<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/NCT04485442</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00301; ch20Schaefer2</org_study_id>
    <nct_id>NCT04485442</nct_id>
  </id_info>
  <brief_title>Patient Reported Outcome Measures After Treatment of Skin Cancers on the Face</brief_title>
  <official_title>Patient Reported Outcome Measures After Treatment of Skin Cancers on the Face - a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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 is to evaluate the psychological well-being in patients diagnosed with skin cancer&#xD;
      (melanoma and Squamous Cell Carcinoma (SCC) in the face) at the time of diagnosis and after&#xD;
      treatment. Patients diagnosed with primary melanoma and/or SCC and/or infiltrative basal cell&#xD;
      carcinoma on the face subjected to surgical treatment (excision or Mohs Surgery) will be&#xD;
      included. All patients will receive questionnaires.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 9, 2020</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Belastungs-Thermometer questionnaire</measure>
    <time_frame>at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)</time_frame>
    <description>extent of distress on a scale from 0-10 (0=no distress, 10=extremely distress).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire</measure>
    <time_frame>at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)</time_frame>
    <description>TheEORTC- QLQ-C30 is composed of both multiitem scales and single-item measures. These include 5 functional scales (cognitive, CF; emotional, EF; physical, PF; role, RF; and social functioning, SF), 3 symptom scales (fatigue, FA; nausea/vomiting, NV; and pain, PA), a global health status/QoL scale and 5 single items assessing additional symptoms (appetite loss, AP; constipation, CO; diarrhea, DI; dyspnea, DY; and sleep disturbance, SL) and perceived financial impact, FI. Each of the multiitem scales includes a different set of items-no item occurs in more than 1 scale. All of the scales and single-item measures range in score from 0-100. A high scale score represents a higher response level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in WHO-DAS questionnaire</measure>
    <time_frame>at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)</time_frame>
    <description>The WHO-DAS measures items in six domains of functioning as experienced over the past 30 days: mobility, self-care, life activities, understanding and communicating (U&amp;C), interpersonal interactions, and participation in society. The 12-item tool assesses each domain with two items that are measured on a 3-point scale in which 1 indicates no disability, 2 indicates mild to moderate disability, and 3 indicates severe to extreme disability. These items were summed to generate a total score between 12 (no disability) and 36 (maximum disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FACE-Q questionnaire</measure>
    <time_frame>at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)</time_frame>
    <description>The FACE-Q questionnaire measures three overarching domains: facial appearance, quality of life and experience of care over the past 7 days. The FACE-Q Skin Cancer Module is composed of 56 items with scales from 1-4 which range in scoring from 0-100. The FACE-Q Skin Cancer module includes two quality of life scales measuring appearance-related distress and skin cancer worry. Additionally, the participants will be asked about skin protection behaviours and adverse events following the skin cancer treatment. The FACE-Q appearance scale consists of satisfaction with the appearance of the face overall and how bothered a patient is by facial scars</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in photos of the patients' tumors</measure>
    <time_frame>at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)</time_frame>
    <description>Change in photos of the patients' tumors</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Skin Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data collection by questionnaires</intervention_name>
    <description>psychological well-being in patients evaluated by Patient Reported Outcomes (PRO)</description>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data collection (photos of the patients' tumors)</intervention_name>
    <description>photos of the patients' tumors will be taken at baseline and at follow-up after the surgery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients diagnosed with melanoma, SCC and /or infiltrative basal cell carcinoma on the&#xD;
        face are eligible for the study and will be recruited at the Department of Dermatology and&#xD;
        Plastic Surgery at University Hospital Basel.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals diagnosed with melanoma, SCC and/or infiltrative basal cell carcinoma on&#xD;
             the face for surgical treatment and planned for excision or Mohs surgery&#xD;
&#xD;
          -  patients who are able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Electrodesication and curettage of the tumour&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dirk J Schaefer, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Plastic, Reconstructive and Aesthetic Surgery, University Hospital Basel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dirk J Schaefer, Prof. Dr. med.</last_name>
    <phone>041 61 265 25 25</phone>
    <email>Dirk.Schaefer@usb.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lara Valeska Maul, Dr. med.</last_name>
    <phone>+41 61 265 40 80</phone>
    <email>laravaleska.maul@usb.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Plastic, Reconstructive and Aesthetic Surgery and Department of Dermatology , University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dirk J Schaefer, Prof. Dr. med.</last_name>
      <phone>041 61 265 25 25</phone>
      <email>Dirk.Schaefer@usb.ch</email>
    </contact>
    <investigator>
      <last_name>Lara Valeska Maul, Dr.med</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>March 1, 2022</last_update_submitted>
  <last_update_submitted_qc>March 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>melanoma</keyword>
  <keyword>SCC in the face</keyword>
  <keyword>infiltrative basal cell carcinoma on the face</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/NCT04485442
org study id: 2018-00301; ch20Schaefer2
nct id: NCT04485442
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is to evaluate the psychological well-being in patients diagnosed with skin cancer
      (melanoma and Squamous Cell Carcinoma (SCC) in the face) at the time of diagnosis and after
      treatment. Patients diagnosed with primary melanoma and/or SCC and/or infiltrative basal cell
      carcinoma on the face subjected to surgical treatment (excision or Mohs Surgery) will be
      included. All patients will receive questionnaires.
