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Aim: To evaluate the viability of an educational intervention for the prevention of breast cancer risk and the modification of their risk behaviors through the use of a web application in women living in the Principality of Asturias.
Design: pilot test Population: 300 women without breast cancer living in Asturias. 25 to 50 years old. Informed consent signed.
Variables: personal characteristics (age, status, educational level, occupation), MIC index, dietary characteristics, level of physical activity, presence of known risks of breast cancer (number of children, breastfeeding, oral contraceptives, family history of cancer, previous cancer, breast density and knowledge related with breast cancer prevention.
Intervention:
Aim: To evaluate the viability of an educational intervention for the prevention of breast cancer risk and the modification of their risk behaviors through the use of a web application in women living in the Principality of Asturias.
Design: pilot test Population: 300 women without breast cancer living in Asturias. 25 to 50 years old. They are recluted for a previous study developed by the same research team. An information document and a written consent was given for the women. Those who signed the consent are included.
The randomization for intervention or control group are doing based on the where the city where the women home is located. the objective of this distribution is to avoid contact between women from different groups.
Variables: personal characteristics (age, status, educational level, civil status), MIC index, dietary characteristics, level of physical activity, knowledge related with breast cancer symptoms and risk factors.
Intervention:
The 6 months intervention are going to be developed using a web-app. The intervention is based on the Behavior Change Wheel model. Capacity and motivation are going to be the determinants on which it will work using for it interventions based on education, persuasion and modeling among others.
Intervention Group: 6 months intervention using a web-app related. The web-app includes some sections:
The Control Group are not going to receive intervention during the study period time. After that, women are going to be access to the web-app.
Statistical analysis
Descriptive statistics will be carried out (means, standard deviation, CI and percentages). In addition, at the end of the study, in order to determine the factibility of the educational intervention, the variation of the intra-group data (from pre to psot-test) and between the groups in post-test will be compared using the chi-square test. , t-student or Mann-Whitney U, for qualitative or quantitative data respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precam Group (Intervention Group) | Experimental | 150 Women without breast cancer, aged from 25 to 50 years old |
|
| Control Group | No Intervention | 150 Women without breast cancer, aged from 25 to 50 years old |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precam | Behavioral | 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of an Educational Intervention: Adherence to the Intervention | Participants that finish the intervention | 6 months |
| Feasibility of an Educational Intervention: Drop Out After the Intervention Period | People that did not finish the intervention | 6 months |
| Number of Diet and Activity Recommendations | Mean number of recommendations done by the participants | 6 months |
| Breast Cancer Awareness | Using 2 dimensions of MARA questionnaire (Scale title)1) knowledge of risk factors of breast cancer (range 0=worst score to 9=better score); 2) knowledge of signs and symptoms of breast cancer (range 0=worst score to 9=better score) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruben Martin Payo, PhD | University of Oviedo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oviedo | Oviedo | Principality of Asturias | 33006 | Spain |
Anonymizes data are going to be published but we are not going to analizase individual data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Precam Group (Intervention Group) | 150 Women without breast cancer, aged from 25 to 50 years old Precam: 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention |
| FG001 | Control Group | 150 Women without breast cancer, aged from 25 to 50 years old |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Women in the Intervention group |
| BG001 | Control Group | Women in the Control group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of an Educational Intervention: Adherence to the Intervention | Participants that finish the intervention | Posted | Count of Participants | Participants | 6 months |
|
|
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Adverse Events were not monitored/assesed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Women in the Intervention group | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vicerrectorado de investigación | University of Oviedo | +34985104190 | viceinvestigacion@uniovi.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 9, 2020 | Jul 26, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Studies | Count of Participants | Participants |
|
| Civil status | Count of Participants | Participants |
|
|
|
| Primary | Feasibility of an Educational Intervention: Drop Out After the Intervention Period | People that did not finish the intervention | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Number of Diet and Activity Recommendations | Mean number of recommendations done by the participants | Posted | Mean | Standard Deviation | Number of recommendations | 6 months |
|
|
|
| Primary | Breast Cancer Awareness | Using 2 dimensions of MARA questionnaire (Scale title)1) knowledge of risk factors of breast cancer (range 0=worst score to 9=better score); 2) knowledge of signs and symptoms of breast cancer (range 0=worst score to 9=better score) | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Group | Women in the Control group | 0 | 0 | 0 | 0 | 0 | 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |