NCT07553702

Brief 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). 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
2mo left

Started Apr 2025

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Apr 2025Jun 2026

Study Start

First participant enrolled

April 20, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

November 22, 2025

Last Update Submit

April 23, 2026

Conditions

Keywords

NeoplasiaDancePainFatigueQuality of Life

Outcome Measures

Primary Outcomes (4)

  • 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.

    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).

    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.

    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.

    From enrollment to end of treatment at 12 weeks

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Also known as: 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
Dance Program Group (DPG)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Maranhao

São Luís, Maranhão, Brazil

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasmsPainFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in the Graduate Program in Physical Education at the Federal University of Maranhão, São Luís - MA, Brazil.

Study Record Dates

First Submitted

November 22, 2025

First Posted

April 28, 2026

Study Start

April 20, 2025

Primary Completion

April 28, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations