NCT06886594

Brief Summary

This study was conducted to evaluate the effects of breast cancer and BSE education given to women aged 40 and over using a breast examination simulator on women's breast cancer knowledge levels and health beliefs. Data were collected in the study using the "Personal Information Form, CHAMPION Health Belief Model Scale, Comprehensive Breast Cancer Knowledge Test". A breast cancer education program was applied to the women in the experimental group. The content of the education given to the experimental group was prepared in accordance with the "Breast Cancer Prevention, Screening, Diagnosis, Treatment and Follow-up Clinical Guide 2020 (Version 1.0)" of the Ministry of Health of the Republic of Turkey. After the completion of the theoretical education, each woman in the experimental group was given BSE practical training using the "Wearable Breast Examination Simulator" by the first researcher in accordance with the steps in the "Breast Self-Examination" brochure by the "Cancer Early Diagnosis, Screening and Education Center of the Ministry of Health of the Republic of Turkey". Then, each woman was provided with the simulator to wear and perform BSE on a model. The application was completed when each woman was able to perform BSE correctly. The success indicator of the practical training was that the woman performed the BSE steps correctly as shown in the brochure and detected at least three tumors in the simulator. The second and third researchers performed the application on the model until each woman in the experimental group performed the procedure steps completely and correctly. The brochure was given to each woman in the experimental group both in print and electronically. A standard reminder message was sent to the experimental group in the 1st, 2nd and 3rd months to perform BSE. Pre-test and post-test data were collected from the control group. No individual in the experimental or control groups was harmed in this study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

February 19, 2025

Last Update Submit

March 13, 2025

Conditions

Keywords

Breast CanserSelf-Breast ExaminationBreast cancer knowledge levelhealth belief

Outcome Measures

Primary Outcomes (4)

  • Comprehensive Breast Cancer Knowledge Test average score

    Scores of women in the experimental and control groups on the Comprehensive Breast Cancer Knowledge Test

    Baseline-T1

  • Champion Health Belief Model Scale

    Champion Health Belief Model Scale mean scores of women in the experimental and control groups

    Baseline-T1

  • Comprehensive Breast Cancer Knowledge Test average score

    Scores of women in the experimental and control groups on the Comprehensive Breast Cancer Knowledge Test

    3 months after Baseline-T1

  • Champion Health Belief Model Scale

    Champion Health Belief Model Scale mean scores of women in the experimental and control groups

    3 months after Baseline-T1

Study Arms (2)

control group

NO INTERVENTION

Procedures Applied to the Control Group 1. The "Personal Information Form, CHAMPION Health Belief Model Scale, Comprehensive Breast Cancer Knowledge Test" was applied to the control group as a pre-test and three months later as a post-test. 2. The "Breast Self-Examination" was given to the control group after completing the study.

Experimental group

OTHER

1\. Pre-test data were collected by the interviewer using the "Personal Information Form, CHAMPION Health Belief Model Scale, Comprehensive Breast Cancer Knowledge Test" before the training for the experimental group. 2. The breast cancer education program for the experimental group was conducted by the first researcher, and the researcher completed her doctorate in Obstetrics, Women's Health and Diseases Nursing. The content of the education given to the experimental group was prepared in accordance with the Ministry of Health of the Republic of Turkey "Breast Cancer Prevention, Screening, Diagnosis, Treatment and Follow-up Clinical Guide 2020 (Version 1.0)". Each woman in the experimental group was given face-to-face individual education in line with the prepared training material by the first researcher, and their questions were answered at the end of the training.

Other: breast cancer education program training

Interventions

The first researcher conducted the breast cancer education program for the experimental group, and the researcher completed her doctorate in Obstetrics, Gynecology and Diseases Nursing. The content of the education given to the experimental group was prepared in accordance with the "Breast Cancer Prevention, Screening, Diagnosis, Treatment and Follow-up Clinical Guide 2020 (Version 1.0)" of the Ministry of Health of the Republic of Turkey. Each woman in the experimental group was given face-to-face individual education in accordance with the education material prepared by the first researcher, and their questions were answered at the end of the education. After the theoretical education was completed, each woman in the experimental group was given BSE practical education using the "Wearable Breast Examination Simulator" by the first researcher using the demonstration method in accordance with the steps in the "Breast Self-Examination" brochure by the "Cancer Early Diagnosis, Screening

Experimental group

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsin terms of breast cancer
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female gender
  • Being 40 years old and above
  • Being at least a primary school graduate
  • Being open to communication
  • Being willing to participate in the study

You may not qualify if:

  • Having a breast cancer diagnosis
  • Having received training from a health care professional on breast cancer or breast self-examination
  • Regular BSE practice
  • Being a health care professional
  • Having a graduation in the health field

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam Üniversitesi

Kahramanmaraş, 45050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health BehaviorBreast Self-Examination

Condition Hierarchy (Ancestors)

BehaviorSelf-Examination

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
triple blinding was done: riple (Participant, Investigator, Outcomes Assessor)
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The content of the training given to the experimental group was prepared in accordance with the "Breast Cancer Prevention, Screening, Diagnosis, Treatment and Follow-up Clinical Guide 2020 (Version 1.0)" of the Ministry of Health of the Republic of Turkey. After the completion of the theoretical training, each woman in the experimental group was given BSE practical training using the demonstration method by the first researcher in line with the steps in the "Breast Self-Examination" brochure prepared by the "Cancer Early Diagnosis, Screening and Training Center of the Ministry of Health of the Republic of Turkey" using the "Wearable Breast Examination Simulator". Then, each woman was provided with the simulator to wear and perform BSE on the model. The application was completed when each woman was provided with BSE correctly. The success indicator of the practical training is that the woman performed the BSE steps correctly as shown in the brochure and detected at least three tumors in
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor.Dr.

Study Record Dates

First Submitted

February 19, 2025

First Posted

March 20, 2025

Study Start

March 15, 2024

Primary Completion

October 20, 2024

Study Completion

March 6, 2025

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Study Protocol Access

Locations