Breast Cancer AwarenessNCT07828119
The Effect of a Hybrid Approach in Breast Cancer Education on Women's Awareness, Fatalism, and Self-Compassion Levels: A Randomized Controlled Trial
A study testing Hybrid Breast Cancer Education in people with Breast Cancer Awareness, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of a hybrid breast cancer education program on women's breast cancer awareness, cancer fatalism, and self-compassion levels. The study will include 128 women aged 20-65 who apply to an obstetrics and gynecology outpatient clinic. 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 Awareness
- What is being tested?
- Hybrid Breast Cancer Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 31 Dec 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between 20 and 65 years of age
- Being female
- Agreeing to participate in the study and signing the informed consent form
- Having no prior diagnosis of breast cancer
- Having the ability to use a mobile application
Who cannot join
- Having a prior diagnosis of breast cancer or active breast pathology
- Having any cognitive, mental, or communication barrier that prevents participation in training
- Refusing to participate or withdraw consent during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kahramanmaras Sutcu Imam University Hospital, Department of Obstetrics and Gynecology, Delivery Room
Kahramanmaraş, Merkez, 46040
About this study
This randomized controlled trial aims to evaluate the effect of a hybrid breast cancer education program on women's breast cancer awareness, cancer fatalism, and self-compassion levels. The study will include 128 women aged 20-65 who apply to an obstetrics and gynecology outpatient clinic. Participants will be randomly assigned to either an experimental group or a control group. The experimental group will receive a hybrid education model. This model consists of a face-to-face training session using a breast model, followed by four weeks of educational materials, informative messages, and reminders delivered via a mobile application. The control group will receive routine healthcare services without this specific educational intervention. Researchers will measure the participants' levels of self-compassion, breast cancer fatalism, and breast cancer awareness using standardized questionnaires. These measurements will be taken at the beginning of the study (pre-test) and four weeks later (post-test) to determine if the technology-supported hybrid education model is effective in improving early diagnosis awareness and psychosocial outcomes
Read the detailed description
Breast cancer remains the most common cancer among women globally, making early detection and screening programs a primary target for public health policies. However, insufficient awareness and high levels of cancer fatalism can negatively impact women's participation in early diagnosis behaviors such as breast self-examination and mammography. Additionally, self-compassion is an emerging concept in women's health associated with better psychological resilience, stress management, and adherence to health behaviors. While digital technologies have transformed health education through hybrid models, there is a limited number of randomized controlled trials examining the combined effects of hybrid education approaches on awareness, fatalism, and self-compassion in community-based female populations. This study is designed to address this gap in the literature. The sample size was determined using a priori power analysis via G*Power software (MANOVA: Repeated measures, within-between interaction), calculating a minimum of 128 participants based on an effect size of f(V)=0.25, α=0.05, and test power of 0.80. Statistical analysis will be conducted using SPSS software. Following normality checks via Kolmogorov-Smirnov tests and the evaluation of skewness and kurtosis coefficients, group comparisons will be performed using appropriate parametric (e.g., Independent Samples t-test) or non-parametric (e.g., Mann-Whitney U, Wilcoxon signed-rank test) statistical methods. A p-value of <0.05 will be considered statistically significant.
- Conditions
- Breast Cancer Awareness
- Being tested
- Hybrid Breast Cancer Education
- Keywords
- Breast Cancer Awareness, Cancer Fatalism, Self-Compassion, Hybrid Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Breast Cancer EducationBehavioural
The experimental group will receive a hybrid breast cancer education model consisting of a face-to-face training session using a breast model, followed by educational materials, informative messages, and reminders delivered via a mobile application over a four-week period
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Breast Cancer Education Group | Experimental | The experimental group will receive a hybrid breast cancer education model consisting of a face-to-face training session using a breast model, followed by educational materials, informative messages, and reminders delivered via a mobile application over a four-week period. Receives: Behavioral: Hybrid Breast Cancer Education |
| Control Group | No intervention | Participants in the control group will not receive the hybrid breast cancer education intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Cancer Awareness Score
Change in participants' breast cancer awareness scores from baseline to 4 weeks post-intervention.
