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Clinical Trials/NCT06886594
NCT06886594CompletedNot Applicable

The Effect of Breast Self Examination Training Using Breast Examination Simulator on Breast Cancer Knowledge Level and Health Beliefs

Kahramanmaras Sutcu Imam University1 site in 1 country95 target enrollmentStarted: March 15, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
95
Locations
1
Primary Endpoint
Comprehensive Breast Cancer Knowledge Test average score

Study Overview

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.

Detailed Description

Methods Objective This study was conducted to evaluate the effect of the training given to women aged 40 and over on breast cancer and BSE using a breast examination simulator on women's breast cancer knowledge levels and health beliefs.

Type of Study This study is a randomised controlled experimental type. The research was conducted with triple blinding method.

The research data were collected by a trained interviewer independent of the researchers. The women in the experimental and control groups were not informed which group they were included in. The data were analysed by a statistician independent of the researchers.

Research Population-Sample The population of the study consisted of patients aged 40 and over who applied to the gynaecology and obstetrics outpatient clinic of XXX Health Practice and Research Hospital and who met the inclusion criteria of the study. In determining the sample size, the mean and standard deviation values (experiment: 23.97±2.40; control: 25.72±3.51) of the post-test score using Champion's Health Belief Model Scale (CHBMS), which was previously conducted in our country, were used, and the effect size (d) was calculated as 0.58.26 Based on the t test in independent groups, the sample size was calculated as 96 at 95% confidence interval and 80% power criteria. Considering that there may be losses from the study, it was decided to include 100 women in the study.

Inclusion criteria

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

triple blinding was done: riple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

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.

Intervention: breast cancer education program training (Other)

Outcomes

Primary Outcomes

Comprehensive Breast Cancer Knowledge Test average score

Time Frame: 3 months after Baseline-T1

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

Champion Health Belief Model Scale

Time Frame: 3 months after Baseline-T1

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

Comprehensive Breast Cancer Knowledge Test average score

Time Frame: Baseline-T1

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

Champion Health Belief Model Scale

Time Frame: Baseline-T1

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Kahramanmaras Sutcu Imam University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Emine Derya Ister

associate professor.Dr.

Kahramanmaras Sutcu Imam University

Study Sites (1)

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