3D Printed Models in Mohs Micrographic Surgery

The Use of 3D Printed Models in Mohs Micrographic Surgery

Patients undergoing Mohs micrographic surgery (MMS) frequently experience anxiety. It has been suggested that enhanced patient education prior to the procedure may decrease patient anxiety. The purpose of the study is to investigate if optimized participant education enhances participant understanding, decreases participant anxiety and increases participant satisfaction.

Study Overview

• Status: Completed
• Conditions: Mohs Micrographic Surgery
• Intervention / Treatment: Behavioral: 3D printed model; Behavioral: Verbal Counselling

Detailed Description

1. To investigate if participant education with a 3 dimensional printed (3DP) MMS model and standardized script protocol increases participant understanding of MMS more than current standard of care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.
2. To investigate if participant education with a 3DP MMS model and standardized script protocol decreases perioperative participant anxiety during MMS more than current standard of care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.
3. To evaluate if participant satisfaction with a 3DP MMS model and standardized script protocol increases participant satisfaction during MMS more than current standard of care (control group) at the University Hospitals Cleveland Medical Center MMS Clinics.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing MMS at University Hospitals Cleveland Medical Center, Chagrin Highlands and Westlake Campus
• Capable of reading and completing all subjective questionnaires

Exclusion Criteria:

• Cannot complete the survey measures independently for any reason

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Education with 3D printed model; The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model	Behavioral: 3D printed model; A printed 3D model of MMS will be created showing a model of skin, and a tumor to visually depict the surgery; Behavioral: Verbal Counselling; Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and MMS
ACTIVE_COMPARATOR: Verbal Counselling; Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script	Behavioral: Verbal Counselling; Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and MMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Correct and Incorrect Mohs Quiz Responses	This is an in-house-designed, short questionnaire with 6 multiple choice objective questions related to the participant's understanding of Mohs. A higher percentage of correct answers indicate a better understanding of Mohs. Reported data are percent of responses answered correctly and incorrectly totaled across all participants in each arm	Post surgery (1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score	The STAI is a well-known, frequently used measure of patient anxiety within the clinical setting. This form consists of two forms to assess state anxiety (Y-1) and a participant's baseline trait anxiety (Y-2). The Y-1 form consists of 20 Likert-type questions with scores ranging from 20 to 80, with higher scores indicating higher anxiety. Reported values are change in "state anxiety' (post-stage minus baseline)	From baseline to post surgery (1 day)
Change in Visual Analog Scale (VAS) Anxiety Score	The VAS is a frequently employed Likert-type scale that is used to measure anxiety. This 0-10 scale documents the patients current state of anxiety, with higher scores indicating worse anxietey, and can be answered by patients with an average reading level. Estimated time of completion is under 30 seconds. This form has been used in 2 studies to date and previously by experimental team to assess intraoperative anxiety in Mohs.	From baseline to post surgery (1 day)
Change in Visual Analog Scale (VAS) Understanding Score	The VAS is a frequently employed Likert-type scale that because of the ease of use this tool has been converted to assess other objective measures including understanding. This 0-10 scale documents the participant's current state of understanding, with higher scores indicating better understanding, and can be answered by patients with an average reading level. Estimated time of completion is under 30 seconds. This form has been used by experimental team to assess intraoperative understanding in Mohs.	From baseline to post surgery (1 day)
Satisfaction Survey Score	Participants were provided 3 subjective questions related to their satisfaction with the explanation of MMS that they received. This scale included questions regarding satisfaction with their explanation of the MMS procedure, if the explanation used could be improved, and if they recommended other patients be provided a similar explanation of MMS, with each question scored from 1 to 5, with higher scores indicating greater satisfaction. Total score range is 0 to 15, with higher scores indicating greater satisfaction.	Post surgery (1 day)

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Margaret Mann, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2018
• Primary Completion (ACTUAL): January 25, 2019
• Study Completion (ACTUAL): January 25, 2019

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (ACTUAL): March 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2021
• Last Update Submitted That Met QC Criteria: April 30, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Patient education; 3D printing
• Other Study ID Numbers: CASE6617; T32AR007569 (NIH)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No