Breast CancerNCT06898229
Effect of Audiovisual Education on Breast Cancer
A study testing Education in people with Breast Cancer, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not having completed the given training sessions
- Having had problems with breast cancer before.
- Having breast conserving surgery for any reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Education
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Education | Active comparator | 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. Receives: Behavioral: Education |
| Control | No intervention | Participants in the control group did not receive any treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Champion Breast Cancer Fear Scale
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.
Measured: 5-10 minutes
Secondary outcomes (1)
Post-Training Screening Behaviour Follow-up Form
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.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start15 Sep 2024
- Primary completion15 Feb 2025
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurten Terkes, Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898229
- Sponsor's protocol ID
- GO 2022/857
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All authors contributed to the interpretation, writing, and approval of the final manuscript.
Publications
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.
PubMed 36462274Joulaei 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.
PubMed 37489226Champion 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.
PubMed 15367754Yamac SU, Terkes N. The Effect of Audiovisual Education on Breast Cancer Screening and Fear Among Illiterate Women: A Double-Blind Randomised Controlled Trial. J Eval Clin Pract. 2026 Feb;32(1):e70387. doi: 10.1111/jep.70387.
PubMed 41709589
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Audiovisual Education on Breast Cancer Screening and Fear in Illiterate Women
- ClinicalTrials.gov ID
- NCT06898229
- Acronym / sponsor ID
- GO 2022/857
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 27 Mar 2025 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Active comparator | Behavioral: EducationIt 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. |
| Control | No intervention | –Participants in the control group did not receive any treatment. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- Not having completed the given training sessions
- Having had problems with breast cancer before.
- Having breast conserving surgery for any reason.
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 |
|---|---|---|
| EducationThe 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. | Behavioural | Education |
Primary outcome
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.
1 secondary outcome
Post-Training Screening Behaviour Follow-up Form
Time frame: 5-10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Results publication: PubMed 36462274Ozdemir 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.
- Results publication: PubMed 37489226Joulaei 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.
- Results publication: PubMed 15367754Champion 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.
- Derived from this study: PubMed 41709589Yamac SU, Terkes N. The Effect of Audiovisual Education on Breast Cancer Screening and Fear Among Illiterate Women: A Double-Blind Randomised Controlled Trial. J Eval Clin Pract. 2026 Feb;32(1):e70387. doi: 10.1111/jep.70387.
- Individual participant dataSharing planned: No. All authors contributed to the interpretation, writing, and approval of the final manuscript.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Breast Cancer, run by Mehmet Akif Ersoy 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 8 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Champion Breast Cancer Fear Scale (time frame: 5-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06898229, which also lists 4 linked publications.
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 27 Mar 2025.