Trial Outcomes & Findings for 3D Printed Models in Mohs Micrographic Surgery (NCT NCT03461965)
NCT ID: NCT03461965
Last Updated: 2021-05-21
Results Overview
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
COMPLETED
NA
82 participants
Post surgery (1 day)
2021-05-21
Participant Flow
Participant milestones
| Measure |
Education With 3D Printed Model
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
|
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
Verbal Counselling: patients will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
|
Overall Study
COMPLETED
|
42
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Education With 3D Printed Model
n=42 Participants
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
|
Verbal Counselling
n=40 Participants
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
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.83 Years
STANDARD_DEVIATION 11.34 • n=42 Participants
|
67.83 Years
STANDARD_DEVIATION 12.89 • n=40 Participants
|
67.83 Years
STANDARD_DEVIATION 12.10 • n=82 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=42 Participants
|
15 Participants
n=40 Participants
|
33 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=42 Participants
|
25 Participants
n=40 Participants
|
49 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
42 participants
n=42 Participants
|
40 participants
n=40 Participants
|
82 participants
n=82 Participants
|
|
Previous MMS experience
Mohs Experience
|
20 Participants
n=42 Participants
|
19 Participants
n=40 Participants
|
39 Participants
n=82 Participants
|
|
Previous MMS experience
No Mohs Experience
|
22 Participants
n=42 Participants
|
21 Participants
n=40 Participants
|
43 Participants
n=82 Participants
|
|
Baseline STAI Y-2 "Trait Anxiety"
|
29.8 units on a scale
STANDARD_DEVIATION 7.53 • n=42 Participants
|
31.1 units on a scale
STANDARD_DEVIATION 8.85 • n=40 Participants
|
30.5 units on a scale
STANDARD_DEVIATION 8.25 • n=82 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Education With 3D Printed Model
n=42 Participants
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
|
Verbal Counselling
n=40 Participants
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
|
|---|---|---|
|
Percent of Correct and Incorrect Mohs Quiz Responses
Correct Quiz Responses
|
93.25 Percent of quiz responses
|
85.83 Percent of quiz responses
|
|
Percent of Correct and Incorrect Mohs Quiz Responses
Incorrect Quiz Responses
|
6.75 Percent of quiz responses
|
14.17 Percent of quiz responses
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Education With 3D Printed Model
n=42 Participants
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
|
Verbal Counselling
n=40 Participants
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
|
|---|---|---|
|
Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score
|
-4.95 Score on a scale
Standard Deviation 6.95
|
-3.3 Score on a scale
Standard Deviation 9.37
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education With 3D Printed Model
n=42 Participants
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
|
Verbal Counselling
n=40 Participants
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
|
|---|---|---|
|
Change in Visual Analog Scale (VAS) Anxiety Score
|
-1.31 Score on a scale
Standard Deviation 2.00
|
-0.53 Score on a scale
Standard Deviation 1.54
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education With 3D Printed Model
n=42 Participants
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
|
Verbal Counselling
n=40 Participants
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
|
|---|---|---|
|
Change in Visual Analog Scale (VAS) Understanding Score
|
1.83 Score on a scale
Standard Deviation 2.22
|
2.46 Score on a scale
Standard Deviation 2.34
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Education With 3D Printed Model
n=42 Participants
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
|
Verbal Counselling
n=40 Participants
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
|
|---|---|---|
|
Satisfaction Survey Score
|
14.69 score on a scale
Standard Deviation 0.811
|
13.58 score on a scale
Standard Deviation 1.599
|
Adverse Events
Education With 3D Printed Model
Verbal Counselling
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Margaret Mann, MD
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place