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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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ClinicalTrials.gov Identifier: NCT06051331
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
Nilgun Kuru Alici, Hacettepe University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Health Knowledge, Attitudes, Practice Behavioral: simulation-based breast health education Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group
Simulation-based breast health education
 Behavioral: simulation-based breast health education
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.
No Intervention: Control group
The control group will not take part the simulation-based breast health education


Outcome Measures
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Primary Outcome Measures :
  1. The Breast Cancer Awareness Measure (BCAM) Score [ Time Frame: up to 8 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06051331


Contacts
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Contact: Nilgün KURU ALICI, PhD 05546832365 nilgun.kuru@hacettepe.edu.tr

Locations
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Turkey
Hacettepe University Recruiting
Ankara, Turkey, 06100
Contact: Nilgün KURU ALICI, PhD    05546832365    nilgun.kuru@hacettepe.edu.tr   
Sponsors and Collaborators
Hacettepe University
More Information
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Responsible Party: Nilgun Kuru Alici, Associate Professor, Hacettepe University
ClinicalTrials.gov Identifier: NCT06051331    
Other Study ID Numbers: D69071
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nilgun Kuru Alici, Hacettepe University:
Afghan
Breast Cancer
Awareness
Health Education
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases