<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/NCT03229083</url>
  </required_header>
  <id_info>
    <org_study_id>UGUK 17036</org_study_id>
    <nct_id>NCT03229083</nct_id>
  </id_info>
  <brief_title>Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma</brief_title>
  <official_title>Monitoring of Treatment Related Toxicities From Oral Targeted Agents and Immunotherapy Among Patients With Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rochester</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 if Carevive software, which monitors treatment-related toxicities and then&#xD;
      generates self-care management plans for these symptoms, will be feasible to implement among&#xD;
      patients with metastatic renal cell carcinoma (RCC). Additionally for collection of&#xD;
      preliminary data on treatment-related toxicities, quality of life, distress level, and drug&#xD;
      adherence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 24, 2019</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Carevive Survey Usage Rates</measure>
    <time_frame>48 weeks</time_frame>
    <description>Carevive software will track subject compliance with survey logins and whether they access the generated care plans. The percentage of times logged in out of the number of study recommended logins will be tabulated. Also, the percentage of times a careplan was accessed out of the number of times it was offered will be determined.&#xD;
To determine the practicality of the intervention, by analyzing the reasons why subjects fail to self-report treatment-related toxicities or utilize software generated care plans after enrollment.&#xD;
To assess the acceptability of this intervention with validated patient reported usability scores of the software.&#xD;
To determine potential implementation obstacles of the intervention, by assessing the reasons eligible study candidates decline participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons Participants Do Not Complete Survey or Utilize Care Plans</measure>
    <time_frame>48 weeks</time_frame>
    <description>After missing a survey, subjects will be asked the reason at their following login. The reason provided will be sorted into pre-specified categories and presented as a percentage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Usability Score Using the Software Usability Scoring System</measure>
    <time_frame>48 weeks</time_frame>
    <description>At the 48 week time point or at the point of subject withdrawal from study, they will be asked to take the System Usability Scale. The survey provides us with a score of between 0 and 40 which is then multiplied by 2.5 to convert to a scale of 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reasons for Declining Study Participation</measure>
    <time_frame>48 weeks</time_frame>
    <description>If a subject declines to participation in the study, he/she will be asked to provide a reason for declination. If willing, we will have them sign a separate consent with a space to write in their reason. The reason provided will be sorted into pre-specified categories and presented as a percentage.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Toxicities Using PRO-CTCAE Questions</measure>
    <time_frame>48 weeks</time_frame>
    <description>Patient reported toxicity data will be collected via Carevive surveys weekly for the first 12 weeks and then every other week for another 36 weeks. We will not deliver the PRO-CTCAE in its entirety but will specifically ask about the following common toxicities that are experienced with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, anorexia, mouth sores, cough and shortness of breath.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician Reported Toxicities Using CTCAE</measure>
    <time_frame>48 weeks</time_frame>
    <description>Toxicities will also be formally assessed in-office every 3-4 months using CTCAE scoring. The categories chosen are common toxicities that occur with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, appetite, mouth sores, cough and shortness of breath</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Determination Using the FKSI-DRS Survey</measure>
    <time_frame>48 weeks</time_frame>
    <description>Subjects will be asked to fill out the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) at baseline and approximately every 3 months in-office.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Level Using the NCCN Distress Thermometer</measure>
    <time_frame>48 weeks</time_frame>
    <description>The subject will be asked to rate their distress level in-office using the NCCN Distress Thermometer, which is a 1 to 10 numerical scale. This will be delivered during routine office visits approximately every 3 months on a tablet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>• Health Care Utilization Assessment By Quantification of Health Care Visits or Hospitalizations</measure>
    <time_frame>48 weeks</time_frame>
    <description>Health care utilization will be self-reported by the subject through CareVive software monthly, in addition at the end of the study or at time of withdrawal, a search of the electronic medical record will be performed to determine the number of calls made to oncology care providers and the number of visits to the oncologist during the study period.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Advanced Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Use of Carevive software</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Carevive software</intervention_name>
