Project Breast47: Effect of an Educational Intervention

Sponsor
University of Oviedo (Other)
Overall Status
Completed
CT.gov ID
NCT05267171
Collaborator
(none)
424
1
2
5.3
79.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Web access
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
424 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 15, 2022
Actual Primary Completion Date :
Apr 4, 2022
Actual Study Completion Date :
Jun 26, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Change for BC risk with an educational intervention for prevention [Baseline and 12 weeks]

    The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire

  2. Feasibility of an educational intervention for BC risk prevention through the use of a Web-App [12 week]

    Feasibility will be measured with satisfaction questionnaire

  3. Change for BC risk with an educational intervention for prevention [Baseline and 12 weeks]

    The information related to knowledge, risk perception and barriers to prevent BC with the MARA questionnaire.

  4. Change for BC risk with an educational intervention for prevention [Baseline and 12 weeks]

    Barriers to prevent BC with the MARA questionnaire.

  5. Change for BC risk with an educational intervention for prevention [Baseline and 12 weeks]

    Risk perception with the MARA questionnaire

  6. Change for BC risk with an educational intervention for prevention [Baseline and 12 weeks]

    Carrying out self-examination through objective questioning.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad de Oviedo Oviedo Asturias Spain 33006

Sponsors and Collaborators

  • University of Oviedo

Investigators

  • Principal Investigator: Claudia Leirós, Universidad de Oviedo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Claudia Leirós, RN; MSC, University of Oviedo
ClinicalTrials.gov Identifier:
NCT05267171
Other Study ID Numbers:
  • 2021.341
First Posted:
Mar 4, 2022
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2022