- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02125487
Hybrid Simulation in Teaching Clinical Breast Examination (HS-CBE)
The Use of Hybrid Simulation (HS) of the Breast in Teaching Clinical Breast Examination (CBE) to Medical Students.
Study Overview
Status
Detailed Description
Breast cancer is a Lebanese national problem. Campaigns for mammography screening are effective but recommendations on breast examinations screening for breast tumors are lacking. On one hand, the Lebanese population is culturally diverse, with women's beliefs ranging from liberal to extremely conservative. On the other hand, Clinical Breast Examination (CBE) is traditionally taught to medicine III students in a lecture, followed by practice on a low-fidelity breast model. The opportunity to clinically practice CBE depends on patient availability and her willingness to be examined by students. This is further limited by some Lebanese women's cultural and religious beliefs. Little is known about the effect of patient cultural practices on the efficacy of CBE.
In this project, we focus on the need for an effective educational tool for teaching CBE to physicians-in-training. The proposed teaching method in this study is hybrid simulation: breast model jacket (simulator) worn by a trained actress (standardized patient, SP). In this study, we compare this standardized educational tool to the traditional teaching method which consists of a lecture and training on a low-fidelity (unrealistic) breast model on a desk (no SP).
We hypothesize that the use of this hybrid simulation tool, as compared to the traditional teaching method, will result in a more complete CBE, better lesion detection and improved culturally sensitive communication skills in terms of awareness of, and ability to deal with, cultural differences related to breast examination.
In order to do so, we will evaluate medical students' performance and examine their attitudes and cultural competencies when they perform CBEs on 3 culturally different standardized patients using hybrid simulation scenarios. Through an experimental design that minimizes biases related to selection of students (randomized controlled), we will compare hybrid simulation (intervention) with low-fidelity simulation (control) in teaching CBE.
Medicine-III students rotating in the Obstetrics and Gynecology department at the American University of Beirut Medical Center (AUBMC) will be asked to participate; they are free to refuse without any effect on their grades in the rotation. The students will be assessed in an Objective Structured Clinical Examination (OSCE) setting similar to their usual oral clinical exams but not contributory to their academic evaluation in the Faculty of Medicine. The OSCE setting will include encounters with 3 culturally different Standardized Patients (1 "outgoing" woman, 1 with "chador", and 1 moderately conservative woman). The assessment tools are questionnaires that are either objective (filled by SP) or self-reporting (filled by students) about (1) met learning objectives, (2) student's attitude, and (3) clinical cultural competency.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beirut, Lebanon
- American University of Beirut Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Third year medical students (Med III) at the American University of Beirut
- Rotating in the Obstetrics and Gynecology department at the American University of Beirut Medical Center
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Low-Fidelity Simulation
Teaching using traditional method
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Students in the "control" group will receive the regular lecture given at the American University of Beirut and will attend the usual simulation lab teaching activities (single breast silicone model without any actors).
The only new introduction to the curriculum is an educational video on the technique of CBE.
Other Names:
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Experimental: Hybrid Simulation
Teaching using Hybrid Simulation of breast examination
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Students in the "intervention/experimental" group will receive the regular lecture given at the American University of Beirut and will attend a screening of an educational video on the technique of CBE, in addition to the hybrid simulation teaching activities in the simulation lab (standardized patient wearing breast examination simulator jackets)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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CBE completeness (in OSCE)
Time Frame: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
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SPs will be objectively grading the students on a scoring sheet
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Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student's attitude about the teaching activity
Time Frame: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
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Self-reported questionnaires
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Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
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Cultural communication skills (in OSCE)
Time Frame: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
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SPs will be objectively grading the students on a scoring sheet
|
Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
|
|
Student's attitude about the assessment activity (OSCE)
Time Frame: On the day of the assessment activity, after an average of 2-3 weeks following the intervention (teaching activity)
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Self-reported questionnaires
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On the day of the assessment activity, after an average of 2-3 weeks following the intervention (teaching activity)
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Collaborators and Investigators
Investigators
- Study Director: Abdul Karim Sleiman, MD, American University of Beirut Medical Center
- Principal Investigator: Rana Sharara-Chami, MD, American University of Beirut Medical Center
Publications and helpful links
General Publications
- Coleman EA, Stewart CB, Wilson S, Cantrell MJ, O'Sullivan P, Carthron DO, Wood LC. An evaluation of standardized patients in improving clinical breast examinations for military women. Cancer Nurs. 2004 Nov-Dec;27(6):474-82. doi: 10.1097/00002820-200411000-00007.
- Costanza ME, Luckmann R, Quirk ME, Clemow L, White MJ, Stoddard AM. The effectiveness of using standardized patients to improve community physician skills in mammography counseling and clinical breast exam. Prev Med. 1999 Oct;29(4):241-8. doi: 10.1006/pmed.1999.0544.
- Facione NC, Katapodi M. Culture as an influence on breast cancer screening and early detection. Semin Oncol Nurs. 2000 Aug;16(3):238-47. doi: 10.1053/sonc.2000.8118.
- Pugh CM, Salud LH; Association for Surgical Education. Fear of missing a lesion: use of simulated breast models to decrease student anxiety when learning clinical breast examinations. Am J Surg. 2007 Jun;193(6):766-70. doi: 10.1016/j.amjsurg.2006.12.033.
- Schubart JR, Erdahl L, Smith JS Jr, Purichia H, Kauffman GL, Kass RB. Use of breast simulators compared with standardized patients in teaching the clinical breast examination to medical students. J Surg Educ. 2012 May-Jun;69(3):416-22. doi: 10.1016/j.jsurg.2011.10.005. Epub 2011 Nov 25.
- Nassif J, Sleiman AK, Nassar AH, Naamani S, Sharara-Chami R. Hybrid Simulation in Teaching Clinical Breast Examination to Medical Students. J Cancer Educ. 2019 Feb;34(1):194-200. doi: 10.1007/s13187-017-1287-3.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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