PFMT Educational Intervention for Patients With Advancer Breast Cancer

Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Breast Cancer
• Intervention / Treatment: Behavioral: PFMT educational intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mireia Pelaez, PhD; Phone Number: +34943838284; Email: mpelaez@onkologikoa.org

Study Locations

• Spain
  • San Sebastián, Spain, 20014
    • Recruiting
    • Onkologikoa
    • Contact: Mireia Pelaez, PhD; Phone Number: +34 943 838284; Email: mpelaez@onkologikoa.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Onkologikoa
• Investigators: Principal Investigator: Mireia Pelaez, Onkologikoa

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): April 10, 2023

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: urinary incontinence; educational intervention; pelvic floor muscle training
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Onkologikoa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No