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NCT Number: NCT06215027

The Effects of Dance for Breast Cancer Patients Undergoing Surgical Treatment

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AC Camargo Cancer Center

São Paulo, 01525-001, Brazil

Location status: Recruiting

Location contact

Letícia Cardenas, PHD

CONTACT

[email protected]

+5511985742277

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dance

Other

Dance protocol

Primary outcomes

  1. ROM

    Time frame: Pre-intervention and after 16 weeks

    Shoulder range of motion

Secondary outcomes

  1. Overall muscle strength

    Time frame: Pre-intervention and after 16 weeks

    Dynamometer

  2. Fatigue

    Time frame: Pre-intervention and after 16 weeks

    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).

  3. respiratory muscle strength

    Time frame: Pre-intervention and after 16 weeks

    Maximum inspiratory and expiratory pressures (MIP and MEP)

  4. Functionality

    Time frame: Pre-intervention and after 16 weeks

    6 minute walk test (6MWT)

  5. Pain intensity

    Time frame: Pre-intervention and after 16 weeks

    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.

  6. Quality of life (physical well-being, social and family well-being, emotional well-being, functional well-being)

    Time frame: Pre-intervention and after 16 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Letícia Cardenas, PHD

CONTACT

[email protected]

5511985742277

Sponsors and collaborators

Lead sponsor

AC Camargo Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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