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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
University of Oviedo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Neoplasm

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
February 3, 2022
Last Updated
July 11, 2022
Sponsor
University of Oviedo
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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

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