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| ID | Type | Description | Link |
|---|---|---|---|
| T32AR007569 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Mann, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | Percent of quiz responses | Post surgery (1 day) |
|
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Adverse Events were not collected because no adverse events were expected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margaret Mann, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | 1-800-641-2422 | CTUReferral@uhhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2018 | Mar 19, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 4, 2019 | Mar 19, 2021 | ICF_001.pdf |
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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.
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| Verbal Counselling | Behavioral | Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and MMS |
|
| 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) |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Previous MMS experience | Number of patients who previously underwent MMS | Count of Participants | Participants |
|
| Baseline STAI Y-2 "Trait Anxiety" | Baseline anxiety from form Y-2 of STAI scale - measures patient's trait or static anxiety 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-2 form consists of 20 Likert-type questions with scores ranging from 20 to 80, with higher scores indicating higher anxiety | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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 |
|
|
|
| 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) | Posted | Mean | Standard Deviation | Score on a scale | From baseline to post surgery (1 day) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score on a scale | From baseline to post surgery (1 day) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Score on a scale | From baseline to post surgery (1 day) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Post surgery (1 day) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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: Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and Mohs Micrographic Surgery | 0 | 0 | 0 | 0 | 0 | 0 |
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| t-test, 2 sided |
| <0.03 |
| Other |
p-value < 0.05 was considered statistically significant |
| Comparing change in scores (post-stage minus baseline) between experimental and control groups | t-test, 2 sided | paired t-test | 0.352 | Other | p-value < 0.05 was considered statistically significant |
| t-test, 2 sided |
| 0.04 |
| Other |
p-value < 0.05 was considered statistically significant |
| Comparing change in scores (post-stage minus baseline) between experimental and control groups | t-test, 2 sided | paired t-test | 0.052 | Other | p-value < 0.05 was considered statistically significant |
| t-test, 2 sided |
| <0.0001 |
| Other |
p-value < 0.05 was considered statistically significant |
| Comparing change in scores (post-stage minus baseline) between experimental and control groups | t-test, 2 sided | paired t-test | 0.208 | Other | p-value < 0.05 was considered statistically significant |