Breast CancerNCT07083310
The Effect of Health Education Conducted Using Two Different Methods on Women's Knowledge of Breast Cancer, Health Beliefs, Mammography Self-Efficacy, and Participation in Screening Programs
A study testing Health Education and Motivational Interviewing in people with Breast Cancer and Breast - Female, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Trial summary
Breast cancer is the most common cancer among women worldwide and can be deadly if not found early. Screening tests like mammograms help find breast cancer early, which improves the chances of successful treatment. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast - Female
- What is being tested?
- Health Education and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Oct 2025
- 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 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate in the study
- Being a woman aged between 40 and 69 years
- Being literate
- Registered at the Family Health Center where the study is conducted
Who cannot join
- Having a first-degree relative (mother/sister) with a history of breast cancer
- Having had a mammogram in the last two years and/or regularly
- Having been diagnosed with any type of cancer
- Being pregnant
- Being in the postpartum period
- Having a physical communication impairment (e.g., hearing, speech)
- Having a diagnosis of neuropsychiatric illness
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Breast cancer is the most common cancer among women worldwide and can be deadly if not found early. Screening tests like mammograms help find breast cancer early, which improves the chances of successful treatment. However, many women do not take part in regular screenings because of fear, lack of knowledge, or other barriers.
This study looks at two ways of teaching women about breast cancer and mammogram screening: traditional health education and a counseling approach called motivational interviewing. Motivational interviewing helps women feel more confident and motivated to get screened by talking about their concerns and encouraging positive decisions.
The goal is to see which method better increases women's knowledge about breast cancer, their beliefs about health, their confidence in getting mammograms, and their actual participation in screening programs. The results will help improve how we support women in taking care of their breast health.
Read the detailed description
Breast cancer, detected in approximately 2.3 million people worldwide each year and resulting in 670,000 deaths, ranks first among cancers in women and accounts for 25% of all cancer cases in women. In Turkey, screening of 2.5 million women in 2025 revealed 36,000 new breast cancer diagnoses. Today, breast cancer is a priority and significant public health issue due to its high morbidity and mortality rates, along with associated economic impacts such as healthcare costs and workforce losses. Factors facilitating the widespread prevalence of breast cancer like an epidemic include rapid population aging, unhealthy lifestyle behaviors, insufficient or inaccessible screening programs, negative attitudes and beliefs leading to refusal of screening, delays in early diagnosis and treatment, lack of knowledge, and underutilization of primary and secondary prevention services. A projection estimates that by 2040, the number of breast cancer cases worldwide will reach nearly three million, with about one million deaths annually.
Early diagnosis of breast cancer is the most important factor in increasing survival rates. Delays in early diagnosis increase mortality and morbidity, reduce treatment success, and lower quality of life. The World Health Organization strongly recommends community-based screening programs including mammography for breast cancer control. Mammography is a proven, effective, and reliable method for early detection of breast cancer. Literature reports that increased participation in mammography screening significantly reduces advanced-stage breast cancer cases and mortality. Mammography screening is conducted free of charge every two years for women aged 40-69 within Turkey's National Breast Cancer Screening Program, as in many developed and developing countries worldwide.
The most effective strategy to combat breast cancer threatening women's health is to screen at least 70% of the at-risk female population every two years by mammography. Participation rates in mammography vary between 7% and 84% across different regions. In Northern Europe, Denmark, Finland, and the Netherlands report participation rates of 84.1%, 82.8%, and 80.8%, respectively. In Southern Europe, Italy reports 61.3%, Latin America's Brazil between 12-31%, and Malaysia in Asia between 7-25%. In Turkey, despite free mammography services, participation ranges between 41-55%, which is below the desired level. Therefore, especially in developing and less developed countries, implementing evidence-based, supportive, and encouraging interventions accepted by the general population is recommended to increase mammography participation.
