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/NCT06037681</url>
    </required_header>
    <id_info>
      <org_study_id>1174865</org_study_id>
      <nct_id>NCT06037681</nct_id>
    </id_info>
    <brief_title>Cannabis Use and Outcomes in Black and White Patients With Cancer</brief_title>
    <acronym>C4C</acronym>
    <official_title>Cannabis Use and Outcomes in Black and White Patients With Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>State University of New York at Buffalo</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Pennsylvania</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Thomas Jefferson University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>State University of New York at Buffalo</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 goal of the observational study is to learn how black and white patients with solid tumor&#xD;
        cancer use cannabis, opioids and tobacco. The investigators are using momentary ecological&#xD;
        assessment through a smart phone app and surveys to assess patient-reported pain and other&#xD;
        symptoms as to inform clinical practice and guidelines for underrepresented populations.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Using an observational design with momentary ecological assessment on a smartphone app&#xD;
        (mEMA), The investigators propose a strong prospective cohort design with repeated-measures&#xD;
        for 12 months regarding patients with cancer and their pain, use of opioids and cannabis. The&#xD;
        design was selected to allow for real-time, real-world assessments, while minimizing risks&#xD;
        due to attrition and burden to the participants. The staff will enroll 100 cannabis users (50&#xD;
        African American, 50 White) and 100 cannabis non-users (50 African American, 50 White)&#xD;
        diagnosed with cancer in the last 3 years and prescribed opioids from each of the three&#xD;
        sites, University of Pennsylvania, PA, University at Buffalo, NY and Thomas Jefferson&#xD;
        University, PA. Assessments will begin at Baseline (Month 0) and continue for 12 months. To&#xD;
        reduce participant burden in terms of travel time, cost and inconvenience, patients will&#xD;
        complete measures remotely via video/phone at 12 time points (Months 1-12). Daily measures of&#xD;
        pain, cannabis and opioid use will be collected via EMA for one week per month for 12 months.&#xD;
        Patients will report on multiple indices of cannabis use. Opioid prescription information and&#xD;
        other covariates and potential moderators will be collected over the 12-month study period.&#xD;
        Many factors affect opioid use, there is little insight into the longitudinal impact of&#xD;
        cannabis use on when or how often patients self-dose opioids. EMA will give much needed&#xD;
        insight into when and why cannabis users do or do not take opioids. Moreover, the focus on&#xD;
        the co-use of cannabis and opioids allows better understanding of the interplay and timing in&#xD;
        self-administration of one or both.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 30, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline of Cannabis use</measure>
      <time_frame>Baseline to 12 months</time_frame>
      <description>descriptive statistics will be generated for all cannabis-related variables across time [frequency of use, composition (ratio of THC:CBD), indication, source (medical vs. non-medical), and route (inhalation/oral/topical)]. Statistical comparisons will be made across key demographics (e.g., age, education, sex, race), cancer-related variables including cancer treatment status (active vs. completed), and other factors such as duration of opioid use (30-90 days vs. &gt;90 days).ecological momentary assessment questions</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cannabis use and patient reported outcomes and opioid use</measure>
      <time_frame>Baseline to 12 months</time_frame>
      <description>For all data collected via EMA (cannabis use, opioid use, pain severity, and pain-related function), data will be aggregated at the daily level (84 days of data). For data collected via monthly surveys (anxiety, sleep, QoL) and EMR and PDMP extraction, each timepoint of data collection will be used (10 total: Baseline, Months 1-6, 8, 10, 12). For all variables, change in PROs and opioid use will be tested using HLMs. First, nested model tests will be used to evaluate the shape of change in each outcome variable (e.g., linear, polynomial, piecewise, etc.) as well as relevant random effects. Next, cannabis use (level-2 predictor) will be introduced into the models and crossed with time. We will evaluate whether the shape of change for each outcome differs by cannabis use group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cannabis use moderate the associations between race and pain</measure>
      <time_frame>Baseline to 12 months</time_frame>
