<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/NCT03249090</url>
  </required_header>
  <id_info>
    <org_study_id>AFT-39</org_study_id>
    <nct_id>NCT03249090</nct_id>
  </id_info>
  <brief_title>Electronic Patient Reporting of Symptoms During Cancer Treatment</brief_title>
  <acronym>PRO-TECT</acronym>
  <official_title>&quot;PRO-TECT&quot; Patient Reported Outcomes to Enhance Cancer Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alliance Foundation Trials, LLC.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Society of Clinical Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alliance Foundation Trials, LLC.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current study is designed to test nationally whether patients' outcomes and utilization&#xD;
      of services can be improved through symptom monitoring via patient-reported outcomes between&#xD;
      visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a cluster RCT at approximately 50 sites where randomization will occur in a 1:1 ratio&#xD;
      at the site level (not at the individual patient level). Therefore, approximately 25 sites&#xD;
      will be randomized to the PRO-TECT intervention arm (patient-reporting of symptoms), and&#xD;
      approximately 25 sites will be randomized to the control arm (usual care delivery).&#xD;
      Approximately 1200 patients will be enrolled. Specifically:&#xD;
&#xD;
      PROCEDURES AT ALL SITES (CONTROL SITES AND INTERVENTION SITES):&#xD;
&#xD;
        -  Site staff (CRA and Nurse Champion required) will attend the site initiation webinar&#xD;
           with UNC staff, including training for the PRO-Core online data management system and&#xD;
           orientation to the symptom management guidelines.&#xD;
&#xD;
        -  At enrollment, all participants will be given a booklet with patient-level symptom&#xD;
           advice and a link to the content online.&#xD;
&#xD;
        -  All participants will receive compensation for participation, mailed to them as gift&#xD;
           cards by UNC.&#xD;
&#xD;
        -  CRAs will train all participants how to complete outcomes questionnaires for the trial&#xD;
           using the PRO-Core online system. Participants will be given a choice to complete these&#xD;
           in clinic or from home online, or if necessary via paper in clinic (with the CRA&#xD;
           entering the data into PRO-Core). If the patient does not self-complete this&#xD;
           information, the CRA will contact them to collect the information and then enter it into&#xD;
           PRO-Core. The outcomes questionnaires will be completed at baseline; and at month 1 (+/-&#xD;
           2 weeks); and at months 3, 6, 9, and 12/off-study (+/- 4 weeks each), and will be&#xD;
           available in English, Spanish, or Mandarin Chinese. At each time point, the CRA will&#xD;
           contact the participant to remind them about the upcoming questionnaire and offer help.&#xD;
&#xD;
        -  Chart abstraction will be conducted by CRAs at baseline and at off-study for each&#xD;
           participant, with data entered into the PRO-Core system. Date of death information will&#xD;
           additionally be abstracted at 18 and 24 months, and possibly later per the UNC study&#xD;
           team.&#xD;
&#xD;
        -  CRAs will be asked to complete a feedback survey (entered by the CRA into the PRO-Core&#xD;
           online system) and may be asked to participate in a brief telephone debriefing and/or&#xD;
           site visit.&#xD;
&#xD;
        -  Accrual will be monitored in a weekly teleconference between the UNC team and site CRAs.&#xD;
&#xD;
      ADDITIONAL PROCEDURES AT INTERVENTION SITES ONLY:&#xD;
&#xD;
        -  At baseline, CRAs will also train patients to self-report symptoms and physical&#xD;
           functioning using the PRO-Core system weekly for up to a year, with a choice to do this&#xD;
           online or via an automated telephone system (patient choice), and a choice of English,&#xD;
           Spanish, or Mandarin Chinese.&#xD;
&#xD;
        -  Whenever a concerning symptom is reported, an automated &quot;email alert&quot; notification will&#xD;
           be sent to the site CRA. The CRA will forward the email alert to the responsible&#xD;
           clinical nurse (or other covering clinician) and CC the site's Nurse Champion. Within 72&#xD;
           hours, the CRA will document what action(s), if any, were taken by the nurse in response&#xD;
           to the alert (entered by the CRA into a form in the PRO-Core system).&#xD;
&#xD;
        -  A symptom report will be printed/generated by the site CRA whenever the patient has a&#xD;
           clinic visit, and will be given to the oncologist and nurse caring for the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Actual">March 30, 2022</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>24 months</time_frame>
    <description>Based on administrative datasets and practice self-report/medical records.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical Functioning</measure>
    <time_frame>month 3</time_frame>
    <description>Physical functioning will be measured via the QLQ-C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Control</measure>
    <time_frame>month 3</time_frame>
    <description>Measured via the QLQ-C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life and symptom burden time</measure>
    <time_frame>month 3</time_frame>
    <description>Measured by QLQ-C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction/Communication</measure>
    <time_frame>month 3</time_frame>
