PFMT Educational Intervention for Patients With Advancer Breast Cancer
Primary Purpose
Advanced Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PFMT educational intervention
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer focused on measuring pelvic floor muscle training, urinary incontinence, educational intervention
Eligibility Criteria
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
Sites / Locations
- OnkologikoaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
PFMT educational intervention including a 120 min workshop and 8 weeks of self training
Outcomes
Primary Outcome Measures
Feasibility- Recruitment rates
Number of patients enrolled divided by number of patients eligible
Feasibility - Qualitative analyses of recruitment
Qualitative information regarding recruitment and reasons for patients not participating will be collected in the researchers log
Feasibility-Quantitative and qualitative retention log
Information about number of participants who dropped out, and reason for drop-out
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.
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.
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.
Secondary Outcome Measures
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.
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)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04953377
Brief Title
PFMT Educational Intervention for Patients With Advancer Breast Cancer
Official Title
Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Onkologikoa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
Keywords
pelvic floor muscle training, urinary incontinence, educational intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
PFMT educational intervention including a 120 min workshop and 8 weeks of self training
Intervention Type
Behavioral
Intervention Name(s)
PFMT educational intervention
Intervention Description
an educational intervention to learn about the pelvic floor and how to train it
Primary Outcome Measure Information:
Title
Feasibility- Recruitment rates
Description
Number of patients enrolled divided by number of patients eligible
Time Frame
8 weeks
Title
Feasibility - Qualitative analyses of recruitment
Description
Qualitative information regarding recruitment and reasons for patients not participating will be collected in the researchers log
Time Frame
8 weeks
Title
Feasibility-Quantitative and qualitative retention log
Description
Information about number of participants who dropped out, and reason for drop-out
Time Frame
8 weeks
Title
Feasibility- Adherence to the program
Description
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.
Time Frame
8 weeks
Title
Feasibility- Satisfaction with the workshop
Description
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.
Time Frame
baseline
Title
Prevalence of urinary incontinence
Description
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.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Changes in urinary incontinence
Description
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.
Time Frame
8 weeks
Title
Impact of urinary incontinence on the quality of life
Description
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)
Time Frame
8 weeks
Title
Knowledge and empowerment
Description
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).
Time Frame
8 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mireia Pelaez, PhD
Phone
+34943838284
Email
mpelaez@onkologikoa.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mireia Pelaez
Organizational Affiliation
Onkologikoa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Onkologikoa
City
San Sebastián
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireia Pelaez, PhD
Phone
+34 943 838284
Email
mpelaez@onkologikoa.org
12. IPD Sharing Statement
Plan to Share IPD
No
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PFMT Educational Intervention for Patients With Advancer Breast Cancer
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