- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06886594
The Effect of BSE Training on Breast Cancer Knowledge Level and Health Beliefs
The Effect of Breast Self Examination Training Using Breast Examination Simulator on Breast Cancer Knowledge Level and Health Beliefs
Study Overview
Status
Conditions
Intervention / Treatment
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
- Pre-test data were collected by the interviewer using the "Personal Information Form, CHBMS and BCKT" before the training for the experimental group.
- 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.
- 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.
- 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.
- 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
- "Personal Information Form, CHBMS and BCKT" were applied to the control group as a pre-test and three months later as a post-test.
- The control group was sent a "Breast Self-Examination" informative video and brochure after completing the study
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Kahramanmaraş, Turkey, 45050
- Kahramanmaraş Sütçü İmam Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
Procedures Applied to the Control Group
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|
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Other: Experimental group
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.
|
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Comprehensive Breast Cancer Knowledge Test average score
Time Frame: Baseline-T1
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Scores of women in the experimental and control groups on the Comprehensive Breast Cancer Knowledge Test
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Baseline-T1
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Champion Health Belief Model Scale
Time Frame: Baseline-T1
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Champion Health Belief Model Scale mean scores of women in the experimental and control groups
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Baseline-T1
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Comprehensive Breast Cancer Knowledge Test average score
Time Frame: 3 months after Baseline-T1
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Scores of women in the experimental and control groups on the Comprehensive Breast Cancer Knowledge Test
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3 months after Baseline-T1
|
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Champion Health Belief Model Scale
Time Frame: 3 months after Baseline-T1
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Champion Health Belief Model Scale mean scores of women in the experimental and control groups
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3 months after Baseline-T1
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSEKSU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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