NCT06371508

Brief 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. In Turkey, 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. 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. Breast self-examination is an important examination method in terms of detecting changes in breast tissue and preventing subsequent complications. It is also an easy-to-apply, cheap and non-invasive method. In Turkey, 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. There are studies showing that fear of breast cancer has a positive and negative impact on early diagnosis behaviors. 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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

April 14, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

breast self examinationbreast cancereducationfear

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Women in the experimental group of the research will be given training content prepared by the researcher. The training presentation content will include information about breast cancer, breast cancer screening programs and breast self-examination.

Behavioral: Education based on breast cancer and breast examination

Control group

NO INTERVENTION

Women in the control group will not be given any training and only their current information will be determined. Additionally, their awareness on this issue will be raised as they participate in the study.

Interventions

Training for the intervention group will be provided with a 40-45 minute training organized by one of the researchers.

Experimental group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocadere Sağlık Evi

Yalova, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsBreast Self-Examination

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSelf-ExaminationHealth BehaviorBehavior

Study Officials

  • Yasemin Hamlacı Başkaya, Phd.

    Sakarya University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

April 14, 2024

First Posted

April 17, 2024

Study Start

February 1, 2024

Primary Completion

May 15, 2024

Study Completion

July 15, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations