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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dance | Experimental | Dance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dance | Other | Dance protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| ROM | Shoulder range of motion | Pre-intervention and after 16 weeks |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LetÃcia Cardenas, PHD | Contact | 5511985742277 | leticia.cardenas@accamargo.org.br |
| Name | Affiliation | Role |
|---|---|---|
| LetÃcia Cardenas, PHD | AC Camargo Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AC Camargo Cancer Center | Recruiting | São Paulo | 01525-001 | Brazil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2023 | Jan 18, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Single group
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| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |