The Effects of Dance for Breast Cancer Patients Undergoing Surgical Treatment

Breast Cancer Clinical Trial

Official title:

Os Efeitos da dança Como Recurso terapêutico em Pacientes Com câncer de Mama Submetidas a Tratamento cirúrgico

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215027
• Other study ID #: 74502023.7.0000.5432
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: January 2024
• Source: AC Camargo Cancer Center
• Contact: Letícia Cardenas, PHD
• Phone: 5511985742277
• Email: leticia.cardenas[@]accamargo.org.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this non randomized clinical trial, with pre- and post-intervention evaluation, longitudinal, with prospective data collection is to evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment.

Description:

The hypothesis is that dance will promote improvements in range of motion, strength, fatigue, functionality, pain and quality of life for breast cancer patients undergoing surgical treatment. Objectives: To evaluate the effects of dance as a therapeutic intervention in breast cancer patients undergoing surgical treatment on: shoulder range of, overall muscle strength, fatigue, respiratory muscle strength, functionality, pain and quality of life. Method: This is a non-randomized randomized clinical trial, with pre- and post-intervention evaluation, prospective data collection. The following will be used for pre-intervention assessment: goniometry, dynamometry, manovacuometry, 6-minute walk test, fatigue and quality of life questionnaire, and quality of life questionnaire, as well as a pain assessment scale. After 16 weeks, the same variables will be assessed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 30, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients diagnosed with breast cancer
• undergone surgical resection
• after medical referral for physiotherapy
• and physiotherapeutic assessment

Exclusion Criteria:

• patients with another previous oncological diagnosis
• previous neuromuscular diseases
• patients who do not agree to take part in the study
• or the impossibility of carrying out the muscle strength assessment and/or other assessments

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Dance
Dance protocol

Locations

Country	Name	City	State
Brazil	AC Camargo Cancer Center	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
AC Camargo Cancer Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ROM	Shoulder range of motion	Pre-intervention and after 16 weeks
Secondary	Overall muscle strength	Dynamometer	Pre-intervention and after 16 weeks
Secondary	Fatigue	Brief Fatigue Inventory. The BFI is a scale with 11 points (0 to 10), including a dichotomous question about whether the patient felt tired or fatigued in the last 7 days. For each question, zero is considered ''no fatigue'' and 10 is ''worst fatigue possible,'' except for the dichotomous question that is not scored. Among the other questions, 3 measures the severity of fatigue in the current, daily situations, and in the last 24 hours. Six questions measure the influence of fatigue in general activities, mood, walk, work, relationship with other people, and recreation. The total score is the average of all questions. According to the total score, fatigue is classified as mild (1 to 3 points), moderate (4 to 6 points), and severe (7 to 10 points).	Pre-intervention and after 16 weeks
Secondary	respiratory muscle strength	Maximum inspiratory and expiratory pressures (MIP and MEP)	Pre-intervention and after 16 weeks
Secondary	Functionality	6 minute walk test (6MWT)	Pre-intervention and after 16 weeks
Secondary	Pain intensity	Analogic visual scale. The visual analogue pain scale is a measure of pain intensity that has been widely used in several languages. For pain intensity, the scale is most commonly ranging from "no pain" (score of 0) to "worst pain imaginable" (score of 10). A higher rating indicates greater pain intensity.	Pre-intervention and after 16 weeks
Secondary	Quality of life (physical well-being, social and family well-being, emotional well-being, functional well-being)	Functional Assessment of Cancer Therapy-Breast (FACT-B). The FACT-B, version 4, is a multidimensional questionnaire composed of 37 questions divided into five domains that assess different dimensions: physical well-being, social and family well-being, emotional well-being, functional well-being and breast cancer subscale.	Pre-intervention and after 16 weeks