Effect of Audiovisual Education on Breast Cancer

NCT ID: NCT06898229

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-09-15

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: BEHAVIORAL

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.

Control

Participants in the control group did not receive any treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Being between the ages of 40-69 (Republic of Turkey Ministry of Health, 2020a).

2. Being a woman living in rural areas.

3. Being an illiterate woman.

4. Not being diagnosed with breast cancer.

5. Not being pregnant, breastfeeding or puerperant.

6. Accepting to participate in the study.

7. Absence of a mental illness.

8. No communication barriers

Exclusion Criteria

1. Not having completed the given training sessions

2. Having had problems with breast cancer before.

3. Having breast conserving surgery for any reason.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mehmet Akif Ersoy University

OTHER

Sponsor Role: lead

Responsible Party

Nurten Terkes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Burdur Mehmet Akif Ersoy University

Burdur, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 36462274 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37489226 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15367754 (View on PubMed)

Other Identifiers

GO 2022/857

Identifier Type: -

Identifier Source: org_study_id