Breast CancerNCT07692464
Training On Self-Breast Examination Using Visual Breast Examination Materials For İlliterate Women.
A study testing Visual-based Breast Self-Examination (BSE) Education in people with Breast Cancer and Breast Self-Examination, run by Inonu University at 2 sites in Turkey (Türkiye).
Trial summary
Breast cancer is the most common malignancy among women and remains a major public health concern despite being largely preventable through early detection and regular screening practices. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Self-Examination
- What is being tested?
- Visual-based Breast Self-Examination (BSE) Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Jan 2027
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Able to communicate,
- Have no vision or hearing problems,
- Between the ages of 15-49,
- Have no diagnosed chronic diseases (cardiovascular diseases, asthma, epilepsy, etc.),
- Have not received breast cancer or breast self-examination training within the last 21 days will be included in the study.
Who cannot join
- Women who are currently pregnant or planning to become pregnant in the near future,
- have a family history of breast cancer,
- or have health problems that prevent them from participating in the training will be excluded from the study.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
İnönü University Faculty of Health Sciences
Malatya, 44
İnönü University Faculty of Health Sciences
Malatya
About this study
Official title: The Effect of Breast Self-Examination Education Using Visual Materials on Breast Cancer Awareness and Health Motivation Among Illiterate Women of Reproductive Age: A Study in Diyarbakır, Türkiye
Breast cancer is the most common malignancy among women and remains a major public health concern despite being largely preventable through early detection and regular screening practices. Increasing early detection rates depends on women's ability to recognize the signs and symptoms of breast cancer, perform regular breast self-examination (BSE), and maintain adequate health motivation. However, women who are illiterate and reside in rural areas generally have low levels of breast cancer awareness, which adversely affects early detection behaviors. This situation is associated with insufficient knowledge, misconceptions, limited access to healthcare services, and low health literacy. Previous studies have demonstrated that educational interventions supported by visual materials are effective in improving health awareness among individuals with low educational attainment. Therefore, this study aims to contribute to the limited literature by evaluating an intervention designed to improve breast cancer awareness among women with low literacy levels.
The study is designed for illiterate women of reproductive age (15-49 years) living in rural areas. Participants will receive breast self-examination (BSE) education using visual materials. The educational content will include breast anatomy, signs and symptoms of breast cancer, the importance of early detection, and the correct steps for performing breast self-examination. Pictures, breast models, videos, and hands-on demonstration techniques will be used throughout the educational sessions. The effectiveness of the intervention will be evaluated using a pretest-posttest design by comparing changes in breast cancer awareness and health motivation before and after the educational program. The research process will include a literature review, development of educational materials, implementation of the intervention, data collection, and statistical analysis, with the principal investigator actively involved in all phases of the study.
The study is expected to improve participants' ability to recognize the signs and symptoms of breast cancer, increase the frequency of breast self-examination, and enhance their health motivation. Furthermore, the findings are expected to support the development of community-based health education skills among midwifery students, encourage their active participation in preventive healthcare services, and strengthen their involvement in scientific research. The results may also provide evidence for planning educational programs targeting women with low educational attainment and contribute to the development of visual material-based educational strategies. Ultimately, the study is anticipated to increase women's awareness of their own health responsibilities, promote early detection behaviors, improve quality of life, and indirectly contribute to reducing breast cancer-related mortality.
Read the detailed description
Breast cancer remains the most common cancer among women worldwide, and early detection is one of the most effective strategies for reducing mortality. However, women with limited literacy often have lower awareness of breast cancer, inadequate knowledge of breast self-examination (BSE), and reduced motivation to engage in preventive health behaviors. Traditional educational approaches that rely heavily on written information may be insufficient for this population.
This randomized controlled trial has been designed to evaluate the effectiveness of a visual educational intervention developed specifically for illiterate women of reproductive age living in rural areas. The intervention incorporates culturally appropriate visual materials, including illustrated educational brochures, demonstration videos, and a handmade amigurumi breast model to facilitate practical learning of breast self-examination techniques.
Participants allocated to the intervention group will receive structured face-to-face education delivered in three educational sessions. The sessions include information on breast anatomy, warning signs of breast cancer, the importance of early detection, recommended breast cancer screening practices, and step-by-step demonstration of breast self-examination using visual teaching materials. Interactive practice and reinforcement activities are incorporated to improve knowledge retention and skill acquisition.
Participants in the control group will receive routine health services without the structured educational intervention during the study period.
The effectiveness of the intervention will be evaluated by comparing changes in breast cancer awareness and health motivation before and after the intervention using validated measurement instruments. The findings are expected to provide evidence regarding the effectiveness of visual education strategies for improving preventive health behaviors among women with low literacy and may contribute to the development of community-based breast cancer education programs for disadvantaged populations.
- Conditions
- Breast Cancer, Breast Self-Examination
- Being tested
- Visual-based Breast Self-Examination (BSE) Education
- Keywords
- Breast Cancer, Breast Cancer Awareness, Health Motivation, Midwifery
- Medical subject headings
- Breast Neoplasms, Breast Self-Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual-based Breast Self-Examination (BSE) EducationBehavioural
Also called Visual breast cancer education program, KKMM training program, Self-Examination (BSE) Training
A structured behavioral education program designed for illiterate women aged 15-49 years to improve breast cancer awareness and breast self-examination (BSE) skills. The intervention is delivered face-to-face using visual educational materials, pictorial brochures, an amigurumi breast model, and guided hands-on demonstrations. The program includes repeated teaching sessions and practical applications to reinforce learning and support behavioral change in breast health practices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive a structured visual breast self-examination education program using illustrated educational materials and an amigurumi breast model, in addition to routine care. Receives: Behavioral: Visual-based Breast Self-Examination (BSE) Education |
| Control Group | No intervention | Participants will receive routine care without the visual breast self-examination education during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer Awareness Level
Breast cancer awareness will be assessed using a validated Breast Cancer Awareness Scale. The scale evaluates participants' knowledge regarding breast cancer symptoms, early detection practices, and screening behaviors. Higher scores reflect greater levels of breast cancer awareness and knowledge.
Measured: Baseline and immediately after the 15-minute intervention session
Secondary outcomes (1)
Health Motivation Level
Health motivation will be assessed using the Health Motivation subscale of the Champion Health Belief Model Scale. This subscale evaluates participants' motivation to engage in preventive health behaviors. Higher scores indicate greater health motivation.
Measured: Baseline and immediately after the 10-15-minute educational intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 May 2026
- Primary completion1 Jun 2026
- Study completion1 Jan 2027 (estimated)
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.
- 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 will be randomly assigned to either the intervention group receiving visual breast self-examination education or the control group receiving routine care. Outcomes will be compared between the two groups.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, ESRA GUNEY, PhD, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692464
- Sponsor's protocol ID
- 8970
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The dataset generated in this study will remain confidential and will only be used for scientific reporting and publication purposes.
Publications
Al-Naggar RA, Al-Naggar DH, Bobryshev YV, Chen R, Assabri A. Practice and barriers toward breast self-examination among young Malaysian women. Asian Pac J Cancer Prev. 2011;12(5):1173-8.
PubMed 21875261
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breast Self-Examination Education Using Visual Materials on Breast Cancer Awareness and Health Motivation Among Illiterate Women of Reproductive Age: A Study in Diyarbakır, Türkiye
- ClinicalTrials.gov ID
- NCT07692464
- Acronym / sponsor ID
- 8970
- Conditions
- Breast Cancer, Breast Self-Examination
- Keywords
- Breast Cancer, Breast Cancer Awareness, Health Motivation, Midwifery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 9 Jul 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.
Breast cancer is the most common malignancy among women and remains a major public health concern despite being largely preventable through early detection and regular screening practices. Increasing early detection rates depends on women's ability to recognize the signs and symptoms of breast cancer, perform regular breast self-examination (BSE), and maintain adequate health motivation. However, women who are illiterate and reside in rural areas generally have low levels of breast cancer awareness, which adversely affects early detection behaviors. This situation is associated with insufficient knowledge, misconceptions, limited access to healthcare services, and low health literacy. Previous studies have demonstrated that educational interventions supported by visual materials are effective in improving health awareness among individuals with low educational attainment. Therefore, this study aims to contribute to the limited literature by evaluating an intervention designed to improve breast cancer awareness among women with low literacy levels.
The study is designed for illiterate women of reproductive age (15-49 years) living in rural areas. Participants will receive breast self-examination (BSE) education using visual materials. The educational content will include breast anatomy, signs and symptoms of breast cancer, the importance of early detection, and the correct steps for performing breast self-examination. Pictures, breast models, videos, and hands-on demonstration techniques will be used throughout the educational sessions. The effectiveness of the intervention will be evaluated using a pretest-posttest design by comparing changes in breast cancer awareness and health motivation before and after the educational program. The research process will include a literature review, development of educational materials, implementation of the intervention, data collection, and statistical analysis, with the principal investigator actively involved in all phases of the study.
