Mohs Micrographic Surgery
Conditions
Keywords
3D printing, Patient education
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.
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.
Interventions
BEHAVIORAL3D printed model
A printed 3D model of MMS will be created showing a model of skin, and a tumor to visually depict the surgery
BEHAVIORALVerbal Counselling
Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and MMS
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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 | 42 |
| 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 | 40 |
| Total | 82 |
Baseline characteristics
| Characteristic | Education With 3D Printed Model | Verbal Counselling | Total |
|---|---|---|---|
| Age, Continuous | 67.83 Years STANDARD_DEVIATION 11.34 | 67.83 Years STANDARD_DEVIATION 12.89 | 67.83 Years STANDARD_DEVIATION 12.1 |
| Baseline STAI Y-2 Trait Anxiety | 29.8 units on a scale STANDARD_DEVIATION 7.53 | 31.1 units on a scale STANDARD_DEVIATION 8.85 | 30.5 units on a scale STANDARD_DEVIATION 8.25 |
| Previous MMS experience Mohs Experience | 20 Participants | 19 Participants | 39 Participants |
| Previous MMS experience No Mohs Experience | 22 Participants | 21 Participants | 43 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 42 participants | 40 participants | 82 participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 24 Participants | 25 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
Time frame: Post surgery (1 day)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Education With 3D Printed Model | Percent of Correct and Incorrect Mohs Quiz Responses | Correct Quiz Responses | 93.25 Percent of quiz responses |
| Education With 3D Printed Model | Percent of Correct and Incorrect Mohs Quiz Responses | Incorrect Quiz Responses | 6.75 Percent of quiz responses |
| Verbal Counselling | Percent of Correct and Incorrect Mohs Quiz Responses | Incorrect Quiz Responses | 14.17 Percent of quiz responses |
| Verbal Counselling | Percent of Correct and Incorrect Mohs Quiz Responses | Correct Quiz Responses | 85.83 Percent of quiz responses |
Comparison: Comparing total responses that were correct across all participants in both armsp-value: 0.007t-test, 2 sided
Secondary
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)
Time frame: From baseline to post surgery (1 day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education With 3D Printed Model | Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score | -4.95 Score on a scale | Standard Deviation 6.95 |
| Verbal Counselling | Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score | -3.3 Score on a scale | Standard Deviation 9.37 |
Comparison: Difference of pre (baseline) and post-test scores within each treatment groupp-value: 0.0001t-test, 2 sided
Comparison: Difference of pre (baseline) and post-test scores within each treatment groupp-value: <0.03t-test, 2 sided
Comparison: Comparing change in scores (post-stage minus baseline) between experimental and control groupsp-value: 0.352t-test, 2 sided
Secondary
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.
Time frame: From baseline to post surgery (1 day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education With 3D Printed Model | Change in Visual Analog Scale (VAS) Anxiety Score | -1.31 Score on a scale | Standard Deviation 2 |
| Verbal Counselling | Change in Visual Analog Scale (VAS) Anxiety Score | -0.53 Score on a scale | Standard Deviation 1.54 |
Comparison: Difference of pre (baseline) and post-test scores within each treatment groupp-value: <0.0001t-test, 2 sided
Comparison: Difference of pre (baseline) and post-test scores within each treatment groupp-value: 0.04t-test, 2 sided
Comparison: Comparing change in scores (post-stage minus baseline) between experimental and control groupsp-value: 0.052t-test, 2 sided
Secondary
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.
Time frame: From baseline to post surgery (1 day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education With 3D Printed Model | Change in Visual Analog Scale (VAS) Understanding Score | 1.83 Score on a scale | Standard Deviation 2.22 |
| Verbal Counselling | Change in Visual Analog Scale (VAS) Understanding Score | 2.46 Score on a scale | Standard Deviation 2.34 |
Comparison: Difference of pre (baseline) and post-test scores within each treatment groupp-value: <0.0001t-test, 2 sided
Comparison: Difference of pre (baseline) and post-test scores within each treatment groupp-value: <0.0001t-test, 2 sided
Comparison: Comparing change in scores (post-stage minus baseline) between experimental and control groupsp-value: 0.208t-test, 2 sided
Secondary
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.
Time frame: Post surgery (1 day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education With 3D Printed Model | Satisfaction Survey Score | 14.69 score on a scale | Standard Deviation 0.811 |
| Verbal Counselling | Satisfaction Survey Score | 13.58 score on a scale | Standard Deviation 1.599 |
p-value: <0.03Chi-squared