PFMT Educational Intervention for Patients With Advancer Breast Cancer

Study Overview
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Brief Summary
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A PFMT educational intervention was designed for women with metastasic breast cancer. It consisted in a 120 min workshop and 8 weeks of non-supervised (but with follow-up) self-training. ICIQ, IQOL and ad hoc questions were performed before the workshop and after the 8 weeks training to see the prevalence of UI, the impact in their quality of life and the empowerment of self-training.

Detailed Description
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Urinary incontinence (UI) affects women of all ages and has a great impact on the quality of life. Cancer treatments such as chemotherapy or hormone therapy may play an important rol in the development and worsening of pelvic floor disorders. Little evidence on the prevalence and impact of UI in metastassis breast cancer women is known. A protocol was designed to analyze the effect of a PFMT educational intervention on the UI and the impact on the QoL, as well as in the empowerment feeling of the participants. Feasibility of the protocol will be analized to design an optimal RCT for testing our hypothesis During the usual visits, oncologist wil recruit women with advanced breast cancer who meet the inclusion criteria for the participation.

Official Title
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Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer

Conditions
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Advanced Breast Cancer

Intervention / Treatment
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* Behavioral: PFMT educational intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced breast cancer Over 18 years old ECOG≤2 No inestable bone metastasis life expentancy>6 months Literate in spanish Exclusion Criteria: Physical exercise contraindications Intense pain Being pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>PFMT educational intervention including a 120 min workshop and 8 weeks of self training | Behavioral: PFMT educational intervention<br>* an educational intervention to learn about the pelvic floor and how to train it<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility- Recruitment rates | Number of patients enrolled divided by number of patients eligible | 8 weeks | 
| Feasibility - Qualitative analyses of recruitment | Qualitative information regarding recruitment and reasons for patients not participating will be collected in the researchers log | 8 weeks | 
| Feasibility-Quantitative and qualitative retention log | Information about number of participants who dropped out, and reason for drop-out | 8 weeks | 
| Feasibility- Adherence to the program | Adherence will be difined as the percentage of completed weeks of training out of 8 weeks. A week will be considerered valid when the train was performed at least in 2 different days. | 8 weeks | 
| Feasibility- Satisfaction with the workshop | A satisfaction 9 item questionnaire was design (Scale 1-5) to obtain information about the satisfaction with the (1) duration, (2) the content, (3) explanations, (4) atmosphere (5)number of participants during the workshop and (6) the importance for other patients to access this information, (7) increase in knowledge, (8) knowledge to train alone and (9) overall satisfaction. | baseline | 
| Prevalence of urinary incontinence | By the ICIQ-UI Short Form, which is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. It has 4 items, and the scoring scale is 0-21. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in urinary incontinence | By the ICIQ-UI Short Form, which is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women in research and clinical practice across the world. It has 4 items, and the scoring scale is 0-21. | 8 weeks | 
| Impact of urinary incontinence on the quality of life | The I-QOL measures the effect of urinary incontinence on quality of life.It is divided into 3 subscales: Avoidance and limiting behavior, Psychosocial impact, and Social embarrassment (SE). Subjects use a 5-point response scale with values ranging from 1 (extremely) to 5 (not at all) | 8 weeks | 
| Knowledge and empowerment | A 11 item questionnaire was designed to analyse the population's initial knowledge of pelvic floor health and compare it with the knowledge maintained after the intervention. 5-point scale (0-4). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic floor muscle training, urinary incontinence, educational intervention