- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06528808
Simple Simulation Based Breast Cancer Awareness Training
July 25, 2024 updated by: YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
The Effect of Simple Simulation-Based Breast Cancer Awareness Training on Women's Breast Cancer Knowledge and Fear Levels
It was planned to determine the effect of simple simulation-based breast cancer awareness training on women's breast cancer knowledge and fear levels.
The research population will consist of female service personnel working in institutions within the University of Health Sciences (SBÜ) (N: 670).
In order to determine the sample size in this research, which was planned as a quasi-experimental with a pre- and post-test design and a control group; The data showed a normal distribution, the standard deviation of the population was estimated to be 1, and the effect size (difference) was estimated to be 0.8.
It was calculated that if two independent n₁=40, n₂=40 samples were taken for the analysis to be carried out, at a 5% significance level, the maximum power value of the research would be 0.942182.
Both groups will be given theoretical training about breast cancer awareness, and women in the intervention group will practice breast cancer awareness with a simple valid simulator.
All groups will be informed before the applications.
The training content will be supported by distributing a 5-page training booklet created from breast health and cancer awareness content to the participants.
"Comprehensive Breast Cancer Knowledge Test", "Breast Cancer Fear Scale" and "Breast Cancer Awareness Scale" will be applied as a pre-test after the information.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34668
- University of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Volunteering to participate in the research.
- To work as female service personnel in institutions within the University of Health Sciences.
Exclusion Criteria:
- Not participating in all applications of simulation teaching.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: İntervention group (n:40)
Women in the intervention group will undergo a simulator breast cancer awareness application in simple reality.
|
Women in the intervention group will be given an application aimed at breast cancer awareness with a simple valid simulator.
|
|
No Intervention: Control group (n:40)
Control group women will receive 2 hours of theoretical training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Introductory Information Form
Time Frame: 10 minutes
|
In this form, created by the researchers based on the literature, participants' age, obstetric history (number of pregnancies, number of births, breastfeeding status, etc.), self-breast examination status, etc. questions are included.
|
10 minutes
|
|
Comprehensive Breast Cancer Knowledge Test
Time Frame: 10 minutes
|
The scale, developed by Stager in 1993, consists of 20 knowledge questions.
The Turkish adaptation of the scale was carried out by Başak and Tosun in 2015.
The scale is answered in a true-false manner, and there are 8 correct and 12 incorrect answers among the questions.
After the test application is carried out; According to the answer key of the scale, "correct" answers are given 1; "Incorrect" and blank answers were given 0 points.
GKMKBT includes two dimensions: general knowledge and treatability.
Questions from 1 to 12; general knowledge about breast cancer; Questions 13 to 20 contain information about the treatability of breast cancer.
The reliability of the scale was found to be 0.71.
|
10 minutes
|
|
Breast Cancer Fear Scale
Time Frame: 10 minutes
|
It was developed by Champion in 2004 to examine women's breast cancer fears by determining their emotional responses to breast cancer and screening.
The Turkish validity and reliability study of the scale was conducted by Seçginli in 2012.
The scale contains eight items and is scored on a 5-point Likert type.
According to this scoring, the lowest possible score is 8 and the highest score is 40.
A higher score from the scale indicates a higher level of breast cancer fear.
On scale; Scoring between 8 and 15 indicates a low level of fear of breast cancer, scoring between 16 and 23 indicates a moderate level of fear of breast cancer, and scoring between 24 and 40 indicates a high level of fear of breast cancer.
Cronbach's Alpha value of the scale was found to be 0.90.
|
10 minutes
|
|
Breast Cancer Awareness Scale
Time Frame: 10 minutes
|
The scale was developed in 2010 by the UK cancer research center, "King's College London" and "University College London" to determine breast cancer awareness.
In our country, the Turkish validity and reliability study of the scale was conducted by Baş and Ursavaş (2022).
The scale consists of a total of 13 items to determine breast cancer awareness, including symptoms (11 items), frequency of breast examination (1 item) and breast cancer age (1 item).
The scale has no cut-off point.
Answering 5 of the symptoms correctly is coded as 1 point, a 70-year-old woman is coded as 1 point, and breast examination once a month is coded as 1.
Incorrect answers are worth 0 points.
Scoring is between 0-3.
Cronbach's alpha value of the scale was found to be 0.89.
As the score obtained from the scale increases, breast cancer awareness increases.
|
10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comprehensive Breast Cancer Knowledge Test
Time Frame: 10 minutes
|
The scale, developed by Stager in 1993, consists of 20 knowledge questions.
The Turkish adaptation of the scale was carried out by Başak and Tosun in 2015.
The scale is answered in a true-false manner, and there are 8 correct and 12 incorrect answers among the questions.
After the test application is carried out; According to the answer key of the scale, "correct" answers are given 1; "Incorrect" and blank answers were given 0 points.
GKMKBT includes two dimensions: general knowledge and treatability.
Questions from 1 to 12; general knowledge about breast cancer; Questions 13 to 20 contain information about the treatability of breast cancer.
The reliability of the scale was found to be 0.71.
|
10 minutes
|
|
Breast Cancer Fear Scale
Time Frame: 10 minutes
|
It was developed by Champion in 2004 to examine women's breast cancer fears by determining their emotional responses to breast cancer and screening.
The Turkish validity and reliability study of the scale was conducted by Seçginli in 2012.
The scale contains eight items and is scored on a 5-point Likert type.
According to this scoring, the lowest possible score is 8 and the highest score is 40.
A higher score from the scale indicates a higher level of breast cancer fear.
On scale; Scoring between 8 and 15 indicates a low level of fear of breast cancer, scoring between 16 and 23 indicates a moderate level of fear of breast cancer, and scoring between 24 and 40 indicates a high level of fear of breast cancer.
Cronbach's Alpha value of the scale was found to be 0.90.
|
10 minutes
|
|
Breast Cancer Awareness Scale
Time Frame: 10 minutes
|
The scale was developed in 2010 by the UK cancer research center, "King's College London" and "University College London" to determine breast cancer awareness.
In our country, the Turkish validity and reliability study of the scale was conducted by Baş and Ursavaş (2022).
The scale consists of a total of 13 items to determine breast cancer awareness, including symptoms (11 items), frequency of breast examination (1 item) and breast cancer age (1 item).
The scale has no cut-off point.
Answering 5 of the symptoms correctly is coded as 1 point, a 70-year-old woman is coded as 1 point, and breast examination once a month is coded as 1.
Incorrect answers are worth 0 points.
Scoring is between 0-3.
Cronbach's alpha value of the scale was found to be 0.89.
As the score obtained from the scale increases, breast cancer awareness increases.
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
October 30, 2024
Study Registration Dates
First Submitted
July 25, 2024
First Submitted That Met QC Criteria
July 25, 2024
First Posted (Actual)
July 30, 2024
Study Record Updates
Last Update Posted (Actual)
July 30, 2024
Last Update Submitted That Met QC Criteria
July 25, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBÜ-AYDINKARTAL-007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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