Effect of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through the Use of a Web-app: Project Breast47
Phase: NA
Conditions: Breast Neoplasm, Primary Prevention, Risk Factors, Telemedicine
Sponsor: University of Oviedo

 
 
 
 
 
 
 
 
 
 
Breast Project 4.7. Effectiveness of an educational intervention for the prevention of 
breast cancer by modifying risk behaviors through the use of a Web-App. 
 
 
NCT 05267171  
January 12, 2022  

INDEX 
1. INTRODUCTION 
2. JUSTIFICATION 
3. HYPOTHESIS AND OBJECTIVES 
3.1. 
Hypothesis 
3.2. 
Objectives 
3.2.1. Main Objective 
3.2.2. Specific Objectives 
4. METHODOLOGY 
4.1. 
Design 
4.2. 
Study population 
4.3. 
Data collection: tools and procedure 
4.4. 
Educational intervention 
5. STATISTICAL ANALYSIS 
6. ETHICAL CONSIDERATIONS 
7. BIBLIOGRAPHY 

1. INTRODUCTION 
Breast cancer (BC) is the most frequently diagnosed malignant tumor in women 
regardless of the country's level of development. In 2018, at a European level it 
accounted for approximately 28% of the total cancers diagnosed in this sex1 and, 
specifically in Spain, the estimated incidence that same year was 101/100,000 women1. 
 
The scientific advances that have occurred in recent years have improved its prognosis. 
Screening or early detection strategies have notably contributed to this evolution for 
some age groups and the elderly. Knowledge of risk factors by the population2,3. 
 
However, it is necessary to take into account that some screening methods have side 
effects and that they can act to the detriment of detection early4,5. On the other hand, 
there is abundant literature that reveals the relationship of various biological, behavioral 
and environmental factors in the development of CM6-66. Specifically, in the case of 
behaviors, making women aware of their influence makes it possible for them to 
establish preventive measures67,68. 
 
Additionally, it is worth noting the individualized estimates of the risk of develop CM69. 
According to Shiek et al.70 these can contribute to less testing, a lower number of false 
positives, and fewer treatments. At present, there are algorithms that have been 
designed to estimate the probability of developing BC. Its use makes it possible to 
determine which risk reduction options are most effective in preventing its 
development68,71. One of the first and most popular is the one developed by Gail et al.72. 
Subsequently, validations were carried out to adjust the risk to specific conditions73. 
Although its validity has been demonstrated for estimations population, it seems to be 
limited for individualized estimates74. The parameters that it includes in its current 
version are the age of the woman (from 35 years), age of the first period, age of the 
woman in which her first child was born (in the case of having them), number of relatives 
of first degree cancer, number of previous biopsies, and race. Despite its effectiveness, 
some authors point out the need to continue with research that allows the development 
of more specific tools75. 

On the other hand, the use of technology is becoming a common channel of 
communication, from a care perspective, between the population and healthcare 
personnel. There are even terms to refer to it specifically. For example, eHealth or the 
use of information and communication technology in the field of health and, more 
specifically, mHealth as the use of mobile devices in the field of health 76,77. 
The Internet is a great source of information used by between 30 and 50% of patients to 
seek information about their illness78. The fact that patients are well informed and 
understand the process of their disease contributes to improving their relationship with 
healthcare personnel and who adopt a more active role in their health 78,79. Although 
these means make it possible for patients to have accessible information quickly and 
permanently, it must not be forgotten that the absence of quality criteria in some 
sources available online can work against it and this justifies the need to help patients 
to discriminate what information is correct, truthful and appropriate to the 
characteristics of each one. 
In this sense, it should be noted that there is beginning to be evidence that includes the 
benefits and ways of using web-apps as means to get people to modify risky behaviors 
and/or acquire healthy behaviors to prevent pathologies such as overweight, diabetes 
and the cancer 80,81. 
2. JUSTIFICATION 
The use of digital media, such as a web-app, to publicize MC 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 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 be aware of the magnitude of the 
problem and take steps to minimize your 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 objectives indicated below. 
continuation. 

3. HYPOTHESIS AND OBJECTIVES 
Based on the reviewed bibliography, it can be affirmed that establishing measures that 
contribute to improving knowledge related to the prevention of a health problem and 
help to perceive the risk of developing said problem, contribute to increasing the 
development of preventive behaviors. 
 
3.1. 
Hypothesis 
The hypothesis that this study will try to demonstrate is that an educational intervention, 
based on the use of a web-app, will be effective in improving knowledge and risk 
behaviors for breast cancer in women between the ages of 25 and 45, residents in health 
area 7 of the Principality of Asturias. 
 
