Persons With Visual DisabilitiesGORSEMNCT07541859
Breast and Cervical Cancer Awareness Training in Visually Impaired Women
A study testing Cancer Screening Awareness Education for Visually Impaired Women in people with Persons With Visual Disabilities and Breast Neoplasms, run by Marmara University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Persons With Visual Disabilities, Breast Neoplasms, Uterine Cervical Neoplasms
- What is being tested?
- Cancer Screening Awareness Education for Visually Impaired Women
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Turkish Association for the Blind
Istanbul, Kadıköy
Cansu Nirgiz, PhD Candidate, +905375024957, cansunirgiz@hotmail.com
Altınokta Association of the Blind
Istanbul, Şişli
About this study
Official title: The Effect of Awareness Education on Breast and Cervical Cancer Screening Among 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?
Read more
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.
Read the detailed description
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.
-
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.
-
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. - 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. - 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.
- Conditions
- Persons With Visual Disabilities, Breast Neoplasms, Uterine Cervical Neoplasms, Awareness, Early Detection of Cancer
- Being tested
- Cancer Screening Awareness Education for Visually Impaired Women
- Keywords
- Cancer Screening, Visual Impairment Awareness, Uterine Cervical Neoplasms, Breast Neoplasms
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Screening Awareness Education for Visually Impaired WomenBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-test (immediately after the training), follow-up test (3 months later).
Secondary outcomes (1)
Change in Knowledge Scores
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).
Measured: Pre-test (before education), post-test (immediately after education), and follow-up test (3 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study startJun 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persons With Visual DisabilitiesStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541859
- Sponsor's protocol ID
- 34.2025fbu
- Acronym
- GORSEM
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Awareness Education on Breast and Cervical Cancer Screening Among Visually Impaired Women
- ClinicalTrials.gov ID
- NCT07541859
- Acronym / sponsor ID
- GORSEM / 34.2025fbu
- Conditions
- Persons With Visual Disabilities, Breast Neoplasms, Uterine Cervical Neoplasms, Awareness, Early Detection of Cancer
- Keywords
- Cancer Screening, Visual Impairment Awareness, Uterine Cervical Neoplasms, Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
-
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.
-
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. - 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. - 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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cancer Screening Awareness Education (Intervention Group) | Experimental | Behavioral: Cancer Screening Awareness Education for Visually Impaired WomenParticipants 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. |
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cancer Screening Awareness Education for Visually Impaired WomenThis 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. | Behavioural | Cancer Screening Awareness Education (Intervention Group) |
Primary outcome
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).
1 secondary outcome
Change in Knowledge Scores
Time frame: Pre-test (before education), post-test (immediately after education), and follow-up test (3 months later)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Persons With Visual Disabilities
Recruiting
VisionWay Accessibility
Persons With Visual Disabilities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Screening Awareness Education for Visually Impaired Women in people with Persons With Visual Disabilities and Breast Neoplasms, run by Marmara University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cansu Nirgiz, Phd candidate (+905375024957, cansunirgiz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cancer Screening Uptake Rate (time frame: Post-test (immediately after the training), follow-up test (3 months later).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.