NCT07777289

Brief Summary

Objective: This study aims to evaluate the effectiveness of the "Teach Back" technique in increasing breast cancer knowledge among women with limited health literacy. Method: This research is a randomized controlled experimental study. The study is planned to be conducted with individuals who applied to the KETEM unit of Healthy Life Center No. 1, affiliated with the Karabağlar District Health Directorate in İzmir. Data will be evaluated for normality; dependent samples t-test will be used for pre- and post-education comparisons, and Wilcoxon signed-rank test will be used if normality is not achieved. Baseline differences between the experimental and control groups will be analyzed with independent samples t-test or Mann-Whitney U test, and categorical variables will be analyzed with the Chi-square test. In the study, the experimental group will receive breast cancer education in groups of 5, consisting of 20-minute sessions with a 4-week interval, presented in simple language avoiding medical jargon, and the education content will be re-explained by the participants in their own words. These sessions will consist of general content such as breast cancer risk factors, symptoms, and the importance of early diagnosis.

  1. 1.What are the risk factors and symptoms of breast cancer?
  2. 2.The importance of early detection of breast cancer (BSE, clinical breast examination (CBE), mammography).
  3. 3.What are the treatment options for breast cancer? (Surgical methods, systemic treatments (endocrine therapy, chemotherapy, hormonal therapy), and radiotherapy) (Kiyat \& Akyüz, 2024; Uçkaç, 2022; Altu et al., 2023; Hosseinifar, Afkhamzadeh \& Moayeri, 2024).

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Sep 2026

Shorter than P25 for not_applicable

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 Progress12%
Sep 2026Jun 2027

First Submitted

Initial submission to the registry

August 17, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

August 20, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 17, 2026

Last Update Submit

August 17, 2026

Conditions

Keywords

Breast CancerHealth LiteracyTeach-Back MethodHealth Education

Outcome Measures

Primary Outcomes (1)

  • Change in Breast Cancer Knowledge Level

    Assessed using the Knowledge Scale for Breast Cancer and Screening Methods (GKMKBT). Total scores range from 0 to 44, with higher scores indicating greater knowledge regarding breast cancer and screening procedures.

    Baseline (pre-intervention) and 1 month post-intervention

Secondary Outcomes (1)

  • Change in Health Literacy Level

    Baseline (pre-intervention) and 1 month post-intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants receive structured individual breast cancer awareness and screening education delivered using the Teach-Back method.

Other: Routine Health Education

Control Group

NO INTERVENTION

Participants receive standard breast cancer awareness and screening education provided through routine health center procedures.

Interventions

Structured individual health education on breast cancer screening and awareness delivered using the Teach-Back method to ensure comprehension among participants with low health literacy.

Also known as: Teach-Back Method Education, Standard Care Education
Intervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women over 18 years of age,
  • Having a health literacy score below 25 on the Turkish Health Literacy Scale.
  • Not having a diagnosed mental, visual, or learning disability by a physician.
  • Not having previously participated in any research project on breast health/breast education.
  • Being able to communicate verbally.
  • Not having breast cancer.

You may not qualify if:

  • Having a previous diagnosis of breast cancer. • Having cognitive impairments that may prevent participation in the study. • Having hearing or visual impairments that may negatively affect participation and interaction in the training process. • Lack of sufficient language proficiency to understand the training materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast NeoplasmsHealth Education

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

huri Yoğurtcu, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the educational intervention, no masking is applied to participants or investigators.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse, MSc

Study Record Dates

First Submitted

August 17, 2026

First Posted

August 20, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

August 20, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participant privacy and maintain confidentiality, as explicit consent for secondary data sharing was not obtained from participants under the approved study protocol.