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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | PFMT educational intervention including a 120 min workshop and 8 weeks of self training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFMT educational intervention | Behavioral | an educational intervention to learn about the pelvic floor and how to train it |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mireia Pelaez, PhD | Contact | +34943838284 | mpelaez@onkologikoa.org |
| Name | Affiliation | Role |
|---|---|---|
| Mireia Pelaez | Onkologikoa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onkologikoa | Recruiting | San Sebastián | 20014 | Spain |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| baseline |
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |