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Trial Title:
Visually Impaired Women Model-based Cancer Education and Breast Self-examination
NCT ID:
NCT06274762
Condition:
Breast Cancer Awareness and BSE in Visually Impaired Women
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Visually impaired women
breast self-examination
breast cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Crossover Assignment
Intervention 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.
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Training and BSE application on a model
Description:
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.
Arm group label:
Control Group
Arm group label:
Experimental group
Other name:
Health Belief Model Based Education
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not being willing to participate in the research
- Not filling out research-related forms completely
- Abandoning the study at any time during the research
Gender:
Female
Gender based:
Yes
Gender description:
Visually impaired women aged 20-69
Minimum age:
20 Years
Maximum age:
69 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Marmara University
Address:
City:
Istanbul
Country:
Turkey
Contact:
Last name:
Marmara University
Email:
sevalsaray.demir@gmail.com
Investigator:
Last name:
Seval Saraydemir Kıromeroglu
Email:
Principal Investigator
Start date:
April 1, 2024
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Marmara University
Agency class:
Other
Source:
Marmara University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06274762