      <description>This will follow the same approach described for Aim 2 with the inclusion of race as a dummy coded level 2 predictor and crossing race with cannabis use and time to form interaction terms. Significant interaction terms will be probed following Preacher et al.131. African Americans are expected to experience higher levels of pain severity and less decline in pain severity over time, and we predict this disparity will be reduced among cannabis users.</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Black cannabis users</arm_group_label>
      <description>African Americans that use cannabis at least once a week</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Black non-cannabis users</arm_group_label>
      <description>African Americans that do not use cannabis for at least 3 months prior to enrollment</description>
    </arm_group>
    <arm_group>
      <arm_group_label>White cannabis users</arm_group_label>
      <description>Caucasians that use cannabis at least once a week</description>
    </arm_group>
    <arm_group>
      <arm_group_label>White non-cannabis users</arm_group_label>
      <description>Caucasians that do not use cannabis for at least 3 month prior to enrollment</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Black and White patients from Local cancer centers of the Buffalo, Univsity of Pennsylvania&#xD;
          and Thomas Jefferson Univeristy areas.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  21 years or older&#xD;
  &#xD;
            -  Black or white race&#xD;
  &#xD;
            -  Solid tumor cancer within 3 years of enrollment&#xD;
  &#xD;
            -  Cannabis use of at least once a week or non cannabis use for 3 months&#xD;
  &#xD;
            -  experience pain but spend less than 50% in bed or chair&#xD;
  &#xD;
            -  Prescribed or take opioid for at least 30 days for pain&#xD;
  &#xD;
            -  Not pregnant or planning to become pregnant in the next 12 months&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lymphoma, leukemia, and melanoma&#xD;
  &#xD;
            -  CBD only use&#xD;
  &#xD;
            -  Synthetic cannabis use in past 3 months = Prescribed Medically-prescribed synthetic&#xD;
               cannabis (e.g., dronabinol [Marinol, Syndros], Epidiolex)&#xD;
  &#xD;
            -  race other than Black or White&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Salimah Meghani, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pennsylvania</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Brooke Worster, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Thomas Jefferson University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rebecca L Ashare, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University at Buffalo</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Colleen Kilanowski, MS</last_name>
      <phone>716-829-5977</phone>
      <email>ckk@buffalo.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Rebecca L Ashare, BA</last_name>
      <phone>716-829-2024</phone>
      <email>rlashare@buffalo.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University at Buffalo</name>
        <address>
          <city>Buffalo</city>
          <state>New York</state>
          <zip>14214</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Colleen Kilanowski, MS</last_name>
        <phone>716-829-5977</phone>
        <email>ckk@buffalo.edu</email>
      </contact>
      <contact_backup>
        <last_name>Rebecca Ashare, PhD</last_name>
        <phone>716-829-2024</phone>
        <email>rlashare@buffalo.edu</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Thomas Jefferson University</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19144</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Brooke Worster, MD</last_name>
        <phone>215-955-1888</phone>
        <email>Brooke.Worster &lt;Brooke.Worster@jefferson.edu&gt;</email>
      </contact>
      <contact_backup>
        <last_name>Amy Leader, MPH</last_name>
        <phone>215-955-7739</phone>
        <email>Amy.Leader@jefferson.edu;</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>University of Pennsylvania</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19176</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andy Robinson</last_name>
        <phone>215-746-7335</phone>
        <email>arobins2@nursing.upenn.edu</email>
      </contact>
      <contact_backup>
        <last_name>Salimah Meghani, PhD</last_name>
        <phone>512-573-7128</phone>
        <email>salimahm@nursing.upenn.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
      <investigator_full_name>Rebecca Ashare</investigator_full_name>
      <investigator_title>Co- Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Solid tumor, opioids, cannabis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Marijuana Abuse</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No PHI will be shared</ipd_description>
    </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/NCT06037681
  org study id: 1174865
  nct id: NCT06037681
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of the observational study is to learn how black and white patients with solid tumor
        cancer use cannabis, opioids and tobacco. The investigators are using momentary ecological
        assessment through a smart phone app and surveys to assess patient-reported pain and other
        symptoms as to inform clinical practice and guidelines for underrepresented populations.
