Clinical trial NCT06898229: Effect of Audiovisual Education on Breast Cancer
Official title: Effect of Audiovisual Education on Breast Cancer Screening and Fear in Illiterate Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 160
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Champion Breast Cancer Fear Scale
timeFrame: 5-10 minutes
Secondary outcomes:
measure: Post-Training Screening Behaviour Follow-up Form
timeFrame: 5-10 minutes
Other outcomes:
Locations:
city: Burdur
country: Turkey
facility: Burdur Mehmet Akif Ersoy University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.