    <description>Measured via Patient Satisfaction Questionnaires</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency room/hospital utilization</measure>
    <time_frame>1 year</time_frame>
    <description>Based on practice self-report/medical records and/or administrative datasets</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1191</enrollment>
  <condition>Metastatic Cancer</condition>
  <arm_group>
    <arm_group_label>Patient Self-Reporting of Symptoms</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients report symptoms weekly via web or automated telephone system. Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care Delivery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evidence-based symptom management pathways provided to patients and clinicians</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Patient Self-Reporting of Symptoms</intervention_name>
    <description>At baseline, CRAs will train patients to self-report symptoms and physical functioning weekly for up to a year, with a choice to do so online or via an automated telephone system. Whenever a concerning symptom is reported, an automated &quot;email alert&quot; notification will be sent to the site CRA. The CRA will forward the alert to the responsible clinical nurse (or other covering clinician) and CC the site's Nurse Champion. Within 72 hours, the CRA will document what action(s), if any, were taken by the nurse in response to the alert (entered by the CRA into a form in the PRO-Core system). A symptom report will be printed/generated by the site CRA whenever the patient has a clinic visit and will be given to the oncologist and nurse caring for the patient.</description>
    <arm_group_label>Patient Self-Reporting of Symptoms</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care Delivery</intervention_name>
    <description>Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms</description>
    <arm_group_label>Usual Care Delivery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults (21+) with metastatic cancer of any type (EXCEPT leukemia or indolent [slow&#xD;
             growing] lymphoma)&#xD;
&#xD;
          2. Receiving outpatient systemic cancer treatment for non-curative/palliative intent,&#xD;
             including chemotherapy, targeted therapy, or immunotherapy.&#xD;
&#xD;
          3. Enrolled at any point in their treatment trajectory, meaning during any line of&#xD;
             treatment, and at any point during a course or cycle of treatment.&#xD;
&#xD;
          4. Can understand English, Spanish, and/or Mandarin Chinese.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cognitive deficits that would preclude understanding of consent form and/or&#xD;
             questionnaires.&#xD;
&#xD;
          2. Current participation in a therapeutic clinical trial (because these often involve PRO&#xD;
             questionnaires and intensive monitoring).&#xD;
&#xD;
          3. Patients being treated with curative intent (e.g., adjuvant chemotherapy for breast,&#xD;
             lung, or ovarian cancer; primary curative therapy for testis cancer or lymphoma).&#xD;
&#xD;
          4. Receiving hormonal therapy only (e.g., tamoxifen or aromatase inhibitors in breast&#xD;
             cancer; androgen deprivation therapy in prostate cancer; or octreotide in&#xD;
             neuroendocrine cancers)&#xD;
&#xD;
          5. Indolent lymphomas (due to their prolonged time courses that may be minimally&#xD;
             symptomatic).&#xD;
&#xD;
          6. Leukemias (time courses inconsistent with other tumor types in chronic and acute&#xD;
             leukemias).&#xD;
&#xD;
          7. Does not understand English, Spanish, or Mandarin Chinese.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ethan Basch, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grand Valley Oncology</name>
      <address>
        <city>Grand Junction</city>
        <state>Colorado</state>
        <zip>81505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gwinnett Medical Center</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ingalls Memorial Hospital</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peoria</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quincy Medical Group</name>
      <address>
        <city>Quincy</city>
        <state>Illinois</state>
        <zip>62301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan Health Indianapolis</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital of South Bend</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital</name>
      <address>
        <city>Terre Haute</city>
        <state>Indiana</state>
        <zip>47804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Healthcare Cancer Services Quad Cities</name>
      <address>
        <city>Bettendorf</city>
        <state>Iowa</state>
        <zip>52722</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Associates at Mercy Medical Center</name>
      <address>
        <city>Cedar Rapids</city>
        <state>Iowa</state>
        <zip>52403</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Eastern Maine Medical Center</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anne Arundel Medical Center</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meritus Medical Center</name>
      <address>
        <city>Hagerstown</city>
        <state>Maryland</state>
        <zip>21742</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lowell General Hospital</name>
      <address>
        <city>Lowell</city>
        <state>Massachusetts</state>
        <zip>01854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Mercy Ann Arbor Hospital</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro Minnesota Community Oncology Research Consortium</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cox Medical Center South</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bozeman Health Deaconess Hospital</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nevada Cancer Specialists</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Hampshire Oncology Hematology PA-Hooksett</name>
      <address>
        <city>Hooksett</city>
        <state>New Hampshire</state>
        <zip>03106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center/ Albert Einstein College of Medicine</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of Central New York</name>
      <address>
        <city>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cape Fear Valley Health System</name>
      <address>
        <city>Fayetteville</city>
        <state>North Carolina</state>
        <zip>28304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27858</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rex Cancer Center</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus NCI Community Oncology Research Program</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Medical Center</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>WellSpan Health - York Cancer Center</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhode Island Hospital</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rapid City Regional Hospital</name>
      <address>
        <city>Rapid City</city>
        <state>South Dakota</state>
        <zip>57701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centra Lynchburg Hematology Oncology Clinic</name>
      <address>
        <city>Lynchburg</city>
        <state>Virginia</state>
        <zip>24501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edwards Comprehensive Cancer Center</name>
      <address>
        <city>Huntington</city>
        <state>West Virginia</state>
        <zip>25701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Basch E. Toward patient-centered drug development in oncology. N Engl J Med. 2013 Aug 1;369(5):397-400. doi: 10.1056/NEJMp1114649. Epub 2013 Jul 3. No abstract available.</citation>
    <PMID>23822654</PMID>
  </reference>
  <reference>
    <citation>Reilly CM, Bruner DW, Mitchell SA, Minasian LM, Basch E, Dueck AC, Cella D, Reeve BB. A literature synthesis of symptom prevalence and severity in persons receiving active cancer treatment. Support Care Cancer. 2013 Jun;21(6):1525-50. doi: 10.1007/s00520-012-1688-0. Epub 2013 Jan 12.</citation>
    <PMID>23314601</PMID>
  </reference>
  <reference>
    <citation>Henry DH, Viswanathan HN, Elkin EP, Traina S, Wade S, Cella D. Symptoms and treatment burden associated with cancer treatment: results from a cross-sectional national survey in the U.S. Support Care Cancer. 2008 Jul;16(7):791-801. doi: 10.1007/s00520-007-0380-2. Epub 2008 Jan 17.</citation>
    <PMID>18204940</PMID>
  </reference>
  <reference>
    <citation>Cleeland CS, Zhao F, Chang VT, Sloan JA, O'Mara AM, Gilman PB, Weiss M, Mendoza TR, Lee JW, Fisch MJ. The symptom burden of cancer: Evidence for a core set of cancer-related and treatment-related symptoms from the Eastern Cooperative Oncology Group Symptom Outcomes and Practice Patterns study. Cancer. 2013 Dec 15;119(24):4333-40. doi: 10.1002/cncr.28376. Epub 2013 Sep 24.</citation>
    <PMID>24114037</PMID>
  </reference>
  <reference>
    <citation>Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004 Sep 1;22(17):3485-90. doi: 10.1200/JCO.2004.03.025.</citation>
    <PMID>15337796</PMID>
  </reference>
  <reference>
    <citation>Laugsand EA, Sprangers MA, Bjordal K, Skorpen F, Kaasa S, Klepstad P. Health care providers underestimate symptom intensities of cancer patients: a multicenter European study. Health Qual Life Outcomes. 2010 Sep 21;8:104. doi: 10.1186/1477-7525-8-104.</citation>
    <PMID>20858248</PMID>
  </reference>
  <reference>
    <citation>Atkinson TM, Li Y, Coffey CW, Sit L, Shaw M, Lavene D, Bennett AV, Fruscione M, Rogak L, Hay J, Gonen M, Schrag D, Basch E. Reliability of adverse symptom event reporting by clinicians. Qual Life Res. 2012 Sep;21(7):1159-64. doi: 10.1007/s11136-011-0031-4. Epub 2011 Oct 8.</citation>
    <PMID>21984468</PMID>
  </reference>
  <reference>
    <citation>Fung CH, Hays RD. Prospects and challenges in using patient-reported outcomes in clinical practice. Qual Life Res. 2008 Dec;17(10):1297-302. doi: 10.1007/s11136-008-9379-5. Epub 2008 Aug 18.</citation>
    <PMID>18709564</PMID>
  </reference>
  <reference>
    <citation>Conway PH, Mostashari F, Clancy C. The future of quality measurement for improvement and accountability. JAMA. 2013 Jun 5;309(21):2215-6. doi: 10.1001/jama.2013.4929. No abstract available.</citation>
    <PMID>23736730</PMID>
  </reference>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 5, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03249090
org study id: AFT-39
nct id: NCT03249090
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current study is designed to test nationally whether patients' outcomes and utilization
      of services can be improved through symptom monitoring via patient-reported outcomes between
      visits.
This is a cluster RCT at approximately 50 sites where randomization will occur in a 1:1 ratio
      at the site level (not at the individual patient level). Therefore, approximately 25 sites
      will be randomized to the PRO-TECT intervention arm (patient-reporting of symptoms), and
      approximately 25 sites will be randomized to the control arm (usual care delivery).
      Approximately 1200 patients will be enrolled. Specifically:

