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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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.

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 groups in NCT07083310
Study groupRoleWhat they receive
Health Education GroupExperimentalParticipants 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 GroupExperimentalParticipants 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 GroupNo interventionParticipants 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.

  1. 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)
  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.

  1. First posted24 Jul 2025
  2. Study startJul 2025 (estimated)
  3. Primary completionOct 2025 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

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)
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

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.

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