Breast NeoplasmBreast47NCT05267171
Project Breast47: Effect of an Educational Intervention
A study testing Web access in people with Breast Neoplasm and Primary Prevention, run by University of Oviedo at 1 site in Spain.
Trial summary
Breast cancer is the most frequently diagnosed malignant tumor in women. In 2018, in Spain, the estimated incidence was 101/100,000 women. Screening strategies and greater knowledge of risk factors by the population have contributed to a better prognosis. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasm, Primary Prevention, Risk Factors
- What is being tested?
- Web access
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2022to 26 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who agree to participate with no previous diagnosis of breast cancer
Who cannot join
- Women who do not have adequate physical or psychological characteristics to participate in the study
- Women who do not have the means to regularly access the web-app that will be used to develop the educational intervention
- Women who cannot be contacted by email
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through the Use of a Web-app: Project Breast47
Breast cancer is the most frequently diagnosed malignant tumor in women. In 2018, in Spain, the estimated incidence was 101/100,000 women.
Screening strategies and greater knowledge of risk factors by the population have contributed to a better prognosis. Specifically, in the case of behavioral factors, making women aware of their influence enables them to establish preventive measures themselves.
Read more
Technologies are becoming a channel of communication, from a healthcare perspective, between the population and healthcare personnel. There are even specific terms like eHealth or mHealth. There is beginning to be evidence that collects the benefits and ways of using web-apps to achieve modification of risky behaviors and/or behaviors to prevent pathologies are acquired.
The use of digital media, such as a web-app, to publicize BC risk factors makes it possible to specifically establish measures aimed at reducing its prevalence, which in turn will contribute to reducing the number of cases of BC. CM.
On the other hand, making women aware of their BC risk factors, as well as quantifying the risk of developing the tumor, is useful for them to become aware of the magnitude of the problem and adopt measures to minimize their risk.
Since there is no digital strategy in Asturias that informs and reduces the risk of developing breast cancer, through the modification of the main risk factors, in young women, the present study has been proposed with the aim of evaluating the effectiveness and feasibility of an educational intervention for BC risk prevention through the use of a Web-App in women residing in health area VII of the Principality of Asturias.
- Conditions
- Breast Neoplasm, Primary Prevention, Risk Factors, Telemedicine
- Being tested
- Web access
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web accessOther
The intervention group will have access to the website where the information is provided. The control group will not have this access.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Web access |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral BC Risk With an Educational Intervention for Prevention
The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire.
The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation).
Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).
Measured: Baseline
Feasibility of an Educational Intervention for BC Risk Prevention Through the Use of a Web-App
PostIntervention - Feasibility will be measured with satisfaction questionnaire.
Satisfaction related to the web-app used in the intervention was measured with the SUS scale in its validated version in Spanish. This is a standardized scale that allows measuring the perception of the usability and satisfaction of a system.
It consists of 10 items that are scored on a Likert-type scale ranging from 1, which is totally disagree, to 5, which is totally agree.
After calculating the result, we will obtain a score in a range from 0 to 100, where its average is 68. Above this figure and up to 84, it is considered "good usability." Equal to or greater than 85 is considered "excellent usability".
This part was only evaluated in those women belonging to the intervention group and who, therefore, had been able to use the web-app.
Measured: 12 weeks (end of intervention)
Knowledge of BC Risk With an Educational Intervention for Prevention
Knowledge of risk factors and signs of BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 9 are related to knowledge of risk factors and 9 to signs and symptoms.
The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.
Measured: Baseline
Barriers to Prevent BC With an Educational Intervention for Prevention
Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies.
The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).
Measured: Baseline
BC Risk Perception With an Educational Intervention for Prevention
Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer.
The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).
Measured: Baseline
Breast Self-examination With an Educational Intervention for Prevention
Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: "Do you perform breast self-examination once a month?" with a dichotomous yes/no response option.
Measured: Baseline
Knowledge of BC Risk With an Educational Intervention for Prevention
Post Intervention - Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer.
The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).
Measured: 12 weeks (end of intervention)
Behavioral BC Risk With an Educational Intervention for Prevention
PostIntervention - The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire.
The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation).
Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).
Measured: 12 weeks (end of intervention)
Knowledge for BC Risk With an Educational Intervention for Prevention
PostIntervention - Knowledge of risk factors and signs of BC with the MARA questionnaire (4 subscales and 31 items of which 9 are related to knowledge of risk factors and 9 to signs and symptoms) The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.
Measured: 12 weeks (end of intervention)
Barriers to Prevent BC With an Educational Intervention for Prevention
PostIntervention - Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies.
The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).
Measured: 12 weeks (end of intervention)
Breast Self-examination With an Educational Intervention for Prevention
PostIntervention - Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: "Do you perform breast self-examination once a month?" with a dichotomous yes/no response option.
Measured: 12 weeks (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start15 Jan 2022
- Primary completion4 Apr 2022
- Study completion26 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Leirós, University of Oviedo
- Investigators
- Claudia Leirós, Principal investigator, Universidad de Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267171
- Sponsor's protocol ID
- 2021.341
- Acronym
- Breast47
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2022
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Martin-Payo R, Leiros-Diaz C, Urena-Lorenzo A, Cachero-Rodriguez J, Fernandez-Arce L, Fernandez-Alvarez MDM. A web-based intervention to promote healthy lifestyles in women under 45 years: a randomized controlled trial (RCT) for breast cancer prevention. Mhealth. 2025 Oct 28;11:54. doi: 10.21037/mhealth-25-2. eCollection 2025.
