Breast Self-ExaminationNCT05960643
The Effect of Education Given According to the Health Belief Model on Breast Examination Skills
A study testing Training and application in breast modeling in people with Breast Self-Examination, run by Zahide Akeren at 1 site in Turkey (Türkiye).
Trial summary
The randomized controlled study to examine the effects of the educational interventions on BSE by revealing the breast self-examination (BSE) practices and breast health beliefs of female students studying at the university were completed with 101 students, 51 of whom were in the "experimental" and 50 "control"… Read more about this study
- Who is it for?
- Ages 17 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Self-Examination
- What is being tested?
- Training and application in breast modeling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Oct 2022to 2 Jan 2023
- 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 17 to 30 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The criteria for inclusion in the study are that female students studying at a university in the Eastern Black Sea region of Turkey continue their education and have their contact addresses, have not received BSE training according to the Health Belief Model, have not been diagnosed with breast cancer, and agree to participate in the research.
Who cannot join
- Students were excluded from the study if they did not want to continue the research at any stage of the study and were diagnosed with breast cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Belief Model on Breast Examination Skills
The randomized controlled study to examine the effects of the educational interventions on BSE by revealing the breast self-examination (BSE) practices and breast health beliefs of female students studying at the university were completed with 101 students, 51 of whom were in the "experimental" and 50 "control" groups. The data were collected between November and December 2022 at a university in the Eastern Black Sea region of Turkey, using the 'Personal Information Form', 'BSE Practice Skill Assessment Form' and the 'Health Belief Model Scale' as a pre-test. As an initiative, 'BSE training given according to the Health Belief Model', which includes 120 minutes of training, including theoretical and model-based BSE practice, was implemented. Then, 3 weeks later, the 'BSE Application Skill Evaluation Form' was applied as a post-test. Data were analyzed using Indepent Sample and Paired Sample t-test, Benferroni test, Pearson correlation analysis.
Read the detailed description
Materials and Methods Type of Research The research was carried out in a randomized controlled manner in order to reveal the breast self-examination (BSE) practices and breast health beliefs of female university students and to examine the effects of educational interventions on BSE.
Place and Time of Research The data of the research were collected at a university located in the Eastern Black Sea region of Turkey between December 2022 and January 2023.
Population and Sample of the Research The universe of the research consisted of female students studying at a university located in the Eastern Black Sea region of Turkey. The number of samples was calculated in the G*Power 3.1.9.7 program so that the error amount was α=0.05, the power of the test was 0.80 (80%) and the effect size was 0.60. As a result of the statistical analysis, it was found that a total of 90 students, 45 in the experimental group and 45 in the control group, should be included in the study. Considering that if the sample size increases, the standard error will decrease and the working power will increase, each group was increased by 22% (10 people) and a total of 110 students, 55 students for each group, were included in the study. The 'simple and stratified sampling' method was used as the randomization method. Simple and stratified randomization method was used in the planning of the research sample. Experimental and control groups within the scope of the study were determined by simple randomization method (coin-toss). In the first stage, the sample consisted of 148 students who agreed to participate in the study. In the second phase of the study, the sample consisted of 110 female students (55 experimental, 55 control) who were selected by simple and stratified randomization method and who had not received BSE training and breast cancer diagnosis according to the Health Belief Model.
Data Collection Tools The data were collected using the 'Personal Information Form' and the 'Health Belief Model Scale', and the 'BSE Practice Skills Evaluation Form' for the students in the experimental group. As an initiative, 'BSE training given according to the Health Belief Model' was carried out.
Personal Information Form This form was created by researchers by scanning the literature. There are 5 questions in the form: age, class, marital status, age at first menstruation, presence of breast cancer diagnosis in the family.
BSE Practice Skill Evaluation Form This form, which was created by the researchers by scanning the literature as a guide to the application made by the students on the wearable breast model, was evaluated over 100 points. The form included 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. The high score was interpreted as having high skills.
Health Belief Model Scale (HBMS) This scale was first developed by Champion in 1984 based on the Health Belief Model. The scale has 8 dimensions: sensitivity, caring, health motivation, BSE barriers, benefits, self-efficacy, mammography benefits and barriers.
Breast Self Examination Training The training included 120 minutes of training on normal breast, breast cancer risk factors, symptoms, etiology, treatment, the role of healthy lifestyles in preventing breast cancer, screening and early diagnosis methods, BSE methods and BSE on a model.
Data Collection Method Experimental Group Data Collection Method This group consisted of 51 female students studying at a university located in the Eastern Black Sea region of Turkey. First of all, students were reached from their electronically registered contact information. On the day of the start of the training, the 'Personal Information Form' and the 'Health Belief Model Scale' as a pre-test were administered to the students by face-to-face interview method by the researchers. Afterwards, the students were given BSE training consisting of two 120-minute sessions. In the first session of the training, theoretical trainings on breast cancer and BSE were given for 30 minutes. In the second session, BSE application was shown on the wearable breast model and each student practiced on the model. The application was evaluated using the 'BSE Application Skill Evaluation Form'. At the end of the "Health Belief Model Scale" application, face-to-face and 3 weeks later, online applications were filled as a post-test.
Control Group Data Collection Method This group consisted of 50 female students studying at a university located in the Eastern Black Sea region of Turkey. First of all, students were reached from their electronically registered contact information. The 'Personal Information Form' and the 'Health Belief Model Scale' as a pre-test were filled in by online applications by the researchers. The individuals in this group did not receive any intervention. As a post-test, the Health Belief Model Scale was filled in online applications 3 weeks later as a post-test.
- Conditions
- Breast Self-Examination
- Being tested
- Training and application in breast modeling, Control
- Keywords
- breast examination, Health Belief Model, skill
- Medical subject headings
- Breast Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and application in breast modelingOther
Also called Experimental: Breast self-examination group
BSE application skill evaluation form will be evaluated out of 100 points. The form includes 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. A high score is interpreted as a high level of skills.
ControlOther
No intervention will be made against people in this group.
| Study group | Role | What they receive |
|---|---|---|
| Breast self-examination group | Experimental | This group was planned to consist of 51 female students studying at the university. First of all, students will be contacted through their electronically registered contact information. In the pre-test, the researchers will apply the 'Personal Information Form' and the 'Health Belief Model Scale' to the students with the self-report method. Afterwards, students will be given BSE training consisting of two 120-minute sessions. In the first session of the training, theoretical trainings about breast cancer and BSE will be given for 30 minutes. In the second session, BSE application will be shown on the wearable breast model and each student will practice on the model. The practice skills of the participants will be evaluated by the researchers using the 'BSE Practice Skill Evaluation Form'. At the end of the 'Health Belief Model Scale' application, face-to-face and 3 weeks later, online applications will be filled as a post-test. Receives: Other: Training and application in breast modeling |
| Control group | Active comparator | No intervention will be made against people in this group. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Self Examination Practice Skill Assessment
The form was created by the researchers by scanning the literature as a guide to the application made by the students on the wearable breast model. The form will be evaluated out of 100 points. The form includes 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. A high score is interpreted as a high level of skills.
Measured: Three weeks
Secondary outcomes (1)
Health Belief Model Scale
The scale does not have a grand total score. Each dimension uses its own total score. Sensitivity, caring, health motivation, BSE benefits, BSE barriers and BSE self-efficac were used. The scale is 5-point Likert type. A score closer to 5 means that sensitivity, caring, health motivation, BSE benefits, BSE barriers and BSE self-efficacy are perceived to be high.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start21 Oct 2022
- Primary completion12 Dec 2022
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Self-ExaminationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample size of the study was calculated in the G\*Power 3.1.9.7 program such that the error amount was α=0.05, the power of the test was 0.80 (80%) and the effect size was 0.60. As a result of the statistical analysis, it was found that a total of 90 students, 45 in the experimental group and 45 in the control group, should be included in the study. Considering that if the sample size increases, the standard error will decrease and the working power will increase, each group was increased by 22% (10 people) and it was planned to include 110 students in the study, 55 students for each group. In the first stage, the sample consisted of 148 students who agreed to participate in the study. In the second phase of the study, the sample was planned to consist of 110 female students selected by simple and stratified randomization method (55 experimental, 55 control).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahide Akeren
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zahide Akeren, Bayburt University
- Investigators
- Bayburt University, Study chair, Bayburt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960643
- Sponsor's protocol ID
- BREAST EXAMINATION SKILLS
- Other IDs
- Bayburt University
- Status last verified
- Jul 2023
- First submitted
- 15 Jun 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Belief Model on Breast Examination Skills
- ClinicalTrials.gov ID
- NCT05960643
- Acronym / sponsor ID
- BREAST EXAMINATION SKILLS
- Conditions
- Breast Self-Examination
- Keywords
- breast examination, Health Belief Model, skill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Zahide AkerenUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The randomized controlled study to examine the effects of the educational interventions on BSE by revealing the breast self-examination (BSE) practices and breast health beliefs of female students studying at the university were completed with 101 students, 51 of whom were in the "experimental" and 50 "control" groups. The data were collected between November and December 2022 at a university in the Eastern Black Sea region of Turkey, using the 'Personal Information Form', 'BSE Practice Skill Assessment Form' and the 'Health Belief Model Scale' as a pre-test. As an initiative, 'BSE training given according to the Health Belief Model', which includes 120 minutes of training, including theoretical and model-based BSE practice, was implemented. Then, 3 weeks later, the 'BSE Application Skill Evaluation Form' was applied as a post-test. Data were analyzed using Indepent Sample and Paired Sample t-test, Benferroni test, Pearson correlation analysis.
Detailed description
Materials and Methods Type of Research The research was carried out in a randomized controlled manner in order to reveal the breast self-examination (BSE) practices and breast health beliefs of female university students and to examine the effects of educational interventions on BSE.
Place and Time of Research The data of the research were collected at a university located in the Eastern Black Sea region of Turkey between December 2022 and January 2023.
Population and Sample of the Research The universe of the research consisted of female students studying at a university located in the Eastern Black Sea region of Turkey. The number of samples was calculated in the G*Power 3.1.9.7 program so that the error amount was α=0.05, the power of the test was 0.80 (80%) and the effect size was 0.60. As a result of the statistical analysis, it was found that a total of 90 students, 45 in the experimental group and 45 in the control group, should be included in the study. Considering that if the sample size increases, the standard error will decrease and the working power will increase, each group was increased by 22% (10 people) and a total of 110 students, 55 students for each group, were included in the study. The 'simple and stratified sampling' method was used as the randomization method. Simple and stratified randomization method was used in the planning of the research sample. Experimental and control groups within the scope of the study were determined by simple randomization method (coin-toss). In the first stage, the sample consisted of 148 students who agreed to participate in the study. In the second phase of the study, the sample consisted of 110 female students (55 experimental, 55 control) who were selected by simple and stratified randomization method and who had not received BSE training and breast cancer diagnosis according to the Health Belief Model.
Data Collection Tools The data were collected using the 'Personal Information Form' and the 'Health Belief Model Scale', and the 'BSE Practice Skills Evaluation Form' for the students in the experimental group. As an initiative, 'BSE training given according to the Health Belief Model' was carried out.
Personal Information Form This form was created by researchers by scanning the literature. There are 5 questions in the form: age, class, marital status, age at first menstruation, presence of breast cancer diagnosis in the family.
BSE Practice Skill Evaluation Form This form, which was created by the researchers by scanning the literature as a guide to the application made by the students on the wearable breast model, was evaluated over 100 points. The form included 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. The high score was interpreted as having high skills.
Health Belief Model Scale (HBMS) This scale was first developed by Champion in 1984 based on the Health Belief Model. The scale has 8 dimensions: sensitivity, caring, health motivation, BSE barriers, benefits, self-efficacy, mammography benefits and barriers.
Breast Self Examination Training The training included 120 minutes of training on normal breast, breast cancer risk factors, symptoms, etiology, treatment, the role of healthy lifestyles in preventing breast cancer, screening and early diagnosis methods, BSE methods and BSE on a model.
Data Collection Method Experimental Group Data Collection Method This group consisted of 51 female students studying at a university located in the Eastern Black Sea region of Turkey. First of all, students were reached from their electronically registered contact information. On the day of the start of the training, the 'Personal Information Form' and the 'Health Belief Model Scale' as a pre-test were administered to the students by face-to-face interview method by the researchers. Afterwards, the students were given BSE training consisting of two 120-minute sessions. In the first session of the training, theoretical trainings on breast cancer and BSE were given for 30 minutes. In the second session, BSE application was shown on the wearable breast model and each student practiced on the model. The application was evaluated using the 'BSE Application Skill Evaluation Form'. At the end of the "Health Belief Model Scale" application, face-to-face and 3 weeks later, online applications were filled as a post-test.
Control Group Data Collection Method This group consisted of 50 female students studying at a university located in the Eastern Black Sea region of Turkey. First of all, students were reached from their electronically registered contact information. The 'Personal Information Form' and the 'Health Belief Model Scale' as a pre-test were filled in by online applications by the researchers. The individuals in this group did not receive any intervention. As a post-test, the Health Belief Model Scale was filled in online applications 3 weeks later as a post-test.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The sample size of the study was calculated in the G*Power 3.1.9.7 program such that the error amount was α=0.05, the power of the test was 0.80 (80%) and the effect size was 0.60. As a result of the statistical analysis, it was found that a total of 90 students, 45 in the experimental group and 45 in the control group, should be included in the study. Considering that if the sample size increases, the standard error will decrease and the working power will increase, each group was increased by 22% (10 people) and it was planned to include 110 students in the study, 55 students for each group. In the first stage, the sample consisted of 148 students who agreed to participate in the study. In the second phase of the study, the sample was planned to consist of 110 female students selected by simple and stratified randomization method (55 experimental, 55 control).
| Arm | Type | Receives |
|---|---|---|
| Breast self-examination group | Experimental | Other: Training and application in breast modelingThis group was planned to consist of 51 female students studying at the university. First of all, students will be contacted through their electronically registered contact information. In the pre-test, the researchers will apply the 'Personal Information Form' and the 'Health Belief Model Scale' to the students with the self-report method. Afterwards, students will be given BSE training consisting of two 120-minute sessions. In the first session of the training, theoretical trainings about breast cancer and BSE will be given for 30 minutes. In the second session, BSE application will be shown on the wearable breast model and each student will practice on the model. The practice skills of the participants will be evaluated by the researchers using the 'BSE Practice Skill Evaluation Form'. At the end of the 'Health Belief Model Scale' application, face-to-face and 3 weeks later, online applications will be filled as a post-test. |
| Control group | Active comparator | Other: ControlNo intervention will be made against people in this group. |
Who may qualify
- Ages
- 17 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The criteria for inclusion in the study are that female students studying at a university in the Eastern Black Sea region of Turkey continue their education and have their contact addresses, have not received BSE training according to the Health Belief Model, have not been diagnosed with breast cancer, and agree to participate in the research.
Key exclusion criteria (1 listed)
- Students were excluded from the study if they did not want to continue the research at any stage of the study and were diagnosed with breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training and application in breast modelingAlso: Experimental: Breast self-examination groupBSE application skill evaluation form will be evaluated out of 100 points. The form includes 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. A high score is interpreted as a high level of skills. | Other | Breast self-examination group |
| ControlNo intervention will be made against people in this group. | Other | Control group |
Primary outcome
Breast Self Examination Practice Skill Assessment
Time frame: Three weeks
The form was created by the researchers by scanning the literature as a guide to the application made by the students on the wearable breast model. The form will be evaluated out of 100 points. The form includes 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. A high score is interpreted as a high level of skills.
1 secondary outcome
Health Belief Model Scale
Time frame: Three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- PubmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayburt University study chair
Bayburt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training and application in breast modeling in people with Breast Self-Examination, run by Zahide Akeren 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 1 inclusion and 1 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 27 Jul 2023. 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?
Breast Self Examination Practice Skill Assessment (time frame: Three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.