Breast Neoplasm, Primary Prevention, Risk Factors, Telemedicine
Conditions
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.
Interventions
OTHERWeb access
The intervention group will have access to the website where the information is provided. The control group will not have this access.
Sponsors
University of Oviedo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral BC Risk With an Educational Intervention for Prevention | Baseline | The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire. The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation). Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations). |
| Feasibility of an Educational Intervention for BC Risk Prevention Through the Use of a Web-App | 12 weeks (end of intervention) | PostIntervention - Feasibility will be measured with satisfaction questionnaire. Satisfaction related to the web-app used in the intervention was measured with the SUS scale in its validated version in Spanish. This is a standardized scale that allows measuring the perception of the usability and satisfaction of a system. It consists of 10 items that are scored on a Likert-type scale ranging from 1, which is totally disagree, to 5, which is totally agree. After calculating the result, we will obtain a score in a range from 0 to 100, where its average is 68. Above this figure and up to 84, it is considered good usability. Equal to or greater than 85 is considered excellent usability. This part was only evaluated in those women belonging to the intervention group and who, therefore, had been able to use the web-app. |
| Knowledge of BC Risk With an Educational Intervention for Prevention | Baseline | Knowledge of risk factors and signs of BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 9 are related to knowledge of risk factors and 9 to signs and symptoms. The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge. |
| Barriers to Prevent BC With an Educational Intervention for Prevention | Baseline | Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers). |
| BC Risk Perception With an Educational Intervention for Prevention | Baseline | Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception). |
| Breast Self-examination With an Educational Intervention for Prevention | Baseline | Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: Do you perform breast self-examination once a month? with a dichotomous yes/no response option. |
| Knowledge for BC Risk With an Educational Intervention for Prevention | 12 weeks (end of intervention) | PostIntervention - Knowledge of risk factors and signs of BC with the MARA questionnaire (4 subscales and 31 items of which 9 are related to knowledge of risk factors and 9 to signs and symptoms) The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Web access: The intervention group will have access to the website where the information is provided. | 207 |
| Control Group The control group will not have this access. | 244 |
| Total | 451 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 38.88 years STANDARD_DEVIATION 5.56 | 38.76 years STANDARD_DEVIATION 5.28 | 38.82 years STANDARD_DEVIATION 5.36 |
| Civil Status Married or in a relationship | 147 Participants | 180 Participants | 327 Participants |
| Civil Status Separated, divorced or widowed | 10 Participants | 4 Participants | 14 Participants |
| Civil Status Single | 50 Participants | 60 Participants | 110 Participants |
| Educational level High school studies | 21 Participants | 24 Participants | 45 Participants |
| Educational level Others | 62 Participants | 73 Participants | 135 Participants |
| Educational level Primary studies | 6 Participants | 2 Participants | 8 Participants |
| Educational level Secondary studies | 17 Participants | 16 Participants | 33 Participants |
| Educational level University studies | 101 Participants | 129 Participants | 230 Participants |
| Employment Employed | 171 Participants | 213 Participants | 384 Participants |
| Employment Unemployed | 36 Participants | 31 Participants | 67 Participants |
| Family history of cancer No | 55 Participants | 67 Participants | 122 Participants |
| Family history of cancer Yes | 152 Participants | 177 Participants | 329 Participants |
| History of breast cancer in the family No | 140 Participants | 158 Participants | 298 Participants |
| History of breast cancer in the family Yes | 67 Participants | 86 Participants | 153 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex/Gender, Customized Women | 207 Participants | 244 Participants | 451 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Barriers to Prevent BC With an Educational Intervention for Prevention
PostIntervention - Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).
Time frame: 12 weeks (end of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Barriers to Prevent BC With an Educational Intervention for Prevention | 29.59 units on a scale | Standard Deviation 3.68 |
| Control Group | Barriers to Prevent BC With an Educational Intervention for Prevention | 28.88 units on a scale | Standard Deviation 4.24 |
Primary
Barriers to Prevent BC With an Educational Intervention for Prevention
Barriers to prevent BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 7 items are perceived barriers to carrying out prevention strategies. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total score of perceived barriers being between 7 and 35 points (the lower the score, the fewer the perceived barriers).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Barriers to Prevent BC With an Educational Intervention for Prevention | 28.60 units on a scale | Standard Deviation 3.7 |
| Control Group | Barriers to Prevent BC With an Educational Intervention for Prevention | 28.77 units on a scale | Standard Deviation 4.03 |
Primary
BC Risk Perception With an Educational Intervention for Prevention
Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | BC Risk Perception With an Educational Intervention for Prevention | 11.34 units on a scale | Standard Deviation 2.89 |
| Control Group | BC Risk Perception With an Educational Intervention for Prevention | 11.22 units on a scale | Standard Deviation 3.04 |
Primary
Behavioral BC Risk With an Educational Intervention for Prevention
The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire. The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation). Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Behavioral BC Risk With an Educational Intervention for Prevention | 8.10 units on a scale | Standard Deviation 2.57 |
| Control Group | Behavioral BC Risk With an Educational Intervention for Prevention | 8.15 units on a scale | Standard Deviation 2.6 |
Primary
Behavioral BC Risk With an Educational Intervention for Prevention
PostIntervention - The information related to the behavioral will be evaluated with the Motiva.Diaf questionnaire. The questionnaire allows you to evaluate adherence to healthy recommendations. This includes 12 multiple choice questions related to diet (questions 1 to 7) and physical activity (questions 8 to 12). Each is expressed dichotomously (follow this recommendation/do not follow this recommendation). Finally, the quantitative variable adherence to healthy recommendations is created as a result of the score of each of the items in its dichotomous interpretation, with a range from 0 (worst adherence to healthy recommendations) to 12 (greatest adherence to healthy recommendations).
