Mohs Micrographic SurgeryNCT03461965
3D Printed Models in Mohs Micrographic Surgery
A study testing 3D printed model and Verbal Counselling in people with Mohs Micrographic Surgery, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mohs Micrographic Surgery
- What is being tested?
- 3D printed model and Verbal Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2018to 25 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing MMS at University Hospitals Cleveland Medical Center, Chagrin Highlands and Westlake Campus
- Capable of reading and completing all subjective questionnaires
Who cannot join
- Cannot complete the survey measures independently for any reason
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: The Use of 3D Printed Models in Mohs Micrographic Surgery
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.
Read the detailed description
- 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.
- 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.
- 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.
- Conditions
- Mohs Micrographic Surgery
- Being tested
- 3D printed model, Verbal Counselling
- Keywords
- 3D printing, Patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed modelBehavioural
A printed 3D model of MMS will be created showing a model of skin, and a tumor to visually depict the surgery
Verbal CounsellingBehavioural
Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and MMS
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Verbal Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post surgery (1 day)
Secondary outcomes (4)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post surgery (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start2 Mar 2018
- Primary completion25 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mohs Micrographic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Margaret Mann, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461965
- Sponsor's protocol ID
- CASE6617
- Other IDs
- T32AR007569
- Status last verified
- Apr 2021
- First submitted
- 5 Mar 2018
- Last updated
- 21 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of 3D Printed Models in Mohs Micrographic Surgery
- ClinicalTrials.gov ID
- NCT03461965
- Acronym / sponsor ID
- CASE6617
- Conditions
- Mohs Micrographic Surgery
- Keywords
- 3D printing, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 25 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Posted 21 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Education with 3D printed model | Experimental | Behavioral: 3D printed model, Behavioral: Verbal CounsellingThe experimental group will be educated on MMS with a standardized script in addition to a 3D MMS model |
| Verbal Counselling | Active comparator | Behavioral: Verbal CounsellingParticipants in the control group will be educated on MMS according to the current standard of care, verbal counselling, with a standardized script |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing MMS at University Hospitals Cleveland Medical Center, Chagrin Highlands and Westlake Campus
- Capable of reading and completing all subjective questionnaires
Key exclusion criteria (1 listed)
- Cannot complete the survey measures independently for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed modelA printed 3D model of MMS will be created showing a model of skin, and a tumor to visually depict the surgery | Behavioural | Education with 3D printed model |
| Verbal CounsellingParticipants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and MMS | Behavioural | Education with 3D printed model, Verbal Counselling |
Primary outcome
Percent of Correct and Incorrect Mohs Quiz Responses
Time frame: 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
4 secondary outcomes
Change in State-Trait Anxiety Inventory (STAI) Y-1 (State Anxiety) Score
Time frame: From baseline to post surgery (1 day)
Change in Visual Analog Scale (VAS) Anxiety Score
Time frame: From baseline to post surgery (1 day)
Change in Visual Analog Scale (VAS) Understanding Score
Time frame: From baseline to post surgery (1 day)
Satisfaction Survey Score
Time frame: Post surgery (1 day)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Mohs Micrographic Surgery
Not yet recruitingPhase 1
Amnion Membrane Powder Mohs Study
Wound Heal
Not yet recruiting
Cyanoacrylate Skin Adhesive After Mohs Surgery or Wide Local Excision
Surgical Site Infection, Skin Cancer
Not yet recruitingPhase 2
The Effects of Timolol On Healing and Cosmesis of Mohs Scalp Wounds: An Open Label Trial
Surgical Wounds, Mohs Surgery
Not yet recruiting
Intraoperative CO₂ (Carbon Dioxide)
Wound Edges
Not yet recruitingPhase 4
Skin Subs vs Secondary Intention
Skin Substitutes, Secondary Intention Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Mann, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printed model and Verbal Counselling in people with Mohs Micrographic Surgery, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Correct and Incorrect Mohs Quiz Responses (time frame: Post surgery (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.