  Using an observational design with momentary ecological assessment on a smartphone app
        (mEMA), The investigators propose a strong prospective cohort design with repeated-measures
        for 12 months regarding patients with cancer and their pain, use of opioids and cannabis. The
        design was selected to allow for real-time, real-world assessments, while minimizing risks
        due to attrition and burden to the participants. The staff will enroll 100 cannabis users (50
        African American, 50 White) and 100 cannabis non-users (50 African American, 50 White)
        diagnosed with cancer in the last 3 years and prescribed opioids from each of the three
        sites, University of Pennsylvania, PA, University at Buffalo, NY and Thomas Jefferson
        University, PA. Assessments will begin at Baseline (Month 0) and continue for 12 months. To
        reduce participant burden in terms of travel time, cost and inconvenience, patients will
        complete measures remotely via video/phone at 12 time points (Months 1-12). Daily measures of
        pain, cannabis and opioid use will be collected via EMA for one week per month for 12 months.
        Patients will report on multiple indices of cannabis use. Opioid prescription information and
        other covariates and potential moderators will be collected over the 12-month study period.
        Many factors affect opioid use, there is little insight into the longitudinal impact of
        cannabis use on when or how often patients self-dose opioids. EMA will give much needed
        insight into when and why cannabis users do or do not take opioids. Moreover, the focus on
        the co-use of cannabis and opioids allows better understanding of the interplay and timing in
        self-administration of one or both.
  observational model: Ecologic or Community
  time perspective: Prospective
  measure: Change from baseline of Cannabis use
  time frame: Baseline to 12 months
  description: descriptive statistics will be generated for all cannabis-related variables across time [frequency of use, composition (ratio of THC:CBD), indication, source (medical vs. non-medical), and route (inhalation/oral/topical)]. Statistical comparisons will be made across key demographics (e.g., age, education, sex, race), cancer-related variables including cancer treatment status (active vs. completed), and other factors such as duration of opioid use (30-90 days vs. >90 days).ecological momentary assessment questions
  measure: Cannabis use and patient reported outcomes and opioid use
  time frame: Baseline to 12 months
  description: For all data collected via EMA (cannabis use, opioid use, pain severity, and pain-related function), data will be aggregated at the daily level (84 days of data). For data collected via monthly surveys (anxiety, sleep, QoL) and EMR and PDMP extraction, each timepoint of data collection will be used (10 total: Baseline, Months 1-6, 8, 10, 12). For all variables, change in PROs and opioid use will be tested using HLMs. First, nested model tests will be used to evaluate the shape of change in each outcome variable (e.g., linear, polynomial, piecewise, etc.) as well as relevant random effects. Next, cannabis use (level-2 predictor) will be introduced into the models and crossed with time. We will evaluate whether the shape of change for each outcome differs by cannabis use group.
  measure: Cannabis use moderate the associations between race and pain
  time frame: Baseline to 12 months
  description: This will follow the same approach described for Aim 2 with the inclusion of race as a dummy coded level 2 predictor and crossing race with cannabis use and time to form interaction terms. Significant interaction terms will be probed following Preacher et al.131. African Americans are expected to experience higher levels of pain severity and less decline in pain severity over time, and we predict this disparity will be reduced among cannabis users.
  arm group label: Black cannabis users
  description: African Americans that use cannabis at least once a week
  arm group label: Black non-cannabis users
  description: African Americans that do not use cannabis for at least 3 months prior to enrollment
  arm group label: White cannabis users
  description: Caucasians that use cannabis at least once a week
  arm group label: White non-cannabis users
  description: Caucasians that do not use cannabis for at least 3 month prior to enrollment
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Salimah Meghani, PhD
  role: Principal Investigator
  affiliation: University of Pennsylvania
  last name: Brooke Worster, MD
  role: Principal Investigator
  affiliation: Thomas Jefferson University
  last name: Rebecca L Ashare, PhD
  role: Principal Investigator
  affiliation: University at Buffalo
  last name: Colleen Kilanowski, MS
  phone: 716-829-5977
  email: ckk@buffalo.edu
  last name: Rebecca L Ashare, BA
  phone: 716-829-2024
  email: rlashare@buffalo.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: State University of New York at Buffalo
  investigator full name: Rebecca Ashare
  investigator title: Co- Principal Investigator
  mesh term: Marijuana Abuse
  sharing ipd: No
  ipd description: No PHI will be shared