Time frame: 12 weeks (end of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Behavioral BC Risk With an Educational Intervention for Prevention | 9.21 units on a scale | Standard Deviation 2.2 |
| Control Group | Behavioral BC Risk With an Educational Intervention for Prevention | 8.40 units on a scale | Standard Deviation 2.59 |
Primary
Breast Self-examination With an Educational Intervention for Prevention
PostIntervention - Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: Do you perform breast self-examination once a month? with a dichotomous yes/no response option.
Time frame: 12 weeks (end of intervention)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Breast Self-examination With an Educational Intervention for Prevention | No breast self-examination | 18 Participants |
| Intervention Group | Breast Self-examination With an Educational Intervention for Prevention | Breast self-examination | 83 Participants |
| Control Group | Breast Self-examination With an Educational Intervention for Prevention | Breast self-examination | 122 Participants |
| Control Group | Breast Self-examination With an Educational Intervention for Prevention | No breast self-examination | 66 Participants |
Primary
Breast Self-examination With an Educational Intervention for Prevention
Carrying out self-examination through objective questioning. To find out whether self-examination was performed, a question was asked: Do you perform breast self-examination once a month? with a dichotomous yes/no response option.
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group | Breast Self-examination With an Educational Intervention for Prevention | Breast self-examination | 123 Participants |
| Intervention Group | Breast Self-examination With an Educational Intervention for Prevention | No breast self-examination | 84 Participants |
| Control Group | Breast Self-examination With an Educational Intervention for Prevention | Breast self-examination | 142 Participants |
| Control Group | Breast Self-examination With an Educational Intervention for Prevention | No breast self-examination | 102 Participants |
Primary
Feasibility of an Educational Intervention for BC Risk Prevention Through the Use of a Web-App
PostIntervention - Feasibility will be measured with satisfaction questionnaire. Satisfaction related to the web-app used in the intervention was measured with the SUS scale in its validated version in Spanish. This is a standardized scale that allows measuring the perception of the usability and satisfaction of a system. It consists of 10 items that are scored on a Likert-type scale ranging from 1, which is totally disagree, to 5, which is totally agree. After calculating the result, we will obtain a score in a range from 0 to 100, where its average is 68. Above this figure and up to 84, it is considered good usability. Equal to or greater than 85 is considered excellent usability. This part was only evaluated in those women belonging to the intervention group and who, therefore, had been able to use the web-app.
Time frame: 12 weeks (end of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Feasibility of an Educational Intervention for BC Risk Prevention Through the Use of a Web-App | 71.87 units on a scale | Standard Deviation 17.94 |
Primary
Knowledge for BC Risk With an Educational Intervention for Prevention
PostIntervention - Knowledge of risk factors and signs of BC with the MARA questionnaire (4 subscales and 31 items of which 9 are related to knowledge of risk factors and 9 to signs and symptoms) The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.
Time frame: 12 weeks (end of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Knowledge for BC Risk With an Educational Intervention for Prevention | 5.87 units on a scale | Standard Deviation 1.71 |
| Control Group | Knowledge for BC Risk With an Educational Intervention for Prevention | 5.13 units on a scale | Standard Deviation 1.97 |
Primary
Knowledge of BC Risk With an Educational Intervention for Prevention
Post Intervention - Risk perception with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 6 items relate to the perception of risk of developing breast cancer. The score is represented on a Likert-type scale with a range from 1 (totally disagree) to 5 (totally agree), with the total risk perception score being between 6 and 30 points (the lower the score, the lower the risk perception).
Time frame: 12 weeks (end of intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Knowledge of BC Risk With an Educational Intervention for Prevention | 10.19 units on a scale | Standard Deviation 3.07 |
| Control Group | Knowledge of BC Risk With an Educational Intervention for Prevention | 11.11 units on a scale | Standard Deviation 3.14 |
Primary
Knowledge of BC Risk With an Educational Intervention for Prevention
Knowledge of risk factors and signs of BC with the MARA questionnaire. This questionnaire consists of 4 subscales and a total of 31 items, of which 9 are related to knowledge of risk factors and 9 to signs and symptoms. The items related to knowledge about risk factors are aimed at both modifiable factors (4 items) and non-modifiable factors (5 items). Each success adds 1 and each failure adds 0, so the range of modifiable factors is 0 to 4 and non-modifiable factors is 0 to 5. The items on knowledge of signs and symptoms address both the specific ones (4 items) as non-specific ones (5 items). In the same way as the previous one, in this section the successes add up to 1 and the failures add up to 0. The range, therefore, of the specific ones is from 0 to 4 and of the non-specific ones is from 0 to 5. The total score range for both Risk as for signs and symptoms is between 0 and 9, with 0 being the maximum error or lack of knowledge and 9 being the maximum success or knowledge.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Knowledge of BC Risk With an Educational Intervention for Prevention | 4.61 units on a scale | Standard Deviation 2.01 |
| Control Group | Knowledge of BC Risk With an Educational Intervention for Prevention | 4.65 units on a scale | Standard Deviation 2.04 |