NCT06112158

Brief Summary

The aim of this study was to examine the effect of web-supported peer education on health beliefs, knowledge levels and breast self-examination in university students.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

October 27, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 13, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

October 27, 2023

Last Update Submit

March 13, 2024

Conditions

Keywords

Breast self-examinationHealth EducationUniversity studentsBreast cancer

Outcome Measures

Primary Outcomes (3)

  • Comprehensive Breast Cancer Information Test

    Questions from 1 to 12 on the scale; general knowledge about breast cancer; Questions 13 to 20 contain information about the treatability of breast cancer. It also consists of 20 questions that can be answered as "true" or "false". 1 point for each correct answer given; 0 points are given for incorrect answers and blank items. As the score obtained from the scale increases, the level of knowledge also increases.

    four months

  • Champion Health Belief Model Scale

    It is used to determine women's beliefs and attitudes about breast cancer and breast self-examination. Each sub-dimension of the scale is evaluated separately. Champion Health Belief Model Scale (CHBMS) has 6 subscales and is a 5-point Likert type. "Perception of sensitivity" (3 items), "perception of seriousness" (7 items), "perception of benefit" (4 items), "perception of obstacle" (11 items), "trust" (10 items), "Health" regarding breast cancer It has sub-dimensions "motivation" (7 items). The total score of the scale is not calculated. Receiving a low score on the "obstacle perception" subscale and a high score on other subscales shows that women have positive attitudes and beliefs about breast cancer and breast self-examination practices.

    four months

  • Breast self-examination proficiency rating instrument-BSEPRI

    This form was used to assess women's ability to perform breast self-examination according to the appropriate stages and their ability to find breast masses. In the form, there are 10 statements including the stages of performing CHBM. Each stage of the examination that is performed correctly is given 10 points, and 0 points are given for incorrect or non-performed stages. Accordingly, a minimum of 0 and a maximum of 100 points are obtained from the form. A score of 90 and above indicates that "CHCMM is performed correctly" and a score of 80 and below indicates that "CHCMM is not performed correctly".

    four months

Secondary Outcomes (1)

  • Semi-structured Interview Form

    four months

Study Arms (2)

Education Intervention

EXPERIMENTAL

The BSE training program for the early diagnosis of breast cancer will be offered to students in two ways: face-to-face and via web support. While the training program prepared by the researchers was applied to the intervention group, it was planned that no application would be applied to the nonınterventıon group. In this study, the training period was determined in two ways: First; In face-to-face training, each training is planned as four sessions of 45 minutes. Each session is planned with a different purpose and application. Latter; The system will continue to be open during the training provided through web support and face-to-face training, but the system will be closed to access immediately after the face-to-face training is completed.

Behavioral: Education Intervention

nonıntervention Group

NO INTERVENTION

Until the research is finalized, no intervention will be made. After the research is finalized, the system will be opened to the nonınterventıon group and the university in general to contribute to their knowledge and awareness.

Interventions

The BSE training program for the early diagnosis of breast cancer will be offered to students in two ways: face-to-face and via web support. Content of training Session 1: Topics such as the structure of the breast, the definition of breast cancer, its prevalence, risk factors and symptoms Session 2: Teaching the importance of early diagnosis in breast cancer, the importance and benefits of BSE, the technique of performing BSE, the obstacles to the application of BSE. Session 3: Teaching the risk factors that cause breast cancer. Session 4: Discussion of case reports of patients diagnosed with breast cancer. Supporting education with web support

Education Intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Young women who do not have any diagnosis of cancer or breast cancer
  • who have no communication barriers
  • who are not pregnant or breastfeeding
  • who volunteer to participate in the study

You may not qualify if:

  • Participants with a previous cancer diagnosis
  • CHCMM training and who were absent for more than two sessions in the intervention group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Medipol Unıversty

Ankara, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Self-ExaminationHealth EducationBreast Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Self-ExaminationHealth BehaviorBehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Web-supported and face-to-face training on breast cancer information and screening will be provided to the experimental group.and outcome assessments will be performed by a investigator who was blinded to group allocation.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Two groups with randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Proff.

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 1, 2023

Study Start

March 13, 2024

Primary Completion

May 30, 2024

Study Completion

June 30, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations