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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02125487
Other study ID # PED.RS1.03
Secondary ID
Status Completed
Phase N/A
First received March 18, 2014
Last updated June 22, 2015
Start date December 2013
Est. completion date February 2015

Study information

Verified date June 2015
Source American University of Beirut Medical Center
Contact n/a
Is FDA regulated No
Health authority Lebanon: Institutional Review Board
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Intervention

Behavioral:
Teaching using Hybrid Simulation of breast examination
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 method
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.

Locations

Country Name City State
Lebanon American University of Beirut Medical Center Beirut

Sponsors (1)

Lead Sponsor Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

References & Publications (5)

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. — View Citation

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. — View Citation

Facione NC, Katapodi M. Culture as an influence on breast cancer screening and early detection. Semin Oncol Nurs. 2000 Aug;16(3):238-47. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CBE completeness (in OSCE) 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) No
Secondary Student's attitude about the teaching activity Self-reported questionnaires Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity) No
Secondary Cultural communication skills (in OSCE) 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) No
Secondary Student's attitude about the assessment activity (OSCE) Self-reported questionnaires On the day of the assessment activity, after an average of 2-3 weeks following the intervention (teaching activity) No
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