Effect of Audiovisual Education on Breast Cancer

NCT06898229 | Active Not Recruiting DMC

• 1 other identifier: GO 2022/857
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  5-10 minutes

Secondary Outcomes (1)

• Post-Training Screening Behaviour Follow-up Form

  5-10 minutes

Study Arms (2)

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.

Behavioral: Education

Control

NO INTERVENTION

Participants in the control group did not receive any treatment.

Interventions

Education 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.

Education

Eligibility Criteria

• Age: 40 Years - 69 Years
• Gender Eligibility Details: Illiterate Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not having completed the given training sessions
• Having had problems with breast cancer before.
• Having breast conserving surgery for any reason.

Sponsors & Collaborators

• Mehmet Akif Ersoy University: lead

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 36462274 RESULT

• 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.

  PMID: 37489226 RESULT

• 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.

  PMID: 15367754 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: They did not know if they were in the control and intervention group at the time of randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: September 15, 2024
• Primary Completion: February 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)