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NCT Number: NCT06898229

Effect of Audiovisual Education on Breast Cancer

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.

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Key information

Conditions

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

Age range

40 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Burdur Mehmet Akif Ersoy University

Burdur, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Post-Training Screening Behaviour Follow-up Form

    Time frame: 5-10 minutes

    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.

Sponsors and collaborators

Lead sponsor

Mehmet Akif Ersoy University

Other

Registry information

Official study title

Effect of Audiovisual Education on Breast Cancer Screening and Fear in Illiterate Women

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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