The Effect of a Health Belief Model-Based Education Program on Breast Self-Examination Practice Behavior, Breast Cancer Fear, and Awareness Levels in Women: A Randomized Controlled Trial (KAU-BSE-RCT)

January 9, 2026 updated by: Cansu Karadağ, Kafkas University
The study titled "The Effect of a Health Belief Model-Based Training Program on Women's Self-Breast Examination Behavior, Breast Cancer Fear and Awareness Levels: A Randomized Controlled Study" aimed to increase breast cancer awareness and the application of breast self-examination techniques among women by providing the necessary training through a training program based on the Health Belief Model.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled study aims to evaluate the effectiveness of a Health Belief Model-based education program on women's breast self-examination practices, breast cancer fear, and awareness levels. Participants will be randomly assigned to either an intervention group receiving a structured education program based on the Health Belief Model or a control group receiving usual care.

Data will be collected using a Personal Information Form, the Champion Health Belief Model Scale, the Comprehensive Breast Cancer Knowledge Test, the Breast Cancer Awareness Scale, and the Champion Breast Cancer Fear Scale at baseline and three months after the intervention. The findings of this study are expected to contribute to the development of effective educational strategies for improving breast cancer awareness and preventive health behaviors among women.

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being affiliated with Family Health Center No. 1 in Ardahan Province,
  • Being a woman between the ages of 20 and 69,
  • Being literate,
  • Not having been diagnosed with breast cancer,
  • Not having a mental or communication disorder,
  • Having a phone available for communication,
  • Women who voluntarily agree to participate in the study.

Exclusion Criteria:

  • Difficulty communicating,
  • Wanting to drop out of the study,
  • Not wanting to participate in the study.
  • Women who did not fill out the data form despite reminders via message and phone call.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Health Belief Model-Based Education Group
Participants receive a structured education program based on the Health Belief Model focusing on breast self-examination.
Behavioral: Health Belief Model-Based Education Program
A structured education program based on the Health Belief Model designed to improve breast self-examination behavior and increase breast cancer awareness.
No Intervention: Control Group
Participants receive usual care without any additional educational intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Breast Self-Examination Behavior
Time Frame: Baseline and 3 months after the intervention
Change in breast self-examination behavior measured as a single self-reported outcome indicating whether participants perform breast self-examination.
Baseline and 3 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Breast Cancer Knowledge Level
Time Frame: Baseline and 3 months after the intervention
Change in breast cancer knowledge assessed using the Comprehensive Breast Cancer Knowledge Test.
Baseline and 3 months after the intervention
Change in Breast Cancer Awareness Level
Time Frame: Baseline and 3 months after the intervention
Change in breast cancer awareness measured using the Breast Cancer Awareness Scale.
Baseline and 3 months after the intervention
Change in Breast Cancer Fear Level
Time Frame: Baseline and 3 months after the intervention
Change in fear related to breast cancer measured using the Champion Breast Cancer Fear Scale.
Baseline and 3 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafkas University

Investigators

  • Principal Investigator: CANSU KARADAĞ, Kafkas Üniversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAU-BSE-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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