Breast Cancer: Feasibility of an Educational Intervention (PRECAM-2)

Feasibility of an Educational Intervention for the Prevention of Breast Cancer by Modifying Risk Behaviors Through a Web Application

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.

Study Overview

• Status: Completed
• Conditions: Women's Health: Neoplasm of Breast
• Intervention / Treatment: Behavioral: Precam

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 Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Asturias
    • Oviedo, Asturias, Spain, 33006
      • University of Oviedo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Informed consent signed
• Capability to use internet

Exclusion Criteria:

• Breast cancer diagnosis duting the intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Precam Group (Intervention Group); 150 Women without breast cancer, aged from 25 to 50 years old	Behavioral: Precam; 6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention
NO_INTERVENTION: Control Group; 150 Women without breast cancer, aged from 25 to 50 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Oviedo
• Investigators: Principal Investigator: Ruben Martin Payo, PhD, University of Oviedo

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ACTUAL): November 9, 2020

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (ACTUAL): May 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2021
• Last Update Submitted That Met QC Criteria: August 19, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Health Promotion; Breast neoplasm; Dietary; Breast cancer risk; Phycical activity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 147/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymizes data are going to be published but we are not going to analizase individual data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No