<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/NCT04462302</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00066906</org_study_id>
    <secondary_id>3UG1CA189824-06S1</secondary_id>
    <secondary_id>WF-1901</secondary_id>
    <secondary_id>NCI-2020-02315</secondary_id>
    <nct_id>NCT04462302</nct_id>
  </id_info>
  <brief_title>An Internet-based Program to Help Cancer Survivors Manage Pain</brief_title>
  <acronym>IMPACTS</acronym>
  <official_title>Internet-delivered Management of Pain Among Cancer Treatment Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To determine whether an Internet-based pain coping skills program plus enhanced usual care,&#xD;
      compared to enhanced usual care alone, yields significant improvements in the co-primary&#xD;
      outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain&#xD;
      interference (also measured by the BPI) from baseline to the post-intervention assessment for&#xD;
      cancer survivors with persistent pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a parallel group randomized controlled, prospective study that examines the effect of&#xD;
      an Internet-based pain coping skills program on pain severity and pain interference among&#xD;
      adult cancer survivors experiencing persistent cancer-related pain. The study also explores&#xD;
      the effects of an Internet-based pain coping skills program on opioid/analgesic medication&#xD;
      use, health-related quality of life, pain management self-efficacy and various other factors&#xD;
      relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress,&#xD;
      positive affect, pain impact, perceived cognitive problems, and cognitive performance), as&#xD;
      well as qualitative assessments of participants experiences with pain and the intervention. A&#xD;
      total of 250 participants will be enrolled (125 per arm) and randomized into the internet&#xD;
      program arm (plus enhanced usual care) or Enhanced Usual Care alone.&#xD;
&#xD;
      Each participant will be enrolled in the study for 9 months (from randomization at week 0 to&#xD;
      the final follow-up assessment at week 34).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 13, 2021</start_date>
  <completion_date type="Anticipated">April 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>Change from Baseline to 10 week</time_frame>
    <description>The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Interference</measure>
    <time_frame>Change from Baseline to 10 week</time_frame>
    <description>The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Severity</measure>
    <time_frame>22 and 34 weeks</time_frame>
    <description>The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Interference</measure>
    <time_frame>22 and 34 weeks</time_frame>
    <description>The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid/analgesic medication use</measure>
    <time_frame>Baseline and 10 week</time_frame>
    <description>A participant recall during clinic visits of typical daily medication use. This will be converted to morphine milligram equivalents (MME).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid/analgesic medication use</measure>
    <time_frame>Baseline, 10, 22, and 24 week</time_frame>
    <description>7-day medication diaries to capture participants' use of all medications each day during a 7-day period. Self-reports will be converted to morphine milligram equivalents (MME).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life</measure>
    <time_frame>Baseline, 10, 22, and 24 week</time_frame>
    <description>Health-Related Quality of Life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form-6b). The six items are summed to give a score from 6 to 30, with higher scores representing better physical function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Management Self-Efficacy</measure>
    <time_frame>Baseline, 10, 22, and 24 week</time_frame>
    <description>Pain Management Self-Efficacy will be assessed with the Chronic Pain Self-Efficacy Scale. The self-efficacy for pain management subscale (PSE) consists of five items summed to give a score from 50-500, the self-efficacy for physical function subscale (FSE) consists of nine items summed to give a score from 90-900, and the self-efficacy for coping with symptoms subscale (CSE) consists of eight items summed to give a score from 80-800. For all subscales, higher scores represent greater self-efficacy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">456</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Internet-based program + Pain Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If you are in this group, in additional to your usual care, you will be provided access to the 8-session Internet-based pain program plus pain education. You will need to complete your sessions within 10 weeks of being provided your log-in code. You will be allowed to revisit sessions that you have completed during this 10 weeks. After completion of the study, you will still be provided access to the 8-session Internet-based pain program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pain Education Only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>If you are in this group, in addition to your usual care, you will be provided pain education at your initial clinic visit. After you have completed the 6-month follow up assessment, you will be provided a secure log-in code and invited to complete the 8 sessions of this Internet-based pain program on your own.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Internet-based pain coping skills program</intervention_name>
    <description>The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain.</description>
