Breast Cancer and Breast Self-examination Education

Breast Cancer Clinical Trial

Official title:

The Effect of Breast Cancer and Breast Self-examination Education Given to Women on Breast Cancer Fear and Breast Examination Skills

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06371508
• Other study ID #: 14042024
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: April 2024
• Source: Sakarya University
• Contact: Yasemin Hamlaci Baskaya, PhD.
• Phone: 05556080628
• Email: yhamlaci[@]sakarya.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

According to a news published by the World Health Organization (WHO); More than 2.3 million cases of breast cancer occur each year, making it the most common cancer among adults. In 95% of all countries, breast cancer is the first or second cause of female cancer death. In 2020, 2.3 million women worldwide were diagnosed with breast cancer and 685,000 deaths occurred (WHO, 2023; https://www.who.int/news/item/03-02-2023-who-launches-new-roadmap- on-breast-cancer). In our country, breast cancer ranks first among the most common cancer types in women, and the number of breast cancer cases in women in 2020 was recorded as 74 638 (IARC, 2023). As a result of this situation, WHO (2023) published the Global Breast Cancer Initiative Framework to save 2.5 million lives from breast cancer by 2040. This published framework includes health promotion for early detection, timely diagnosis and comprehensive management of breast cancer. One of the most effective ways to reduce breast cancer mortality and morbidity rate is early diagnosis. It is important to determine early diagnosis and signs and symptoms of cancer before they appear. Early diagnosis of breast cancer is possible with breast self-examination (BSE), clinical breast examination and mammography (Kayar, 2019). Breast self-examination is an important examination method in terms of detecting changes in breast tissue and preventing subsequent complications (Abo Al-Shiekh et al., 2021). It is also an easy-to-apply, cheap and non-invasive method. In our country, it is recommended that women regularly perform breast self-examination every month after the age of 20, women between the ages of 20 and 40 should have a clinical breast examination every two years, and women between the ages of 40 and 69 should have a clinical breast examination every year and have a mammogram every two years (Ministry of Health, 2019). . There are studies showing that fear of breast cancer has a positive and negative impact on early diagnosis behaviors (Champion et al., 2004; Yavan et al., 2010). Champion et al. (2004) stated that women with moderate breast cancer fear had a high rate of early detection behavior, whereas low and high fear levels had a negative effect on behavior. In the study conducted by Yavan et al. (2010) on 188 women, 2% of the women. They found that 3 of them had regular BSE and 78.7% of them had never had a mammography. In addition, 85% of the women included in the study stated that they had a fear of breast cancer due to a family history of breast cancer, being diagnosed with breast cancer, and the presence of risk factors. Study results show that fear of breast cancer affects screening results. Therefore, our aim in the study is; To determine the effect of breast cancer and BSE training given to women on breast cancer fear and BSE skills.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Able to read and write, Having no history of breast cancer, No communication barriers, Not pregnant or lactating, Those who are willing and agree to participate in the research.

Exclusion Criteria:

• Having a mental illness, Those who wish to withdraw from any part of the research.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Education based on breast cancer and breast examination
Training for the intervention group will be provided with a 40-45 minute training organized by one of the researchers.

Locations

Country	Name	City	State
Turkey	Kocadere Saglik Evi	Yalova

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Champion Breast Cancer Fear Scale Change	Breast Cancer Fear Scale; Champion et al. The scale developed by (2004) is an 8-item, one-dimensional, five-point Likert type measurement tool. The measurement tool was adapted to Turkish culture by Seçginli (2012). The items in the scale are scored by the participants as "strongly disagree" 1 point, "disagree" 2 points, "undecided" 3 points, "agree" 4 points, "completely agree" 5 points. The lowest score from the scale is 8 and the highest score is 40. As the scores from the scale increase, the level of breast cancer fear increases. 8-15 points from the scale indicate "low level of fear", 16-23 points indicate "medium level fear", and 24-40 points indicate "high level fear".	pre-intervention, 1 month after intervention
Primary	Breast Self Examination Checklist Success Score	Breast self-examination proficiency rating instrument-BSEPRI was developed by Robin Wood in 1994. In the study, the form will be used to evaluate women's ability to perform breast self-examination according to appropriate stages and their ability to detect breast masses. There are 10 statements in the form that include the stages of performing BSE. 10 points are given for each stage of the examination that is completed correctly, and 0 points are given for any stage that is incorrectly performed or not performed. Accordingly, a minimum of 0 and a maximum of 100 points are taken from the form. A BSE score of 90 or above indicates that the BSE was performed correctly, and a score of 80 or below indicates that the BSE was not performed correctly.	pre-intervention, 1 month after intervention