      PROCEDURES AT ALL SITES (CONTROL SITES AND INTERVENTION SITES):

        -  Site staff (CRA and Nurse Champion required) will attend the site initiation webinar
           with UNC staff, including training for the PRO-Core online data management system and
           orientation to the symptom management guidelines.

        -  At enrollment, all participants will be given a booklet with patient-level symptom
           advice and a link to the content online.

        -  All participants will receive compensation for participation, mailed to them as gift
           cards by UNC.

        -  CRAs will train all participants how to complete outcomes questionnaires for the trial
           using the PRO-Core online system. Participants will be given a choice to complete these
           in clinic or from home online, or if necessary via paper in clinic (with the CRA
           entering the data into PRO-Core). If the patient does not self-complete this
           information, the CRA will contact them to collect the information and then enter it into
           PRO-Core. The outcomes questionnaires will be completed at baseline; and at month 1 (+/-
           2 weeks); and at months 3, 6, 9, and 12/off-study (+/- 4 weeks each), and will be
           available in English, Spanish, or Mandarin Chinese. At each time point, the CRA will
           contact the participant to remind them about the upcoming questionnaire and offer help.

        -  Chart abstraction will be conducted by CRAs at baseline and at off-study for each
           participant, with data entered into the PRO-Core system. Date of death information will
           additionally be abstracted at 18 and 24 months, and possibly later per the UNC study
           team.

        -  CRAs will be asked to complete a feedback survey (entered by the CRA into the PRO-Core
           online system) and may be asked to participate in a brief telephone debriefing and/or
           site visit.

        -  Accrual will be monitored in a weekly teleconference between the UNC team and site CRAs.

      ADDITIONAL PROCEDURES AT INTERVENTION SITES ONLY:

        -  At baseline, CRAs will also train patients to self-report symptoms and physical
           functioning using the PRO-Core system weekly for up to a year, with a choice to do this
           online or via an automated telephone system (patient choice), and a choice of English,
           Spanish, or Mandarin Chinese.

        -  Whenever a concerning symptom is reported, an automated "email alert" notification will
           be sent to the site CRA. The CRA will forward the email alert to the responsible
           clinical nurse (or other covering clinician) and CC the site's Nurse Champion. Within 72
           hours, the CRA will document what action(s), if any, were taken by the nurse in response
           to the alert (entered by the CRA into a form in the PRO-Core system).

        -  A symptom report will be printed/generated by the site CRA whenever the patient has a
           clinic visit, and will be given to the oncologist and nurse caring for the patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Overall Survival
time frame: 24 months
description: Based on administrative datasets and practice self-report/medical records.
measure: Physical Functioning
time frame: month 3
description: Physical functioning will be measured via the QLQ-C30
measure: Symptom Control
time frame: month 3
description: Measured via the QLQ-C30
measure: Health-related quality of life and symptom burden time
time frame: month 3
description: Measured by QLQ-C30
measure: Patient Satisfaction/Communication
time frame: month 3
description: Measured via Patient Satisfaction Questionnaires
measure: Emergency room/hospital utilization
time frame: 1 year
description: Based on practice self-report/medical records and/or administrative datasets
arm group label: Patient Self-Reporting of Symptoms
arm group type: Experimental
description: Patients report symptoms weekly via web or automated telephone system. Email alerts to nurses for severe/worsening symptoms; printouts for clinicians at visits. Evidence based symptom management pathways provided to patients and clinicians.
arm group label: Usual Care Delivery
arm group type: Active Comparator
description: Evidence-based symptom management pathways provided to patients and clinicians
intervention type: Other
intervention name: Patient Self-Reporting of Symptoms
description: At baseline, CRAs will train patients to self-report symptoms and physical functioning weekly for up to a year, with a choice to do so online or via an automated telephone system. Whenever a concerning symptom is reported, an automated "email alert" notification will be sent to the site CRA. The CRA will forward the alert to the responsible clinical nurse (or other covering clinician) and CC the site's Nurse Champion. Within 72 hours, the CRA will document what action(s), if any, were taken by the nurse in response to the alert (entered by the CRA into a form in the PRO-Core system). A symptom report will be printed/generated by the site CRA whenever the patient has a clinic visit and will be given to the oncologist and nurse caring for the patient.
arm group label: Patient Self-Reporting of Symptoms
intervention type: Other
intervention name: Usual Care Delivery
description: Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
arm group label: Usual Care Delivery
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ethan Basch, MD
role: Study Chair
affiliation: University of North Carolina, Chapel Hill
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country: United States
citation: Basch E. Toward patient-centered drug development in oncology. N Engl J Med. 2013 Aug 1;369(5):397-400. doi: 10.1056/NEJMp1114649. Epub 2013 Jul 3. No abstract available.
PMID: 23822654
citation: Reilly CM, Bruner DW, Mitchell SA, Minasian LM, Basch E, Dueck AC, Cella D, Reeve BB. A literature synthesis of symptom prevalence and severity in persons receiving active cancer treatment. Support Care Cancer. 2013 Jun;21(6):1525-50. doi: 10.1007/s00520-012-1688-0. Epub 2013 Jan 12.
PMID: 23314601
citation: Henry DH, Viswanathan HN, Elkin EP, Traina S, Wade S, Cella D. Symptoms and treatment burden associated with cancer treatment: results from a cross-sectional national survey in the U.S. Support Care Cancer. 2008 Jul;16(7):791-801. doi: 10.1007/s00520-007-0380-2. Epub 2008 Jan 17.
PMID: 18204940
citation: Cleeland CS, Zhao F, Chang VT, Sloan JA, O'Mara AM, Gilman PB, Weiss M, Mendoza TR, Lee JW, Fisch MJ. The symptom burden of cancer: Evidence for a core set of cancer-related and treatment-related symptoms from the Eastern Cooperative Oncology Group Symptom Outcomes and Practice Patterns study. Cancer. 2013 Dec 15;119(24):4333-40. doi: 10.1002/cncr.28376. Epub 2013 Sep 24.
PMID: 24114037
citation: Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004 Sep 1;22(17):3485-90. doi: 10.1200/JCO.2004.03.025.
PMID: 15337796
citation: Laugsand EA, Sprangers MA, Bjordal K, Skorpen F, Kaasa S, Klepstad P. Health care providers underestimate symptom intensities of cancer patients: a multicenter European study. Health Qual Life Outcomes. 2010 Sep 21;8:104. doi: 10.1186/1477-7525-8-104.
PMID: 20858248
citation: Atkinson TM, Li Y, Coffey CW, Sit L, Shaw M, Lavene D, Bennett AV, Fruscione M, Rogak L, Hay J, Gonen M, Schrag D, Basch E. Reliability of adverse symptom event reporting by clinicians. Qual Life Res. 2012 Sep;21(7):1159-64. doi: 10.1007/s11136-011-0031-4. Epub 2011 Oct 8.
PMID: 21984468
citation: Fung CH, Hays RD. Prospects and challenges in using patient-reported outcomes in clinical practice. Qual Life Res. 2008 Dec;17(10):1297-302. doi: 10.1007/s11136-008-9379-5. Epub 2008 Aug 18.
PMID: 18709564
citation: Conway PH, Mostashari F, Clancy C. The future of quality measurement for improvement and accountability. JAMA. 2013 Jun 5;309(21):2215-6. doi: 10.1001/jama.2013.4929. No abstract available.
PMID: 23736730
responsible party type: Sponsor
mesh term: Neoplasm Metastasis
sharing ipd: No
submitted: April 5, 2023