    <arm_group_label>Internet-based program + Pain Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Must have a documented diagnosis of invasive cancer that has been treated with either&#xD;
        single modality therapy or any combination of surgery, radiation, and chemotherapy/drug&#xD;
        therapy (e.g. cytotoxic therapy, targeted therapy, immunotherapy, hormonal therapy, etc.).&#xD;
        Patients with a cancer history of only superficial skin cancers or in situ malignancy are&#xD;
        not eligible.&#xD;
&#xD;
          -  May be either off all treatment OR actively receiving anticancer therapy in an&#xD;
             adjuvant setting, maintenance setting, or for active cancer.&#xD;
&#xD;
               -  Patients who currently undergoing anticancer therapy should not have any plans to&#xD;
                  change or adjust their treatment during the intervention period. This includes&#xD;
                  changing to another therapy or ending therapy entirely.&#xD;
&#xD;
               -  Patients who are currently receiving anticancer therapy at the screening process&#xD;
                  must have been on current therapy for at least four weeks. Alternatively, if they&#xD;
                  are planning to discontinue therapy before enrolling, they must have been off&#xD;
                  therapy for four weeks prior to enrollment.&#xD;
&#xD;
               -  A minimum of four weeks must have elapsed since the most recent MAJOR surgical&#xD;
                  intervention.&#xD;
&#xD;
               -  A minimum of two weeks must have elapsed since the most recent MINOR surgical&#xD;
                  procedure (e.g., port placement).&#xD;
&#xD;
               -  In addition, eligible patients must not have a planned surgical procedure or&#xD;
                  course of radiation therapy during the 3-month study intervention period (i.e.,&#xD;
                  the three months leading up to primary outcome evaluation-timepoint.&#xD;
&#xD;
          -  Patients who are no longer receiving anticancer therapy must be less than/equal to 5&#xD;
             years since the completion of their anticancer therapy (e.g., time since the last day&#xD;
             of chemotherapy administration, time since last day of radiotherapy, etc.).&#xD;
&#xD;
          -  Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using&#xD;
             the Pain Eligibility Interview.&#xD;
&#xD;
          -  Must have a score of &quot;Most Days&quot; or higher on the Graded Chronic Pain Scale Revised&#xD;
             (Abbreviated) using the Pain Eligibility Interview.&#xD;
&#xD;
          -  Patients do not have to be on analgesic medications of any kind in order to&#xD;
             participate. If they are taking analgesics, they must be on a stable analgesic regimen&#xD;
             (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14&#xD;
             days prior to enrollment. Eligible patients should not have planned upward dose&#xD;
             titration of their analgesics during the 3-month study intervention period (i.e., the&#xD;
             three months leading up to primary outcome evaluation timepoint. Patients may elect to&#xD;
             decrease their analgesic use during the study as per discussions with their provider.&#xD;
             Unexpected dose adjustments including dose escalations as a result of unforeseen&#xD;
             clinical need is allowed in all patients at all times during the study. Cannabis&#xD;
             prescribed for medicinal purposes would qualify as an analgesic in this context.&#xD;
&#xD;
          -  Must have pain of new onset or significantly exacerbated since the time of cancer&#xD;
             diagnosis or initiation of cancer treatment&#xD;
&#xD;
          -  Must be expected to be able to complete all study activities including the 22- and&#xD;
             34-week follow-up assessments according to the treating/referring clinician (e.g.,&#xD;
             treating clinician feels the patient is unlikely to develop progressive disease&#xD;
             requiring additional active cancer therapy through the 6-month follow-up period).&#xD;
&#xD;
          -  ECOG performance status of 0, 1, or 2.&#xD;
&#xD;
          -  Age ≥18 years at the time of study entry&#xD;
&#xD;
          -  Must be able to speak, read and understand English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a disability that precludes completion of study activities (e.g., severe vision or&#xD;
             hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive&#xD;
             impairment, diagnosis or clinical evidence of severe psychiatric disorder, or&#xD;
             diagnosed drug or alcohol abuse disorder), as per patient report or documented in the&#xD;
             medical record.&#xD;
&#xD;
          -  Reports only preexisting pain conditions unrelated to cancer or cancer treatment&#xD;
             (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis,&#xD;
             injuries, fibromyalgia).&#xD;
&#xD;
          -  Has a known or suspected diagnosable substance use disorder or opioid overuse disorder&#xD;
             (according to DSM-5 criteria), or is actively receiving treatment for a substance use&#xD;
             disorder, as per patient report or documented in the medical record.&#xD;
&#xD;
          -  Currently being prescribed buprenorphine or suboxone.&#xD;
&#xD;
          -  Patients enrolled on hospice care or end-of-life palliative care are not eligible for&#xD;
             enrollment. Patients whose local care network provides an opportunity for palliative&#xD;
             (symptom management) or supportive care concurrent with active treatment following&#xD;
             diagnosis (i.e. not solely as a palliative or end-of-life measure) are considered&#xD;
             eligible for this study.&#xD;
&#xD;
