The Effects of Dance for Breast Cancer Patients Undergoing Surgical Treatment

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Dance

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Letícia Cardenas, PHD; Phone Number: 5511985742277; Email: leticia.cardenas@accamargo.org.br

Study Locations

• Brazil
  • Sao Paulo, Brazil, 01525-001
    • AC Camargo Câncer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dance	Other: Dance; Dance protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ROM	Shoulder range of motion	Pre-intervention and after 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall muscle strength	Dynamometer	Pre-intervention and after 16 weeks
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
respiratory muscle strength	Maximum inspiratory and expiratory pressures (MIP and MEP)	Pre-intervention and after 16 weeks
Functionality	6 minute walk test (6MWT)	Pre-intervention and after 16 weeks
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
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

Collaborators and Investigators

• Sponsor: AC Camargo Cancer Center
• Investigators: Principal Investigator: Letícia Cardenas, PHD, AC Camargo Câncer Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 74502023.7.0000.5432

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