<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03756792</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00054156</org_study_id>
    <nct_id>NCT03756792</nct_id>
  </id_info>
  <brief_title>Assessing Patient Anxiety During Mohs Micrographic Surgery</brief_title>
  <official_title>Assessing Patient Anxiety During Mohs Micrographic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the anxiety that patients are experiencing during a Mohs micrographic&#xD;
      surgery. The study will compare the feelings of anxiety experienced by patients returning for&#xD;
      Mohs surgery after already undergoing the surgery at least one time to feelings experienced&#xD;
      by patients who have never had Mohs surgery before. The study will also compare the feelings&#xD;
      experienced by patients who have read a vignette about the typical Mohs experience to the&#xD;
      feelings of patients who have not read a vignette.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There has been a continual increase in cases of nonmelanoma skin cancer and melanoma over the&#xD;
      last several decades. With the increase in incidence, there is also the need for increased&#xD;
      treatment. Mohs micrographic surgery (MMS) is highly efficacious, with cure rates in the&#xD;
      upper 90% for both basal cell carcinoma and squamous cell carcinoma, the two most common&#xD;
      forms of skin cancer. MMS is used for tumors in cosmetically sensitive areas or areas of&#xD;
      recurrence.&#xD;
&#xD;
      While MMS is usually performed in the outpatient setting, it may be an anxiety provoking&#xD;
      experience for patients, ranging from the fear of a cancer diagnosis, to concerns about the&#xD;
      procedural events of the surgery and associated pain, to the anticipation of their final&#xD;
      cosmetic result. During a MMS procedure, unlike many other types of surgery or procedures,&#xD;
      the patient is awake and aware of his or her surroundings, with periods of waiting&#xD;
      interspersed throughout the procedure. Such aspects can lead to the high level of&#xD;
      perioperative anxiety in MMS patients. The effects of listening to music, watching&#xD;
      preoperative informational videos, and the use of web-based applications have been used to&#xD;
      attempt to decrease anxiety in MMS patients. However, causes for differences in anxiety level&#xD;
      between first time MMS patients and patients returning for a subsequent MMS procedure are not&#xD;
      well characterized.&#xD;
&#xD;
      One approach to reduce patient anxiety involves patient education, where patients are&#xD;
      presented statistics about the small likelihood of complication from the MMS procedure.&#xD;
      However, patients interpret these data very subjectively. The study team proposes an&#xD;
      alternative approach to patient education through patient vignettes. A previous study&#xD;
      explored using a narrative video that included patient testimonials, but this video also used&#xD;
      patient-physician interaction and drawings. In this study, patients will be provided short&#xD;
      vignettes, that would include information about the experience of a typical MMS patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 26, 2019</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale for Anxiety Scores</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>This outcome will assess the difference in VAS-A scores for patients based on prior experience with MMS versus first-time MMS. A higher score denotes a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analog Scale Scores</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>This outcome will assess the difference the difference in VAS-A score between the control and intervention groups that read patient vignettes. A higher score denotes a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survey to identify factors that modify anxiety - Positive statements</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>The survey presents 2 statements to be answered each on a 5-point likert scale to assess patients feelings of anxiety in the perioperative period. A higher score denotes a better outcome. Total score 0-10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survey to identify factors that modify anxiety - Negative statements</measure>
    <time_frame>up to 10 minutes</time_frame>
    <description>The survey presents 2 statements to be answered each on a 5-point likert scale to assess patients feelings of anxiety in the perioperative period. A higher score denotes a worse outcome. Total score 0-10</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>First Time Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with no prior experience of Mohs surgery will be randomly assigned to the control group. The control group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology, then fill out a brief survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>First Time Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with no prior experience of Mohs surgery will be randomly assigned to the intervention group. The intervention group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology and read a vignette about the typical experience of a Mohs patient, then fill out a brief survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Previous Experience Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with prior experience of Mohs surgery will be randomly assigned to the control group. The control group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology, then fill out a brief survey.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Previous Experience Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with prior experience of Mohs surgery will be randomly assigned to the intervention group. The intervention group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology and read a vignette about the typical experience of a Mohs patient, then fill out a brief survey.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Normal Education Material</intervention_name>
