Breast Self-ExaminationKAU-BSE-RCTNCT07348744
The Effect of a Health Belief Model-Based Education Program on Breast Self-Examination Practice Behavior, Breast Cancer Fear, and Awareness Levels in Women: A Randomized Controlled Trial
A study testing Health Belief Model-Based Education Program in people with Breast Self-Examination and Breast Cancer, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial summary
The study titled "The Effect of a Health Belief Model-Based Training Program on Women's Self-Breast Examination Behavior, Breast Cancer Fear and Awareness Levels: A Randomized Controlled Study" aimed to increase breast cancer awareness and the application of breast self-examination techniques among women by providing… Read more about this study
- Who is it for?
- Ages 20 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Self-Examination, Breast Cancer
- What is being tested?
- Health Belief Model-Based Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being affiliated with Family Health Center No. 1 in Ardahan Province,
- Being a woman between the ages of 20 and 69,
- Being literate,
- Not having been diagnosed with breast cancer,
- Not having a mental or communication disorder,
- Having a phone available for communication,
- Women who voluntarily agree to participate in the study.
Who cannot join
- Difficulty communicating,
- Wanting to drop out of the study,
- Not wanting to participate in the study.
- Women who did not fill out the data form despite reminders via message and phone call.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The study titled "The Effect of a Health Belief Model-Based Training Program on Women's Self-Breast Examination Behavior, Breast Cancer Fear and Awareness Levels: A Randomized Controlled Study" aimed to increase breast cancer awareness and the application of breast self-examination techniques among women by providing the necessary training through a training program based on the Health Belief Model.
Read the detailed description
This randomized controlled study aims to evaluate the effectiveness of a Health Belief Model-based education program on women's breast self-examination practices, breast cancer fear, and awareness levels. Participants will be randomly assigned to either an intervention group receiving a structured education program based on the Health Belief Model or a control group receiving usual care.
Data will be collected using a Personal Information Form, the Champion Health Belief Model Scale, the Comprehensive Breast Cancer Knowledge Test, the Breast Cancer Awareness Scale, and the Champion Breast Cancer Fear Scale at baseline and three months after the intervention. The findings of this study are expected to contribute to the development of effective educational strategies for improving breast cancer awareness and preventive health behaviors among women.
- Conditions
- Breast Self-Examination, Breast Cancer
- Being tested
- Health Belief Model-Based Education Program
- Keywords
- Breast Self-Examination, Breast Cancer, Health Belief Model
- Medical subject headings
- Breast Self-Examination, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Belief Model-Based Education ProgramBehavioural
A structured education program based on the Health Belief Model designed to improve breast self-examination behavior and increase breast cancer awareness.
| Study group | Role | What they receive |
|---|---|---|
| Health Belief Model-Based Education Group | Experimental | Participants receive a structured education program based on the Health Belief Model focusing on breast self-examination. Receives: Behavioral: Health Belief Model-Based Education Program |
| Control Group | No intervention | Participants receive usual care without any additional educational intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Breast Self-Examination Behavior
Change in breast self-examination behavior measured as a single self-reported outcome indicating whether participants perform breast self-examination.
Measured: Baseline and 3 months after the intervention
Secondary outcomes (3)
Change in Breast Cancer Knowledge Level
Change in breast cancer knowledge assessed using the Comprehensive Breast Cancer Knowledge Test.
Measured: Baseline and 3 months after the intervention
Change in Breast Cancer Awareness Level
Change in breast cancer awareness measured using the Breast Cancer Awareness Scale.
Measured: Baseline and 3 months after the intervention
Change in Breast Cancer Fear Level
Change in fear related to breast cancer measured using the Champion Breast Cancer Fear Scale.
Measured: Baseline and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to an intervention group receiving a Health Belief Model-based education program or to a control group receiving usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu Karadağ, Kafkas University
- Investigators
- CANSU KARADAĞ, Principal investigator, Kafkas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348744
- Sponsor's protocol ID
- KAU-BSE-RCT
- Acronym
- KAU-BSE-RCT
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 16 Jan 2026
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Health Belief Model-Based Education Program on Breast Self-Examination Practice Behavior, Breast Cancer Fear, and Awareness Levels in Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07348744
- Acronym / sponsor ID
- KAU-BSE-RCT / KAU-BSE-RCT
- Conditions
- Breast Self-Examination, Breast Cancer
- Keywords
- Breast Self-Examination, Breast Cancer, Health Belief Model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 16 Jan 2026 (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 study titled "The Effect of a Health Belief Model-Based Training Program on Women's Self-Breast Examination Behavior, Breast Cancer Fear and Awareness Levels: A Randomized Controlled Study" aimed to increase breast cancer awareness and the application of breast self-examination techniques among women by providing the necessary training through a training program based on the Health Belief Model.
Detailed description
This randomized controlled study aims to evaluate the effectiveness of a Health Belief Model-based education program on women's breast self-examination practices, breast cancer fear, and awareness levels. Participants will be randomly assigned to either an intervention group receiving a structured education program based on the Health Belief Model or a control group receiving usual care.
Data will be collected using a Personal Information Form, the Champion Health Belief Model Scale, the Comprehensive Breast Cancer Knowledge Test, the Breast Cancer Awareness Scale, and the Champion Breast Cancer Fear Scale at baseline and three months after the intervention. The findings of this study are expected to contribute to the development of effective educational strategies for improving breast cancer awareness and preventive health behaviors among women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to an intervention group receiving a Health Belief Model-based education program or to a control group receiving usual care.
| Arm | Type | Receives |
|---|---|---|
| Health Belief Model-Based Education Group | Experimental | Behavioral: Health Belief Model-Based Education ProgramParticipants receive a structured education program based on the Health Belief Model focusing on breast self-examination. |
| Control Group | No intervention | –Participants receive usual care without any additional educational intervention. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being affiliated with Family Health Center No. 1 in Ardahan Province,
- Being a woman between the ages of 20 and 69,
- Being literate,
- Not having been diagnosed with breast cancer,
- Not having a mental or communication disorder,
Key exclusion criteria (4 listed)
- Difficulty communicating,
- Wanting to drop out of the study,
- Not wanting to participate in the study.
- Women who did not fill out the data form despite reminders via message and phone call.
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 |
|---|---|---|
| Health Belief Model-Based Education ProgramA structured education program based on the Health Belief Model designed to improve breast self-examination behavior and increase breast cancer awareness. | Behavioural | Health Belief Model-Based Education Group |
Primary outcome
Change in Breast Self-Examination Behavior
Time frame: Baseline and 3 months after the intervention
Change in breast self-examination behavior measured as a single self-reported outcome indicating whether participants perform breast self-examination.
3 secondary outcomes
Change in Breast Cancer Knowledge Level
Time frame: Baseline and 3 months after the intervention
Change in Breast Cancer Awareness Level
Time frame: Baseline and 3 months after the intervention
Change in Breast Cancer Fear Level
Time frame: Baseline and 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- 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.
CANSU KARADAĞ principal investigator
Kafkas 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 Health Belief Model-Based Education Program in people with Breast Self-Examination and Breast Cancer, run by Kafkas 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Jan 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CANSU KARADAĞ (05414233218, cansukaradag@ardahan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Breast Self-Examination Behavior (time frame: Baseline and 3 months after the intervention). 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 16 Jan 2026.