- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06898229
Effect of Audiovisual Education on Breast Cancer
March 26, 2025 updated by: Nurten Terkes, Mehmet Akif Ersoy University
Effect of Audiovisual Education on Breast Cancer Screening and Fear in Illiterate Women
This study was conducted as a double-blind randomised controlled trial to determine the effect of education using audio-visual methods and simulation techniques on breast cancer screening and breast cancer fears in illiterate women.
The study was conducted in the villages of a district in the south of Turkey with a distance of over 100 km to health institutions.
The sample size of the study was calculated with the G*Power 3.1 programme based on the mean breast cancer fear scores (22.42±8.30
for those without family history and 28.14±6.23 for those with family history) in a study, with a 95% confidence interval, 5% margin of error, 0.92 effect size and 95% power.
As a result of this analysis, the minimum sample size required was determined as 64 people in total.
However, a total of 120 women were included in the study in order to increase the power of the research, to prevent possible data loss and to make the results more reliable.
Participants were divided into intervention (n=60) and control (n=60) groups by simple random sampling method.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
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
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Burdur, Turkey
- Burdur Mehmet Akif Ersoy University
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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:
- Being between the ages of 40-69 (Republic of Turkey Ministry of Health, 2020a).
- Being a woman living in rural areas.
- Being an illiterate woman.
- Not being diagnosed with breast cancer.
- Not being pregnant, breastfeeding or puerperant.
- Accepting to participate in the study.
- Absence of a mental illness.
- No communication barriers
Exclusion Criteria:
- Not having completed the given training sessions
- Having had problems with breast cancer before.
- Having breast conserving surgery for any reason.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Education
It focussed on informing and raising awareness.
In this process, basic information about the definition, importance, risk factors and symptoms of breast cancer was conveyed through audio-visual materials supported by short videos, animations and photographs.
In addition, group discussions were organised on the importance of breast cancer screening, the advantages of early diagnosis, and fears and concerns about breast cancer.
At the end of the training, the simulation applications were evaluated and the questions and concerns of the participants were discussed.
The trainings were repeated at the first follow-up, 3rd month and 6th month and the long-term effects of the study were evaluated.
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The intervention program aimed to increase participation in breast cancer screenings and reduce fear among illiterate women.
The three-month training was structured in three phases.
In the first month, awareness was raised through visual-audio materials about breast cancer, risk factors, and the importance of early diagnosis.
In the second month, practical training was provided on breast self-examination (BSE), and clinical breast examination (CBE) and mammography procedures were introduced.
In the final month, group discussions and success stories supported behavioral change, reinforcing knowledge.
The program's effectiveness was evaluated through pre-test and post-test comparisons.
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No Intervention: Control
Participants in the control group did not receive any treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Champion Breast Cancer Fear Scale
Time Frame: 5-10 minutes
|
The Scale is an 8-item measurement tool developed by Victoria Champion et al. in 2004.
In the original study of the scale, Cronbach's alpha coefficient was found to be 0.91 for African-American and white women and 0.94 for African-American women.
This scale was developed to determine the relationship between breast cancer, mammography behaviour and women's emotional reactions and is a Likert-type scale scored from 1 to 5. The highest score to be obtained from the scale is 40 and the lowest score is 8.
In the evaluation of the scores; 8-15 points indicate low level fear, 16-23 points indicate medium level fear and 24-40 points indicate high level fear.
Breast Cancer Fear Scale was adapted into Turkish by Seçginli in 2012.
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5-10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-Training Screening Behaviour Follow-up Form
Time Frame: 5-10 minutes
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This form was used as a post-test after the training and follow-up of the women.
With this form, it was determined which of the early diagnosis practices such as CHC, MMC and mammography the women performed.
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5-10 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Champion VL, Skinner CS, Menon U, Rawl S, Giesler RB, Monahan P, Daggy J. A breast cancer fear scale: psychometric development. J Health Psychol. 2004 Nov;9(6):753-62. doi: 10.1177/1359105304045383.
- Ozdemir A, Unal E. The effect of breast self-examination training on nursing students by using hybrid-based simulation on knowledge, skills, and ability to correctly evaluate pathological findings: Randomized Controlled Study. Nurse Educ Pract. 2023 Jan;66:103530. doi: 10.1016/j.nepr.2022.103530. Epub 2022 Nov 29.
- Joulaei H, Delshad MH, Pourhaji F. The Correlation of Social Support and Fear of Breast Cancer among Women in Northeast of Iran: A Cross-Sectional Study. Int J Community Based Nurs Midwifery. 2023 Jul;11(3):210-221. doi: 10.30476/IJCBNM.2023.98094.2225.
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 (Actual)
September 15, 2024
Primary Completion (Actual)
February 15, 2025
Study Completion (Estimated)
September 15, 2025
Study Registration Dates
First Submitted
March 20, 2025
First Submitted That Met QC Criteria
March 26, 2025
First Posted (Actual)
March 27, 2025
Study Record Updates
Last Update Posted (Actual)
March 27, 2025
Last Update Submitted That Met QC Criteria
March 26, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 2022/857
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All authors contributed to the interpretation, writing, and approval of the final manuscript.
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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