Breast CancerNCT06051331
The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices
A study testing simulation-based breast health education in people with Breast Cancer and Health Knowledge, Attitudes, Practice, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the effect of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women. The study hypothesized that simulation-based breast health education would have an effect on breast cancer awareness and breast self-examination… Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Health Knowledge, Attitudes, Practice
- What is being tested?
- simulation-based breast health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2023to 22 Nov 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 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20-65 years,
- must be able to speak Turkish or Dari.
Who cannot join
- breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices of Afgan Refugee Women: A Randomized Control Trial
This study aimed to evaluate the effect of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women. The study hypothesized that simulation-based breast health education would have an effect on breast cancer awareness and breast self-examination practices scores among Afghan refugee women.
Read the detailed description
Purpose: The aim of the research is to examine the effects of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women.
Methods: The study will conduct with 64 (32 in the intervention group, and 32 in the control group) Afghan. The study population consisted of Afghan women. The simulation-based breast health education will applied to the intervention group once a week for 8 weeks.
No intervention will offer to the control group. Data will collected by a socio-demographic questionnaire, Breast Cancer Awareness Measure (BCAM) and breast self-examination practices checklist.
- Being tested
- simulation-based breast health education
- Keywords
- Afghan, Breast Cancer, Awareness, Health Education
- Medical subject headings
- Breast Neoplasms, Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simulation-based breast health educationBehavioural
The intervention group will receive simulation-based breast health education once a week for eight weeks. The simulation- based breast health education program will compose two part. The first part, it will theoretical education and second part will continue as practical education. On the plan date, a 60-min lecture will give about breast cancer, its risk factors, interventions to reduce the risk of breast cancer, the value of early diagnosis and cancer screening. After a 10-min break, course attendees watched a 20-min video, after which the course attendees' questions will answer.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Simulation-based breast health education Receives: Behavioral: simulation-based breast health education |
| Control group | No intervention | The control group will not take part the simulation-based breast health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Breast Cancer Awareness Measure Score
The Breast Cancer Awareness Measure was developed by the Cancer Research UK group of Kings College London in 2009.It is a questionnaire that assesses seven domains of Breast Cancer (BC) awareness: knowledge of BC symptoms, breast self-examination, confidence of noticing a change in the breasts, age and lifetime risk of Breast Cancer, urgency if a change in breast is noticed, BC risk factors, and Breast Cancer screening. In this study, Dari version of The Breast Cancer Awareness Measure which was translated from English into Dari by an official translator. The respondent receives 1 point if they can correctly identify at least 5 signs of breast cancer, 1 point if they select the oldest woman for the age-related risk item, and 1 point if they report performing breast examination once a month. Incorrect answers receive 0 points. The total score is between 0 and 3 and there is no cut-off point.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start22 Nov 2023
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgun Kuru Alici, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051331
- Sponsor's protocol ID
- D69071
- Status last verified
- Apr 2024
- First submitted
- 17 Sep 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kuru Alici N, Arikan Donmez A, Aktas O, Zeytun Z. The effect of simulation-based breast health education on breast cancer awareness and breast self-examination skills of Afghan refugee women: a randomized controlled trial. BMC Public Health. 2025 Jun 2;25(1):2048. doi: 10.1186/s12889-025-23313-y.
PubMed 40457306
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices of Afgan Refugee Women: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06051331
- Acronym / sponsor ID
- D69071
- Keywords
- Afghan, Breast Cancer, Awareness, Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 22 Sep 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.
This study aimed to evaluate the effect of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women. The study hypothesized that simulation-based breast health education would have an effect on breast cancer awareness and breast self-examination practices scores among Afghan refugee women.
Detailed description
Purpose: The aim of the research is to examine the effects of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women.
Methods: The study will conduct with 64 (32 in the intervention group, and 32 in the control group) Afghan. The study population consisted of Afghan women. The simulation-based breast health education will applied to the intervention group once a week for 8 weeks.
No intervention will offer to the control group. Data will collected by a socio-demographic questionnaire, Breast Cancer Awareness Measure (BCAM) and breast self-examination practices checklist.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: simulation-based breast health educationSimulation-based breast health education |
| Control group | No intervention | –The control group will not take part the simulation-based breast health education |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 20-65 years,
- must be able to speak Turkish or Dari.
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| simulation-based breast health educationThe intervention group will receive simulation-based breast health education once a week for eight weeks. The simulation- based breast health education program will compose two part. The first part, it will theoretical education and second part will continue as practical education. On the plan date, a 60-min lecture will give about breast cancer, its risk factors, interventions to reduce the risk of breast cancer, the value of early diagnosis and cancer screening. After a 10-min break, course attendees watched a 20-min video, after which the course attendees' questions will answer. | Behavioural | Experimental group |
Primary outcome
The Breast Cancer Awareness Measure Score
Time frame: up to 8 weeks
The Breast Cancer Awareness Measure was developed by the Cancer Research UK group of Kings College London in 2009.It is a questionnaire that assesses seven domains of Breast Cancer (BC) awareness: knowledge of BC symptoms, breast self-examination, confidence of noticing a change in the breasts, age and lifetime risk of Breast Cancer, urgency if a change in breast is noticed, BC risk factors, and Breast Cancer screening. In this study, Dari version of The Breast Cancer Awareness Measure which was translated from English into Dari by an official translator. The respondent receives 1 point if they can correctly identify at least 5 signs of breast cancer, 1 point if they select the oldest woman for the age-related risk item, and 1 point if they report performing breast examination once a month. Incorrect answers receive 0 points. The total score is between 0 and 3 and there is no cut-off point.
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 24 Apr 2026.
- Derived from this study: PubMed 40457306Kuru Alici N, Arikan Donmez A, Aktas O, Zeytun Z. The effect of simulation-based breast health education on breast cancer awareness and breast self-examination skills of Afghan refugee women: a randomized controlled trial. BMC Public Health. 2025 Jun 2;25(1):2048. doi: 10.1186/s12889-025-23313-y.
- Published PaperLink provided by the sponsor.
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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.
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 simulation-based breast health education in people with Breast Cancer and Health Knowledge, Attitudes, Practice, run by Hacettepe 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 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: finished, as of the sponsor's last update on 24 Apr 2026. 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?
The Breast Cancer Awareness Measure Score (time frame: up to 8 weeks). 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 NCT06051331, 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 24 Apr 2026.