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PFMT Educational Intervention for Patients With Advancer Breast Cancer

Sponsor
Onkologikoa (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04953377
Collaborator
(none)
42
Enrollment
1
Arm
17.4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PFMT educational intervention
 N/A

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 QL, as well as in the empowerment feeling of the participants.

During the usual visits, oncologist wil recruit women with advanced breast cancer who meet the inclusion criteria for the participation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer
Anticipated Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Prevalence and severity of urinary incontienece [baseline]

    ICIQ-SF

  2. Changes in prevalence and severity of urinary incontienece [8 weeks after baseline]

    ICIQ-SF

Secondary Outcome Measures

  1. impact on the quality of life [baseline]

    IQOL

  2. changes in impact on the quality of life [8 weeks after baseline]

    IQOL

  3. questionnaire on changes of knowledge and empowerment [pretest and 8 weeks later]

    ad hoc questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Onkologikoa

Investigators

  • Principal Investigator: Mireia Pelaez, Onkologikoa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mireia Peláez Puente, PhD, Onkologikoa
ClinicalTrials.gov Identifier:
NCT04953377
Other Study ID Numbers:
  • Onkologikoa
First Posted:
Jul 8, 2021
Last Update Posted:
Jul 8, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mireia Peláez Puente, PhD, Onkologikoa
pelvic floor muscle training
urinary incontinence
educational intervention
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Jul 8, 2021