          -  Does not have reliable access to Internet or sufficient personal data plan, and is not&#xD;
             willing to participate in the Tablet Lending Program provided for this study.&#xD;
&#xD;
          -  Does not have a working email address.&#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>Glenn Lesser, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karen Craver</last_name>
    <phone>336-716-0891</phone>
    <email>NCORP@wakehealth.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mercy Hospital Fort Smith</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-378-9373</phone>
    </contact>
    <investigator>
      <last_name>Jay W Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Deer Valley Medical Center</name>
      <address>
        <city>Antioch</city>
        <state>California</state>
        <zip>94531</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Dublin</name>
      <address>
        <city>Dublin</city>
        <state>California</state>
        <zip>94568</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Fremont</name>
      <address>
        <city>Fremont</city>
        <state>California</state>
        <zip>94538</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Fresno</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Modesto</name>
      <address>
        <city>Modesto</city>
        <state>California</state>
        <zip>95356</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente- Marshall Medical Offices</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Richmond</name>
      <address>
        <city>Richmond</city>
        <state>California</state>
        <zip>94801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Roseville</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Downtown Commons</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95814</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-South Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Santa Teresa-San Jose</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95119</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Naalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente San Leandro</name>
      <address>
        <city>San Leandro</city>
        <state>California</state>
        <zip>94577</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser San Rafael-Gallinas</name>
      <address>
        <city>San Rafael</city>
        <state>California</state>
        <zip>94903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center - Santa Clara</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Santa Rosa</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-South San Francisco</name>
      <address>
        <city>South San Francisco</city>
        <state>California</state>
        <zip>94080</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greys-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Stockton</name>
      <address>
        <city>Stockton</city>
        <state>California</state>
        <zip>95210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Medical Center-Vacaville</name>
      <address>
        <city>Vacaville</city>
        <state>California</state>
        <zip>95688</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Vallejo</name>
      <address>
        <city>Vallejo</city>
        <state>California</state>
        <zip>94589</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>877-642-4691</phone>
      <email>Kpoct@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Franklin</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>303-720-2685</phone>
      <email>kristi.m.bronkan@kp.org</email>
    </contact>
    <investigator>
      <last_name>Alexander Menter</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Rock Creek</name>
      <address>
        <city>Lafayette</city>
        <state>Colorado</state>
        <zip>80026</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>303-720-2685</phone>
      <email>kristi.m.bronkan@kp.org</email>
    </contact>
    <investigator>
      <last_name>Alexander Menter</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente-Lone Tree</name>
      <address>
        <city>Lone Tree</city>
        <state>Colorado</state>
        <zip>80124</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>303-720-2685</phone>
      <email>kristi.m.bronkan@kp.org</email>
    </contact>
    <investigator>
      <last_name>Alexander Menter</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lewis Cancer and Research Pavilion at Saint Joseph's/Candler</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>underberga@sjchs.org</email>
    </contact>
    <contact_backup>
      <phone>(912) 819-5704</phone>
    </contact_backup>
    <investigator>
      <last_name>Mark A Taylor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hawaii Cancer Care - Savio</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-539-2273</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hawaii Cancer Care - Westridge</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>808-539-2273</phone>
      <email>info@hawaiicancercare.com</email>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pali Momi Medical Center</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-486-6000</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hawaii Cancer Care Inc - Waterfront Plaza</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-524-6115</phone>
      <email>i.webster@hawaiicancercare.com</email>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen's Cancer Cenrer - POB I</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-532-0315</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen's Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-545-8548</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Straub Clinic and Hospital</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-522-4333</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Queen's Cancer Center - Kuakini</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-531-8521</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente Moanalua Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96819</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>808-432-5195</phone>
      <email>shelley.a.clark@kp.org</email>
    </contact>
    <investigator>
      <last_name>Natalya Greyz-Yusupov</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kapiolani Medical Center for Women and Children</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96826</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>808-983-6090</phone>
    </contact>
    <investigator>
      <last_name>Christa Braun-Inglis</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle BroMenn Outpatient Center</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Suparna Mantha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Bloomington</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>309-243-3605</phone>
      <email>andersonj@illinoiscancercare.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Canton</name>
      <address>
        <city>Canton</city>
        <state>Illinois</state>
        <zip>61520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>309-243-3605</phone>
      <email>andersonj@illinoiscancercare.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>312-695-1301</phone>
      <email>cancer@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Christine Rini</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle on Vermilion</name>
      <address>
        <city>Danville</city>
        <state>Illinois</state>
        <zip>61832</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Suparna Mantha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Care Specialists of Illinois - Decatur</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>217-876-4740</phone>
      <email>rhamrick@dmhhs.org</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Galesburg</name>
      <address>
        <city>Galesburg</city>
        <state>Illinois</state>
        <zip>61401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>309-243-3605</phone>
      <email>andersonj@illinoiscancercare.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Mattoon/Charleston</name>
      <address>
        <city>Mattoon</city>
        <state>Illinois</state>
        <zip>61938</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Suparna Mantha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle BroMenn Medical Center</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-446-5532</phone>
      <email>Research@Carle.com</email>
    </contact>
    <investigator>
      <last_name>Suparna Mantha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Institute Normal</name>
      <address>
        <city>Normal</city>
        <state>Illinois</state>
        <zip>61761</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-446-5532</phone>
      <email>Research@Carle.com</email>
    </contact>
    <investigator>
      <last_name>Suparna Mantha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Ottawa Clinic</name>
      <address>
        <city>Ottawa</city>
        <state>Illinois</state>
        <zip>61350</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>309-243-3605</phone>
      <email>andersonj@illinoiscancercare.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Pekin</name>
      <address>
        <city>Pekin</city>
        <state>Illinois</state>
        <zip>61554</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>309-243-3605</phone>
      <email>andersonj@illinoiscancercare.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peoria</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>309-243-3605</phone>
      <email>andersonj@illinoiscancercare.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peru</name>
      <address>
        <city>Peru</city>
        <state>Illinois</state>
        <zip>61354</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>309-243-3605</phone>
      <email>andersonj@illinoiscancercare.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A. Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Suparna Mantha</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare - Washington</name>
      <address>
        <city>Washington</city>
        <state>Illinois</state>
        <zip>61571</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>309-243-3605</phone>
      <email>andersonj@illinoiscancercare.com</email>
    </contact>
    <investigator>
      <last_name>Bryan A Faller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Physicians' Clinic of Iowa PC</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52402</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>319-297-2900</phone>
    </contact>
    <investigator>
      <last_name>William P Fusselman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical Oncology and Hematology Associates-Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>515-282-2921</phone>
    </contact>
    <investigator>
      <last_name>Robert J. Behrens</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Broadlawns Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>515-282-2200</phone>
    </contact>
    <investigator>
      <last_name>Robert J. Behrens</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center - Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>515-358-6613</phone>
      <email>cancerresearch@mercydesmoines.org</email>
    </contact>
    <investigator>
      <last_name>Richard L Deming</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Flaget Memorial Hospital</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>859-629-7169</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Richard L Deming</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Radiation Oncology Resource Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>859-629-7169</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Richard L Deming</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Hospital East</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>859-629-7169</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Richard L Deming</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph London</name>
      <address>
        <city>London</city>
        <state>Kentucky</state>
        <zip>40741</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>859-629-7169</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Richard L Deming</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ochsner High Grove</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70836</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>225-761-5346</phone>
      <email>Camielle.beck@ochsner.org</email>
    </contact>
    <investigator>
      <last_name>John T Cole</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Kenner</name>
      <address>
        <city>Kenner</city>
        <state>Louisiana</state>
        <zip>70065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>504-464-8789</phone>
      <email>awendt@ochsner.org</email>
    </contact>
    <investigator>
      <last_name>John T Cole</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Jefferson</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>504-842-8084</phone>
      <email>Elisemarie.curry@ochsner.org</email>
    </contact>
    <investigator>
      <last_name>John T Cole</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRISTUS Highland Medical Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>318-681-4763</phone>
      <email>Nancy.hassan@christushealth.org</email>
    </contact>
    <investigator>
      <last_name>John T Cole</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Trinity Health Saint Joseph Mercy Hospital Ann Arbor</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>734-712-7251</phone>
      <email>MCRCwebsitecontactform@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Tareq Al baghdadi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Trinity Health Medical Center - Brighton</name>
      <address>
        <city>Brighton</city>
        <state>Michigan</state>
        <zip>48114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Tareq Al baghdadi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Trinity Health Medical Center - Canton</name>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>734-712-7251</phone>
      <email>MCRCwebsitecontactform@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Tareq Al baghdadi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chelsea Hospital</name>
      <address>
        <city>Chelsea</city>
        <state>Michigan</state>
        <zip>48118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>734-712-7251</phone>
      <email>MCRCwebsitecontactform@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Tareq Al baghdadi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Genesee Cancer and Blood Disease Treatment Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>810-762-8038</phone>
      <email>wstrong@ghci.org</email>
    </contact>
    <investigator>
      <last_name>Tareq Al baghdadi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Genesee Hematology Oncology PC</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>810-762-8038</phone>
      <email>wstrong@ghci.org</email>
    </contact>
    <investigator>
      <last_name>Tareq Al baghdadi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Genesys Hurley Cancer Institute</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>810-762-8038</phone>
      <email>wstrong@ghci.org</email>
    </contact>
    <investigator>
      <last_name>Tareq Al baghdadi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Trinity Health Saint Mary Mercy Livonia Hospital</name>
      <address>
        <city>Livonia</city>
        <state>Michigan</state>
        <zip>48154</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>734-712-7251</phone>
      <email>MCRCwebsitecontactform@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>Tareq Tareq</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamala A Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fairview Southdale Hospital</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamala A Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint John's Hospital - Healtheast</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamala A Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Abbott-Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamela A Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>North Memorial Medical Health Center</name>
      <address>
        <city>Robbinsdale</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamala A Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Clinic - Saint Louis Park</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamala A Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamela A Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>United Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamala A. Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lakeview Hospital</name>
      <address>
        <city>Stillwater</city>
        <state>Minnesota</state>
        <zip>55082</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamala A Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rice Memorial Hospital</name>
      <address>
        <city>Willmar</city>
        <state>Minnesota</state>
        <zip>56201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamala A Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology PA-Woodbury</name>
      <address>
        <city>Woodbury</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>Pamala A. Pawloski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Heartland Regional Medical Center</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>816-271-7937</phone>
      <email>linda.schumacher@mymlc.com</email>
    </contact>
    <investigator>
      <last_name>Jay W Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CentraState Medical Center</name>
      <address>
        <city>Freehold</city>
        <state>New Jersey</state>
        <zip>07728</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>732-303-5047</phone>
    </contact>
    <investigator>
      <last_name>Alexander Itskovich</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Peter's University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>732-745-8600</phone>
      <phone_ext>6163</phone_ext>
      <email>kcovert@saintpetersuh.com</email>
    </contact>
    <investigator>
      <last_name>Valerie Shander</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>336-713-6771</phone>
    </contact>
    <investigator>
      <last_name>Thomas Lycan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Mark H Zangmeister Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>614-488-2118</phone>
      <email>sheree@columbusccop.org</email>
    </contact>
    <investigator>
      <last_name>Timothy D. Moore</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Mark H Zangmeister Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>614-488-2118</phone>
      <email>sheree@columbusccop.org</email>
    </contact>
    <investigator>
      <last_name>Timothy D Moore</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Knox Community Hospital</name>
      <address>
        <city>Mount Vernon</city>
        <state>Ohio</state>
        <zip>43050</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>740-393-9000</phone>
      <email>sheree@columbusccop.org</email>
    </contact>
    <investigator>
      <last_name>Timothy D Moore</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Southern Ohio Medical Center</name>
      <address>
        <city>Portsmouth</city>
        <state>Ohio</state>
        <zip>45662</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>614-488-2118</phone>
      <email>sheree@columbusccop.org</email>
    </contact>
    <investigator>
      <last_name>Timothy D Moore</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph's/Candler - Bluffton Campus</name>
      <address>
        <city>Bluffton</city>
        <state>South Carolina</state>
        <zip>29910</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>912-819-5704</phone>
      <email>underberga@sjchs.org</email>
    </contact>
    <investigator>
      <last_name>Mark A Taylor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Spartanburg</name>
      <address>
        <city>Boiling Springs</city>
        <state>South Carolina</state>
        <zip>29316</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-522-2066</phone>
      <email>kim.williams3@prismahealth.org</email>
    </contact>
    <investigator>
      <last_name>Jeffrey K. Giguere</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>843-792-9321</phone>
      <email>hcc-clinical-trials@musc.edu</email>
    </contact>
    <investigator>
      <last_name>Sarah T. Price</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Easley</name>
      <address>
        <city>Easley</city>
        <state>South Carolina</state>
        <zip>29640</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-522-2066</phone>
      <email>kim.williams3@prismahealth.org</email>
    </contact>
    <investigator>
      <last_name>Jeffrey K. Giguere</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tidelands Georgetown Memorial Hospital</name>
      <address>
        <city>Georgetown</city>
        <state>South Carolina</state>
        <zip>29440</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>843-545-5600</phone>
      <email>broe@tidelandshealth.org</email>
    </contact>
    <investigator>
      <last_name>Sarah T. Price</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Butternut</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-522-2066</phone>
      <email>kim.williams3@prismahealth.org</email>
    </contact>
    <investigator>
      <last_name>Jeffrey K. Giguere</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Faris</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-522-2066</phone>
      <email>kim.williams3@prismahealth.org</email>
    </contact>
    <investigator>
      <last_name>Jeffrey K. Giguere</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Eastside</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-522-2066</phone>
      <email>kim.williams3@prismahealth.org</email>
    </contact>
    <investigator>
      <last_name>Jeffrey K. Giguere</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Greer</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29650</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-522-2066</phone>
      <email>kim.williams3@prismahealth.org</email>
    </contact>
    <investigator>
      <last_name>Jeffrey K. Giguere</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>South Carolina Cancer Specialists PC</name>
      <address>
        <city>Hilton Head Island</city>
        <state>South Carolina</state>
        <zip>29926</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>912-819-5704</phone>
      <email>underberga@sjchs.org</email>
    </contact>
    <investigator>
      <last_name>Mark A Taylor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Prisma Health Cancer Institute - Seneca</name>
      <address>
        <city>Seneca</city>
        <state>South Carolina</state>
        <zip>29672</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>864-522-2066</phone>
      <email>kim.williams3@prismahealth.org</email>
    </contact>
    <investigator>
      <last_name>Jeffrey K. Giguere</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peninsula Cancer Institute - Gloucester</name>
      <address>
        <city>Gloucester</city>
        <state>Virginia</state>
        <zip>23061</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>757-534-5565</phone>
      <email>oramae.jackson@rivhs.com</email>
    </contact>
    <investigator>
      <last_name>Suzanne Ameringer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peninsula Cancer Institute - Newport News</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>757-534-5565</phone>
      <email>oramae.jackson@rivhs.com</email>
    </contact>
    <investigator>
      <last_name>Suzanne Ameringer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>VCU Massey Cancer Center at Stony Point</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>ctoclinops@vcu.edu</email>
    </contact>
    <investigator>
      <last_name>Suzanne W Ameringer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <email>CTOclinops@vcu.edu</email>
    </contact>
    <investigator>
      <last_name>Suzanne W W Ameringer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>VCU Community Memorial Health Center</name>
      <address>
        <city>South Hill</city>
        <state>Virginia</state>
        <zip>23970</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>434-774-2442</phone>
      <email>sherman.baker@vcuhealth.org</email>
    </contact>
    <investigator>
      <last_name>Suzanne W Ameringer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peninsula Cancer Institute - Cancer Specialists of Tidewater</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Suzanne Ameringer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peninsula Cancer Institute - Williamsburg</name>
      <address>
        <city>Williamsburg</city>
        <state>Virginia</state>
        <zip>23185</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>757-534-5565</phone>
      <email>oramae.jackson@rivhs.com</email>
    </contact>
    <investigator>
      <last_name>Suzanne Ameringer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic-Chippewa Center</name>
      <address>
        <city>Chippewa Falls</city>
        <state>Wisconsin</state>
        <zip>54729</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <phone_ext>94457</phone_ext>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-EC Cancer Center</name>
      <address>
        <city>Eau Claire</city>
        <state>Wisconsin</state>
        <zip>54701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <phone_ext>16119</phone_ext>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center - Ladysmith</name>
      <address>
        <city>Ladysmith</city>
        <state>Wisconsin</state>
        <zip>54848</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Marshfield</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <phone_ext>94457</phone_ext>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center - Minocqua</name>
      <address>
        <city>Minocqua</city>
        <state>Wisconsin</state>
        <zip>54548</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <phone_ext>94457</phone_ext>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center - Neillsville</name>
      <address>
        <city>Neillsville</city>
        <state>Wisconsin</state>
        <zip>54456</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <phone_ext>7-5416</phone_ext>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Rice Lake</name>
      <address>
        <city>Rice Lake</city>
        <state>Wisconsin</state>
        <zip>54868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <phone_ext>94457</phone_ext>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-River Region at Stevens Point</name>
      <address>
        <city>Stevens Point</city>
        <state>Wisconsin</state>
        <zip>54482</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic-Wausau Center</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <phone_ext>94457</phone_ext>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center - Weston</name>
      <address>
        <city>Weston</city>
        <state>Wisconsin</state>
        <zip>54476</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A, Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic - Wisconsin Rapids Center</name>
      <address>
        <city>Wisconsin Rapids</city>
        <state>Wisconsin</state>
        <zip>54494</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Dean A Delmastro</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 14, 2023</last_update_submitted>
  <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer pain</keyword>
  <keyword>Survivor</keyword>
  <keyword>Pain</keyword>
  <keyword>Pain coping</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.</ipd_description>
    <ipd_time_frame>6 months after publication for a 2 year duration</ipd_time_frame>
    <ipd_access_criteria>upon request to NCORP@wakehealth.edu</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04462302
org study id: IRB00066906
secondary id: 3UG1CA189824-06S1
secondary id: WF-1901
secondary id: NCI-2020-02315
nct id: NCT04462302
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To determine whether an Internet-based pain coping skills program plus enhanced usual care,
      compared to enhanced usual care alone, yields significant improvements in the co-primary
      outcomes of pain severity (as measured by the Brief Pain Inventory (BPI)) and pain
      interference (also measured by the BPI) from baseline to the post-intervention assessment for
      cancer survivors with persistent pain.