Meeting women's information needs regarding breast cancer and screening, positively influencing health beliefs, attitudes, and behaviors, and improving mammography self-efficacy are key factors in increasing participation. Factors negatively impacting participation include limited access to screening, fear of examination, low risk perception, lack of knowledge, and negative attitudes and beliefs about screening. Even though women may be aware of early breast cancer detection, low education levels, poor self-efficacy, and lack of motivation contribute to low screening participation. The literature recommends various methods to motivate women and remove perceived barriers to mammography screening. In Turkey, face-to-face interventions, home visits, and various educational methods and tools have increased mammography participation to varying degrees. Studies show that face-to-face and online counseling about breast cancer and early detection raise women's knowledge and motivation, improve health beliefs and attitudes, increase perceived benefits and self-efficacy, decrease perceived barriers, and consequently increase mammography participation. However, despite various health education interventions improving knowledge, awareness, and positive attitudes, participation rates rarely exceed 70%. Thus, raising knowledge and awareness alone is insufficient, and increasing motivation for screening behavior is essential.
Motivational interviewing (MI) is often used to encourage desired health behaviors. MI is a client-centered approach that helps individuals recognize ambivalence, make informed decisions, and resolve issues by enhancing motivation for positive health behaviors. MI consists of four stages: engaging, focusing, evoking, and planning. These aim to stimulate motivation for change, strengthen belief in change, support sustainability, and develop concrete plans for behavior change. MI has been shown to increase mammography participation. For example, a nurse navigation program including MI significantly increased mammography participation among Syrian refugee women. A randomized controlled trial with 120 Iranian women reported that MI counseling positively affected breast cancer screening behaviors, though mammography participation increased only to 26%. Systematic reviews and meta-analyses indicate that MI interventions may increase participation in breast cancer screening programs. However, no study in Turkish populations has investigated the effect of MI on mammography participation. Furthermore, randomized controlled trials on MI and breast cancer screening participation remain limited in quantity and quality, highlighting the need for well-designed, adequately powered, standardized MI trials. Additionally, no study has compared traditional health education with MI-based education on participation rates in breast cancer screening programs.
Therefore, well-designed randomized controlled trials comparing traditional health education and MI-based health education on women's breast cancer knowledge, health beliefs, mammography self-efficacy, and screening participation are needed.
This study aims to evaluate the effects of health education and motivational interviewing-based health education on women's breast cancer knowledge, health beliefs, mammography self-efficacy, and participation in screening programs.
- Conditions
- Breast Cancer, Breast - Female
- Being tested
- Health Education, Motivational Interviewing
- Keywords
- breast cancer, mammography, motivational interview
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationBehavioural
Also called Assign to Arm: Health Education Group
Structured group education focused on breast cancer awareness, risk reduction, and early detection.
Motivational InterviewingBehavioural
Also called Motivational Interviewing group
Individual counseling sessions using motivational interviewing to enhance screening behavior.
| Study group | Role | What they receive |
|---|---|---|
| Health Education Group | Experimental | Participants will receive structured education sessions focused on increasing knowledge about breast cancer, risk factors, and the importance of early screening. Receives: Behavioral: Health Education |
| Motivational Interviewing Group | Experimental | Participants will engage in one-on-one counseling sessions using motivational interviewing techniques to enhance motivation and reduce barriers to mammography screening. Receives: Behavioral: Motivational Interviewing |
| Control Group | No intervention | Participants will not receive any intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mammography Screening Participation Rate
The rate of participants who attend mammography screening within 6 months will be evaluated using health records and surveys.
