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

NCT07348744 | Not Yet Recruiting

• 1 other identifier: KAU-BSE-RCT
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Self-Examination; Breast Cancer

Keywords

Breast Self-Examination; Breast Cancer; Health Belief Model

Outcome Measures

Primary Outcomes (1)

• Change in Breast Self-Examination Behavior

  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 Outcomes (3)

• Change in Breast Cancer Knowledge Level

  Baseline and 3 months after the intervention

• Change in Breast Cancer Awareness Level

  Baseline and 3 months after the intervention

• Change in Breast Cancer Fear Level

  Baseline and 3 months after the intervention

Study Arms (2)

Health Belief Model-Based Education Group

EXPERIMENTAL

Participants receive a structured education program based on the Health Belief Model focusing on breast self-examination.

Behavioral: Health Belief Model-Based Education Program

Control Group

NO INTERVENTION

Participants receive usual care without any additional educational intervention.

Interventions

Health Belief Model-Based Education Program BEHAVIORAL

A structured education program based on the Health Belief Model designed to improve breast self-examination behavior and increase breast cancer awareness.

Health Belief Model-Based Education Group

Eligibility Criteria

• Age: 20 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Kafkas University

Kars, Kars, 36100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Self-Examination; Breast Neoplasms

Condition Hierarchy (Ancestors)

Self-Examination; Health Behavior; Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• CANSU KARADAĞ

  Kafkas University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CANSU KARADAĞ

CONTACT

05414233218; cansukaradag@ardahan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to group allocation. Due to the nature of the educational intervention, participants and intervention providers are not blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to an intervention group receiving a Health Belief Model-based education program or to a control group receiving usual care.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)