AzTrials
AzTrials

Health BehaviorNCT06886594

The Effect of BSE Training on Breast Cancer Knowledge Level and Health Beliefs

A study testing breast cancer education program training in people with Health Behavior and Healthy Female, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Health Behavior, Healthy Female, Education
What is being tested?
breast cancer education program training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2024to 6 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kahramanmaraş Sütçü İmam Üniversitesi

    Kahramanmaraş, 45050

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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

  • Female gender
  • Age 40 and over
  • At least primary school graduation
  • Being open to communication
  • Volunteering to participate in the study Exclusion criteria
  • Diagnosis of breast cancer
  • Receiving training on breast cancer or breast self-examination from health personnel before
  • Regular BSE application
  • Being a health personnel
  • Graduation in the field of health Data Collection Data in the study was collected using the "Personal Information Form, CHAMPION Health Belief Model Scale (CHBMS), Comprehensive Breast Cancer Knowledge Test (BCKT)".

Personal Information Form It consists of questions regarding the sociodemographic characteristics of women and family history of breast cancer. Personal Information Form consists of a total of 10 questions including age, marital status, education level, family history of breast cancer, number of births, breastfeeding status, duration of breastfeeding, and knowledge and practice of breast examination.

Comprehensive Breast Cancer Knowledge Test (BCKT) Comprehensive Breast Cancer Knowledge Test was developed by Stager (1993) in 1993.27 The validity and reliability study of the scale in Turkish was conducted by Başak (2015)28. There are a total of 20 information questions in the scale. The scale is answered as True-False. There are 8 correct and 12 incorrect statements in the questions. There are two dimensions in BCKT: general information and treatability. Questions 1-12 include general information about breast cancer, questions 13-20 include information about the treatability of breast cancer. The Cronbach alpha coefficient of the scale is 0.71.28 In this study, the Cronbach alpha coefficient of BCKT is 0.78.

Champion Health Belief Model Scale (CHBMS) The Health Belief Model, developed by Champion in 1984, consists of six dimensions and 43 items covering six concepts.

Wearable Breast Examination Simulator The Wearable Breast Model (Product code: L50) was used during BSE training so that women could wear it from the front and try to detect masses in the breast model as if it were their own tissue. The model has the features of a visible left nipple depression anomaly and a cellulite image in the left breast tissue, 2 benign tumors that can be felt with palpation examination, 4 malignant tumors, and anomalies that can be felt with palpation examination in the left armpit. This model was used because it was thought that performing breast examination on the woman's own breast would violate the woman's privacy and would not last long. It was also thought that repeated palpation applications as if it were her own breast during the training would increase the courage of women to perform regular BSE.

Research Process Procedures Procedures and Surveys Conducted to the Experimental Group

  1. Pre-test data were collected by the interviewer using the "Personal Information Form, CHBMS and BCKT" before the training for the experimental group.
  2. The training program for breast cancer was conducted by the first researcher for the experimental group, and the researcher completed her doctorate in Obstetrics, Women's Health and Diseases Nursing. 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.31 Face-to-face individual training was provided to each woman in the experimental group by the first researcher in line with the training material prepared, and their questions were answered at the end of the training.
  3. 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 using the "Wearable Breast Examination Simulator" and the steps in the "Breast Self-Examination" brochure of the "Cancer Early Diagnosis, Screening and Training Center of the Ministry of Health of the Republic of Turkey". Then, the second and third researchers had each woman wear the simulator and perform her BSE on the model. The application was completed when each woman performed the 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 had each woman in the experimental group perform the procedure on the model until she performed the procedure steps completely and correctly. The brochure was given to each woman in the experimental group both in print and electronically.
  4. A standard reminder message was sent to the experimental group in the 1st, 2nd and 3rd months to perform the BSE. Any questions the women had were answered.
  5. Three months after the completion of the Breast Cancer and BSE training program, "CHBMS and BCKT" were applied and the post-test data were collected by the interviewer.

Procedures Performed on the Control Group

  1. "Personal Information Form, CHBMS and BCKT" were applied to the control group as a pre-test and three months later as a post-test.
  2. The control group was sent a "Breast Self-Examination" informative video and brochure after completing the study
Being tested
breast cancer education program training
Keywords
Breast Canser, Self-Breast Examination, Breast cancer knowledge level, health belief
Medical subject headings
Health Behavior, Breast Self-Examination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • breast cancer education program trainingOther

    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

Study groups in NCT06886594
Study groupRoleWhat they receive
control groupNo interventionProcedures 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 groupOther1. 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.
Receives: Other: breast cancer education program training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comprehensive Breast Cancer Knowledge Test average score

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

    Measured: Baseline-T1

  2. Champion Health Belief Model Scale

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

    Measured: Baseline-T1

  3. Comprehensive Breast Cancer Knowledge Test average score

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

    Measured: 3 months after Baseline-T1

  4. Champion Health Belief Model Scale

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

    Measured: 3 months after Baseline-T1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2025
  2. Study start15 Mar 2024
  3. Primary completion20 Oct 2024
  4. Study completion6 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06886594
Sponsor's protocol ID
BSEKSU
Status last verified
Mar 2025
First submitted
19 Feb 2025
Last updated
20 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Badem A, Ister ED, Gulpak M. Effects of an Integrated Breast Self-Examination Education Program Incorporating Practice with a Wearable Breast Examination Simulator on Breast Cancer Knowledge and Health Beliefs: A Randomized Controlled Trial. Healthcare (Basel). 2026 Sep 28;14(19):3191. doi: 10.3390/healthcare14193191.

    PubMed 42881630

Questions about this trial

What is this clinical trial studying?

A study testing breast cancer education program training in people with Health Behavior and Healthy Female, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comprehensive Breast Cancer Knowledge Test average score (time frame: Baseline-T1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06886594, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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