3.2. 
Objetives 
3.2.1. Main Objetive 
To evaluate the effectiveness of an educational intervention for the prevention of breast 
cancer risk through the use of a Web-App in women residing in health area VII of the 
Principality of Asturias. 
3.2.2. Specific Objetive 
 Evaluate adherence to behavioral recommendations before and after 
after the educational intervention for each group separately. 
 To compare adherence to behavioral recommendations after the intervention 
between the intervention and control groups. 
 Evaluate, in each group separately, the knowledge in relation to the risk factors 
and symptoms of breast cancer before and after the intervention. 
 To compare the level of knowledge in relation to the risk factors and symptoms 
of breast cancer between the intervention and control groups before and after 
the intervention. 
 Estimate the risk and self-perception of developing breast cancer before and 
after the intervention for each of the groups. 
 To compare the risk and self-perception of developing breast cancer between the 
intervention and control groups after the educational intervention. 

4. METHODOLOGY 
4.1. 
Design 
Experimental, randomized, with a control group without intervention. 
4.2. 
Study population 
It will be made up of women belonging to the VII health area of the Principality of 
Asturias, aged between 25 and 45 years, without a previous diagnosis of BC. 
All women who give written consent to participate in the study will be included. Those 
who: (i) do not have adequate physical or psychological characteristics to participate in 
the study will be excluded; (ii) do not have the means to regularly access the web-app 
that will be used to carry out the educational intervention; (iii) your contact by email is 
not possible. 
The recruitment of women will be carried out, between the months of January and 
February 2022, by sending a letter of invitation to participate from the health area. A 
random sample of 361 women will be sufficient to estimate, with 95% confidence and 
an accuracy of +/- 5 percentage units, a population percentage that is expected to be 
approximately 75%. The percentage of necessary replacements has been predicted to 
be 20%. 
The health area VII technician and member of the research team (María Dolores Martín) 
will draw up a list of all the women likely to be included in the study. The members of 
the research team prepare a letter for each of the women and they will be sent from the 
management of Sanitary Area VII to the women by postal mail. 
The letter contains a contact email to which they will write if they are interested in 
participating. The women will be answered as the emails are received and when we have 
obtained the necessary sample, the project will be explained in detail with an 
information sheet that they may have at their disposal and they will be given their 
consent informed, which they will sign by selecting the box "I wish to participate 
voluntarily" that will appear at the end of the consent. Finally, they will be asked for a 
username and password to access the web-app. In other words, the user or pseudonym 
to access the web-app will be selected by the woman herself. 
 
The selected women will be distributed, in March 2022, between the intervention (IG) 
and control (CG) groups using the simple randomization method and with a 1:1 ratio. 

4.3. 
Data collection: tools and procedure 
The data collection will take place during the months of March (pre-test) and June 2022 
(post-test). At both times it will be done virtually, using a digital form. Participants will 
access this form through the project's web-app. The pre-test collection will be carried 
out after signing the consent and the post-test, after the educational intervention, that 
is, at 12 weeks. 
At both moments, information will be collected related to personal, anthropometric, and 
behavioral variables (diet and physical activity), self-examination, knowledge related to 
risk factors and symptoms of breast cancer, perception of risk of developing breast 
cancer, and barriers to carry out. take actions to prevent it. 
Additionally, after the educational intervention, satisfaction with the use of the web-app 
will be evaluated. 
The information on the behavioral variables will be recorded using the Motiva.Diaf 
questionnaire. It includes 12 items that measure adherence to and motivation to carry 
out recommendations related to nutrition (questions 1 to 7) and physical activity 
(questions 8 to 12). Each item presents a Likert-type response format with a range from 
0 (lack of motivation to make the recommendation) to 5 (intrinsic motivation). In 
addition, each separate recommendation can be interpreted dichotomously (makes=1 
or does not make the recommendation=0). Finally, the synthetic variable adherence to 
healthy recommendations is elaborated as a result of scoring each item in its 
dichotomous interpretation (range 0=worst adherence to healthy recommendations to 
12=greatest adherence to healthy recommendations). 
The self-examination is carried out by means of the question, do you perform the breast 
self-examination once a month. 
The information related to knowledge, risk perception and barriers with the MARA 
questionnaire. This questionnaire, specifically related to breast cancer, consists of 31 
items that measure the following constructs: knowledge related to risk factors (9 items), 
knowledge related to signs and symptoms (9 items), perception of risk of developing 
breast cancer breast (6 items) and perceived barriers to carry out prevention strategies 
(7 items). Items related to knowledge have a score of 0 (error) and 1 (correct), therefore 
the range of scores, both for risk factors and for signs and symptoms, is between 0 and 
9. The score of the other two scales is represented on a Likert-type scale ranging from 1 

(totally disagree) to 5 (totally agree), the total perception score being between 6 and 30 
points (the lower the score, the lower the perception of risk and the barriers between 7 
and 35 points (the lower the score, the fewer perceived barriers). 
 
4.4. 
Educational intervention 
The IG women will receive an intervention based on the use of a web-app with a duration 
of 12 weeks, which will be complementary to the preventive activities carried out in the 
health area. The CG participants will not have access to the web-app during the 12 weeks 
that the intervention lasts and will only receive the usual health care. 
The design and evaluation of the intervention is based on the Behavior Change Wheel 
(BCW)82 model and the web-app will be used as the central axis of the same. 
 
