Impact of a Dance Program for Women on Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pain evaluation
研究概览
简要总结
This study aims to evaluate the effects of a dance program on physical and psychological outcomes in women undergoing breast cancer treatment. It is a randomized clinical trial with participants allocated into two groups: Dance Program Group (DPG) and Control Group (CG). The DPG will engage in 50-minute dance sessions twice weekly for 12 weeks, while the CG will maintain their regular routines. Exercise intensity will be monitored using heart rate and the Borg Rating of Perceived Exertion Scale (6-20), recorded 25 minutes into each session based on musical tempo (slow, moderate, fast). Primary and secondary outcomes include pain, fatigue, quality of life, balance, functional and motor capacity, flexibility, self-esteem, sleep, anxiety, and depression. Assessments will occur at baseline, 8 weeks, and 12 weeks. Data will be analyzed using multivariate models to explore group, time, and interaction effects, with significance set at 5% (SPSS version 24.0). The intervention is expected to mitigate adverse effects of cancer treatment and promote improvements in health and well-being across multiple dimensions.
详细描述
Globally, breast cancer (BC) is among the most frequent neoplasms, ranking as the second most commonly diagnosed cancer and the most prevalent among women. Its treatment varies according to the clinical stage of the disease and tumor type, as determined by medical management. The drugs used to treat breast cancer are considered systemic therapies and can be administered orally, intramuscularly, or directly into the bloodstream. These treatments often lead to adverse effects, such as anxiety, depression, fatigue, among others. In this context, the present study aims to evaluate the effects of a dance program on pain, fatigue, quality of life, balance, functional capacity, motor ability, flexibility, self-esteem, sleep, anxiety, and depression in women undergoing breast cancer treatment. This is a randomized clinical trial involving patients undergoing cancer therapy, who will be randomly assigned to two groups: Dance Program Group (DPG) and Control Group (CG). The intervention will last 12 weeks, during which the DPG will participate in 50-minute dance sessions twice a week, while the CG will continue their routine activities. Dance session intensity will be monitored through heart rate and the Borg Rating of Perceived Exertion Scale (6-20), measured 25 minutes into each session according to musical tempo (slow, moderate, and fast). Outcomes will be assessed using validated instruments: Brief Pain Inventory (BPI), Piper Fatigue Scale (PFS-P), EORTC QLQ-C30, Berg Balance Scale, Six-Minute Walk Test (6MWT), Lower Extremity Motor Coordination Test (LEMOCOT), Schober Test, Rosenberg Self-Esteem Scale, Pittsburgh Sleep Quality Index (PSQI-BR), and Hospital Anxiety and Depression Scale (HADS). Data will be collected at baseline, after 8 weeks, and after 12 weeks, and will be analyzed using multivariate methods to evaluate the effects of group, time, and their interaction. Statistical analyses will be conducted using SPSS software version 24.0, adopting a 5% significance level. Expected results: A reduction in adverse effects of cancer treatment across the investigated domains (pain, fatigue, quality of life, balance, functional capacity, motor ability, flexibility, self-esteem, sleep, anxiety, and depression), thereby promoting better health outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or older;
- •Diagnosed with breast cancer;
- •Undergoing adjuvant breast cancer treatment (chemotherapy, radiotherapy, immunotherapy, and/or hormone therapy);
- •Women at least 3 months post-surgery.
排除标准
- •To have another type of cancer;
- •To have a cognitive impairment or injury that prevents the ability to complete physical assessments or fill out questionnaires.
研究组 & 干预措施
Control Group (CG)
The participants in the Control Group (CG) will receive usual care. They will not take part in the intervention, participating only in the questionnaires and tests during the evaluation periods at baseline, 8 weeks, and 12 weeks.
Dance Program Group (DPG)
The intervention will consist of 12 weeks of in-person dance classes, held twice a week on non-consecutive mornings, totaling 24 sessions of up to 50 minutes each.
干预措施: Dance Program Group (Behavioral)
结局指标
主要结局
Pain evaluation
时间窗: From enrollment to end of treatment at 12 weeks
The instrument used to assess pain will be the Brief Pain Inventory (BPI). The questions using a numerical scale from 0 to 10. The higher scores mean a worse pain and lower scores mean a better pain or absence of pain.
Fatigue
时间窗: From enrollment to end of treatment at 12 weeks
The Piper Fatigue Scale (PFS-P) will be the multidimensional instrument used to assess fatigue. It uses a score of 4 as the cutoff point (a score equal to or less than 4 indicates no fatigue; a score greater than 4 indicates the presence of fatigue).
General quality of life evaluation
时间窗: From enrollment to end of treatment at 12 weeks
The instrument used to assess Quality of life will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The questions are using a numerical scale from 0 to 100 for scales. In the functional and global scales the EORTC-BR 30, the higher scores mean a better quality of life and lower scores mean a worse quality of life. Unlike, in the symptom scale EORTC-BR 30, the higher scores mean a worse quality of life and lower scores mean a better quality of life.
Quality of life specifically for breast cancer
时间窗: From enrollment to end of treatment at 12 weeks
The instrument used to assess Quality of life specifically for breast cancer will be the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-BR). The questions are using a numerical scale from 0 to 100 for scales. In the functional scale the EORTC-BR 23, the higher scores mean a better quality of life and lower scores mean a worse quality of life. Unlike, in the symptom scale the EORTC-BR 23, the higher scores mean a worse quality of life and lower scores mean a better quality of life.
次要结局
- Balance(From enrollment to end of treatment at 12 weeks)
- Functional capacity(From enrollment to end of treatment at 12 weeks)
- Motor Capacity(From enrollment to end of treatment at 12 weeks)
- Flexibility(From enrollment to end of treatment at 12 weeks)
- Self- esteem(From enrollment to end of treatment at 12 weeks)
- Sleep(From enrollment to end of treatment at 12 weeks)
- Anxiety and depression(From enrollment to end of treatment at 12 weeks)
研究者
Andréa Dias Reis
Professor in the Graduate Program in Physical Education at the Federal University of Maranhão, São Luís - MA, Brazil.
Federal University of Maranhao