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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04953377
Other study ID # Onkologikoa
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2, 2021
Est. completion date April 10, 2023

Study information

Verified date March 2023
Source Onkologikoa
Contact Mireia Pelaez, PhD
Phone +34943838284
Email mpelaez@onkologikoa.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 42
Est. completion date April 10, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PFMT educational intervention
an educational intervention to learn about the pelvic floor and how to train it

Locations

Country Name City State
Spain Onkologikoa San Sebastián

Sponsors (1)

Lead Sponsor Collaborator
Onkologikoa

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility- Recruitment rates Number of patients enrolled divided by number of patients eligible 8 weeks
Primary Feasibility - Qualitative analyses of recruitment Qualitative information regarding recruitment and reasons for patients not participating will be collected in the researchers log 8 weeks
Primary Feasibility-Quantitative and qualitative retention log Information about number of participants who dropped out, and reason for drop-out 8 weeks
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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