Medical EducationHS-CBENCT02125487
Hybrid Simulation in Teaching Clinical Breast Examination
A study testing Teaching using Hybrid Simulation of breast examination and Teaching using traditional method in people with Medical Education and Clinical Breast Examination, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
The purpose of this study is to determine whether the use of hybrid simulation of the breast are more effective in teaching CBE technique and culturally sensitive doctor-patient communication skills to medical students than the traditional method. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Education, Clinical Breast Examination, Medical Simulation
- What is being tested?
- Teaching using Hybrid Simulation of breast examination and Teaching using traditional method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteLebanon
- Study dates
- Dec 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Hybrid Simulation (HS) of the Breast in Teaching Clinical Breast Examination (CBE) to Medical Students.
The purpose of this study is to determine whether the use of hybrid simulation of the breast are more effective in teaching CBE technique and culturally sensitive doctor-patient communication skills to medical students than the traditional method.
Read the 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.
- Being tested
- Teaching using Hybrid Simulation of breast examination, Teaching using traditional method
- Keywords
- Clinical Breast Examination, Breast Cancer detection, Breast Simulator, Hybrid Simulation, Patient Simulation, Standardized Patient, Medical student education, Health Communication, Communication Barriers, Cultural competency, Cultural, Middle East, Lebanon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching using Hybrid Simulation of breast examinationBehavioural
Also called Standardized Patient wearing breast jacket
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)
Teaching using traditional methodBehavioural
Also called Lecture with low-fidelity breast model
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.
| Study group | Role | What they receive |
|---|---|---|
| Low-Fidelity Simulation | Active comparator | Teaching using traditional method Receives: Behavioral: Teaching using traditional method |
| Hybrid Simulation | Experimental | Teaching using Hybrid Simulation of breast examination Receives: Behavioral: Teaching using Hybrid Simulation of breast examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
CBE completeness (in OSCE)
SPs will be objectively grading the students on a scoring sheet
Measured: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
Secondary outcomes (3)
Student's attitude about the teaching activity
Self-reported questionnaires
Measured: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
Cultural communication skills (in OSCE)
SPs will be objectively grading the students on a scoring sheet
Measured: 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)
Self-reported questionnaires
Measured: On the day of the assessment activity, after an average of 2-3 weeks following the intervention (teaching activity)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Sharara, American University of Beirut Medical Center
- Investigators
- Abdul Karim Sleiman, MD, Study director, American University of Beirut Medical CenterRana Sharara-Chami, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125487
- Sponsor's protocol ID
- PED.RS1.03
- Acronym
- HS-CBE
- Status last verified
- Jun 2015
- First submitted
- 18 Mar 2014
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15640625Costanza 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.
PubMed 10547049Facione 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.
PubMed 10967796Pugh 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.
PubMed 17512293Schubart 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.
PubMed 22483147Nassif 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.
PubMed 29019167
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Hybrid Simulation (HS) of the Breast in Teaching Clinical Breast Examination (CBE) to Medical Students.
- ClinicalTrials.gov ID
- NCT02125487
- Acronym / sponsor ID
- HS-CBE / PED.RS1.03
- Keywords
- Clinical Breast Examination, Breast Cancer detection, Breast Simulator, Hybrid Simulation, Patient Simulation, Standardized Patient, Medical student education, Health Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the use of hybrid simulation of the breast are more effective in teaching CBE technique and culturally sensitive doctor-patient communication skills to medical students than the traditional method.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Fidelity Simulation | Active comparator | Behavioral: Teaching using traditional methodTeaching using traditional method |
| Hybrid Simulation | Experimental | Behavioral: Teaching using Hybrid Simulation of breast examinationTeaching using Hybrid Simulation of breast examination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teaching using Hybrid Simulation of breast examinationAlso: Standardized Patient wearing breast jacketStudents 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) | Behavioural | Hybrid Simulation |
| Teaching using traditional methodAlso: Lecture with low-fidelity breast modelStudents 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. | Behavioural | Low-Fidelity Simulation |
Primary outcome
CBE completeness (in OSCE)
Time frame: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)
SPs will be objectively grading the students on a scoring sheet
3 secondary outcomes
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Background: PubMed 15640625Coleman 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.
- Background: PubMed 10547049Costanza 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.
- Background: PubMed 10967796Facione 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.
- Background: PubMed 17512293Pugh 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.
- Background: PubMed 22483147Schubart 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.
- Derived from this study: PubMed 29019167Nassif 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Karim Sleiman, MD study director
American University of Beirut Medical Center
Rana Sharara-Chami, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teaching using Hybrid Simulation of breast examination and Teaching using traditional method in people with Medical Education and Clinical Breast Examination, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBE completeness (in OSCE) (time frame: Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02125487, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015; AzTrials last refreshed its copy on 31 Oct 2026.