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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: İntervention group (n:40)
Women in the intervention group will undergo a simulator breast cancer awareness application in simple reality.
Other: Simple reality simulator application
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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