The study is expected to improve participants' ability to recognize the signs and symptoms of breast cancer, increase the frequency of breast self-examination, and enhance their health motivation. Furthermore, the findings are expected to support the development of community-based health education skills among midwifery students, encourage their active participation in preventive healthcare services, and strengthen their involvement in scientific research. The results may also provide evidence for planning educational programs targeting women with low educational attainment and contribute to the development of visual material-based educational strategies. Ultimately, the study is anticipated to increase women's awareness of their own health responsibilities, promote early detection behaviors, improve quality of life, and indirectly contribute to reducing breast cancer-related mortality.
Detailed description
Breast cancer remains the most common cancer among women worldwide, and early detection is one of the most effective strategies for reducing mortality. However, women with limited literacy often have lower awareness of breast cancer, inadequate knowledge of breast self-examination (BSE), and reduced motivation to engage in preventive health behaviors. Traditional educational approaches that rely heavily on written information may be insufficient for this population.
This randomized controlled trial has been designed to evaluate the effectiveness of a visual educational intervention developed specifically for illiterate women of reproductive age living in rural areas. The intervention incorporates culturally appropriate visual materials, including illustrated educational brochures, demonstration videos, and a handmade amigurumi breast model to facilitate practical learning of breast self-examination techniques.
Participants allocated to the intervention group will receive structured face-to-face education delivered in three educational sessions. The sessions include information on breast anatomy, warning signs of breast cancer, the importance of early detection, recommended breast cancer screening practices, and step-by-step demonstration of breast self-examination using visual teaching materials. Interactive practice and reinforcement activities are incorporated to improve knowledge retention and skill acquisition.
Participants in the control group will receive routine health services without the structured educational intervention during the study period.
The effectiveness of the intervention will be evaluated by comparing changes in breast cancer awareness and health motivation before and after the intervention using validated measurement instruments. The findings are expected to provide evidence regarding the effectiveness of visual education strategies for improving preventive health behaviors among women with low literacy and may contribute to the development of community-based breast cancer education programs for disadvantaged populations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intervention group receiving visual breast self-examination education or the control group receiving routine care. Outcomes will be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Visual-based Breast Self-Examination (BSE) EducationParticipants will receive a structured visual breast self-examination education program using illustrated educational materials and an amigurumi breast model, in addition to routine care. |
| Control Group | No intervention | –Participants will receive routine care without the visual breast self-examination education during the study period. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Able to communicate,
- Have no vision or hearing problems,
- Between the ages of 15-49,
- Have no diagnosed chronic diseases (cardiovascular diseases, asthma, epilepsy, etc.),
- Have not received breast cancer or breast self-examination training within the last 21 days will be included in the study.
Key exclusion criteria (3 listed)
- Women who are currently pregnant or planning to become pregnant in the near future,
- have a family history of breast cancer,
- or have health problems that prevent them from participating in the training will be excluded from the study.
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 |
|---|---|---|
| Visual-based Breast Self-Examination (BSE) EducationAlso: Visual breast cancer education program, KKMM training program, Self-Examination (BSE) TrainingA structured behavioral education program designed for illiterate women aged 15-49 years to improve breast cancer awareness and breast self-examination (BSE) skills. The intervention is delivered face-to-face using visual educational materials, pictorial brochures, an amigurumi breast model, and guided hands-on demonstrations. The program includes repeated teaching sessions and practical applications to reinforce learning and support behavioral change in breast health practices. | Behavioural | Intervention Group |
Primary outcome
Breast Cancer Awareness Level
Time frame: Baseline and immediately after the 15-minute intervention session
Breast cancer awareness will be assessed using a validated Breast Cancer Awareness Scale. The scale evaluates participants' knowledge regarding breast cancer symptoms, early detection practices, and screening behaviors. Higher scores reflect greater levels of breast cancer awareness and knowledge.
1 secondary outcome
Health Motivation Level
Time frame: Baseline and immediately after the 10-15-minute educational intervention session
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 15 Jul 2026.
- Background: PubMed 21875261Al-Naggar RA, Al-Naggar DH, Bobryshev YV, Chen R, Assabri A. Practice and barriers toward breast self-examination among young Malaysian women. Asian Pac J Cancer Prev. 2011;12(5):1173-8.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The dataset generated in this study will remain confidential and will only be used for scientific reporting and publication purposes.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual-based Breast Self-Examination (BSE) Education in people with Breast Cancer and Breast Self-Examination, run by Inonu University at 2 sites 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 5 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Cancer Awareness Level (time frame: Baseline and immediately after the 15-minute intervention session). 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 NCT07692464, 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 15 Jul 2026.