The web-app will consist of 6 sections: information related to BC risk factors; self- 
exploration; feeding; physical activity; news and community the risk factors section will 
be merely informative. It will collect information in relation to the modifiable and non- 
modifiable factors that increase the risk of developing this tumor. 
The self-examination section will include information related to the signs compatible 
with the CM and an explanatory video on how to perform the examination of your 
breasts. This information will enable women to identify the symptoms and signs that are 
consistent with the onset of cancer. 
The food will be subdivided into 3 sections: nutritionist; recipes; tips. A nutrition expert 
will provide information in the form of videos about the characteristics of a healthy diet. 
In the recipes section, information related to healthy recipes will be provided. Finally, 
the advice section will be included where information obtained from secondary sources 
will be provided. 
The physical activity section will also be subdivided into 3 sections: your 30 minutes; 
routes; options in your environment. First, information will be provided about the 
importance of doing 30 minutes of physical activity a day, indicating "walking" as an 
essential activity. In addition, 4 videos will be included with routines that women can 
perform at home. The routes section will include links to the pages of the municipalities 
belonging to the VII health area where the routes that can be taken in the area appear. 
The last section will include the health assets that women can find in the basic health 

area (parks, sports spaces, walks...) with basic information about the type of activity that 
can be carried out in each of them. 
Links to resources related to any aspect that may be of interest to the participants will 
be uploaded in the news section. 
Finally, the community section will have a blog structure through which participants will 
be encouraged to make contributions (routes, recipes, information...) that may be of 
interest to the rest of the participants. This information will not be public until it is 
validated by the members of the research team. 
 
5. STATISTICAL ANALYSIS 
Initially, the normality of the distribution of the variables will be verified, the 
Kolmogorov-Smirnov test will be used. A description of the variables will be made using 
percentages, means (standard deviation) or median (interquatile range) depending on 
their nature and distribution. 
To determine the association between variables, the chi-square test, McNemar for 
qualitative variables, will be used. For qualitative variables, they will be determined 
based on the distribution of variables. 
Linear regression analyzes will be carried out to determine which variables best predict 
the score after the intervention in terms of knowledge about risk factors, signs- 
symptoms of early detection of breast cancer, knowledge and adherence to healthy 
behaviors. 
The analyzes will be carried out using the IBM SPSS version 24.0®, considering that the 
results were statistically significant when the value of p is ≤ 0.05. 
 
6. ETHICAL CONSIDERATIONS 
In general, the precepts of the Declaration of Helsinki will be respected. This defines the 
principles that must be scrupulously respected by all the people involved in the present 
investigation. Specifically, informed consent will be requested, the free will to abandon 
the research will be respected without this causing any harm to the person, and the 
confidentiality of the data of the subjects participating in the study will be respected. 
The treatment, communication and transfer of personal data of all participants will 
comply with the provisions of Organic Law 3/2018, of December 5. The project has been 

reviewed and authorized by the Research Ethics Committee of the Principality of Asturias 
and prior to its start it will be registered in ClinicalTrials.gov. 
 
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INFORMED CONSENT 
I, 
Mrs................................................. 
................................................................ 
............................................, with ID no ............................... I have been informed of the 
objectives of the “Breast4-7” research project and I have had the opportunity to make 
questions about him, for which I have obtained sufficient clarifying information. 
I know that the "Breast4-7" project is an investigation that will evaluate the effectiveness 
of an educational intervention, through the use of a web-app, to reduce the risk factors 
of breast cancer in women of the health area VII of the Principality of Asturias. 
I know that the project is developed by the Precam research team of the University of 
Oviedo/ISPA, and that the VII health area collaborates, and that I can contact them at 
any time via email precam@uniovi.es. 
I understand that the information obtained may not be used to modify in any way my 
relationship with the Principality of Asturias Health Service, and the data provided will 
only be used for the purpose of the investigation. 
I know that the data I provide to the research team of the “Breast4-7” project is 
completely confidential and anonymous. In no way will personal data be disclosed. The 
protection of the information you provide will be governed by the provisions of Organic 
Law 3/2018, of December 5, on Data Protection. 
I am aware that if I decide to withdraw from the study and revoke my consent, I may do 
so without giving any reason. In this case, my relationship with the health professionals 
will not be altered, nor will there be any harm in my clinical monitoring or treatment. 
I freely and voluntarily give my consent to participate in the "Breast4-7" project, to 
consult my medical record to complete the information necessary to achieve the 
objectives of the project and to be contacted by email at the following address.... 
................................................................ ........ 
SIGNATURE DATE 
 
 
 
 
 
 
 
Revocation of participation: 
Me, Mrs............ with DNI............ I am requesting my withdrawal from the Breast47 
Project. I request that I no longer be contacted and that my data be removed from your 
database.