NCT06410573

Brief Summary

The aim of the present research was to detect the effect of self-breast examination provided to women between 18 and 49 years of age and practice on the belief of women on their breast health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2023

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

June 1, 2023

Last Update Submit

May 10, 2024

Conditions

Keywords

NeoplasmsEarly Detection of CancerBreast Neoplasmshealth education

Outcome Measures

Primary Outcomes (1)

  • Breast Self-Examination Training and Breast Health Beliefs

    This outcome is assessed with the Champion Health Belief Model Scale. A higher score on the scale indicates an increase in sensitivity and caring, a higher perception of benefits for the perception of benefits, and a higher perception of obstacles for the perception of obstacles.

    1 month will be followed

Study Arms (2)

Training on Breast Self-Examination

EXPERIMENTAL

In the training, women will be divided into 5 groups and the training will be held in 5 separate sessions in one day. A training program will be completed with 9 women. All trainings will be conducted under the same conditions in the school's training room. Before the training, women will be informed about the training and their permission and consent will be obtained. The training prepared by the researcher will be presented to the women in the experimental group of the study. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination.

Behavioral: Breast Self-Examination and Practice

Control

NO INTERVENTION

1 week follow-up.

Interventions

In the training, women will be divided into 5 groups and the training will be held in 5 separate sessions in one day. A training program will be completed with 9 women. All trainings will be conducted under the same conditions in the school's training room. Before the training, women will be informed about the training and their permission and consent will be obtained. The training prepared by the researcher will be presented to the women in the experimental group of the study. The presentation used in the training will include information about breast cancer, breast cancer screening programs and breast self-examination. In the presentation, the steps of breast self-examination will be shown step by step using visual materials.

Training on Breast Self-Examination

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fertility process to continue
  • No communication problems
  • Not having a disease that will affect perception

You may not qualify if:

  • Having been previously diagnosed with breast cancer or receiving breast cancer treatment
  • Being diagnosed with a medical mental illness and receiving treatment for this reason
  • Being under active treatment in hospital due to any problem

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KTO Karatay University

Konya, Karatay, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsBreast NeoplasmsHealth Education

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2023

First Posted

May 13, 2024

Study Start

November 6, 2022

Primary Completion

February 1, 2023

Study Completion

March 1, 2023

Last Updated

May 13, 2024

Record last verified: 2024-05

Locations