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The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices

Primary Purpose

Breast Cancer, Health Knowledge, Attitudes, Practice

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
simulation-based breast health education
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring Afghan, Breast Cancer, Awareness, Health Education

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: The inclusion criteria of the study were determined as being 20-65 years, speaking and understanding Turkish or Dari. Exclusion Criteria: being younger than 20 years old, not having the ability to read, write and speak Dari or Turkish

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Simulation-based breast health education

The control group will not take part the simulation-based breast health education

Outcomes

Primary Outcome Measures

The Breast Cancer Awareness Measure (BCAM) Score
BCAM was developed by the Cancer Research UK group of Kings College London in 2009. BCAM is a questionnaire that assesses seven domains of BC awareness: knowledge of BC symptoms, breast self-examination, confidence of noticing a change in the breasts, age and lifetime risk of BC, urgency if a change in breast is noticed, BC risk factors, and BC screening. The questionnaire can be administered face-to-face or via telephone.26 BCAM is highly readable for patients, has good test-retest reliability, good construct validity, and is sensitive to changes in awareness. BCAM has been validated in Muslim and Middle Eastern populations. For the present study, Dari version of BCAM which was translated from English into Dari by an official translator, and participant responses were translated back to English from previous study that published in LANCET.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2023
Last Updated
September 17, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT06051331
Brief Title
The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices
Official Title
The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices of Afgan Refugee Women: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aimed to evaluate the effect of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women. The study hypothesized that simulation-based breast health education would have an effect on breast cancer awareness and breast self-examination practices scores among Afghan refugee women.
Detailed Description
Purpose: The aim of the research is to examine the effects of simulation-based breast health education on breast cancer awareness and breast self-examination practices of Afghan refugee women. Methods: The study will conduct with 64 (32 in the intervention group, and 32 in the control group) Afghan. The study population consisted of Afghan women. The simulation-based breast health education will applied to the intervention group once a week for 8 weeks. No intervention will offer to the control group. Data will collected by a socio-demographic questionnaire, Breast Cancer Awareness Measure (BCAM) and breast self-examination practices checklist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Health Knowledge, Attitudes, Practice
Keywords
Afghan, Breast Cancer, Awareness, Health Education

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Simulation-based breast health education
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not take part the simulation-based breast health education
Intervention Type
Behavioral
Intervention Name(s)
simulation-based breast health education
Intervention Description
The intervention group will receive simulation-based breast health education once a week for eight weeks. The simulation- based breast health education program will compose two part. The first part, it will theoretical education and second part will continue as practical education. On the plan date, a 60-min lecture will give about breast cancer, its risk factors, interventions to reduce the risk of breast cancer, the value of early diagnosis and cancer screening. After a 10-min break, course attendees watched a 20-min video, after which the course attendees' questions will answer.
Primary Outcome Measure Information:
Title
The Breast Cancer Awareness Measure (BCAM) Score
Description
BCAM was developed by the Cancer Research UK group of Kings College London in 2009. BCAM is a questionnaire that assesses seven domains of BC awareness: knowledge of BC symptoms, breast self-examination, confidence of noticing a change in the breasts, age and lifetime risk of BC, urgency if a change in breast is noticed, BC risk factors, and BC screening. The questionnaire can be administered face-to-face or via telephone.26 BCAM is highly readable for patients, has good test-retest reliability, good construct validity, and is sensitive to changes in awareness. BCAM has been validated in Muslim and Middle Eastern populations. For the present study, Dari version of BCAM which was translated from English into Dari by an official translator, and participant responses were translated back to English from previous study that published in LANCET.
Time Frame
up to 8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The inclusion criteria of the study were determined as being 20-65 years, speaking and understanding Turkish or Dari. Exclusion Criteria: being younger than 20 years old, not having the ability to read, write and speak Dari or Turkish
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nilgün KURU ALICI, PhD
Phone
05546832365
Email
nilgun.kuru@hacettepe.edu.tr
Facility Information:
Facility Name
Hacettepe University
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilgün KURU ALICI, PhD
Phone
05546832365
Email
nilgun.kuru@hacettepe.edu.tr

12. IPD Sharing Statement

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The Effect of Simulation-Based Breast Health Education on Breast Cancer Awareness and Breast Self-Examination Practices

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