Breast Cancer: Feasibility of an Educational Intervention

Not Applicable

Completed

• Conditions: Women's Health: Neoplasm of Breast
• Interventions: Behavioral: Precam

• Registration Number: NCT04396665
• Lead Sponsor: University of Oviedo

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.

Study Timeline

• Study Start: 2019-12-01
• Primary Completion: 2020-01-31
• Study First Submitted: 2020-03-29
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-20
• Study Completion: 2020-11-09
• Results First Submitted: 2021-05-14
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-19
• Last Update Submitted: 2021-08-19
• Results First Posted: 2021-08-20
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

Inclusion Criteria

• Informed consent signed
• Capability to use internet

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Exclusion Criteria

• Breast cancer diagnosis duting the intervention

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Precam Group (Intervention Group)	Precam	150 Women without breast cancer, aged from 25 to 50 years old

Primary Outcome Measures

Name	Time	Method
Number of Diet and Activity Recommendations	6 months	Mean number of recommendations done by the participants
Feasibility of an Educational Intervention: Adherence to the Intervention	6 months	Participants that finish the intervention
Feasibility of an Educational Intervention: Drop Out After the Intervention Period	6 months	People that did not finish the intervention
Breast Cancer Awareness	6 months	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)

Trial Locations

Locations (1)

University of Oviedo; 🇪🇸 Oviedo, Asturias, Spain