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Completed

NCT Number: NCT04396665

Breast Cancer: Feasibility of an Educational 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. 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.

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Key information

Conditions

Women's Health: Neoplasm of Breast Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent signed
  • Capability to use internet

Exclusion criteria

  • Breast cancer diagnosis duting the intervention

Treatment and study plan

Precam

Behavioral

6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention

Primary outcomes

  1. Feasibility of an Educational Intervention: Adherence to the Intervention

    Time frame: 6 months

    Participants that finish the intervention

  2. Feasibility of an Educational Intervention: Drop Out After the Intervention Period

    Time frame: 6 months

    People that did not finish the intervention

  3. Number of Diet and Activity Recommendations

    Time frame: 6 months

    Mean number of recommendations done by the participants

  4. Breast Cancer Awareness

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Oviedo

Other

Registry information

Official study title

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

Acronym: PRECAM-2

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 20, 2020
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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