NCT04953377

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 2, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

June 25, 2021

Last Update Submit

March 21, 2023

Conditions

Advanced Breast Cancer

Keywords

pelvic floor muscle trainingurinary incontinenceeducational intervention

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • Changes in urinary incontinence

    8 weeks

  • Impact of urinary incontinence on the quality of life

    8 weeks

  • Knowledge and empowerment

    8 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

PFMT educational intervention including a 120 min workshop and 8 weeks of self training

Behavioral: PFMT educational intervention

Interventions

PFMT educational interventionBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced breast cancer
  • Over 18 years old
  • ECOG≤2
  • No inestable bone metastasis
  • life expentancy\>6 months
  • Literate in spanish

You may not qualify if:

  • Physical exercise contraindications
  • Intense pain
  • Being pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onkologikoa

San Sebastián, 20014, Spain

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mireia Pelaez

    Onkologikoa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mireia Pelaez, PhD

CONTACT

+34943838284mpelaez@onkologikoa.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 25, 2021

First Posted

July 8, 2021

Study Start

September 2, 2021

Primary Completion

March 30, 2023

Study Completion

April 10, 2023

Last Updated

March 24, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)