NCT02125487

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

March 18, 2014

Last Update Submit

June 22, 2015

Conditions

Keywords

Clinical Breast ExaminationBreast Cancer detectionBreast SimulatorHybrid SimulationPatient SimulationStandardized PatientMedical student educationHealth CommunicationCommunication BarriersCultural competencyCulturalMiddle EastLebanon

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (3)

  • Student's attitude about the teaching activity

    Each participant will be assessed once, after an average of 2-3 weeks following the intervention (teaching activity)

  • Cultural communication skills (in OSCE)

    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)

    On the day of the assessment activity, after an average of 2-3 weeks following the intervention (teaching activity)

Study Arms (2)

Low-Fidelity Simulation

ACTIVE COMPARATOR

Teaching using traditional method

Behavioral: Teaching using traditional method

Hybrid Simulation

EXPERIMENTAL

Teaching using Hybrid Simulation of breast examination

Behavioral: Teaching using Hybrid Simulation of breast examination

Interventions

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)

Also known as: Standardized Patient wearing breast jacket
Hybrid Simulation

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.

Also known as: Lecture with low-fidelity breast model
Low-Fidelity Simulation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

Related Publications (6)

  • 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.

    PMID: 15640625BACKGROUND
  • 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.

    PMID: 10547049BACKGROUND
  • 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.

    PMID: 10967796BACKGROUND
  • 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.

    PMID: 17512293BACKGROUND
  • 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.

    PMID: 22483147BACKGROUND
  • 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 Officials

  • Abdul Karim Sleiman, MD

    American University of Beirut Medical Center

    STUDY DIRECTOR
  • Rana Sharara-Chami, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Simulation Program Director

Study Record Dates

First Submitted

March 18, 2014

First Posted

April 29, 2014

Study Start

December 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations