Project Breast47: Effect of an Educational Intervention (Breast47)
Primary Purpose
Breast Neoplasm, Primary Prevention, Risk Factors
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Web access
Sponsored by

About this trial
This is an interventional prevention trial for Breast Neoplasm
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
Sites / Locations
- Universidad de Oviedo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Change for BC risk with an educational intervention for prevention
The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire
Feasibility of an educational intervention for BC risk prevention through the use of a Web-App
Feasibility will be measured with satisfaction questionnaire
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.
Change for BC risk with an educational intervention for prevention
Barriers to prevent BC with the MARA questionnaire.
Change for BC risk with an educational intervention for prevention
Risk perception with the MARA questionnaire
Change for BC risk with an educational intervention for prevention
Carrying out self-examination through objective questioning.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05267171
Brief Title
Project Breast47: Effect of an Educational Intervention
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
April 4, 2022 (Actual)
Study Completion Date
June 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oviedo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Primary Prevention, Risk Factors, Telemedicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
424 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Web access
Intervention Description
The intervention group will have access to the website where the information is provided. The control group will not have this access.
Primary Outcome Measure Information:
Title
Change for BC risk with an educational intervention for prevention
Description
The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire
Time Frame
Baseline and 12 weeks
Title
Feasibility of an educational intervention for BC risk prevention through the use of a Web-App
Description
Feasibility will be measured with satisfaction questionnaire
Time Frame
12 week
Title
Change for BC risk with an educational intervention for prevention
Description
The information related to knowledge, risk perception and barriers to prevent BC with the MARA questionnaire.
Time Frame
Baseline and 12 weeks
Title
Change for BC risk with an educational intervention for prevention
Description
Barriers to prevent BC with the MARA questionnaire.
Time Frame
Baseline and 12 weeks
Title
Change for BC risk with an educational intervention for prevention
Description
Risk perception with the MARA questionnaire
Time Frame
Baseline and 12 weeks
Title
Change for BC risk with an educational intervention for prevention
Description
Carrying out self-examination through objective questioning.
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Leirós
Organizational Affiliation
Universidad de Oviedo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Oviedo
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Project Breast47: Effect of an Educational Intervention
We'll reach out to this number within 24 hrs