PFMT Educational Intervention for Patients With Advancer Breast Cancer

Advanced Breast Cancer Clinical Trial

Official title:

Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953377
• Other study ID #: Onkologikoa
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Advanced Breast Cancer
• Breast Neoplasms

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