    <description>Patients will receive standard educational material about Mohs micrographic surgery.</description>
    <arm_group_label>First Time Control</arm_group_label>
    <arm_group_label>First Time Intervention</arm_group_label>
    <arm_group_label>Previous Experience Control</arm_group_label>
    <arm_group_label>Previous Experience Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Vignette</intervention_name>
    <description>Patients will receive standard educational material about Mohs micrographic surgery and read a vignette detailing the typical experience of a Mohs patient.</description>
    <arm_group_label>First Time Intervention</arm_group_label>
    <arm_group_label>Previous Experience Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient undergoing Mohs micrographic surgery for cutaneous cancer, soft tissue&#xD;
             tumors, and adnexal tumors&#xD;
&#xD;
          -  Subjects with a working knowledge of English&#xD;
&#xD;
          -  Age 18-80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to fill out a paper or electronic survey or read a short pamphlet on&#xD;
             prior patient experiences, or those unwilling to have either of the previously stated&#xD;
             items read aloud to them.&#xD;
&#xD;
          -  Individuals less than 18 or greater than 80 years old (line of questioning necessary&#xD;
             for the study may be beyond understanding in this group)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Feldman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol. 2015 Oct;151(10):1081-6. doi: 10.1001/jamadermatol.2015.1187.</citation>
    <PMID>25928283</PMID>
  </reference>
  <reference>
    <citation>Dubas LE, Ingraffea A. Nonmelanoma skin cancer. Facial Plast Surg Clin North Am. 2013 Feb;21(1):43-53. doi: 10.1016/j.fsc.2012.10.003.</citation>
    <PMID>23369588</PMID>
  </reference>
  <reference>
    <citation>Kamangar F, Petukhova TA, Monico G, Mathis S, Joo J, Zhuang A, Li CS, Liu Y, Lee E, Eisen D. Anxiety levels of patients undergoing common dermatologic procedures versus those seeking general dermatologic care. Dermatol Online J. 2017 May 15;23(5):13030/qt64d8r1gq.</citation>
    <PMID>28537871</PMID>
  </reference>
  <reference>
    <citation>Persichetti GB, Walling HW, Ceilley RI. Personalized music enhances patient perception of the Mohs surgery experience. Dermatol Surg. 2009 Feb;35(2):265-7. doi: 10.1111/j.1524-4725.2008.34422.x. No abstract available.</citation>
    <PMID>19215268</PMID>
  </reference>
  <reference>
    <citation>Vachiramon V, Sobanko JF, Rattanaumpawan P, Miller CJ. Music reduces patient anxiety during Mohs surgery: an open-label randomized controlled trial. Dermatol Surg. 2013 Feb;39(2):298-305. doi: 10.1111/dsu.12047. Epub 2013 Jan 24.</citation>
    <PMID>23346989</PMID>
  </reference>
  <reference>
    <citation>Newsom E, Lee E, Rossi A, Dusza S, Nehal K. Modernizing the Mohs Surgery Consultation: Instituting a Video Module for Improved Patient Education and Satisfaction. Dermatol Surg. 2018 Jun;44(6):778-784. doi: 10.1097/DSS.0000000000001473.</citation>
    <PMID>29642110</PMID>
  </reference>
  <reference>
    <citation>Hawkins SD, Koch SB, Williford PM, Feldman SR, Pearce DJ. Web App- and Text Message-Based Patient Education in Mohs Micrographic Surgery-A Randomized Controlled Trial. Dermatol Surg. 2018 Jul;44(7):924-932. doi: 10.1097/DSS.0000000000001489.</citation>
    <PMID>29406486</PMID>
  </reference>
  <reference>
    <citation>Zhang J, Miller CJ, O'Malley V, Etzkorn JR, Shin TM, Sobanko JF. Patient quality of life fluctuates before and after Mohs micrographic surgery: A longitudinal assessment of the patient experience. J Am Acad Dermatol. 2018 Jun;78(6):1060-1067. doi: 10.1016/j.jaad.2018.02.065. Epub 2018 Mar 5.</citation>
    <PMID>29518455</PMID>
  </reference>
  <reference>
    <citation>Locke MC, Wilkerson EC, Mistur RL, Nisar M, Love WE. 2015 Arte Poster Competition First Place Winner: Assessing the Correlation Between Patient Anxiety and Satisfaction for Mohs Surgery. J Drugs Dermatol. 2015 Sep;14(9):1070-2.</citation>
    <PMID>26355630</PMID>
  </reference>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mohs Micographic Surgery</keyword>
  <keyword>skin cancer</keyword>
  <keyword>melanoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03756792
org study id: IRB00054156
nct id: NCT03756792
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will assess the anxiety that patients are experiencing during a Mohs micrographic
      surgery. The study will compare the feelings of anxiety experienced by patients returning for
      Mohs surgery after already undergoing the surgery at least one time to feelings experienced
      by patients who have never had Mohs surgery before. The study will also compare the feelings
      experienced by patients who have read a vignette about the typical Mohs experience to the
      feelings of patients who have not read a vignette.
