xml: <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/NCT06036251</url>
    </required_header>
    <id_info>
      <org_study_id>23804</org_study_id>
      <secondary_id>NCI-2023-06245</secondary_id>
      <nct_id>NCT06036251</nct_id>
    </id_info>
    <brief_title>COVID-19 Pandemic Induced Stress and Symptoms</brief_title>
    <official_title>COVID-19 Pandemic Induced Stress and Symptoms - Follow-up Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, San Francisco</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 previous survey of oncology patients at University of California, San Francisco in&#xD;
        2020-2021 found an alarmingly high symptom burden and high levels of stress and loneliness&#xD;
        among respondents. This is a follow-up study with the same sample of oncology patients and&#xD;
        survivors who participated in the previous study&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        OBJECTIVES:&#xD;
  &#xD;
          1. Evaluate for associations among general and disease-specific measures of stress and&#xD;
             measures of social isolation and loneliness.&#xD;
  &#xD;
          2. Evaluate for associations between general and disease-specific stress and common&#xD;
             symptoms associated with cancer and its treatments.&#xD;
  &#xD;
          3. Evaluate for associations between social isolation and loneliness and common symptoms&#xD;
             associated with cancer and its treatments.&#xD;
  &#xD;
          4. Evaluate for associations between social isolation and loneliness and health behaviors&#xD;
             and quality of life (QOL) as compared to our last survey. as a baseline.&#xD;
  &#xD;
          5. Evaluate for changes in stress, social isolation, loneliness and symptom burden between&#xD;
             the two time points.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients will be asked to complete self-report questionnaires online. Questionnaires will&#xD;
        take approximately 60 minutes to complete. and directed to take rest periods at 20 minute&#xD;
        intervals. Participants will be given two weeks to complete the instruments.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2028</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2028</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>Correlation of scores on perceived stress scale (PSS) and social isolation scale (SIS)</measure>
      <time_frame>2 days</time_frame>
      <description>Scores on the Perceived Stress Scale (PSS) from the previous study and this study, along with scores on the Social Isolation Scale (SIS) from the previous study, this study will be compared. The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. Scores of each item ranging from 0 = &quot;Never&quot; to 4 = &quot;Very Often&quot; for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 &amp; 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress. The Social Isolation Scale (SIS) is a measure used to assess an individual's tendency to isolate themselves from social situations. Scores on this scale are distributed with a mean of 15.0 and a standard deviation of 4.5.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation of scores on the perceived stress scale (PSS) and loneliness scale</measure>
      <time_frame>2 days</time_frame>
      <description>Scores on the Perceived Stress Scale (PSS) from the previous study and this study, along with scores on the University of California, Los Angeles (UCLA) Loneliness Scale from the previous study, and this study will be compared. The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. Scores of each item ranging from 0 = &quot;Never&quot; to 4 = &quot;Very Often&quot; for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 &amp; 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress. The 3-item UCLA loneliness scale is a 3-item scale used for measuring loneliness with scores ranging from 1='Hardly ever&quot; to 3=Often. Scores are summed to generate a total score with higher scores indicating a higher degree of loneliness.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation of scores on the perceived stress scale (PSS) and symptom severity scores</measure>
      <time_frame>2 days</time_frame>