Measured: Within 6 months after education/motivational interviewing intervention
Secondary outcomes (1)
Breast Cancer Knowledge Level
Measured: Baseline and 1 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 were randomized into two intervention groups and one control group using block randomization via a digital program (randomiser.org). Six letter combinations of "A," "B," and "C" were created and randomly assigned to 78 participants in blocks of 13. The sequence of combinations was predetermined (see Figure 3.5). Letters "A," "B," and "C" were assigned to the health education, control, and motivational interviewing groups, respectively.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serpil Özdemir, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083310
- Sponsor's protocol ID
- 00004646
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 24 Jul 2025
- 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 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Education Conducted Using Two Different Methods on Women's Knowledge of Breast Cancer, Health Beliefs, Mammography Self-Efficacy, and Participation in Screening Programs
- ClinicalTrials.gov ID
- NCT07083310
- Acronym / sponsor ID
- 00004646
- Conditions
- Breast Cancer, Breast - Female
- Keywords
- breast cancer, mammography, motivational interview
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 24 Jul 2025 (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 cancer among women worldwide and can be deadly if not found early. Screening tests like mammograms help find breast cancer early, which improves the chances of successful treatment. However, many women do not take part in regular screenings because of fear, lack of knowledge, or other barriers.
This study looks at two ways of teaching women about breast cancer and mammogram screening: traditional health education and a counseling approach called motivational interviewing. Motivational interviewing helps women feel more confident and motivated to get screened by talking about their concerns and encouraging positive decisions.
The goal is to see which method better increases women's knowledge about breast cancer, their beliefs about health, their confidence in getting mammograms, and their actual participation in screening programs. The results will help improve how we support women in taking care of their breast health.
Detailed description
Breast cancer, detected in approximately 2.3 million people worldwide each year and resulting in 670,000 deaths, ranks first among cancers in women and accounts for 25% of all cancer cases in women. In Turkey, screening of 2.5 million women in 2025 revealed 36,000 new breast cancer diagnoses. Today, breast cancer is a priority and significant public health issue due to its high morbidity and mortality rates, along with associated economic impacts such as healthcare costs and workforce losses. Factors facilitating the widespread prevalence of breast cancer like an epidemic include rapid population aging, unhealthy lifestyle behaviors, insufficient or inaccessible screening programs, negative attitudes and beliefs leading to refusal of screening, delays in early diagnosis and treatment, lack of knowledge, and underutilization of primary and secondary prevention services. A projection estimates that by 2040, the number of breast cancer cases worldwide will reach nearly three million, with about one million deaths annually.
Early diagnosis of breast cancer is the most important factor in increasing survival rates. Delays in early diagnosis increase mortality and morbidity, reduce treatment success, and lower quality of life. The World Health Organization strongly recommends community-based screening programs including mammography for breast cancer control. Mammography is a proven, effective, and reliable method for early detection of breast cancer. Literature reports that increased participation in mammography screening significantly reduces advanced-stage breast cancer cases and mortality. Mammography screening is conducted free of charge every two years for women aged 40-69 within Turkey's National Breast Cancer Screening Program, as in many developed and developing countries worldwide.
The most effective strategy to combat breast cancer threatening women's health is to screen at least 70% of the at-risk female population every two years by mammography. Participation rates in mammography vary between 7% and 84% across different regions. In Northern Europe, Denmark, Finland, and the Netherlands report participation rates of 84.1%, 82.8%, and 80.8%, respectively. In Southern Europe, Italy reports 61.3%, Latin America's Brazil between 12-31%, and Malaysia in Asia between 7-25%. In Turkey, despite free mammography services, participation ranges between 41-55%, which is below the desired level. Therefore, especially in developing and less developed countries, implementing evidence-based, supportive, and encouraging interventions accepted by the general population is recommended to increase mammography participation.
Meeting women's information needs regarding breast cancer and screening, positively influencing health beliefs, attitudes, and behaviors, and improving mammography self-efficacy are key factors in increasing participation. Factors negatively impacting participation include limited access to screening, fear of examination, low risk perception, lack of knowledge, and negative attitudes and beliefs about screening. Even though women may be aware of early breast cancer detection, low education levels, poor self-efficacy, and lack of motivation contribute to low screening participation. The literature recommends various methods to motivate women and remove perceived barriers to mammography screening. In Turkey, face-to-face interventions, home visits, and various educational methods and tools have increased mammography participation to varying degrees. Studies show that face-to-face and online counseling about breast cancer and early detection raise women's knowledge and motivation, improve health beliefs and attitudes, increase perceived benefits and self-efficacy, decrease perceived barriers, and consequently increase mammography participation. However, despite various health education interventions improving knowledge, awareness, and positive attitudes, participation rates rarely exceed 70%. Thus, raising knowledge and awareness alone is insufficient, and increasing motivation for screening behavior is essential.