Measured: Baseline and 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer AwarenessStudies 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 one of two parallel groups in a 1:1 ratio: an experimental group receiving the hybrid breast cancer education model, and a control group receiving standard routine care.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Aksut Akcay, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07828119
- Sponsor's protocol ID
- KSU-TAREK-244
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and privacy in accordance with the ethical approval terms.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Hybrid Approach in Breast Cancer Education on Women's Awareness, Fatalism, and Self-Compassion Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07828119
- Acronym / sponsor ID
- KSU-TAREK-244
- Conditions
- Breast Cancer Awareness
- Keywords
- Breast Cancer Awareness, Cancer Fatalism, Self-Compassion, Hybrid Education
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Sep 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.
This randomized controlled trial aims to evaluate the effect of a hybrid breast cancer education program on women's breast cancer awareness, cancer fatalism, and self-compassion levels. The study will include 128 women aged 20-65 who apply to an obstetrics and gynecology outpatient clinic. Participants will be randomly assigned to either an experimental group or a control group. The experimental group will receive a hybrid education model. This model consists of a face-to-face training session using a breast model, followed by four weeks of educational materials, informative messages, and reminders delivered via a mobile application. The control group will receive routine healthcare services without this specific educational intervention. Researchers will measure the participants' levels of self-compassion, breast cancer fatalism, and breast cancer awareness using standardized questionnaires. These measurements will be taken at the beginning of the study (pre-test) and four weeks later (post-test) to determine if the technology-supported hybrid education model is effective in improving early diagnosis awareness and psychosocial outcomes
Detailed description
Breast cancer remains the most common cancer among women globally, making early detection and screening programs a primary target for public health policies. However, insufficient awareness and high levels of cancer fatalism can negatively impact women's participation in early diagnosis behaviors such as breast self-examination and mammography. Additionally, self-compassion is an emerging concept in women's health associated with better psychological resilience, stress management, and adherence to health behaviors. While digital technologies have transformed health education through hybrid models, there is a limited number of randomized controlled trials examining the combined effects of hybrid education approaches on awareness, fatalism, and self-compassion in community-based female populations. This study is designed to address this gap in the literature. The sample size was determined using a priori power analysis via G*Power software (MANOVA: Repeated measures, within-between interaction), calculating a minimum of 128 participants based on an effect size of f(V)=0.25, α=0.05, and test power of 0.80. Statistical analysis will be conducted using SPSS software. Following normality checks via Kolmogorov-Smirnov tests and the evaluation of skewness and kurtosis coefficients, group comparisons will be performed using appropriate parametric (e.g., Independent Samples t-test) or non-parametric (e.g., Mann-Whitney U, Wilcoxon signed-rank test) statistical methods. A p-value of <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups in a 1:1 ratio: an experimental group receiving the hybrid breast cancer education model, and a control group receiving standard routine care.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Breast Cancer Education Group | Experimental | Behavioral: Hybrid Breast Cancer EducationThe experimental group will receive a hybrid breast cancer education model consisting of a face-to-face training session using a breast model, followed by educational materials, informative messages, and reminders delivered via a mobile application over a four-week period. |
| Control Group | No intervention | –Participants in the control group will not receive the hybrid breast cancer education intervention during the study period. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between 20 and 65 years of age
- Being female
- Agreeing to participate in the study and signing the informed consent form
- Having no prior diagnosis of breast cancer
- Having the ability to use a mobile application
Key exclusion criteria (3 listed)
- Having a prior diagnosis of breast cancer or active breast pathology
- Having any cognitive, mental, or communication barrier that prevents participation in training
- Refusing to participate or withdraw consent during 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 |
|---|---|---|
| Hybrid Breast Cancer EducationThe experimental group will receive a hybrid breast cancer education model consisting of a face-to-face training session using a breast model, followed by educational materials, informative messages, and reminders delivered via a mobile application over a four-week period | Behavioural | Hybrid Breast Cancer Education Group |
Primary outcome
Breast Cancer Awareness Score
Time frame: Baseline and 4 weeks post-intervention
Change in participants' breast cancer awareness scores from baseline to 4 weeks post-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 18 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and privacy in accordance with the ethical approval terms.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Breast Cancer Education in people with Breast Cancer Awareness, run by Kahramanmaras Sutcu Imam 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 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: opening soon, as of the sponsor's last update on 18 Sep 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 Emine A AKSÜT AKÇAY, Assistant Professor (0553594 52 60, emineaksutakcay@ksu.edu.tr/), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer Awareness Score (time frame: Baseline and 4 weeks post-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 18 Sep 2026.