Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04396665 |
| Other study ID # |
147/19 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2019 |
| Est. completion date |
November 9, 2020 |
Study information
| Verified date |
August 2021 |
| Source |
University of Oviedo |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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:
- Intervention Group:6 months intervention using a web-app related with personal care and
breast cancer risks, diet and physical activity.
- Control Group: no intervention.
Description:
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:
- Information related with breast cancer risk.
- Breast self examination. Written text and videos done by a nurse.
- Physical exercise. Written text and videos done by a physiotherapist .
- Dietary information. Written text and videos done by a nutrition expert.
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.
