Project Breast47: Effect of an Educational Intervention

Telemedicine Clinical Trial

— Breast47  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05267171
• Other study ID #: 2021.341
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: June 26, 2022

Study information

• Verified date: July 2022
• Source: University of Oviedo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: June 26, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Primary Prevention
• Risk Factors
• Telemedicine

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad de Oviedo	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
University of Oviedo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change for BC risk with an educational intervention for prevention	The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire	Baseline and 12 weeks
Primary	Feasibility of an educational intervention for BC risk prevention through the use of a Web-App	Feasibility will be measured with satisfaction questionnaire	12 week
Primary	Change for BC risk with an educational intervention for prevention	The information related to knowledge, risk perception and barriers to prevent BC with the MARA questionnaire.	Baseline and 12 weeks
Primary	Change for BC risk with an educational intervention for prevention	Barriers to prevent BC with the MARA questionnaire.	Baseline and 12 weeks
Primary	Change for BC risk with an educational intervention for prevention	Risk perception with the MARA questionnaire	Baseline and 12 weeks
Primary	Change for BC risk with an educational intervention for prevention	Carrying out self-examination through objective questioning.	Baseline and 12 weeks