Breast CancerNCT07553702
Dance Intervention in Breast Cancer Treatment
A study testing Dance Program Group in people with Breast Cancer and Breast - Female, run by Federal University of Maranhao at 1 site in Brazil.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast - Female, Breast Cancer Females
- What is being tested?
- Dance Program Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Apr 2025to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Dance Program for Women on Breast Cancer Treatment
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Breast - Female, Breast Cancer Females
- Being tested
- Dance Program Group
- Keywords
- Neoplasia, Dance, Pain, Fatigue, Quality of Life
- Medical subject headings
- Breast Neoplasms, Neoplasms, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dance Program GroupBehavioural
Also called Dance Intervention in Breast Cancer Treatment, Effects of Dance on Breast Cancer Care, Effects of a Dance-Based Intervention on Women Receiving Treatment for Breast Cancer
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.
| Study group | Role | What they receive |
|---|---|---|
| Dance Program Group (DPG) | Experimental | 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. Receives: Behavioral: Dance Program Group |
| Control Group (CG) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: From enrollment to end of treatment at 12 weeks
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start20 Apr 2025
- Primary completion28 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Maranhao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andréa Dias Reis, Federal University of Maranhao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553702
- Sponsor's protocol ID
- 77648524.4.0000.5087
- Status last verified
- May 2026
- First submitted
- 22 Nov 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Dance Program for Women on Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT07553702
- Acronym / sponsor ID
- 77648524.4.0000.5087
- Conditions
- Breast Cancer, Breast - Female, Breast Cancer Females
- Keywords
- Neoplasia, Dance, Pain, Fatigue, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Federal University of MaranhaoUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dance Program Group (DPG) | Experimental | Behavioral: Dance Program GroupThe 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. |
| Control Group (CG) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dance Program GroupAlso: Dance Intervention in Breast Cancer Treatment, Effects of Dance on Breast Cancer Care, Effects of a Dance-Based Intervention on Women Receiving Treatment for Breast CancerThe 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. | Behavioural | Dance Program Group (DPG) |
Primary outcome
Pain evaluation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Balance
Time frame: From enrollment to end of treatment at 12 weeks
Functional capacity
Time frame: From enrollment to end of treatment at 12 weeks
Motor Capacity
Time frame: From enrollment to end of treatment at 12 weeks
Flexibility
Time frame: From enrollment to end of treatment at 12 weeks
Self- esteem
Time frame: From enrollment to end of treatment at 12 weeks
Sleep
Time frame: From enrollment to end of treatment at 12 weeks
Anxiety and depression
Time frame: From enrollment to end of treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dance Program Group in people with Breast Cancer and Breast - Female, run by Federal University of Maranhao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain evaluation (time frame: From enrollment to end of treatment at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.