PubMed 41211018
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through the Use of a Web-app: Project Breast47
- ClinicalTrials.gov ID
- NCT05267171
- Acronym / sponsor ID
- Breast47 / 2021.341
- Conditions
- Breast Neoplasm, Primary Prevention, Risk Factors, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 26 Jun 2022 (actual)
- First posted
- 4 Mar 2022 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast cancer is the most frequently diagnosed malignant tumor in women. In 2018, in Spain, the estimated incidence was 101/100,000 women.
Screening strategies and greater knowledge of risk factors by the population have contributed to a better prognosis. Specifically, in the case of behavioral factors, making women aware of their influence enables them to establish preventive measures themselves.
Technologies are becoming a channel of communication, from a healthcare perspective, between the population and healthcare personnel. There are even specific terms like eHealth or mHealth. There is beginning to be evidence that collects the benefits and ways of using web-apps to achieve modification of risky behaviors and/or behaviors to prevent pathologies are acquired.
The use of digital media, such as a web-app, to publicize BC risk factors makes it possible to specifically establish measures aimed at reducing its prevalence, which in turn will contribute to reducing the number of cases of BC. CM.
On the other hand, making women aware of their BC risk factors, as well as quantifying the risk of developing the tumor, is useful for them to become aware of the magnitude of the problem and adopt measures to minimize their risk.
Since there is no digital strategy in Asturias that informs and reduces the risk of developing breast cancer, through the modification of the main risk factors, in young women, the present study has been proposed with the aim of evaluating the effectiveness and feasibility of an educational intervention for BC risk prevention through the use of a Web-App in women residing in health area VII of the Principality of Asturias.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Web access |
| Control group | No intervention | – |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who agree to participate with no previous diagnosis of breast cancer
Key exclusion criteria (3 listed)
- Women who do not have adequate physical or psychological characteristics to participate in the study
- Women who do not have the means to regularly access the web-app that will be used to develop the educational intervention
- Women who cannot be contacted by email
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 |
|---|---|---|
| Web accessThe intervention group will have access to the website where the information is provided. The control group will not have this access. | Other | Intervention group |
Primary outcome
Behavioral BC Risk With an Educational Intervention for Prevention
Time frame: Baseline
The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire. The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation). Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).
Feasibility of an Educational Intervention for BC Risk Prevention Through the Use of a Web-App
Time frame: 12 weeks (end of intervention)
PostIntervention - Feasibility will be measured with satisfaction questionnaire. Satisfaction related to the web-app used in the intervention was measured with the SUS scale in its validated version in Spanish. This is a standardized scale that allows measuring the perception of the usability and satisfaction of a system. It consists of 10 items that are scored on a Likert-type scale ranging from 1, which is totally disagree, to 5, which is totally agree. After calculating the result, we will obtain a score in a range from 0 to 100, where its average is 68. Above this figure and up to 84, it is considered "good usability." Equal to or greater than 85 is considered "excellent usability". This part was only evaluated in those women belonging to the intervention group and who, therefore, had been able to use the web-app.
Knowledge of BC Risk With an Educational Intervention for Prevention
Time frame: Baseline
Knowledge of risk factors and signs of BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 9 are related to knowledge of risk factors and 9 to signs and symptoms. The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.
Barriers to Prevent BC With an Educational Intervention for Prevention
Time frame: Baseline
Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).
BC Risk Perception With an Educational Intervention for Prevention
Time frame: Baseline
Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).
Breast Self-examination With an Educational Intervention for Prevention
Time frame: Baseline
Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: "Do you perform breast self-examination once a month?" with a dichotomous yes/no response option.
Knowledge of BC Risk With an Educational Intervention for Prevention
Time frame: 12 weeks (end of intervention)
Post Intervention - Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).
Behavioral BC Risk With an Educational Intervention for Prevention
Time frame: 12 weeks (end of intervention)
PostIntervention - The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire. The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation). Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).
Knowledge for BC Risk With an Educational Intervention for Prevention
Time frame: 12 weeks (end of intervention)
PostIntervention - Knowledge of risk factors and signs of BC with the MARA questionnaire (4 subscales and 31 items of which 9 are related to knowledge of risk factors and 9 to signs and symptoms) The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.
Barriers to Prevent BC With an Educational Intervention for Prevention
Time frame: 12 weeks (end of intervention)
PostIntervention - Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).
Breast Self-examination With an Educational Intervention for Prevention
Time frame: 12 weeks (end of intervention)
PostIntervention - Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: "Do you perform breast self-examination once a month?" with a dichotomous yes/no response option.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41211018Martin-Payo R, Leiros-Diaz C, Urena-Lorenzo A, Cachero-Rodriguez J, Fernandez-Arce L, Fernandez-Alvarez MDM. A web-based intervention to promote healthy lifestyles in women under 45 years: a randomized controlled trial (RCT) for breast cancer prevention. Mhealth. 2025 Oct 28;11:54. doi: 10.21037/mhealth-25-2. eCollection 2025.
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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.
Claudia Leirós principal investigator
Universidad de Oviedo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web access in people with Breast Neoplasm and Primary Prevention, run by University of Oviedo 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 1 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: finished, as of the sponsor's last update on 29 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 29 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral BC Risk With an Educational Intervention for Prevention (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05267171, which also lists 1 linked publication.
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 29 Oct 2024.