      <description>Scores on the PSS from the previous study and this study, along with scores on Memorial Symptom Assessment Scale (MSAS) from the previous study, and this study will be compared. The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. Scores of each item ranging from 0 = &quot;Never&quot; to 4 = &quot;Very Often&quot; for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 &amp; 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress. The MSAS is used to assess common physical symptoms experienced by persons with cancer. The values for severity and frequency measurements are 1='slight' or 'rarely' and 4= 'very severe'/'almost constantly' .Higher values indicate a greater number of symptoms.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">1200</enrollment>
    <condition>Stress Reaction</condition>
    <condition>Stress, Emotional</condition>
    <condition>Stress</condition>
    <condition>COVID-19 Pandemic</condition>
    <arm_group>
      <arm_group_label>Prior oncology participants</arm_group_label>
      <description>Oncology patients at University of California, San Francisco who participated in the previous study which evaluated the additional stressors imposed by COVID-19 (i.e., social isolation, loneliness) and ongoing general and disease specific stress on the symptom burden of cancer patients and survivors.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaires</intervention_name>
      <description>Self-reported quality of life (QOL) measures completed online</description>
      <arm_group_label>Prior oncology participants</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Only previous patients and survivors who took part in our last COVID survey in 2020-2021&#xD;
          who agreed to be re-contacted for future research at University of California, San&#xD;
          Francisco&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Current/Previous diagnosis of cancer&#xD;
  &#xD;
            -  Able to read, write, and understand English&#xD;
  &#xD;
            -  Able to complete the study questionnaires on line&#xD;
  &#xD;
            -  Able consent to participate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants of our previous COVID survey study who opted out of future research.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christine Miaskowski, RN,PhD,FAAN</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Karin Snowberg</last_name>
      <phone>415-514-2935</phone>
      <email>Karin.Snowberg@ucsf.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of California, San Francisco</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94143</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Karin Snowberg</last_name>
        <phone>415-514-2935</phone>
        <email>Karin.Snowberg@ucsf.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Miaskowski C, Paul SM, Snowberg K, Abbott M, Borno HT, Chang SM, Chen LM, Cohen B, Cooper BA, Hammer MJ, Kenfield SA, Kober KM, Laffan A, Levine JD, Pozzar R, Rhoads K, Tsai KK, Van Blarigan EL, Van Loon K. Loneliness and symptom burden in oncology patients during the COVID-19 pandemic. Cancer. 2021 Sep 1;127(17):3246-3253. doi: 10.1002/cncr.33603. Epub 2021 Apr 27.</citation>
      <PMID>33905528</PMID>
    </reference>
    <reference>
      <citation>Miaskowski C, Paul SM, Snowberg K, Abbott M, Borno H, Chang S, Chen LM, Cohen B, Hammer MJ, Kenfield SA, Kober KM, Levine JD, Pozzar R, Rhoads KF, Van Blarigan EL, Van Loon K. Stress and Symptom Burden in Oncology Patients During the COVID-19 Pandemic. J Pain Symptom Manage. 2020 Nov;60(5):e25-e34. doi: 10.1016/j.jpainsymman.2020.08.037. Epub 2020 Sep 2.</citation>
      <PMID>32889039</PMID>
    </reference>
    <reference>
      <citation>Miaskowski C, Paul SM, Snowberg K, Abbott M, Borno H, Chang S, Chen LM, Cohen B, Cooper BA, Hammer MJ, Kenfield SA, Laffan A, Levine JD, Pozzar R, Tsai KK, Van Blarigan EL, Van Loon K. Oncology patients' perceptions of and experiences with COVID-19. Support Care Cancer. 2021 Apr;29(4):1941-1950. doi: 10.1007/s00520-020-05684-7. Epub 2020 Aug 18.</citation>
      <PMID>32809060</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Follow-up Study</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Fractures, Stress</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036251
  org study id: 23804
  secondary id: NCI-2023-06245
  nct id: NCT06036251
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The previous survey of oncology patients at University of California, San Francisco in
        2020-2021 found an alarmingly high symptom burden and high levels of stress and loneliness
        among respondents. This is a follow-up study with the same sample of oncology patients and
        survivors who participated in the previous study
  OBJECTIVES:
  
