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NCT Number: NCT07541859

Breast and Cervical Cancer Awareness Training in Visually Impaired Women

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.

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Key information

About this study

Cancer is recognized as a significant public health problem both worldwide and in Türkiye; with its physical and psychosocial burden, it reduces individuals' quality of life and imposes a substantial economic burden on the healthcare system. Breast and cervical cancer are among the most common types of cancer in women, and mortality rates can be significantly reduced through early diagnosis methods. However, not all segments of society have equal opportunities to access these screening programs. Especially, individuals with disabilities face serious barriers in accessing healthcare services; this situation decreases the rate of benefiting from screening services and deepens health inequalities.

Visually impaired women are among the most disadvantaged groups due to gender norms and physical access difficulties. At this point, the nursing profession plays an important role. Nurses, through professional roles such as practitioner, educator, advocate, counselor, and case manager, contribute to ensuring equal access to healthcare services for individuals. The assessment of healthcare needs of individuals with disabilities, providing appropriate training, and increasing awareness are integral parts of nursing care.

In this context, health education programs planned by nurses for individuals with disabilities present an important opportunity to increase early diagnosis behaviors and reduce health inequalities. This project aims to evaluate the effect of breast and cervical cancer awareness training on the screening behavior of visually impaired women. In the project, the "GORSEM" (Awareness Training on Breast and Cervical Cancer for Visually Impaired Women) program, developed based on the Health Belief Model, will be implemented. The training content includes recognizing risk factors, the importance of early diagnosis, screening methods, and information on accessing primary healthcare centers. Participants will be referred to screening centers.

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Aim

The main aim of this project is to evaluate the effect of breast and cervical cancer awareness training on participation behavior in cancer screenings and the level of knowledge of visually impaired women. With the "GORSEM" program developed within the scope of the project, the goal is to increase early diagnosis behaviors and reduce health inequalities.

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Objectives

  • To increase the participation rate in breast cancer (mammography) screening among participants in the intervention group compared to the control group
  • To increase the participation rate in cervical cancer (Pap smear) screening among participants in the intervention group compared to the control group
  • To increase the cancer knowledge level scale score of participants in the intervention group compared to the control group
  • To increase the benefit, seriousness, and self-efficacy subscale scores in the Health Belief Model scale of participants in the intervention group compared to the control group
  • To decrease the perceived barriers subscale scores in the Health Belief Model scale of participants in the intervention group compared to the control group

Research Question

  • Does awareness training increase the participation of visually impaired women in breast and cervical cancer screenings?

Hypotheses

  • The participation rate in breast cancer screening will be higher in the intervention group compared to the control group.
  • The participation rate in cervical cancer screening will be higher in the intervention group compared to the control group.
  • The level of knowledge about cancers will be higher among participants in the intervention group compared to the control group.
  • The benefit, seriousness, and self-efficacy subscale scores of the Health Belief Model scale will be higher in the intervention group.
  • The perceived barriers subscale scores will be lower in the intervention group.

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Research Design

This project will be conducted using a non-randomized quasi-experimental design with control groups. Participants will be divided into intervention and control groups, and the groups will be determined.

Independent Variable:

  • "GORSEM" program (awareness training)

Dependent Variables:

  • Participation status in breast and cervical cancer screenings (mammography and Pap smear rates)
  • Level of knowledge about cancers
  • Health Belief Model scale subscale scores (benefit, seriousness, self-efficacy, perceived barriers)

Participants and Sample

The sample of the project will consist of visually impaired women over the age of 40, sexually active, who are members of the Turkish Association of the Visually Impaired Kadıköy Branch (intervention group) and the Six Dots Association of the Blind Şişli Branch (control group) in Istanbul. The minimum sample size determined by power analysis (G*Power 3.1) was calculated as 62 (at least 31 people in each group), and considering possible dropouts, the target is a total of 74 people. Efforts will be made to ensure that the intervention and control group samples are similar in terms of age, sexual experience, and screening history.

Inclusion criteria

Women who have only a visual impairment (congenital or acquired), can communicate, speak and understand Turkish, and voluntarily agree to participate in the study will be included.

Exclusion criteria

Women who have been diagnosed with either breast or cervical cancer, have undergone screening for at least one of these two cancer types within the last year, have never had sexual intercourse before, or are under the age of 40 will be excluded.

According to the Turkish Ministry of Health, General Directorate of Public Health, in current screenings conducted in Türkiye, 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 participants will be referred by the investigators to CEDSTC 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.

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Data Collection Method and Tools

Data will be collected by the investigators, on the day and time of the training, in the training room where the participants are present, by providing information about the research and answering questions about the research process. The Informed Consent Form will be read, and signed consent will be obtained from those who agree to sign, and verbal consent will be obtained via audio recording from those who cannot sign. Separate informed consent forms will be signed for the intervention group and the control group. Then, participants will be taken one by one to a private room, and the pre-test questions of the Descriptive Information Form, the Cancer Screening Knowledge Scale, the Cervical Cancer and Pap Smear Screening Health Belief Model Scale, and the Champion's Health Belief Model Scale for Breast Cancer Screenings will be read and the answers marked.

Descriptive Information Form The form, created by the investigators after a literature review, consists of 26 questions related to age, education level, household composition, employment status, income status, social security, disability pension status, having children, disability status, level of vision, menopausal status, smoking and alcohol use, family history of cancer, status of receiving information/counseling about screenings, and the persons from whom such information/counseling was received.

Cancer Screening Knowledge Scale The scale, developed by Öztürk and Uyar (2023), consists of 25 items and three sub-dimensions. The sub-dimensions are not specifically named. The first sub-dimension contains 10 items, the second contains 9, and the third contains 6 items. The scale is answered on a range from 1 to 3 as "1: True, 2: False, 3: I don't know." In scoring the scale, "True" answers are given 1 point, and "False" and "I don't know" answers are given 0 points. The lowest possible score is 0, and the highest is 25. Three items (items 2, 11, and 24) with negative meaning are reverse-coded when calculating the scale score. There is no cut-off point for the scale. Participants scoring 70% or more of the total score (17.5 points or more) are considered to have sufficient knowledge. The Cronbach's alpha coefficient of the scale is 0.89.

Cervical Cancer and Pap Smear Screening Health Belief Model Scale The Health Belief Model (HBM), developed by Champion for breast cancer and mammography, was adapted to cervical cancer and Pap smear testing by Güvenç et al. (2010) after Turkish validity and reliability analyses. The HBM was developed to help explain how changes occur in individuals' health behaviors. The Cervical Cancer and Pap Smear Screening Health Belief Model Scale consists of 35 items and five subscales. The Cronbach's alpha reliability coefficients of the subscales are: 0.95 for perceived susceptibility, 0.89 for perceived seriousness, 0.80 for perceived benefits and motivation, 0.71 for health motivation, and 0.88 for Pap smear barriers. The average Cronbach's alpha reliability coefficient of the scale is 0.77. Since all scores are above 0.70, the scale is considered reliable. The subscales of the HBM scale have Cronbach's alpha values of 0.968 for benefits and motivation, 0.927 for barriers, 0.921 for seriousness, 0.894 for susceptibility, and 0.854 for health motivation, indicating high reliability. The subscales are: cervical cancer susceptibility (3 items), cervical cancer health motivation (7 items), Pap smear benefits and motivation (4 items), Pap smear barriers (14 items), and cervical cancer seriousness (7 items). The scale is a 5-point Likert type, ranging from "strongly disagree" (1 point) to "strongly agree" (5 points).

Champion's Health Belief Model Scale for Breast Cancer Screenings The first form of the scale, developed by Victoria Champion in 1984 to measure beliefs about breast cancer and Breast Self-Examination (BSE), was revised in 1997 to update the dimensions related to BSE and add two new subscales related to mammography (mammography barriers and mammography benefits). In this revision, Cronbach's alpha reliability coefficients ranged from .65 to .90, and test-retest correlations ranged from .40 to .68. The Turkish adaptation was conducted by Gözüm et al. (2004). The scale includes dimensions such as "susceptibility," "seriousness," and "health motivation" related to judgments about breast cancer and general health; "barriers," "benefits," and "self-efficacy/confidence" related to BSE; and "benefits" and "barriers" related to mammography. Which dimensions of the scale are used depends on the purpose of the study and the characteristics of the study group. The scale is a 5-point Likert type.

Screening Test Attendance Form Prepared by the investigators, this form consists of a total of 4 open-ended questions (two for each cancer type) and is designed to determine, two weeks (post-test) and three months (follow-up test) after training, whether participants underwent screening, where the tests were conducted, to evaluate the results of those who had the tests, and to determine the reasons for not having the tests among those who did not. Screening results will be requested from the e-Nabız system without showing personal identification information two weeks and three months after the screening. The investigators will assist individuals who do not have an e-Nabız account or cannot log in.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Eligibility Criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Treatment and study plan

Cancer Screening Awareness Education for Visually Impaired Women

Behavioral

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.

Primary outcomes

  1. Change in Cancer Screening Uptake Rate

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

    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).

Secondary outcomes

  1. Change in Knowledge Scores

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

    Change in scores regarding breast and cervical cancer risk factors and screening methods.

    • Scale Title: Cancer Screening Knowledge Scale (Öztürk & Uyar, 2023).
    • Range: 0 - 25 points.
    • Interpretation: Higher scores indicate better knowledge.
    • Assessment Points: Pre-test (before education), post-test (immediately after education), follow-up test (3 months later).

Study contacts

Contact information is provided by the study sponsor or research team.

Cansu Nirgiz, Phd candidate

CONTACT

[email protected]

+905375024957

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

The Effect of Awareness Education on Breast and Cervical Cancer Screening Among Visually Impaired Women

Acronym: GORSEM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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