NCT07692464

Brief Summary

Breast cancer is the most common malignancy among women and remains a major public health concern despite being largely preventable through early detection and regular screening practices. Increasing early detection rates depends on women's ability to recognize the signs and symptoms of breast cancer, perform regular breast self-examination (BSE), and maintain adequate health motivation. However, women who are illiterate and reside in rural areas generally have low levels of breast cancer awareness, which adversely affects early detection behaviors. This situation is associated with insufficient knowledge, misconceptions, limited access to healthcare services, and low health literacy. Previous studies have demonstrated that educational interventions supported by visual materials are effective in improving health awareness among individuals with low educational attainment. Therefore, this study aims to contribute to the limited literature by evaluating an intervention designed to improve breast cancer awareness among women with low literacy levels. The study is designed for illiterate women of reproductive age (15-49 years) living in rural areas. Participants will receive breast self-examination (BSE) education using visual materials. The educational content will include breast anatomy, signs and symptoms of breast cancer, the importance of early detection, and the correct steps for performing breast self-examination. Pictures, breast models, videos, and hands-on demonstration techniques will be used throughout the educational sessions. The effectiveness of the intervention will be evaluated using a pretest-posttest design by comparing changes in breast cancer awareness and health motivation before and after the educational program. The research process will include a literature review, development of educational materials, implementation of the intervention, data collection, and statistical analysis, with the principal investigator actively involved in all phases of the study. The study is expected to improve participants' ability to recognize the signs and symptoms of breast cancer, increase the frequency of breast self-examination, and enhance their health motivation. Furthermore, the findings are expected to support the development of community-based health education skills among midwifery students, encourage their active participation in preventive healthcare services, and strengthen their involvement in scientific research. The results may also provide evidence for planning educational programs targeting women with low educational attainment and contribute to the development of visual material-based educational strategies. Ultimately, the study is anticipated to increase women's awareness of their own health responsibilities, promote early detection behaviors, improve quality of life, and indirectly contribute to reducing breast cancer-related mortality.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
May 2026Jan 2027

Study Start

First participant enrolled

May 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

July 2, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

Breast CancerBreast Cancer AwarenessHealth MotivationMidwifery

Outcome Measures

Primary Outcomes (1)

  • Breast Cancer Awareness Level

    Breast cancer awareness will be assessed using a validated Breast Cancer Awareness Scale. The scale evaluates participants' knowledge regarding breast cancer symptoms, early detection practices, and screening behaviors. Higher scores reflect greater levels of breast cancer awareness and knowledge.

    Baseline and immediately after the 15-minute intervention session

Secondary Outcomes (1)

  • Health Motivation Level

    Baseline and immediately after the 10-15-minute educational intervention session

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants will receive a structured visual breast self-examination education program using illustrated educational materials and an amigurumi breast model, in addition to routine care.

Behavioral: Visual-based Breast Self-Examination (BSE) Education

Control Group

NO INTERVENTION

Participants will receive routine care without the visual breast self-examination education during the study period.

Interventions

A structured behavioral education program designed for illiterate women aged 15-49 years to improve breast cancer awareness and breast self-examination (BSE) skills. The intervention is delivered face-to-face using visual educational materials, pictorial brochures, an amigurumi breast model, and guided hands-on demonstrations. The program includes repeated teaching sessions and practical applications to reinforce learning and support behavioral change in breast health practices.

Also known as: Visual breast cancer education program, KKMM training program, Self-Examination (BSE) Training
Intervention Group

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Able to communicate,
  • Have no vision or hearing problems,
  • Between the ages of 15-49,
  • Have no diagnosed chronic diseases (cardiovascular diseases, asthma, epilepsy, etc.),
  • Have not received breast cancer or breast self-examination training within the last 21 days will be included in the study.

You may not qualify if:

  • Women who are currently pregnant or planning to become pregnant in the near future,
  • have a family history of breast cancer,
  • or have health problems that prevent them from participating in the training will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

İnönü University Faculty of Health Sciences

Malatya, 44, Turkey (Türkiye)

Location

İnönü University Faculty of Health Sciences

Malatya, Turkey (Türkiye)

Location

Related Publications (1)

  • Al-Naggar RA, Al-Naggar DH, Bobryshev YV, Chen R, Assabri A. Practice and barriers toward breast self-examination among young Malaysian women. Asian Pac J Cancer Prev. 2011;12(5):1173-8.

    PMID: 21875261BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsBreast Self-Examination

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSelf-ExaminationHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the intervention group receiving visual breast self-examination education or the control group receiving routine care. Outcomes will be compared between the two groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 9, 2026

Study Start

May 1, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared. The dataset generated in this study will remain confidential and will only be used for scientific reporting and publication purposes.

Locations