the routine exercises recommended by their physicians. After their data is collected as part of the control group, they will be invited by the researcher to participate in the online yoga sessions conducted with the intervention group.
结局指标
主要结局
Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
时间窗: through study completion, average of one year
Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES): This comprehensive scale was developed to evaluate the quality of life of cancer patients, particularly those receiving endocrine therapy. The scale consists of 46 items rated on a scale from 0 to 4, and it includes five primary subscales: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, Functional Well-Being, Endocrine Symptom Subscale. Subscale scores are calculated separately, and the total score is the sum of the subscale scores. Higher scores indicate better quality of life and fewer symptoms. It is valid for cancer patients aged 18 and over, assessing experiences over the past seven days. The assessment uses a 5-point Likert scale and takes approximately 10-15 minutes.
次要结局
未报告次要终点
研究者
Gözde Gür
PhD Candidate
Istanbul University - Cerrahpasa