<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/NCT04500600</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0473</org_study_id>
    <secondary_id>NCI-2020-04604</secondary_id>
    <secondary_id>2020-0473</secondary_id>
    <nct_id>NCT04500600</nct_id>
  </id_info>
  <brief_title>Well-Being and Health-Related Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic</brief_title>
  <official_title>Well-Being and Quality of Life in Cancer Patients and Survivors During the 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>
      This study investigates the well-being and health-related quality of life in cancer patients&#xD;
      and survivors during the COVID-19 pandemic. Using questionnaires may help researchers gain an&#xD;
      understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors,&#xD;
      testing, isolation, seropositivity, hospitalization, loss of family or friends, loss of&#xD;
      income), may impact multiple domains of health-related quality of life (physical, emotional&#xD;
      and social well-being), and other areas such as COVID-19-specific psychological distress&#xD;
      (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and&#xD;
      social interactions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Assess experiences during the coronavirus disease 2019 (COVID-19) pandemic (e.g.,&#xD;
      exposure, risk factors, testing, isolation, seropositivity, hospitalization, loss of family&#xD;
      or friends); COVID-19-specific psychological distress (e.g., fear, anxiety and depressive&#xD;
      symptoms); health, financial and social disruptions; perceived benefits and social support;&#xD;
      and health-related quality of life (HRQoL) in a convenience sample of cancer patients and&#xD;
      survivors.&#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;
      OUTLINE:&#xD;
&#xD;
      Patients complete an online questionnaire over 10 minutes regarding the COVID-19 pandemic&#xD;
      including testing, risks of exposure, whether people they know have acquired COVID-19, as&#xD;
      well as questions on how the pandemic has impacted their quality of life.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2025</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 coronavirus disease 2019 (COVID-19) pandemic</measure>
    <time_frame>2 months</time_frame>
    <description>This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific psychological distress</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific health</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific financial and social disruptions</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific perceived benefits and social support</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-specific health related quality of life (HRQoL)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL</measure>
    <time_frame>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>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50000</enrollment>
  <condition>COVID-19 Infection</condition>
  <condition>Hematopoietic and Lymphoid Cell Neoplasm</condition>
  <condition>Malignant Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>Observational (questionnaire)</arm_group_label>
    <description>Patients complete an online questionnaire over 10 minutes regarding the COVID-19 pandemic including testing, risks of exposure, whether people they know have acquired COVID-19, as well as questions on how the pandemic has impacted their quality of life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Observational (questionnaire)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Complete questionnaire</description>
    <arm_group_label>Observational (questionnaire)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with a confirmed cancer diagnosis and cancer survivors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  MD Anderson active patient (visit within past 5 years)&#xD;
&#xD;
          -  ICD-10 confirmed cancer diagnosis&#xD;
&#xD;
          -  Documentation of being alive per the cancer registry&#xD;
&#xD;
          -  Patients who have signed consent for one of the following protocols: PA14-0241 or&#xD;
             LAB03-0320&#xD;
&#xD;
          -  Has an active email address and/or can be contacted via MyChart&#xD;
&#xD;
          -  English or Spanish speaker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-active patient (i.e., no visit within past 5 years)&#xD;
&#xD;
          -  Language other than English or Spanish&#xD;
&#xD;
          -  Patients who have previously consented to the following protocols: 2012-0112,&#xD;
             2009-0976, 2005-0035, or PA15-0336, because they will be contacted through separate&#xD;
             IRB protocols to complete this same survey&#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>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>MD Anderson Cancer Center</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>April 7, 2023</last_update_submitted>
  <last_update_submitted_qc>April 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 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>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/NCT04500600
org study id: 2020-0473
secondary id: NCI-2020-04604
secondary id: 2020-0473
nct id: NCT04500600
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the well-being and health-related quality of life in cancer patients
      and survivors during the COVID-19 pandemic. Using questionnaires may help researchers gain an
      understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors,
      testing, isolation, seropositivity, hospitalization, loss of family or friends, loss of
      income), may impact multiple domains of health-related quality of life (physical, emotional
      and social well-being), and other areas such as COVID-19-specific psychological distress
      (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and
      social interactions.
PRIMARY OBJECTIVES:

      I. Assess experiences during the coronavirus disease 2019 (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 a convenience sample of cancer patients and
      survivors.

      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.

      OUTLINE:

      Patients complete an online questionnaire over 10 minutes regarding the COVID-19 pandemic
      including testing, risks of exposure, whether people they know have acquired COVID-19, as
      well as questions on how the pandemic has impacted their quality of life.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Experiences during the coronavirus disease 2019 (COVID-19) pandemic
time frame: 2 months
description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.
measure: COVID-19-specific psychological distress
time frame: Up to 2 months
description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.
measure: COVID-19-specific health
time frame: Up to 2 months
description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.
measure: COVID-19-specific financial and social disruptions
time frame: Up to 2 months
description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.
measure: COVID-19-specific perceived benefits and social support
time frame: Up to 2 months
description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.
measure: COVID-19-specific health related quality of life (HRQoL)
time frame: Up to 2 months
description: This will be measure with a COVID-19 questionnaire created to collect COVID-19 experience information, Quality of life (QOL), and other psychosocial variables from participating patients. Using this questionnaire may help researchers gain an understanding of how experiences during the COVID-19 pandemic (e.g., exposure, risk factors, testing,isolation,seropositivity, hospitalization, loss of family or friends, loss of income), may impact multiple domains of health-related quality of life (physical, emotional and social well-being), and other areas such as COVID-19-specific psychological distress (e.g., fear, anxiety and depressive symptoms), and disruptions to health care, finances, and social interactions.
measure: Effects of COVID-19 experiences on COVID-19-specific psychological distress and HRQoL
time frame: 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.
arm group label: Observational (questionnaire)
description: Patients complete an online questionnaire over 10 minutes regarding the COVID-19 pandemic including testing, risks of exposure, whether people they know have acquired COVID-19, as well as questions on how the pandemic has impacted their quality of life.
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Observational (questionnaire)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Complete questionnaire
arm group label: Observational (questionnaire)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
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: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Neoplasms