Breast Cancer: Feasibility of an Educational Intervention

NCT04396665 | Completed Results

• 1 other identifier: 147/19
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Women's Health: Neoplasm of Breast

Keywords

Breast neoplasm; Health Promotion; Dietary; Phycical activity; Breast cancer risk

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Precam Group (Intervention Group)

EXPERIMENTAL

150 Women without breast cancer, aged from 25 to 50 years old

Behavioral: Precam

Control Group

NO INTERVENTION

150 Women without breast cancer, aged from 25 to 50 years old

Interventions

Precam BEHAVIORAL

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

Precam Group (Intervention Group)

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent signed
• Capability to use internet

You may not qualify if:

• Breast cancer diagnosis duting the intervention

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Vicerrectorado de investigación
• Organization: University of Oviedo

viceinvestigacion@uniovi.es

+34985104190

Study Officials

• Ruben Martin Payo, PhD

  University of Oviedo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: May 20, 2020
• Study Start: December 1, 2019
• Primary Completion: January 31, 2020
• Study Completion: November 9, 2020
• Last Updated: August 20, 2021
• Results First Posted: August 20, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)