- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07553702
Dance Intervention in Breast Cancer Treatment
May 11, 2026 updated by: Andréa Dias Reis, Federal University of Maranhao
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maranhão
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São Luís, Maranhão, Brazil
- Federal University of Maranhao
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
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|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to end of treatment at 12 weeks
|
|
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).
|
From enrollment to end of treatment at 12 weeks
|
|
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.
|
From enrollment to end of treatment at 12 weeks
|
|
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.
|
From enrollment to end of treatment at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: From enrollment to end of treatment at 12 weeks
|
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).
|
From enrollment to end of treatment at 12 weeks
|
|
Functional capacity
Time Frame: From enrollment to end of treatment at 12 weeks
|
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.
|
From enrollment to end of treatment at 12 weeks
|
|
Motor Capacity
Time Frame: From enrollment to end of treatment at 12 weeks
|
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.
|
From enrollment to end of treatment at 12 weeks
|
|
Flexibility
Time Frame: From enrollment to end of treatment at 12 weeks
|
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.
|
From enrollment to end of treatment at 12 weeks
|
|
Self- esteem
Time Frame: From enrollment to end of treatment at 12 weeks
|
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.
|
From enrollment to end of treatment at 12 weeks
|
|
Sleep
Time Frame: From enrollment to end of treatment at 12 weeks
|
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.
|
From enrollment to end of treatment at 12 weeks
|
|
Anxiety and depression
Time Frame: From enrollment to end of treatment at 12 weeks
|
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.
|
From enrollment to end of treatment at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 20, 2025
Primary Completion (Estimated)
June 28, 2026
Study Completion (Estimated)
August 30, 2026
Study Registration Dates
First Submitted
November 22, 2025
First Submitted That Met QC Criteria
April 23, 2026
First Posted (Actual)
April 28, 2026
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 77648524.4.0000.5087
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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