ClinicalTrials.gg
Not yet recruitingNCT07828119Updated Sep 18, 2026

The Effect of a Hybrid Approach in Breast Cancer Education on Women's Awareness, Fatalism, and Self-Compassion Levels: A Randomized Controlled Trial

An interventional study of Hybrid Breast Cancer Education in Breast Cancer Awareness, sponsored by Kahramanmaras Sutcu Imam University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Breast Cancer Awareness

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Keywords

  • Breast Cancer Awareness
  • Cancer Fatalism
  • Self-Compassion
  • Hybrid Education
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 128 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 198 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being between 20 and 65 years of age
  • Being female
  • Agreeing to participate in the study and signing the form
  • Having no prior diagnosis of breast cancer
  • Having the ability to use a mobile application

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    Hybrid Breast Cancer Education Group

    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.

    Behavioral: Hybrid Breast Cancer Education

  • No intervention
    Control Group

    Participants in the control group will not receive the hybrid breast cancer education intervention during the study period.

Interventions

  • BehavioralHybrid Breast Cancer Education

    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

06

What researchers measure

Primary outcomes

  1. Breast Cancer Awareness Score

    Change in participants' breast cancer awareness scores from baseline to 4 weeks post-intervention.

    Time frame: Baseline and 4 weeks post-intervention

07

Study locations

1 site
  • Kahramanmaras Sutcu Imam University Hospital, Department of Obstetrics and Gynecology, Delivery Room
    Kahramanmaraş, Merkez 46040, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared to protect participant confidentiality and privacy in accordance with the ethical approval terms.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 3 months is below that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2026
First posted
Sep 18, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07828119
Responsible party
Emine Aksut Akcay (Asst. Prof. Dr., Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Sep 18, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 18, 2026

Study contacts

Emine A AKSÜT AKÇAY, Assistant Professor
Contact
emineaksutakcay@ksu.edu.tr/
0553594 52 60
Hülya KAMALAK, Master's Student
Contact
hulyakoca31@windowslive.com
0553594 52 60

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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