observational model: Cohort
time perspective: Prospective
measure: Change in Belastungs-Thermometer questionnaire
time frame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
description: extent of distress on a scale from 0-10 (0=no distress, 10=extremely distress).
measure: Change in European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire
time frame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
description: TheEORTC- QLQ-C30 is composed of both multiitem scales and single-item measures. These include 5 functional scales (cognitive, CF; emotional, EF; physical, PF; role, RF; and social functioning, SF), 3 symptom scales (fatigue, FA; nausea/vomiting, NV; and pain, PA), a global health status/QoL scale and 5 single items assessing additional symptoms (appetite loss, AP; constipation, CO; diarrhea, DI; dyspnea, DY; and sleep disturbance, SL) and perceived financial impact, FI. Each of the multiitem scales includes a different set of items-no item occurs in more than 1 scale. All of the scales and single-item measures range in score from 0-100. A high scale score represents a higher response level.
measure: Change in WHO-DAS questionnaire
time frame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
description: The WHO-DAS measures items in six domains of functioning as experienced over the past 30 days: mobility, self-care, life activities, understanding and communicating (U&C), interpersonal interactions, and participation in society. The 12-item tool assesses each domain with two items that are measured on a 3-point scale in which 1 indicates no disability, 2 indicates mild to moderate disability, and 3 indicates severe to extreme disability. These items were summed to generate a total score between 12 (no disability) and 36 (maximum disability).
measure: Change in FACE-Q questionnaire
time frame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
description: The FACE-Q questionnaire measures three overarching domains: facial appearance, quality of life and experience of care over the past 7 days. The FACE-Q Skin Cancer Module is composed of 56 items with scales from 1-4 which range in scoring from 0-100. The FACE-Q Skin Cancer module includes two quality of life scales measuring appearance-related distress and skin cancer worry. Additionally, the participants will be asked about skin protection behaviours and adverse events following the skin cancer treatment. The FACE-Q appearance scale consists of satisfaction with the appearance of the face overall and how bothered a patient is by facial scars
measure: Change in photos of the patients' tumors
time frame: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
description: Change in photos of the patients' tumors
intervention type: Other
intervention name: data collection by questionnaires
description: psychological well-being in patients evaluated by Patient Reported Outcomes (PRO)
intervention type: Other
intervention name: data collection (photos of the patients' tumors)
description: photos of the patients' tumors will be taken at baseline and at follow-up after the surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dirk J Schaefer, Prof. Dr. med.
role: Principal Investigator
affiliation: Department of Plastic, Reconstructive and Aesthetic Surgery, University Hospital Basel
last name: Dirk J Schaefer, Prof. Dr. med.
phone: 041 61 265 25 25
email: Dirk.Schaefer@usb.ch
last name: Lara Valeska Maul, Dr. med.
phone: +41 61 265 40 80
email: laravaleska.maul@usb.ch
facility: 
status: Recruiting
contact: 
investigator: 
country: Switzerland
responsible party type: Sponsor
mesh term: Skin Neoplasms