Advanced Breast CancerNCT04953377
PFMT Educational Intervention for Patients With Advancer Breast Cancer
A study testing PFMT educational intervention in people with Advanced Breast Cancer, run by Onkologikoa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- PFMT educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2021to 10 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced breast cancer
- Over 18 years old
- ECOG≤2
- No inestable bone metastasis
- life expentancy>6 months
- Literate in spanish
Who cannot join
- Physical exercise contraindications
- Intense pain
- Being pregnant
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Onkologikoa
San Sebastián, 20014
Mireia Pelaez, PhD, +34 943 838284, mpelaez@onkologikoa.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Advanced Breast Cancer
- Being tested
- PFMT educational intervention
- Keywords
- pelvic floor muscle training, urinary incontinence, educational intervention
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFMT educational interventionBehavioural
an educational intervention to learn about the pelvic floor and how to train it
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | PFMT educational intervention including a 120 min workshop and 8 weeks of self training Receives: Behavioral: PFMT educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Recruitment rates
Number of patients enrolled divided by number of patients eligible
Measured: 8 weeks
Feasibility - Qualitative analyses of recruitment
Qualitative information regarding recruitment and reasons for patients not participating will be collected in the researchers log
Measured: 8 weeks
Feasibility-Quantitative and qualitative retention log
Information about number of participants who dropped out, and reason for drop-out
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
Secondary outcomes (3)
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.
Measured: 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)
Measured: 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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start2 Sep 2021
- Primary completion30 Mar 2023 (estimated)
- Study completion10 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onkologikoa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireia Peláez Puente, Onkologikoa
- Investigators
- Mireia Pelaez, Principal investigator, Onkologikoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953377
- Sponsor's protocol ID
- Onkologikoa
- Status last verified
- Mar 2023
- First submitted
- 25 Jun 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Floor Muscle Training Educational Intervention for Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT04953377
- Acronym / sponsor ID
- Onkologikoa
- Conditions
- Advanced Breast Cancer
- Keywords
- pelvic floor muscle training, urinary incontinence, educational intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- OnkologikoaUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 10 Apr 2023 (estimated)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: PFMT educational interventionPFMT educational intervention including a 120 min workshop and 8 weeks of self training |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Advanced breast cancer
- Over 18 years old
- ECOG≤2
- No inestable bone metastasis
- life expentancy>6 months
Key exclusion criteria (3 listed)
- Physical exercise contraindications
- Intense pain
- Being pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFMT educational interventionan educational intervention to learn about the pelvic floor and how to train it | Behavioural | Intervention |
Primary outcome
Feasibility- Recruitment rates
Time frame: 8 weeks
Number of patients enrolled divided by number of patients eligible
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
Feasibility-Quantitative and qualitative retention log
Time frame: 8 weeks
Information about number of participants who dropped out, and reason for drop-out
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- 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.
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.
3 secondary outcomes
Changes in urinary incontinence
Time frame: 8 weeks
Impact of urinary incontinence on the quality of life
Time frame: 8 weeks
Knowledge and empowerment
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mireia Pelaez principal investigator
Onkologikoa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFMT educational intervention in people with Advanced Breast Cancer, run by Onkologikoa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mireia Pelaez, PhD (+34943838284, mpelaez@onkologikoa.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- Recruitment rates (time frame: 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.