NCT05960643

Brief Summary

The randomized controlled study to examine the effects of the educational interventions on BSE by revealing the breast self-examination (BSE) practices and breast health beliefs of female students studying at the university were completed with 101 students, 51 of whom were in the "experimental" and 50 "control" groups. The data were collected between November and December 2022 at a university in the Eastern Black Sea region of Turkey, using the 'Personal Information Form', 'BSE Practice Skill Assessment Form' and the 'Health Belief Model Scale' as a pre-test. As an initiative, 'BSE training given according to the Health Belief Model', which includes 120 minutes of training, including theoretical and model-based BSE practice, was implemented. Then, 3 weeks later, the 'BSE Application Skill Evaluation Form' was applied as a post-test. Data were analyzed using Indepent Sample and Paired Sample t-test, Benferroni test, Pearson correlation analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

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

October 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

June 15, 2023

Last Update Submit

July 21, 2023

Conditions

Keywords

breast examinationHealth Belief Modelskill

Outcome Measures

Primary Outcomes (1)

  • Breast Self Examination Practice Skill Assessment

    The form was created by the researchers by scanning the literature as a guide to the application made by the students on the wearable breast model. The form will be evaluated out of 100 points. The form includes 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. A high score is interpreted as a high level of skills.

    Three weeks

Secondary Outcomes (1)

  • Health Belief Model Scale

    Three weeks

Study Arms (2)

Breast self-examination group

EXPERIMENTAL

This group was planned to consist of 51 female students studying at the university. First of all, students will be contacted through their electronically registered contact information. In the pre-test, the researchers will apply the 'Personal Information Form' and the 'Health Belief Model Scale' to the students with the self-report method. Afterwards, students will be given BSE training consisting of two 120-minute sessions. In the first session of the training, theoretical trainings about breast cancer and BSE will be given for 30 minutes. In the second session, BSE application will be shown on the wearable breast model and each student will practice on the model. The practice skills of the participants will be evaluated by the researchers using the 'BSE Practice Skill Evaluation Form'. At the end of the 'Health Belief Model Scale' application, face-to-face and 3 weeks later, online applications will be filled as a post-test.

Other: Training and application in breast modeling

Control group

ACTIVE COMPARATOR

No intervention will be made against people in this group.

Other: Control

Interventions

BSE application skill evaluation form will be evaluated out of 100 points. The form includes 7 skills: carefully reviewing the model, using three types of pressure, massage, hand position, performing three types of movement, examining each breast for five minutes, and detecting the nodule in the model. A high score is interpreted as a high level of skills.

Also known as: Experimental: Breast self-examination group
Breast self-examination group
ControlOTHER

No intervention will be made against people in this group.

Control group

Eligibility Criteria

Age17 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast Self Examination Practice Skill
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may not qualify if:

  • Students were excluded from the study if they did not want to continue the research at any stage of the study and were diagnosed with breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayburt University

Bayburt, 6900, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Breast Self-Examination

Condition Hierarchy (Ancestors)

Self-ExaminationHealth BehaviorBehavior

Study Officials

  • Bayburt University

    Bayburt University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The sample size of the study was calculated in the G\*Power 3.1.9.7 program such that the error amount was α=0.05, the power of the test was 0.80 (80%) and the effect size was 0.60. As a result of the statistical analysis, it was found that a total of 90 students, 45 in the experimental group and 45 in the control group, should be included in the study. Considering that if the sample size increases, the standard error will decrease and the working power will increase, each group was increased by 22% (10 people) and it was planned to include 110 students in the study, 55 students for each group. In the first stage, the sample consisted of 148 students who agreed to participate in the study. In the second phase of the study, the sample was planned to consist of 110 female students selected by simple and stratified randomization method (55 experimental, 55 control).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer Doctor

Study Record Dates

First Submitted

June 15, 2023

First Posted

July 27, 2023

Study Start

October 21, 2022

Primary Completion

December 12, 2022

Study Completion

January 2, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations