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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • Maranhão
      • São Luís, Maranhão, Brazil
        • Federal University of Maranhao

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Dance Program Group
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:
  • 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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Maranhao

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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