Motivational interviewing (MI) is often used to encourage desired health behaviors. MI is a client-centered approach that helps individuals recognize ambivalence, make informed decisions, and resolve issues by enhancing motivation for positive health behaviors. MI consists of four stages: engaging, focusing, evoking, and planning. These aim to stimulate motivation for change, strengthen belief in change, support sustainability, and develop concrete plans for behavior change. MI has been shown to increase mammography participation. For example, a nurse navigation program including MI significantly increased mammography participation among Syrian refugee women. A randomized controlled trial with 120 Iranian women reported that MI counseling positively affected breast cancer screening behaviors, though mammography participation increased only to 26%. Systematic reviews and meta-analyses indicate that MI interventions may increase participation in breast cancer screening programs. However, no study in Turkish populations has investigated the effect of MI on mammography participation. Furthermore, randomized controlled trials on MI and breast cancer screening participation remain limited in quantity and quality, highlighting the need for well-designed, adequately powered, standardized MI trials. Additionally, no study has compared traditional health education with MI-based education on participation rates in breast cancer screening programs.
Therefore, well-designed randomized controlled trials comparing traditional health education and MI-based health education on women's breast cancer knowledge, health beliefs, mammography self-efficacy, and screening participation are needed.
This study aims to evaluate the effects of health education and motivational interviewing-based health education on women's breast cancer knowledge, health beliefs, mammography self-efficacy, and participation in screening programs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants were randomized into two intervention groups and one control group using block randomization via a digital program (randomiser.org). Six letter combinations of "A," "B," and "C" were created and randomly assigned to 78 participants in blocks of 13. The sequence of combinations was predetermined (see Figure 3.5). Letters "A," "B," and "C" were assigned to the health education, control, and motivational interviewing groups, respectively.
| Arm | Type | Receives |
|---|---|---|
| Health Education Group | Experimental | Behavioral: Health EducationParticipants will receive structured education sessions focused on increasing knowledge about breast cancer, risk factors, and the importance of early screening. |
| Motivational Interviewing Group | Experimental | Behavioral: Motivational InterviewingParticipants will engage in one-on-one counseling sessions using motivational interviewing techniques to enhance motivation and reduce barriers to mammography screening. |
| Control Group | No intervention | –Participants will not receive any intervention during the study period. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willingness to participate in the study
- Being a woman aged between 40 and 69 years
- Being literate
- Registered at the Family Health Center where the study is conducted
Key exclusion criteria (7 listed)
- Having a first-degree relative (mother/sister) with a history of breast cancer
- Having had a mammogram in the last two years and/or regularly
- Having been diagnosed with any type of cancer
- Being pregnant
- Being in the postpartum period
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 EducationAlso: Assign to Arm: Health Education GroupStructured group education focused on breast cancer awareness, risk reduction, and early detection. | Behavioural | Health Education Group |
| Motivational InterviewingAlso: Motivational Interviewing groupIndividual counseling sessions using motivational interviewing to enhance screening behavior. | Behavioural | Motivational Interviewing Group |
Primary outcome
Mammography Screening Participation Rate
Time frame: Within 6 months after education/motivational interviewing intervention
The rate of participants who attend mammography screening within 6 months will be evaluated using health records and surveys.
1 secondary outcome
Breast Cancer Knowledge Level
Time frame: Baseline and 1 month after 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 24 Jul 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education and Motivational Interviewing in people with Breast Cancer and Breast - Female, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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 4 inclusion and 7 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 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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 serpil ozdemir (+90 533 451 85 04, serpil.ozdemir@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mammography Screening Participation Rate (time frame: Within 6 months after education/motivational interviewing 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 24 Jul 2025.