NCT07828119

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

September 3, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

September 18, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 3, 2026

Last Update Submit

September 15, 2026

Conditions

Keywords

Breast Cancer AwarenessCancer FatalismSelf-CompassionHybrid Education

Outcome Measures

Primary Outcomes (1)

  • Breast Cancer Awareness Score

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

    Baseline and 4 weeks post-intervention

Study Arms (2)

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.

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.

Interventions

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

Hybrid Breast Cancer Education Group

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants are eligible to participate in this study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaras Sutcu Imam University Hospital, Department of Obstetrics and Gynecology, Delivery Room

Kahramanmaraş, Merkez, 46040, Turkey (Türkiye)

Location

Central Study Contacts

Emine A AKSÜT AKÇAY, Assistant Professor

CONTACT

Hülya KAMALAK, Master's Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

September 3, 2026

First Posted

September 18, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

September 18, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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

Locations