This is a parallel group randomized controlled, prospective study that examines the effect of
      an Internet-based pain coping skills program on pain severity and pain interference among
      adult cancer survivors experiencing persistent cancer-related pain. The study also explores
      the effects of an Internet-based pain coping skills program on opioid/analgesic medication
      use, health-related quality of life, pain management self-efficacy and various other factors
      relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress,
      positive affect, pain impact, perceived cognitive problems, and cognitive performance), as
      well as qualitative assessments of participants experiences with pain and the intervention. A
      total of 250 participants will be enrolled (125 per arm) and randomized into the internet
      program arm (plus enhanced usual care) or Enhanced Usual Care alone.

      Each participant will be enrolled in the study for 9 months (from randomization at week 0 to
      the final follow-up assessment at week 34).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain Severity
time frame: Change from Baseline to 10 week
description: The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
measure: Pain Interference
time frame: Change from Baseline to 10 week
description: The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
measure: Pain Severity
time frame: 22 and 34 weeks
description: The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
measure: Pain Interference
time frame: 22 and 34 weeks
description: The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
measure: Opioid/analgesic medication use
time frame: Baseline and 10 week
description: A participant recall during clinic visits of typical daily medication use. This will be converted to morphine milligram equivalents (MME).
measure: Opioid/analgesic medication use
time frame: Baseline, 10, 22, and 24 week
description: 7-day medication diaries to capture participants' use of all medications each day during a 7-day period. Self-reports will be converted to morphine milligram equivalents (MME).
measure: Health-Related Quality of Life
time frame: Baseline, 10, 22, and 24 week
description: Health-Related Quality of Life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form-6b). The six items are summed to give a score from 6 to 30, with higher scores representing better physical function.
measure: Pain Management Self-Efficacy
time frame: Baseline, 10, 22, and 24 week
description: Pain Management Self-Efficacy will be assessed with the Chronic Pain Self-Efficacy Scale. The self-efficacy for pain management subscale (PSE) consists of five items summed to give a score from 50-500, the self-efficacy for physical function subscale (FSE) consists of nine items summed to give a score from 90-900, and the self-efficacy for coping with symptoms subscale (CSE) consists of eight items summed to give a score from 80-800. For all subscales, higher scores represent greater self-efficacy.
arm group label: Internet-based program + Pain Education
arm group type: Experimental
description: If you are in this group, in additional to your usual care, you will be provided access to the 8-session Internet-based pain program plus pain education. You will need to complete your sessions within 10 weeks of being provided your log-in code. You will be allowed to revisit sessions that you have completed during this 10 weeks. After completion of the study, you will still be provided access to the 8-session Internet-based pain program.
arm group label: Pain Education Only
arm group type: No Intervention
description: If you are in this group, in addition to your usual care, you will be provided pain education at your initial clinic visit. After you have completed the 6-month follow up assessment, you will be provided a secure log-in code and invited to complete the 8 sessions of this Internet-based pain program on your own.
intervention type: Behavioral
intervention name: Internet-based pain coping skills program
description: The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain.
arm group label: Internet-based program + Pain Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Glenn Lesser, MD
role: Study Chair
affiliation: Wake Forest University Health Sciences
last name: Karen Craver
phone: 336-716-0891
email: NCORP@wakehealth.edu
facility: 
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country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
ipd time frame: 6 months after publication for a 2 year duration
ipd access criteria: upon request to NCORP@wakehealth.edu