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

September 15, 2026 updated by: Emine Aksut Akcay, Kahramanmaras Sutcu Imam University
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
No Intervention: Control Group
Participants in the control group will not receive the hybrid breast cancer education intervention during the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kahramanmaras Sutcu Imam University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

September 3, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KSU-TAREK-244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect participant confidentiality and privacy in accordance with the ethical approval terms.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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