Breast Cancer Awareness and BSE in Visually Impaired WomenNCT06274762
Visually Impaired Women Model-based Cancer Education and Breast Self-examination
A study testing Training and BSE application on a model in people with Breast Cancer Awareness and BSE in Visually Impaired Women, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to raise awareness among visually impaired women, who are in the vulnerable group, about breast cancer, which ranks first among female cancers, and to teach breast self-examination. Read more about this study
- Who is it for?
- Ages 20 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Awareness and BSE in Visually Impaired Women
- What is being tested?
- Training and BSE application on a model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being visually impaired
- Volunteering to participate in research
- Not having any disability other than visual impairment
- Being knowledgeable individuals who can communicate
- Not being diagnosed with breast cancer
Who cannot join
- Not being willing to participate in the research
- Not filling out research-related forms completely
- Abandoning the study at any time during the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University
Istanbul
Marmara University, sevalsaray.demir@gmail.com
Seval Saraydemir Kıromeroglu
About this study
Official title: Breast Cancer Awareness of Women With Visual Impairment and Self-administered Health Belief Model-Based Education Effect on Breast Examination Skills
The aim of our study was to raise awareness among visually impaired women, who are in the vulnerable group, about breast cancer, which ranks first among female cancers, and to teach breast self-examination.
Read the detailed description
Cancer ranks second after cardiovascular diseases among the causes of death in the world and in our country and it is predicted that by 2030 this situation will change due to changing living and environmental conditions and cancer will take the first place. Breast cancer is the most common type of cancer among female cancers. Breast cancer is a type of cancer that can be prevented and treated if diagnosed early. For this reason, screening programs have been developed to prevent breast cancer and these screening programs include breast self-examination (BSE), clinical breast examination and mammography. These screening programs, which are also accepted in our country, include all women between the ages of 20-69. should be included. However, 11% of breast cancer cases are diagnosed at a distant stage. Disability for women, it affects their access to health services; people's perceptions of disability, inappropriate health services facilities and equipment, stereotypes and discrimination, economic inadequacy, negative treatment from staff, unequal allocation of time and money within the household for their care, limited health service coverage and lack of disability-related education, sensitization or recognition of women as a person in need of sexual and reproductive health care impede women's seeking, use and access to health care. However, every woman has the right to regular gynecological examinations and good care. In our study, the breast cancer awareness of visually impaired women and the effect of training based on the health belief model on their ability to perform breast self-examination will be evaluated. The population of the study consists of visually impaired women between the ages of 20-69. The sample of the study was calculated based on Cohen's effect size study.
Taking d (effect size) as 0.8, α= 0.05 and power as 0.95, the experimental group was determined as 42 and the control group as 42 people. G power 3.1 program was used in the calculations. Considering the problems that may occur during the research process, 45 in the experimental group and 45 in the control group, a total of 90 people constitute the sample of the study. As data collection tools; a questionnaire form including sociodemographic data created by the researchers, Champion's Health Belief Model Scale and KKMM Skill Checklist on Model will be used. The data will be analyzed with descriptive analyses in SPSS program and pre-test - post-test comparative analyses will be performed to determine the effectiveness of the intervention.
- Being tested
- Training and BSE application on a model
- Keywords
- Visually impaired women, breast self-examination, breast cancer
- Medical subject headings
- Breast Self-Examination, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training and BSE application on a modelOther
Also called Health Belief Model Based Education
A breast cancer awareness training designed according to the headings of sensitivity, seriousness, benefit, obstacle perception, health motivation and self-efficacy, which are the steps of the health belief model, followed by applied BSE on a model.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A pre-test will be conducted to determine socio-demographic data and to assess breast cancer awareness (champion health belief model scale). Experimental and control groups will be formed. The 45 people in the experimental group will be divided into 5 groups of 8 people. Each group will receive 45 minutes of theoretical training and 60 minutes of BSE application and will be explained and applications will be provided on the model. Question - Answer - 20 minutes will be allocated for feedback. 5 groups will be allocated one day each.4 weeks after the training, the experimental group will be called again in 5 groups and the champion health belief model scale will be repeated, they will be asked to perform the BSE application on the model and evaluation will be made according to the BSE evaluation form prepared by the researcher. 6 months after the study, the whatsapp group will be questioned about whether individuals have BSE. Receives: Other: Training and BSE application on a model |
| Control Group | Active comparator | A pre-test will be conducted to determine socio-demographic data and to assess breast cancer awareness (champion health belief model scale). Experimental and control groups will be formed.The control group will not be intervened until the study is over. Receives: Other: Training and BSE application on a model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Champion health belief model scale
The scale evaluates the individual's judgment about breast cancer and general health, including "sensitivity", "importance/seriousness" and "health motivation", "obstacles", "benefits" regarding BSE, "self-efficacy/confidence", "benefits" regarding mammography. " and "obstacles" dimensions. Which dimensions of the scale will be used varies depending on the purpose of the study and the characteristics of the study group. A 5-point Likert type scaling method ranging from 1 to 5 was used to evaluate the scale. Each dimension of the scale is evaluated separately and is not combined into a single total score. Accordingly, points equal to the number of dimensions used are obtained for each individual. Although completing the scale depends on which dimensions are used, it takes approximately 12-15 minutes when all of them are used. The scale consists of 36 items and 6 factors.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Awareness and BSE in Visually Impaired WomenStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- There is an experimental group of 45 visually impaired women aged 20-69 and a control group of 45. Randomization was not possible. Blinding could not be done.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seval Saray Demir, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274762
- Sponsor's protocol ID
- MARU-SBF-ROKÇ-01
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Awareness of Women With Visual Impairment and Self-administered Health Belief Model-Based Education Effect on Breast Examination Skills
- ClinicalTrials.gov ID
- NCT06274762
- Acronym / sponsor ID
- MARU-SBF-ROKÇ-01
- Keywords
- Visually impaired women, breast self-examination, breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Feb 2024 (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.
