NCT07541859

Brief Summary

This quasi-experimental study aims to determine whether a breast and cervical cancer awareness training program can increase participation in cancer screening among women with visual impairments. The study also aims to identify barriers to screening and improve knowledge about cancer risk factors and screening methods. The main questions this study will address are:

  • Does the training increase the rate at which women with visual impairments attend cancer screening appointments?
  • Does the training improve participants' knowledge about breast and cervical cancer? Participants will:
  • Receive training on breast and cervical cancer risk factors and screening methods.
  • Learn how to apply to the Cancer Early Diagnosis, Screening, and Training Center.
  • Be encouraged to attend cancer screening during the study period.
  • Have knowledge and screening status assessed before the training, immediately after, and three months later.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 20, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 21, 2026

Status Verified

August 1, 2025

Enrollment Period

1 month

First QC Date

August 20, 2025

Last Update Submit

April 14, 2026

Conditions

Keywords

Cancer ScreeningVisual Impairment AwarenessUterine Cervical NeoplasmsBreast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Change in Cancer Screening Uptake Rate

    Change in the percentage of visually impaired women who undergo breast and cervical cancer screening at Cancer Early Diagnosis, Screening, and Training Centers (KETEM) after the educational intervention. * Scale: Not applicable (measured as percentage). * Range: 0% - 100%. * Interpretation: Higher percentages indicate a better outcome (higher screening participation).

    Post-test (immediately after the training), follow-up test (3 months later).

Secondary Outcomes (1)

  • Change in Knowledge Scores

    Pre-test (before education), post-test (immediately after education), and follow-up test (3 months later)

Study Arms (2)

Cancer Screening Awareness Education (Intervention Group)

EXPERIMENTAL

Participants in the experimental group will receive an educational intervention on breast and cervical cancer awareness, including information on risk factors, screening methods, and guidance on how to apply to Cancer Early Diagnosis, Screening, and Training Centers. Participants will also be encouraged to accompany a visually impaired peer to a screening appointment. All participants will complete a pre-test, a post-test immediately after the intervention, and a follow-up test at 3 months.

Behavioral: Cancer Screening Awareness Education for Visually Impaired Women

No Education (Control Group)

NO INTERVENTION

Participants in the control group will not receive any educational intervention during the study period. After the completion of the study, they will be offered the same educational content provided to the experimental group. All participants will complete a pre-test, a post-test at the end of the study period, and a follow-up test at 3 months.

Interventions

This intervention is an educational program designed to increase awareness among visually impaired women regarding breast cancer, cervical cancer, and colorectal cancer screenings. The training covers cancer risk factors, screening methods, the application process for Cancer Early Diagnosis, Screening and Training Centers (KETEM), communication methods, and recommended screening intervals. Following the training, participants will receive individual counseling to support them in scheduling screening appointments. A pre-test, post-test, and follow-up test will be administered during the intervention process.

Cancer Screening Awareness Education (Intervention Group)

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study includes only individuals who are biologically female.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with only a visual impairment (congenital or acquired)
  • Able to communicate, speak, and understand Turkish
  • Voluntarily agree to participate in the study
  • Over the age of 40
  • Have had previous sexual intercourse (Pap smear screening requires sexual activity)

You may not qualify if:

  • Diagnosed with breast or cervical cancer
  • Under the age of 40
  • Have not had sexual intercourse before
  • Have undergone screening for at least one of these two cancer types (breast or cervical) within the last year
  • According to the Turkish Ministry of Health, General Directorate of Public Health, in current screenings conducted in our country, within the breast cancer screening program for women, mammography is recommended every two years for women aged 40-69, and within the cervical cancer screening program, Pap smear and HPV-DNA tests are recommended every five years for women aged 30-65. Since women will be referred by the researchers to KETEM centers after training to undergo mammography and Pap smear screening tests, visually impaired women over the age of 40 who have previously had sexual intercourse will be included in the study, as these two screening tests are performed in this common age group and Pap smear screening requires being sexually active.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Turkish Association for the Blind

Istanbul, Kadıköy, Turkey (Türkiye)

Location

Altınokta Association of the Blind

Istanbul, Şişli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Cansu Nirgiz, Phd candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: The study will use a parallel assignment model. Participants will be divided into two groups: * Intervention group: Visually impaired women will receive education on breast and cervical cancer risk factors, screening methods, and the application process for Cancer Early Diagnosis, Screening, and Training Centers. * Control group: Will not receive the training during the study period and will continue with usual care (training will be provided after the study). In both groups, knowledge levels and screening participation status will be assessed before the intervention, immediately after, and three months later. No randomization or blinding will be applied in this study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2025

First Posted

April 21, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 21, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The IPD will not be shared due to confidentiality and privacy concerns, as the dataset contains sensitive personal health information of visually impaired participants. Data sharing could risk breaching participant anonymity despite de-identification efforts.

Locations