3D Printed Models in Mohs Micrographic Surgery

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03461965
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 7.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mohs Micrographic Surgery	Behavioral: 3D printed model; Behavioral: Verbal Counselling	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Use of 3D Printed Models in Mohs Micrographic Surgery
• Actual Study Start Date: Mar 2, 2018
• Actual Primary Completion Date: Jan 25, 2019
• Actual Study Completion Date: Jan 25, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percent of Correct and Incorrect Mohs Quiz Responses [Post surgery (1 day)]

   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

Secondary Outcome Measures

1. Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score [From baseline to post surgery (1 day)]

   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)

2. Change in Visual Analog Scale (VAS) Anxiety Score [From baseline to post surgery (1 day)]

   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.

3. Change in Visual Analog Scale (VAS) Understanding Score [From baseline to post surgery (1 day)]

   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.

4. Satisfaction Survey Score [Post surgery (1 day)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• Case Comprehensive Cancer Center
• 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 Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 2, 2018
• Informed Consent Form - Feb 4, 2019

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT03461965
• Other Study ID Numbers: CASE6617; T32AR007569
• First Posted: Mar 12, 2018
• Last Update Posted: May 21, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Case Comprehensive Cancer Center: 3D printing; Patient education

Study Results

Participant Flow

Arm/Group Title	Education With 3D Printed Model	Verbal Counselling
Arm/Group Description	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model 3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery	Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery
Period Title: Overall Study
STARTED	42	40
COMPLETED	42	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Education With 3D Printed Model	Verbal Counselling	Total
Arm/Group Description	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model 3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery	Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery	Total of all reporting groups
Overall Participants	42	40	82
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67.83 (11.34)	67.83 (12.89)	67.83 (12.10)
Sex: Female, Male (Count of Participants)
Female	18 42.9%	15 37.5%	33 40.2%
Male	24 57.1%	25 62.5%	49 59.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	42 100%	40 100%	82 100%
Previous MMS experience (Count of Participants)
Mohs Experience	20 47.6%	19 47.5%	39 47.6%
No Mohs Experience	22 52.4%	21 52.5%	43 52.4%
Baseline STAI Y-2 "Trait Anxiety" (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	29.8 (7.53)	31.1 (8.85)	30.5 (8.25)

Outcome Measures

1. Primary Outcome

Title	Percent of Correct and Incorrect Mohs Quiz Responses
Description	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
Time Frame	Post surgery (1 day)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education With 3D Printed Model	Verbal Counselling
Arm/Group Description	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model 3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery	Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery
Measure Participants	42	40
Correct Quiz Responses	93.25	85.83
Incorrect Quiz Responses	6.75	14.17

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Education With 3D Printed Model, Verbal Counselling
	Comments	Comparing total responses that were correct across all participants in both arms
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score
Description	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)
Time Frame	From baseline to post surgery (1 day)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education With 3D Printed Model	Verbal Counselling
Arm/Group Description	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model 3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery	Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery
Measure Participants	42	40
Mean (Standard Deviation) [Score on a scale]	-4.95 (6.95)	-3.3 (9.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Education With 3D Printed Model
	Comments	Difference of pre (baseline) and post-test scores within each treatment group
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Verbal Counselling
	Comments	Difference of pre (baseline) and post-test scores within each treatment group
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	<0.03
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Education With 3D Printed Model, Verbal Counselling
	Comments	Comparing change in scores (post-stage minus baseline) between experimental and control groups
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	0.352
	Comments
	Method	t-test, 2 sided
	Comments	paired t-test

3. Secondary Outcome

Title	Change in Visual Analog Scale (VAS) Anxiety Score
Description	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.
Time Frame	From baseline to post surgery (1 day)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education With 3D Printed Model	Verbal Counselling
Arm/Group Description	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model 3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery	Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery
Measure Participants	42	40
Mean (Standard Deviation) [Score on a scale]	-1.31 (2.00)	-0.53 (1.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Education With 3D Printed Model
	Comments	Difference of pre (baseline) and post-test scores within each treatment group
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Verbal Counselling
	Comments	Difference of pre (baseline) and post-test scores within each treatment group
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	0.04
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Education With 3D Printed Model, Verbal Counselling
	Comments	Comparing change in scores (post-stage minus baseline) between experimental and control groups
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	0.052
	Comments
	Method	t-test, 2 sided
	Comments	paired t-test

4. Secondary Outcome

Title	Change in Visual Analog Scale (VAS) Understanding Score
Description	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.
Time Frame	From baseline to post surgery (1 day)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education With 3D Printed Model	Verbal Counselling
Arm/Group Description	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model 3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery	Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery
Measure Participants	42	40
Mean (Standard Deviation) [Score on a scale]	1.83 (2.22)	2.46 (2.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Education With 3D Printed Model
	Comments	Difference of pre (baseline) and post-test scores within each treatment group
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Verbal Counselling
	Comments	Difference of pre (baseline) and post-test scores within each treatment group
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Education With 3D Printed Model, Verbal Counselling
	Comments	Comparing change in scores (post-stage minus baseline) between experimental and control groups
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	0.208
	Comments
	Method	t-test, 2 sided
	Comments	paired t-test

5. Secondary Outcome

Title	Satisfaction Survey Score
Description	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.
Time Frame	Post surgery (1 day)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Education With 3D Printed Model	Verbal Counselling
Arm/Group Description	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model 3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery	Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery
Measure Participants	42	40
Mean (Standard Deviation) [score on a scale]	14.69 (0.811)	13.58 (1.599)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Education With 3D Printed Model, Verbal Counselling
	Comments
	Type of Statistical Test	Other
	Comments	p-value < 0.05 was considered statistically significant
Statistical Test of Hypothesis	p-Value	<0.03
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Adverse Event Reporting Description	Adverse Events were not collected because no adverse events were expected
Arm/Group Title	Education With 3D Printed Model		Verbal Counselling
Arm/Group Description	The experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model 3D printed model: A printed 3D model of Mohs Micrographic Surgery will be created showing a model of skin, and a tumor to visually depict the surgery Verbal Counselling: Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery		Participants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script Verbal Counselling: Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery
All Cause Mortality
	Education With 3D Printed Model		Verbal Counselling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Education With 3D Printed Model		Verbal Counselling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Education With 3D Printed Model		Verbal Counselling
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.