There has been a continual increase in cases of nonmelanoma skin cancer and melanoma over the
      last several decades. With the increase in incidence, there is also the need for increased
      treatment. Mohs micrographic surgery (MMS) is highly efficacious, with cure rates in the
      upper 90% for both basal cell carcinoma and squamous cell carcinoma, the two most common
      forms of skin cancer. MMS is used for tumors in cosmetically sensitive areas or areas of
      recurrence.

      While MMS is usually performed in the outpatient setting, it may be an anxiety provoking
      experience for patients, ranging from the fear of a cancer diagnosis, to concerns about the
      procedural events of the surgery and associated pain, to the anticipation of their final
      cosmetic result. During a MMS procedure, unlike many other types of surgery or procedures,
      the patient is awake and aware of his or her surroundings, with periods of waiting
      interspersed throughout the procedure. Such aspects can lead to the high level of
      perioperative anxiety in MMS patients. The effects of listening to music, watching
      preoperative informational videos, and the use of web-based applications have been used to
      attempt to decrease anxiety in MMS patients. However, causes for differences in anxiety level
      between first time MMS patients and patients returning for a subsequent MMS procedure are not
      well characterized.

      One approach to reduce patient anxiety involves patient education, where patients are
      presented statistics about the small likelihood of complication from the MMS procedure.
      However, patients interpret these data very subjectively. The study team proposes an
      alternative approach to patient education through patient vignettes. A previous study
      explored using a narrative video that included patient testimonials, but this video also used
      patient-physician interaction and drawings. In this study, patients will be provided short
      vignettes, that would include information about the experience of a typical MMS patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Visual Analog Scale for Anxiety Scores
time frame: up to 10 minutes
description: This outcome will assess the difference in VAS-A scores for patients based on prior experience with MMS versus first-time MMS. A higher score denotes a worse outcome.
measure: Visual Analog Scale Scores
time frame: up to 10 minutes
description: This outcome will assess the difference the difference in VAS-A score between the control and intervention groups that read patient vignettes. A higher score denotes a worse outcome.
measure: Survey to identify factors that modify anxiety - Positive statements
time frame: up to 10 minutes
description: The survey presents 2 statements to be answered each on a 5-point likert scale to assess patients feelings of anxiety in the perioperative period. A higher score denotes a better outcome. Total score 0-10
measure: Survey to identify factors that modify anxiety - Negative statements
time frame: up to 10 minutes
description: The survey presents 2 statements to be answered each on a 5-point likert scale to assess patients feelings of anxiety in the perioperative period. A higher score denotes a worse outcome. Total score 0-10
arm group label: First Time Control
arm group type: Active Comparator
description: Patients with no prior experience of Mohs surgery will be randomly assigned to the control group. The control group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology, then fill out a brief survey.
arm group label: First Time Intervention
arm group type: Experimental
description: Patients with no prior experience of Mohs surgery will be randomly assigned to the intervention group. The intervention group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology and read a vignette about the typical experience of a Mohs patient, then fill out a brief survey.
