3D Printed Models in Mohs Micrographic Surgery

NCT03461965 | Completed Results DMC

• 2 other identifiers: CASE6617T32AR007569
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mohs Micrographic Surgery

Keywords

3D printing; Patient education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score

  From baseline to post surgery (1 day)

• Change in Visual Analog Scale (VAS) Anxiety Score

  From baseline to post surgery (1 day)

• Change in Visual Analog Scale (VAS) Understanding Score

  From baseline to post surgery (1 day)

• Satisfaction Survey Score

  Post surgery (1 day)

Study Arms (2)

Education with 3D printed model

EXPERIMENTAL

The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model

Behavioral: 3D printed model; Behavioral: Verbal Counselling

Verbal Counselling

ACTIVE COMPARATOR

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

Interventions

3D printed model BEHAVIORAL

A printed 3D model of MMS will be created showing a model of skin, and a tumor to visually depict the surgery

Education with 3D printed model

Verbal Counselling BEHAVIORAL

Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and MMS

Education with 3D printed model; Verbal Counselling

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cannot complete the survey measures independently for any reason

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Results Point of Contact

• Title: Dr. Margaret Mann, MD
• Organization: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

CTUReferral@uhhospitals.org

1-800-641-2422

Study Officials

• Margaret Mann, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be recruited from University Hospitals Department of Dermatology MMS Clinics at the Cleveland Medical Center, Chagrin Highlands and Westlake Locations. These patients will be randomly assigned to a control (50%) or experimental group (50%) prior to the onset of the study protocol.

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 12, 2018
• Study Start: March 2, 2018
• Primary Completion: January 25, 2019
• Study Completion: January 25, 2019
• Last Updated: May 21, 2021
• Results First Posted: May 21, 2021

Record last verified: 2021-04

Locations

US (1)