The aim of our study was to raise awareness among visually impaired women, who are in the vulnerable group, about breast cancer, which ranks first among female cancers, and to teach breast self-examination.
Detailed description
Cancer ranks second after cardiovascular diseases among the causes of death in the world and in our country and it is predicted that by 2030 this situation will change due to changing living and environmental conditions and cancer will take the first place. Breast cancer is the most common type of cancer among female cancers. Breast cancer is a type of cancer that can be prevented and treated if diagnosed early. For this reason, screening programs have been developed to prevent breast cancer and these screening programs include breast self-examination (BSE), clinical breast examination and mammography. These screening programs, which are also accepted in our country, include all women between the ages of 20-69. should be included. However, 11% of breast cancer cases are diagnosed at a distant stage. Disability for women, it affects their access to health services; people's perceptions of disability, inappropriate health services facilities and equipment, stereotypes and discrimination, economic inadequacy, negative treatment from staff, unequal allocation of time and money within the household for their care, limited health service coverage and lack of disability-related education, sensitization or recognition of women as a person in need of sexual and reproductive health care impede women's seeking, use and access to health care. However, every woman has the right to regular gynecological examinations and good care. In our study, the breast cancer awareness of visually impaired women and the effect of training based on the health belief model on their ability to perform breast self-examination will be evaluated. The population of the study consists of visually impaired women between the ages of 20-69. The sample of the study was calculated based on Cohen's effect size study.
Taking d (effect size) as 0.8, α= 0.05 and power as 0.95, the experimental group was determined as 42 and the control group as 42 people. G power 3.1 program was used in the calculations. Considering the problems that may occur during the research process, 45 in the experimental group and 45 in the control group, a total of 90 people constitute the sample of the study. As data collection tools; a questionnaire form including sociodemographic data created by the researchers, Champion's Health Belief Model Scale and KKMM Skill Checklist on Model will be used. The data will be analyzed with descriptive analyses in SPSS program and pre-test - post-test comparative analyses will be performed to determine the effectiveness of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There is an experimental group of 45 visually impaired women aged 20-69 and a control group of 45. Randomization was not possible. Blinding could not be done.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Training and BSE application on a modelA pre-test will be conducted to determine socio-demographic data and to assess breast cancer awareness (champion health belief model scale). Experimental and control groups will be formed. The 45 people in the experimental group will be divided into 5 groups of 8 people. Each group will receive 45 minutes of theoretical training and 60 minutes of BSE application and will be explained and applications will be provided on the model. Question - Answer - 20 minutes will be allocated for feedback. 5 groups will be allocated one day each.4 weeks after the training, the experimental group will be called again in 5 groups and the champion health belief model scale will be repeated, they will be asked to perform the BSE application on the model and evaluation will be made according to the BSE evaluation form prepared by the researcher. 6 months after the study, the whatsapp group will be questioned about whether individuals have BSE. |
| Control Group | Active comparator | Other: Training and BSE application on a modelA pre-test will be conducted to determine socio-demographic data and to assess breast cancer awareness (champion health belief model scale). Experimental and control groups will be formed.The control group will not be intervened until the study is over. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being visually impaired
- Volunteering to participate in research
- Not having any disability other than visual impairment
- Being knowledgeable individuals who can communicate
- Not being diagnosed with breast cancer
Key exclusion criteria (3 listed)
- Not being willing to participate in the research
- Not filling out research-related forms completely
- Abandoning the study at any time during the research
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 |
|---|---|---|
| Training and BSE application on a modelAlso: Health Belief Model Based EducationA breast cancer awareness training designed according to the headings of sensitivity, seriousness, benefit, obstacle perception, health motivation and self-efficacy, which are the steps of the health belief model, followed by applied BSE on a model. | Other | Control Group, Experimental group |
Primary outcome
Champion health belief model scale
Time frame: two weeks
The scale evaluates the individual's judgment about breast cancer and general health, including "sensitivity", "importance/seriousness" and "health motivation", "obstacles", "benefits" regarding BSE, "self-efficacy/confidence", "benefits" regarding mammography. " and "obstacles" dimensions. Which dimensions of the scale will be used varies depending on the purpose of the study and the characteristics of the study group. A 5-point Likert type scaling method ranging from 1 to 5 was used to evaluate the scale. Each dimension of the scale is evaluated separately and is not combined into a single total score. Accordingly, points equal to the number of dimensions used are obtained for each individual. Although completing the scale depends on which dimensions are used, it takes approximately 12-15 minutes when all of them are used. The scale consists of 36 items and 6 factors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training and BSE application on a model in people with Breast Cancer Awareness and BSE in Visually Impaired Women, run by Marmara University at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Champion health belief model scale (time frame: two weeks). 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 23 Feb 2024.