<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/NCT02230462</url>
  </required_header>
  <id_info>
    <org_study_id>H13-02922</org_study_id>
    <nct_id>NCT02230462</nct_id>
  </id_info>
  <brief_title>Patient Satisfaction After Facial Reconstruction</brief_title>
  <official_title>Effects of Visualization of Pre-operative Defects on Patient Satisfaction After Facial Reconstruction for Skin Cancer Resection.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effects of visualization of skin cancer resection&#xD;
      defects on the face on the post-operative satisfaction of patients after their&#xD;
      reconstruction. To achieve this aim, patients invited to participate in this study will be&#xD;
      randomized to either seeing or not seeing their skin cancer excision defect prior to&#xD;
      reconstruction. After reconstruction, patient satisfaction will be assessed in both groups to&#xD;
      determine if visualization of the defect prior to reconstruction has any effect on patient&#xD;
      satisfaction and if any detected effect has durability over time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      The purpose of this study is to assess patient satisfaction after reconstruction of Mohs skin&#xD;
      cancer resection defects in the face, with the resection defect either seen or unseen by the&#xD;
      patient. In this way, the investigators will determine the effects of visualization of the&#xD;
      pre-operative defects on patient satisfaction after facial reconstruction. Any effects on&#xD;
      patient satisfaction that are identified will then be tracked over time.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The null hypothesis for this study is that patient satisfaction after reconstruction of Mohs&#xD;
      defects on the face is unaffected by the opportunity to visualize the defect prior to&#xD;
      reconstruction, and that this observation persists over time. Furthermore, patients are able&#xD;
      to recall the size of their cancer resection defect as accurately from a detailed description&#xD;
      as from seeing the defect in a mirror.&#xD;
&#xD;
      Justification:&#xD;
&#xD;
      This study will address whether visualization of a defect prior to its reconstruction affects&#xD;
      patient satisfaction. Visualization of a defect prior to reconstruction is not standardized&#xD;
      and is occasionally, but by no means necessarily, a portion of their consent for the&#xD;
      reconstruction procedure. For the excision and reconstruction procedure in this study, all&#xD;
      patients will be receiving the gold standard treatment for skin cancer. This includes a Mohs&#xD;
      excision of their cancer and subsequent reconstruction of the excision defect using either&#xD;
      primary closure or local flaps. Alternative treatments to this approach include various forms&#xD;
      of excision and reconstruction where cancer free margins cannot be immediately determined.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The objectives of this study are to determine whether visualization of a cancer excision&#xD;
      defect on the face, prior to its reconstruction, improves post-reconstruction patient&#xD;
      satisfaction. The satisfaction measures sought will primarily be satisfaction with the&#xD;
      cosmetic result but will also include measures pertaining to symptomatic scarring, skin&#xD;
      related quality of life and ability to recall defect size will also be collected.&#xD;
&#xD;
      Research Method:&#xD;
&#xD;
      Patients meeting research criteria will be recruited to this study. These patients will all&#xD;
      undergo cancer excision and reconstruction of the skin cancer defect during the same clinic&#xD;
      visit. After their cancer excision is complete, they will be and randomized to either viewing&#xD;
      or not-viewing their skin cancer excision defect prior to its reconstruction. After&#xD;
      reconstruction they will be provided a series of surveys that assess the research questions&#xD;
      posed by this study. Surveys will be distributed in the clinic on the day of surgery and at&#xD;
      routine follow-up appointments at one week and two to three months.&#xD;
&#xD;
      Statistical Analysis:&#xD;
&#xD;
      The planned sample size for this study is eighty patients randomized to two groups of forty.&#xD;
      Study end points will be sought from patient answers to three sets of surveys that determine&#xD;
      patient satisfaction with the cosmetic appearance of their reconstruction, ranked on an&#xD;
      ordinal scale, as a primary end-point. Secondary end points using ordinal and binary measures&#xD;
      will also be sought and include skin related quality of life (as measured by the Skindex 16),&#xD;
      scarring, and the ability to accurately recall the size of the skin cancer excision defect. A&#xD;
      chi-squared analysis of the data will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.</measure>
    <time_frame>The day of reconstruction.</time_frame>
    <description>Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be assessed on a ten point scale on the day of surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ability to recall cancer excision defect size.</measure>
    <time_frame>3 months after reconstruction</time_frame>
    <description>Patients will be asked to draw what they recall to be the size of their cancer excision defect prior to its reconstruction. This will be done at the final routine surgical follow up appointment (3 months after surgery).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptomatic scarring</measure>
    <time_frame>3 months after reconstruction</time_frame>
    <description>Patients will complete survey questions to determine whether they are bothered by their scar appearance, texture or any neuropathic symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Persistence of patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.</measure>
    <time_frame>2 weeks, and 3 months after reconstruction.</time_frame>
    <description>Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be reassessed on a ten point scale at the two week and 3 month routine followup appointments.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Skindex -16</measure>
    <time_frame>The day of reconstruction, 2 weeks, and 3 months after reconstruction.</time_frame>
    <description>Patient quality of life relating to their skin cancer will be assessed using the Skindex-16 (a validated tool for this purpose).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Skin Neoplasms</condition>
  <arm_group>
    <arm_group_label>Viewing of cancer excision defect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm of the study will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No viewing of cancer excision defect</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm of the study will not be invited to view their cancer excision defect prior to its reconstruction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Viewing of cancer excision defect</intervention_name>
    <description>Patients will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.</description>
    <arm_group_label>Viewing of cancer excision defect</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients recruited for this study must undergo Mohs resection of skin cancer of the&#xD;
             face with negative margins at the completion of their cancer resection.&#xD;
&#xD;
          -  Patients recruited for this study must have a post cancer resection defect on the face&#xD;
             at least 1.5 centimeters in size in the greatest dimension.&#xD;
&#xD;
          -  Patients recruited for this study must undergo single stage repair of their post&#xD;
             cancer resection defect with primary closure or local flaps.&#xD;
&#xD;
          -  Patients must be from the Greater Vancouver area.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with insufficient visual acuity to be able to appreciate wound and scarring&#xD;
             changes to their face post-operatively will be excluded.&#xD;
&#xD;
          -  Patients lacking the cognitive capacity to complete the data collection forms utilized&#xD;
             in this study will be excluded.&#xD;
&#xD;
          -  Patients suffering from significant psychiatric conditions will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bryce J Cowan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dermatology &amp; Skin Science (UBC), The Skin Care Centre</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Bryce J Cowan, MD, PhD</last_name>
      <phone>604-875-4888</phone>
      <email>skinsurg@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Jorga Zabojova, MD, PhD</last_name>
      <email>jorga.zabojova@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Bryce J Cowan, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jorga Zabojova, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>patient satisfaction</keyword>
  <keyword>Mohs surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02230462
org study id: H13-02922
nct id: NCT02230462
lead sponsor: 
has dmc: No
The purpose of this study is to assess the effects of visualization of skin cancer resection
      defects on the face on the post-operative satisfaction of patients after their
      reconstruction. To achieve this aim, patients invited to participate in this study will be
      randomized to either seeing or not seeing their skin cancer excision defect prior to
      reconstruction. After reconstruction, patient satisfaction will be assessed in both groups to
      determine if visualization of the defect prior to reconstruction has any effect on patient
      satisfaction and if any detected effect has durability over time.
Purpose:

      The purpose of this study is to assess patient satisfaction after reconstruction of Mohs skin
      cancer resection defects in the face, with the resection defect either seen or unseen by the
      patient. In this way, the investigators will determine the effects of visualization of the
      pre-operative defects on patient satisfaction after facial reconstruction. Any effects on
      patient satisfaction that are identified will then be tracked over time.

      Hypothesis:

      The null hypothesis for this study is that patient satisfaction after reconstruction of Mohs
      defects on the face is unaffected by the opportunity to visualize the defect prior to
      reconstruction, and that this observation persists over time. Furthermore, patients are able
      to recall the size of their cancer resection defect as accurately from a detailed description
      as from seeing the defect in a mirror.

      Justification:

      This study will address whether visualization of a defect prior to its reconstruction affects
      patient satisfaction. Visualization of a defect prior to reconstruction is not standardized
      and is occasionally, but by no means necessarily, a portion of their consent for the
      reconstruction procedure. For the excision and reconstruction procedure in this study, all
      patients will be receiving the gold standard treatment for skin cancer. This includes a Mohs
      excision of their cancer and subsequent reconstruction of the excision defect using either
      primary closure or local flaps. Alternative treatments to this approach include various forms
      of excision and reconstruction where cancer free margins cannot be immediately determined.

      Objectives:

      The objectives of this study are to determine whether visualization of a cancer excision
      defect on the face, prior to its reconstruction, improves post-reconstruction patient
      satisfaction. The satisfaction measures sought will primarily be satisfaction with the
      cosmetic result but will also include measures pertaining to symptomatic scarring, skin
      related quality of life and ability to recall defect size will also be collected.

      Research Method:

      Patients meeting research criteria will be recruited to this study. These patients will all
      undergo cancer excision and reconstruction of the skin cancer defect during the same clinic
      visit. After their cancer excision is complete, they will be and randomized to either viewing
      or not-viewing their skin cancer excision defect prior to its reconstruction. After
      reconstruction they will be provided a series of surveys that assess the research questions
      posed by this study. Surveys will be distributed in the clinic on the day of surgery and at
      routine follow-up appointments at one week and two to three months.

      Statistical Analysis:

      The planned sample size for this study is eighty patients randomized to two groups of forty.
      Study end points will be sought from patient answers to three sets of surveys that determine
      patient satisfaction with the cosmetic appearance of their reconstruction, ranked on an
      ordinal scale, as a primary end-point. Secondary end points using ordinal and binary measures
      will also be sought and include skin related quality of life (as measured by the Skindex 16),
      scarring, and the ability to accurately recall the size of the skin cancer excision defect. A
      chi-squared analysis of the data will be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
time frame: The day of reconstruction.
description: Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be assessed on a ten point scale on the day of surgery.
measure: Ability to recall cancer excision defect size.
time frame: 3 months after reconstruction
description: Patients will be asked to draw what they recall to be the size of their cancer excision defect prior to its reconstruction. This will be done at the final routine surgical follow up appointment (3 months after surgery).
measure: Symptomatic scarring
time frame: 3 months after reconstruction
description: Patients will complete survey questions to determine whether they are bothered by their scar appearance, texture or any neuropathic symptoms.
measure: Persistence of patient satisfaction with the cosmetic appearance of their skin cancer reconstruction.
time frame: 2 weeks, and 3 months after reconstruction.
description: Patient satisfaction with the cosmetic appearance of their skin cancer reconstruction site will be reassessed on a ten point scale at the two week and 3 month routine followup appointments.
measure: Skindex -16
time frame: The day of reconstruction, 2 weeks, and 3 months after reconstruction.
description: Patient quality of life relating to their skin cancer will be assessed using the Skindex-16 (a validated tool for this purpose).
arm group label: Viewing of cancer excision defect
arm group type: Experimental
description: Patients in this arm of the study will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.
arm group label: No viewing of cancer excision defect
arm group type: No Intervention
description: Patients in this arm of the study will not be invited to view their cancer excision defect prior to its reconstruction.
intervention type: Other
intervention name: Viewing of cancer excision defect
description: Patients will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.
arm group label: Viewing of cancer excision defect
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bryce J Cowan, MD, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Skin Neoplasms