Project Breast47: Effect of an Educational Intervention

NCT ID: NCT05267171

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 451 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2022-06-26

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.

Conditions

Breast Neoplasm; Primary Prevention; Risk Factors; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

Web access

Intervention Type: OTHER

The intervention group will have access to the website where the information is provided. The control group will not have this access.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Web access

The intervention group will have access to the website where the information is provided. The control group will not have this access.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oviedo

OTHER

Sponsor Role: lead

Responsible Party

Claudia Leirós

RN; MSC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Leirós

Role: PRINCIPAL_INVESTIGATOR

Universidad de Oviedo

Locations

Universidad de Oviedo

Oviedo, Principality of Asturias, Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2021.341

Identifier Type: -

Identifier Source: org_study_id