Clinical trial NCT04396665: Breast Cancer: Feasibility of an Educational Intervention
Official title: Feasibility of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through a Web Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women's Health: Neoplasm of Breast
Keywords: Breast neoplasm
Health Promotion
Dietary
Phycical activity
Breast cancer risk
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 224
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Informed consent signed
* Capability to use internet

Exclusion Criteria:

* Breast cancer diagnosis duting the intervention

Primary outcomes:
measure: Feasibility of an Educational Intervention: Adherence to the Intervention
timeFrame: 6 months
measure: Feasibility of an Educational Intervention: Drop Out After the Intervention Period
timeFrame: 6 months
measure: Number of Diet and Activity Recommendations
timeFrame: 6 months
measure: Breast Cancer Awareness
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
affiliation: University of Oviedo
name: Ruben Martin Payo, PhD
role: PRINCIPAL_INVESTIGATOR
References: