Breast Cancer Awareness TrainingNCT06528808
Simple Simulation Based Breast Cancer Awareness Training
A study testing Simple reality simulator application in people with Breast Cancer Awareness Training, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
It was planned to determine the effect of simple simulation-based breast cancer awareness training on women's breast cancer knowledge and fear levels. The research population will consist of female service personnel working in institutions within the University of Health Sciences (SBÜ) (N: 670). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Awareness Training
- What is being tested?
- Simple reality simulator application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 30 Oct 2024
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the research.
- To work as female service personnel in institutions within the University of Health Sciences.
Who cannot join
- Not participating in all applications of simulation teaching.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simple Simulation-Based Breast Cancer Awareness Training on Women's Breast Cancer Knowledge and Fear Levels
It was planned to determine the effect of simple simulation-based breast cancer awareness training on women's breast cancer knowledge and fear levels. The research population will consist of female service personnel working in institutions within the University of Health Sciences (SBÜ) (N: 670). In order to determine the sample size in this research, which was planned as a quasi-experimental with a pre- and post-test design and a control group; The data showed a normal distribution, the standard deviation of the population was estimated to be 1, and the effect size (difference) was estimated to be 0.8. It was calculated that if two independent n₁=40, n₂=40 samples were taken for the analysis to be carried out, at a 5% significance level, the maximum power value of the research would be 0.942182. Both groups will be given theoretical training about breast cancer awareness, and women in the intervention group will practice breast cancer awareness with a simple valid simulator. All groups will be informed before the applications. The training content will be supported by distributing a 5-page training booklet created from breast health and cancer awareness content to the participants. "Comprehensive Breast Cancer Knowledge Test", "Breast Cancer Fear Scale" and "Breast Cancer Awareness Scale" will be applied as a pre-test after the information.
- Conditions
- Breast Cancer Awareness Training
- Being tested
- Simple reality simulator application
- Keywords
- Simulation Based, Breast Cancer Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple reality simulator applicationOther
Women in the intervention group will be given an application aimed at breast cancer awareness with a simple valid simulator.
| Study group | Role | What they receive |
|---|---|---|
| İntervention group (n:40) | Experimental | Women in the intervention group will undergo a simulator breast cancer awareness application in simple reality. Receives: Other: Simple reality simulator application |
| Control group (n:40) | No intervention | Control group women will receive 2 hours of theoretical training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
In this form, created by the researchers based on the literature, participants' age, obstetric history (number of pregnancies, number of births, breastfeeding status, etc.), self-breast examination status, etc. questions are included.
Measured: 10 minutes
Comprehensive Breast Cancer Knowledge Test
The scale, developed by Stager in 1993, consists of 20 knowledge questions. The Turkish adaptation of the scale was carried out by Başak and Tosun in 2015. The scale is answered in a true-false manner, and there are 8 correct and 12 incorrect answers among the questions. After the test application is carried out; According to the answer key of the scale, "correct" answers are given 1; "Incorrect" and blank answers were given 0 points. GKMKBT includes two dimensions: general knowledge and treatability. Questions from 1 to 12; general knowledge about breast cancer; Questions 13 to 20 contain information about the treatability of breast cancer. The reliability of the scale was found to be 0.71.
Measured: 10 minutes
Breast Cancer Fear Scale
It was developed by Champion in 2004 to examine women's breast cancer fears by determining their emotional responses to breast cancer and screening. The Turkish validity and reliability study of the scale was conducted by Seçginli in 2012. The scale contains eight items and is scored on a 5-point Likert type. According to this scoring, the lowest possible score is 8 and the highest score is 40. A higher score from the scale indicates a higher level of breast cancer fear. On scale; Scoring between 8 and 15 indicates a low level of fear of breast cancer, scoring between 16 and 23 indicates a moderate level of fear of breast cancer, and scoring between 24 and 40 indicates a high level of fear of breast cancer. Cronbach's Alpha value of the scale was found to be 0.90.
Measured: 10 minutes
Breast Cancer Awareness Scale
The scale was developed in 2010 by the UK cancer research center, "King's College London" and "University College London" to determine breast cancer awareness. In our country, the Turkish validity and reliability study of the scale was conducted by Baş and Ursavaş (2022). The scale consists of a total of 13 items to determine breast cancer awareness, including symptoms (11 items), frequency of breast examination (1 item) and breast cancer age (1 item). The scale has no cut-off point. Answering 5 of the symptoms correctly is coded as 1 point, a 70-year-old woman is coded as 1 point, and breast examination once a month is coded as 1. Incorrect answers are worth 0 points. Scoring is between 0-3. Cronbach's alpha value of the scale was found to be 0.89. As the score obtained from the scale increases, breast cancer awareness increases.
Measured: 10 minutes
Secondary outcomes (3)
Comprehensive Breast Cancer Knowledge Test
The scale, developed by Stager in 1993, consists of 20 knowledge questions. The Turkish adaptation of the scale was carried out by Başak and Tosun in 2015. The scale is answered in a true-false manner, and there are 8 correct and 12 incorrect answers among the questions. After the test application is carried out; According to the answer key of the scale, "correct" answers are given 1; "Incorrect" and blank answers were given 0 points. GKMKBT includes two dimensions: general knowledge and treatability. Questions from 1 to 12; general knowledge about breast cancer; Questions 13 to 20 contain information about the treatability of breast cancer. The reliability of the scale was found to be 0.71.
Measured: 10 minutes
Breast Cancer Fear Scale
It was developed by Champion in 2004 to examine women's breast cancer fears by determining their emotional responses to breast cancer and screening. The Turkish validity and reliability study of the scale was conducted by Seçginli in 2012. The scale contains eight items and is scored on a 5-point Likert type. According to this scoring, the lowest possible score is 8 and the highest score is 40. A higher score from the scale indicates a higher level of breast cancer fear. On scale; Scoring between 8 and 15 indicates a low level of fear of breast cancer, scoring between 16 and 23 indicates a moderate level of fear of breast cancer, and scoring between 24 and 40 indicates a high level of fear of breast cancer. Cronbach's Alpha value of the scale was found to be 0.90.
Measured: 10 minutes
Breast Cancer Awareness Scale
The scale was developed in 2010 by the UK cancer research center, "King's College London" and "University College London" to determine breast cancer awareness. In our country, the Turkish validity and reliability study of the scale was conducted by Baş and Ursavaş (2022). The scale consists of a total of 13 items to determine breast cancer awareness, including symptoms (11 items), frequency of breast examination (1 item) and breast cancer age (1 item). The scale has no cut-off point. Answering 5 of the symptoms correctly is coded as 1 point, a 70-year-old woman is coded as 1 point, and breast examination once a month is coded as 1. Incorrect answers are worth 0 points. Scoring is between 0-3. Cronbach's alpha value of the scale was found to be 0.89. As the score obtained from the scale increases, breast cancer awareness increases.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Awareness TrainingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528808
- Sponsor's protocol ID
- SBÜ-AYDINKARTAL-007
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 30 Jul 2024
- 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 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simple Simulation-Based Breast Cancer Awareness Training on Women's Breast Cancer Knowledge and Fear Levels
- ClinicalTrials.gov ID
- NCT06528808
- Acronym / sponsor ID
- SBÜ-AYDINKARTAL-007
- Conditions
- Breast Cancer Awareness Training
- Keywords
- Simulation Based, Breast Cancer Awareness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 30 Jul 2024 (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.
It was planned to determine the effect of simple simulation-based breast cancer awareness training on women's breast cancer knowledge and fear levels. The research population will consist of female service personnel working in institutions within the University of Health Sciences (SBÜ) (N: 670). In order to determine the sample size in this research, which was planned as a quasi-experimental with a pre- and post-test design and a control group; The data showed a normal distribution, the standard deviation of the population was estimated to be 1, and the effect size (difference) was estimated to be 0.8. It was calculated that if two independent n₁=40, n₂=40 samples were taken for the analysis to be carried out, at a 5% significance level, the maximum power value of the research would be 0.942182. Both groups will be given theoretical training about breast cancer awareness, and women in the intervention group will practice breast cancer awareness with a simple valid simulator. All groups will be informed before the applications. The training content will be supported by distributing a 5-page training booklet created from breast health and cancer awareness content to the participants. "Comprehensive Breast Cancer Knowledge Test", "Breast Cancer Fear Scale" and "Breast Cancer Awareness Scale" will be applied as a pre-test after the information.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Quasi-experimental randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| İntervention group (n:40) | Experimental | Other: Simple reality simulator applicationWomen in the intervention group will undergo a simulator breast cancer awareness application in simple reality. |
| Control group (n:40) | No intervention | –Control group women will receive 2 hours of theoretical training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteering to participate in the research.
- To work as female service personnel in institutions within the University of Health Sciences.
Key exclusion criteria (1 listed)
- Not participating in all applications of simulation teaching.
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 |
|---|---|---|
| Simple reality simulator applicationWomen in the intervention group will be given an application aimed at breast cancer awareness with a simple valid simulator. | Other | İntervention group (n:40) |
Primary outcome
Introductory Information Form
Time frame: 10 minutes
In this form, created by the researchers based on the literature, participants' age, obstetric history (number of pregnancies, number of births, breastfeeding status, etc.), self-breast examination status, etc. questions are included.
Comprehensive Breast Cancer Knowledge Test
Time frame: 10 minutes
The scale, developed by Stager in 1993, consists of 20 knowledge questions. The Turkish adaptation of the scale was carried out by Başak and Tosun in 2015. The scale is answered in a true-false manner, and there are 8 correct and 12 incorrect answers among the questions. After the test application is carried out; According to the answer key of the scale, "correct" answers are given 1; "Incorrect" and blank answers were given 0 points. GKMKBT includes two dimensions: general knowledge and treatability. Questions from 1 to 12; general knowledge about breast cancer; Questions 13 to 20 contain information about the treatability of breast cancer. The reliability of the scale was found to be 0.71.
Breast Cancer Fear Scale
Time frame: 10 minutes
It was developed by Champion in 2004 to examine women's breast cancer fears by determining their emotional responses to breast cancer and screening. The Turkish validity and reliability study of the scale was conducted by Seçginli in 2012. The scale contains eight items and is scored on a 5-point Likert type. According to this scoring, the lowest possible score is 8 and the highest score is 40. A higher score from the scale indicates a higher level of breast cancer fear. On scale; Scoring between 8 and 15 indicates a low level of fear of breast cancer, scoring between 16 and 23 indicates a moderate level of fear of breast cancer, and scoring between 24 and 40 indicates a high level of fear of breast cancer. Cronbach's Alpha value of the scale was found to be 0.90.
Breast Cancer Awareness Scale
Time frame: 10 minutes
The scale was developed in 2010 by the UK cancer research center, "King's College London" and "University College London" to determine breast cancer awareness. In our country, the Turkish validity and reliability study of the scale was conducted by Baş and Ursavaş (2022). The scale consists of a total of 13 items to determine breast cancer awareness, including symptoms (11 items), frequency of breast examination (1 item) and breast cancer age (1 item). The scale has no cut-off point. Answering 5 of the symptoms correctly is coded as 1 point, a 70-year-old woman is coded as 1 point, and breast examination once a month is coded as 1. Incorrect answers are worth 0 points. Scoring is between 0-3. Cronbach's alpha value of the scale was found to be 0.89. As the score obtained from the scale increases, breast cancer awareness increases.
3 secondary outcomes
Comprehensive Breast Cancer Knowledge Test
Time frame: 10 minutes
Breast Cancer Fear Scale
Time frame: 10 minutes
Breast Cancer Awareness Scale
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simple reality simulator application in people with Breast Cancer Awareness Training, run by Saglik Bilimleri Universitesi 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 2 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. 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?
Results are not available in the source record.
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?
Introductory Information Form (time frame: 10 minutes). 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?
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 30 Jul 2024; AzTrials last refreshed its copy on 28 Oct 2026.