arm group label: Previous Experience Control
arm group type: Active Comparator
description: Patients with prior experience of Mohs surgery will be randomly assigned to the control group. The control group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology, then fill out a brief survey.
arm group label: Previous Experience Intervention
arm group type: Experimental
description: Patients with prior experience of Mohs surgery will be randomly assigned to the intervention group. The intervention group will receive the normal education material that MMS patients receive from Wake Forest Baptist Health Dermatology and read a vignette about the typical experience of a Mohs patient, then fill out a brief survey.
intervention type: Behavioral
intervention name: Normal Education Material
description: Patients will receive standard educational material about Mohs micrographic surgery.
arm group label: First Time Control
arm group label: First Time Intervention
arm group label: Previous Experience Control
arm group label: Previous Experience Intervention
intervention type: Behavioral
intervention name: Vignette
description: Patients will receive standard educational material about Mohs micrographic surgery and read a vignette detailing the typical experience of a Mohs patient.
arm group label: First Time Intervention
arm group label: Previous Experience Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Steven Feldman, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
citation: Rogers HW, Weinstock MA, Feldman SR, Coldiron BM. Incidence Estimate of Nonmelanoma Skin Cancer (Keratinocyte Carcinomas) in the U.S. Population, 2012. JAMA Dermatol. 2015 Oct;151(10):1081-6. doi: 10.1001/jamadermatol.2015.1187.
PMID: 25928283
citation: Dubas LE, Ingraffea A. Nonmelanoma skin cancer. Facial Plast Surg Clin North Am. 2013 Feb;21(1):43-53. doi: 10.1016/j.fsc.2012.10.003.
PMID: 23369588
citation: Kamangar F, Petukhova TA, Monico G, Mathis S, Joo J, Zhuang A, Li CS, Liu Y, Lee E, Eisen D. Anxiety levels of patients undergoing common dermatologic procedures versus those seeking general dermatologic care. Dermatol Online J. 2017 May 15;23(5):13030/qt64d8r1gq.
PMID: 28537871
citation: Persichetti GB, Walling HW, Ceilley RI. Personalized music enhances patient perception of the Mohs surgery experience. Dermatol Surg. 2009 Feb;35(2):265-7. doi: 10.1111/j.1524-4725.2008.34422.x. No abstract available.
PMID: 19215268
citation: Vachiramon V, Sobanko JF, Rattanaumpawan P, Miller CJ. Music reduces patient anxiety during Mohs surgery: an open-label randomized controlled trial. Dermatol Surg. 2013 Feb;39(2):298-305. doi: 10.1111/dsu.12047. Epub 2013 Jan 24.
PMID: 23346989
citation: Newsom E, Lee E, Rossi A, Dusza S, Nehal K. Modernizing the Mohs Surgery Consultation: Instituting a Video Module for Improved Patient Education and Satisfaction. Dermatol Surg. 2018 Jun;44(6):778-784. doi: 10.1097/DSS.0000000000001473.
PMID: 29642110
citation: Hawkins SD, Koch SB, Williford PM, Feldman SR, Pearce DJ. Web App- and Text Message-Based Patient Education in Mohs Micrographic Surgery-A Randomized Controlled Trial. Dermatol Surg. 2018 Jul;44(7):924-932. doi: 10.1097/DSS.0000000000001489.
PMID: 29406486
citation: Zhang J, Miller CJ, O'Malley V, Etzkorn JR, Shin TM, Sobanko JF. Patient quality of life fluctuates before and after Mohs micrographic surgery: A longitudinal assessment of the patient experience. J Am Acad Dermatol. 2018 Jun;78(6):1060-1067. doi: 10.1016/j.jaad.2018.02.065. Epub 2018 Mar 5.
PMID: 29518455
citation: Locke MC, Wilkerson EC, Mistur RL, Nisar M, Love WE. 2015 Arte Poster Competition First Place Winner: Assessing the Correlation Between Patient Anxiety and Satisfaction for Mohs Surgery. J Drugs Dermatol. 2015 Sep;14(9):1070-2.
PMID: 26355630
responsible party type: Sponsor
mesh term: Anxiety Disorders
sharing ipd: No