Clinical trial NCT05267171: Project Breast47: Effect of an Educational Intervention
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Primary Prevention
Risk Factors
Telemedicine
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 451
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Women who agree to participate with no previous diagnosis of breast cancer

Exclusion Criteria:

* 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

Primary outcomes:
measure: Behavioral BC Risk With an Educational Intervention for Prevention
timeFrame: Baseline
measure: Feasibility of an Educational Intervention for BC Risk Prevention Through the Use of a Web-App
timeFrame: 12 weeks (end of intervention)
measure: Knowledge of BC Risk With an Educational Intervention for Prevention
timeFrame: Baseline
measure: Barriers to Prevent BC With an Educational Intervention for Prevention
timeFrame: Baseline
measure: BC Risk Perception With an Educational Intervention for Prevention
timeFrame: Baseline
measure: Breast Self-examination With an Educational Intervention for Prevention
timeFrame: Baseline
measure: Knowledge of BC Risk With an Educational Intervention for Prevention
timeFrame: 12 weeks (end of intervention)
measure: Behavioral BC Risk With an Educational Intervention for Prevention
timeFrame: 12 weeks (end of intervention)
measure: Knowledge for BC Risk With an Educational Intervention for Prevention
timeFrame: 12 weeks (end of intervention)
measure: Barriers to Prevent BC With an Educational Intervention for Prevention
timeFrame: 12 weeks (end of intervention)
measure: Breast Self-examination With an Educational Intervention for Prevention
timeFrame: 12 weeks (end of intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Universidad de Oviedo
state: Asturias
Study officials:
affiliation: Universidad de Oviedo
name: Claudia Leirós
role: PRINCIPAL_INVESTIGATOR
References: