<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/NCT04474301</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0470</org_study_id>
    <secondary_id>NCI-2020-04587</secondary_id>
    <secondary_id>2020-0470</secondary_id>
    <nct_id>NCT04474301</nct_id>
  </id_info>
  <brief_title>Well-Being and Health-Related Quality of Life in Melanoma Patients During COVID-19 Pandemic</brief_title>
  <official_title>Well-Being and Quality of Life in Melanoma Patients During COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
      The primary purpose of this study is to gain an understanding of how experiences during the&#xD;
      COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domains of&#xD;
      health-related quality of life and other areas such as COVID-19 specific psychological&#xD;
      distress, and disruptions to health care, finances and social interactions. We will also&#xD;
      evaluate the extent to which resiliency factors such as social support, perceived benefits&#xD;
      under times of stress, and ability to manage stress may buffer associations between COVID-19&#xD;
      experiences and HRQoL. To meet these objectives, we have developed a 10-minute questionnaire&#xD;
      that taps into these areas and is based on prior work addressing concerns of other pandemics&#xD;
      or national crises. Participants will have previously consented to protocol PA15-0336 and&#xD;
      have provided prior lifestyle data. This will allow us to connect the COVID-19 survey data&#xD;
      with prior existing data.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Assess experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,&#xD;
      isolation, seropositivity, hospitalization, loss of family or friends); COVID-19-specific&#xD;
      psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and&#xD;
      social disruptions; perceived benefits and social support; and health-related quality of life&#xD;
      (HRQoL) in melanoma patients who participated in protocol PA15-0336.&#xD;
&#xD;
      II. Evaluate the extent to which COVID-19 experiences are associated with COVID-19-specific&#xD;
      psychological distress, health, financial and social disruptions, perceived benefits and&#xD;
      social support, and HRQoL.&#xD;
&#xD;
      III. Evaluate the extent to which resiliency factors such as social support and perceived&#xD;
      benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological&#xD;
      distress and HRQoL.&#xD;
&#xD;
      IV. Explore the association between prior lifestyle data collected as part of PA15-0336 and&#xD;
      COVID-19-specific psychological distress and HRQoL.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients complete a survey over 10 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Experiences during the COVID-19 pandemic</measure>
    <time_frame>Survey completion Up to 2 months</time_frame>
    <description>Including exposure, risk factors, testing, isolation, seropositivity, hospitalization, or loss of family or friends.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific psychological distress</measure>
    <time_frame>Survey completion Up to 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific health</measure>
    <time_frame>Survey completion Up to 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific financial and social disruptions</measure>
    <time_frame>Survey completion Up to 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific perceived benefits and social support</measure>
    <time_frame>Survey completion Up to 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific health related quality of life (HRQoL)</measure>
    <time_frame>Survey completion Up to 2 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL</measure>
    <time_frame>Survey completion Up to 2 months</time_frame>
    <description>Will evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prior lifestyle data</measure>
    <time_frame>Survey completion Up to 2 months</time_frame>
    <description>Will explore the association between prior lifestyle data collected as part of PA15-0336 and COVID-19-specific psychological distress and HRQoL.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1152</enrollment>
  <condition>COVID-19 Infection</condition>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Observational (survey administration)</arm_group_label>
    <description>Patients complete a survey over 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Complete survey</description>
    <arm_group_label>Observational (survey administration)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have signed consent for PA15-0336.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who have signed consent for PA15-0336&#xD;
&#xD;
          -  Has an active email address and can be contacted via MyChart&#xD;
&#xD;
          -  Documentation of being alive per the cancer registry&#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>Lorenzo Cohen</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lorenzo Cohen</last_name>
    <phone>(713) 745-4260</phone>
    <email>lcohen@mdanderson.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lorenzo Cohen</last_name>
      <email>lcohen@mdanderson.org</email>
    </contact>
    <investigator>
      <last_name>Lorenzo Cohen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>M D Anderson Cancer Center</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Melanoma</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/NCT04474301
org study id: 2020-0470
secondary id: NCI-2020-04587
secondary id: 2020-0470
nct id: NCT04474301
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study is to gain an understanding of how experiences during the
      COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domains of
      health-related quality of life and other areas such as COVID-19 specific psychological
      distress, and disruptions to health care, finances and social interactions. We will also
      evaluate the extent to which resiliency factors such as social support, perceived benefits
      under times of stress, and ability to manage stress may buffer associations between COVID-19
      experiences and HRQoL. To meet these objectives, we have developed a 10-minute questionnaire
      that taps into these areas and is based on prior work addressing concerns of other pandemics
      or national crises. Participants will have previously consented to protocol PA15-0336 and
      have provided prior lifestyle data. This will allow us to connect the COVID-19 survey data
      with prior existing data.
PRIMARY OBJECTIVES:

      I. Assess experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,
      isolation, seropositivity, hospitalization, loss of family or friends); COVID-19-specific
      psychological distress (e.g., fear, anxiety and depressive symptoms); health, financial and
      social disruptions; perceived benefits and social support; and health-related quality of life
      (HRQoL) in melanoma patients who participated in protocol PA15-0336.

      II. Evaluate the extent to which COVID-19 experiences are associated with COVID-19-specific
      psychological distress, health, financial and social disruptions, perceived benefits and
      social support, and HRQoL.

      III. Evaluate the extent to which resiliency factors such as social support and perceived
      benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological
      distress and HRQoL.

      IV. Explore the association between prior lifestyle data collected as part of PA15-0336 and
      COVID-19-specific psychological distress and HRQoL.

      OUTLINE:

      Patients complete a survey over 10 minutes.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Experiences during the COVID-19 pandemic
time frame: Survey completion Up to 2 months
description: Including exposure, risk factors, testing, isolation, seropositivity, hospitalization, or loss of family or friends.
measure: COVID-19-specific psychological distress
time frame: Survey completion Up to 2 months
measure: COVID-19-specific health
time frame: Survey completion Up to 2 months
measure: COVID-19-specific financial and social disruptions
time frame: Survey completion Up to 2 months
measure: COVID-19-specific perceived benefits and social support
time frame: Survey completion Up to 2 months
measure: COVID-19-specific health related quality of life (HRQoL)
time frame: Survey completion Up to 2 months
measure: Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL
time frame: Survey completion Up to 2 months
description: Will evaluate the extent to which resiliency factors such as social support and perceived benefits moderate the effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL.
measure: Prior lifestyle data
time frame: Survey completion Up to 2 months
description: Will explore the association between prior lifestyle data collected as part of PA15-0336 and COVID-19-specific psychological distress and HRQoL.
arm group label: Observational (survey administration)
description: Patients complete a survey over 10 minutes.
intervention type: Other
intervention name: Survey Administration
description: Complete survey
arm group label: Observational (survey administration)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lorenzo Cohen
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Lorenzo Cohen
phone: (713) 745-4260
email: lcohen@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: M D Anderson Cancer Center
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Melanoma