Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Feasibility-Quantitative and qualitative retention log
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Advanced breast cancer
- •Over 18 years old
- •No inestable bone metastasis
- •life expentancy>6 months
- •Literate in spanish
Exclusion Criteria
- •Physical exercise contraindications
- •Intense pain
- •Being pregnant
Arms & Interventions
Intervention
PFMT educational intervention including a 120 min workshop and 8 weeks of self training
Intervention: PFMT educational intervention (Behavioral)
Outcomes
Primary Outcomes
Feasibility-Quantitative and qualitative retention log
Time Frame: 8 weeks
Information about number of participants who dropped out, and reason for drop-out
Feasibility- Satisfaction with the workshop
Time Frame: baseline
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.
Feasibility- Adherence to the program
Time Frame: 8 weeks
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- Recruitment rates
Time Frame: 8 weeks
Number of patients enrolled divided by number of patients eligible
Prevalence of urinary incontinence
Time Frame: baseline
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.
Feasibility - Qualitative analyses of recruitment
Time Frame: 8 weeks
Qualitative information regarding recruitment and reasons for patients not participating will be collected in the researchers log
Secondary Outcomes
- Impact of urinary incontinence on the quality of life(8 weeks)
- Changes in urinary incontinence(8 weeks)
- Knowledge and empowerment(8 weeks)
Investigators
Mireia Peláez Puente
PhD
Onkologikoa