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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
28
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. Music will be pre-selected and categorized into slow (40-72 bpm), moderate (72-120 bpm), and fast (120-208 bpm) tempos, using the Rhythmo app. Exercise intensity will be monitored by heart rate (Polar® monitor) and measured 25 minutes into each session (%HRmax = 220 - age), targeting 64-95% of maximum heart rate. Perceived exertion will also be assessed using the Borg Scale (6-20). Each session will include a 10-minute warm-up, a 30-minute main activity with music of varying intensities, and a 5-10-minute cool-down.
Federal University of Maranhao
São Luís, Maranhão, Brazil
Pain evaluation
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.
Time frame: From enrollment to end of treatment at 12 weeks
Fatigue
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).
Time frame: From enrollment to end of treatment at 12 weeks
General quality of life evaluation
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.
Time frame: From enrollment to end of treatment at 12 weeks
Quality of life specifically for breast cancer
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.
Time frame: From enrollment to end of treatment at 12 weeks
Balance
The Berg Balance Scale will be the multidimensional test used to assess balance. It uses a score of 4 as the cutoff point (a score equal to or less than 4 indicates unable; a score greater than 4 indicates independent).
Time frame: From enrollment to end of treatment at 12 weeks
Functional capacity
In the 6-minute walk test, the distance covered accurately reflects the patients' physical capacity to perform routine tasks. The higher scores mean a better functional capacity and lower scores mean a worse functional capacity.
Time frame: From enrollment to end of treatment at 12 weeks
Motor Capacity
The Lower Extremity Motor Coordination Test this is a simple test performed in a seated position, with the individual barefoot. A platform with two red circles, spaced 30 cm apart, is placed on the floor in front of the participant. The individual must alternately touch the circles with the big toe for a duration of 20 seconds. The score is given by the number of correct answers. The higher scores mean a better motor capacity and lower scores mean a worse motor capacity.
Time frame: From enrollment to end of treatment at 12 weeks
Flexibility
Flexibility will be assessed using the Schober Test, which measures functional flexibility and is specifically focused on the low back. The test assesses lumbar movement restrictions through markings: over the lumbosacral joint (connecting the posterior superior iliac spines) and 10 cm above; the distance between these marks is recorded while in an upright position. Immediately after, the subject performs a maximal trunk flexion (with lower limbs extended), and the evaluator measures the new distance between the points with a measuring tape and records the difference between the marks based on the patient's best reach in relation to the floor. The higher scores mean a better flexibility and lower scores mean a worse flexibility.
Time frame: From enrollment to end of treatment at 12 weeks
Self- esteem
To assess self-esteem, the adapted and validated Portuguese version by Hutz of the Rosenberg Self-Esteem Scale will be used. The total score ranges from 10 to 40 points. The higher scores mean a better self-esteemy and lower scores mean a worse self-esteem.
Time frame: From enrollment to end of treatment at 12 weeks
Sleep
The Pittsburgh Sleep Quality Index (PSQI-BR) is used to assess sleep quality. The total score ranges from 0 to 21 points. Scores above five indicate poor sleep quality, and scores equal to or lower five indicate good quality.
Time frame: From enrollment to end of treatment at 12 weeks
Anxiety and depression
Anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire. The total score ranges from 0 to 21 points. It cutoff points will be adopted: an anxiety indicative score equal to or greater than 8; and a depression indicative score equal to or higher than 9.
Time frame: From enrollment to end of treatment at 12 weeks
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