          1. Evaluate for associations among general and disease-specific measures of stress and
             measures of social isolation and loneliness.
  
          2. Evaluate for associations between general and disease-specific stress and common
             symptoms associated with cancer and its treatments.
  
          3. Evaluate for associations between social isolation and loneliness and common symptoms
             associated with cancer and its treatments.
  
          4. Evaluate for associations between social isolation and loneliness and health behaviors
             and quality of life (QOL) as compared to our last survey. as a baseline.
  
          5. Evaluate for changes in stress, social isolation, loneliness and symptom burden between
             the two time points.
  
        OUTLINE:
  
        Patients will be asked to complete self-report questionnaires online. Questionnaires will
        take approximately 60 minutes to complete. and directed to take rest periods at 20 minute
        intervals. Participants will be given two weeks to complete the instruments.
  observational model: Cohort
  time perspective: Prospective
  measure: Correlation of scores on perceived stress scale (PSS) and social isolation scale (SIS)
  time frame: 2 days
  description: Scores on the Perceived Stress Scale (PSS) from the previous study and this study, along with scores on the Social Isolation Scale (SIS) from the previous study, this study will be compared. The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. Scores of each item ranging from 0 = "Never" to 4 = "Very Often" for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress. The Social Isolation Scale (SIS) is a measure used to assess an individual's tendency to isolate themselves from social situations. Scores on this scale are distributed with a mean of 15.0 and a standard deviation of 4.5.
  measure: Correlation of scores on the perceived stress scale (PSS) and loneliness scale
  time frame: 2 days
  description: Scores on the Perceived Stress Scale (PSS) from the previous study and this study, along with scores on the University of California, Los Angeles (UCLA) Loneliness Scale from the previous study, and this study will be compared. The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. Scores of each item ranging from 0 = "Never" to 4 = "Very Often" for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress. The 3-item UCLA loneliness scale is a 3-item scale used for measuring loneliness with scores ranging from 1='Hardly ever" to 3=Often. Scores are summed to generate a total score with higher scores indicating a higher degree of loneliness.
  measure: Correlation of scores on the perceived stress scale (PSS) and symptom severity scores
  time frame: 2 days
  description: Scores on the PSS from the previous study and this study, along with scores on Memorial Symptom Assessment Scale (MSAS) from the previous study, and this study will be compared. The PSS is a 10-item questionnaire which asks participants about feelings and thoughts during the last month. Scores of each item ranging from 0 = "Never" to 4 = "Very Often" for a total score range of 0 to 40. Scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to 4 of the 10 positively stated items and scores are calculated by summing the total. Higher scores indicate higher degree of perceived stress. The MSAS is used to assess common physical symptoms experienced by persons with cancer. The values for severity and frequency measurements are 1='slight' or 'rarely' and 4= 'very severe'/'almost constantly' .Higher values indicate a greater number of symptoms.
  arm group label: Prior oncology participants
  description: Oncology patients at University of California, San Francisco who participated in the previous study which evaluated the additional stressors imposed by COVID-19 (i.e., social isolation, loneliness) and ongoing general and disease specific stress on the symptom burden of cancer patients and survivors.
  intervention type: Other
  intervention name: Questionnaires
  description: Self-reported quality of life (QOL) measures completed online
  arm group label: Prior oncology participants
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Christine Miaskowski, RN,PhD,FAAN
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Karin Snowberg
  phone: 415-514-2935
  email: Karin.Snowberg@ucsf.edu
  facility: 
  contact: 
  country: United States
  citation: Miaskowski C, Paul SM, Snowberg K, Abbott M, Borno HT, Chang SM, Chen LM, Cohen B, Cooper BA, Hammer MJ, Kenfield SA, Kober KM, Laffan A, Levine JD, Pozzar R, Rhoads K, Tsai KK, Van Blarigan EL, Van Loon K. Loneliness and symptom burden in oncology patients during the COVID-19 pandemic. Cancer. 2021 Sep 1;127(17):3246-3253. doi: 10.1002/cncr.33603. Epub 2021 Apr 27.
  PMID: 33905528
  citation: Miaskowski C, Paul SM, Snowberg K, Abbott M, Borno H, Chang S, Chen LM, Cohen B, Hammer MJ, Kenfield SA, Kober KM, Levine JD, Pozzar R, Rhoads KF, Van Blarigan EL, Van Loon K. Stress and Symptom Burden in Oncology Patients During the COVID-19 Pandemic. J Pain Symptom Manage. 2020 Nov;60(5):e25-e34. doi: 10.1016/j.jpainsymman.2020.08.037. Epub 2020 Sep 2.
  PMID: 32889039
  citation: Miaskowski C, Paul SM, Snowberg K, Abbott M, Borno H, Chang S, Chen LM, Cohen B, Cooper BA, Hammer MJ, Kenfield SA, Laffan A, Levine JD, Pozzar R, Tsai KK, Van Blarigan EL, Van Loon K. Oncology patients' perceptions of and experiences with COVID-19. Support Care Cancer. 2021 Apr;29(4):1941-1950. doi: 10.1007/s00520-020-05684-7. Epub 2020 Aug 18.
  PMID: 32809060
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Fractures, Stress
  sharing ipd: No