    <description>In this study, Carevive will deliver a link to subjects so that an online survey can be completed. The survey will occur weekly for the first 12 weeks of the study and will be spaced out to every other week thereafter. The questions will mostly focus on side effects from their cancer therapy, as well as a few questions about drug compliance and healthcare utilization. After completion of the survey, the subject will be given a care plan with at home self-management options for drug-related toxicities.</description>
    <arm_group_label>Use of Carevive software</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either&#xD;
             pathological or radiographic evidence of metastatic disease&#xD;
&#xD;
          -  Greater than 18 years of age&#xD;
&#xD;
          -  A participating Wilmot Cancer Center oncologist has determined that candidate should&#xD;
             be started on either oral targeted therapy or immunotherapy for treatment of their&#xD;
             advanced RCC; this can be for first-line or any subsequent line therapy&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
          -  Proficient in the English language and self-reports as literate&#xD;
&#xD;
          -  Must have an active email address or access to a smart device on which text messages&#xD;
             can be received&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women cannot be breast-feeding&#xD;
&#xD;
          -  Does not have regular access to the internet&#xD;
&#xD;
          -  Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for&#xD;
             routine visits with their primary oncologist&#xD;
&#xD;
          -  Subjects who were on the study previously will not be allowed to re-enroll in the&#xD;
             event of a treatment change&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Rochester - Wilmot Cancer Institute</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicholas Gerbino</last_name>
      <phone>585-273-2605</phone>
      <email>nicholas_gerbino@urmc.rochester.edu</email>
    </contact>
    <contact_backup>
      <last_name>Rachel Turner</last_name>
      <email>Rachael_Turner@URMC.Rochester.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Chunkit Fung</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03229083
org study id: UGUK 17036
nct id: NCT03229083
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To determine if Carevive software, which monitors treatment-related toxicities and then
      generates self-care management plans for these symptoms, will be feasible to implement among
      patients with metastatic renal cell carcinoma (RCC). Additionally for collection of
      preliminary data on treatment-related toxicities, quality of life, distress level, and drug
      adherence.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Carevive Survey Usage Rates
time frame: 48 weeks
description: Carevive software will track subject compliance with survey logins and whether they access the generated care plans. The percentage of times logged in out of the number of study recommended logins will be tabulated. Also, the percentage of times a careplan was accessed out of the number of times it was offered will be determined.
To determine the practicality of the intervention, by analyzing the reasons why subjects fail to self-report treatment-related toxicities or utilize software generated care plans after enrollment.
To assess the acceptability of this intervention with validated patient reported usability scores of the software.
To determine potential implementation obstacles of the intervention, by assessing the reasons eligible study candidates decline participation.
measure: Reasons Participants Do Not Complete Survey or Utilize Care Plans
time frame: 48 weeks
description: After missing a survey, subjects will be asked the reason at their following login. The reason provided will be sorted into pre-specified categories and presented as a percentage.
measure: Average Usability Score Using the Software Usability Scoring System
time frame: 48 weeks
description: At the 48 week time point or at the point of subject withdrawal from study, they will be asked to take the System Usability Scale. The survey provides us with a score of between 0 and 40 which is then multiplied by 2.5 to convert to a scale of 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
measure: Reasons for Declining Study Participation
time frame: 48 weeks
description: If a subject declines to participation in the study, he/she will be asked to provide a reason for declination. If willing, we will have them sign a separate consent with a space to write in their reason. The reason provided will be sorted into pre-specified categories and presented as a percentage.
measure: Patient Reported Toxicities Using PRO-CTCAE Questions
time frame: 48 weeks
description: Patient reported toxicity data will be collected via Carevive surveys weekly for the first 12 weeks and then every other week for another 36 weeks. We will not deliver the PRO-CTCAE in its entirety but will specifically ask about the following common toxicities that are experienced with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, anorexia, mouth sores, cough and shortness of breath.
measure: Clinician Reported Toxicities Using CTCAE
time frame: 48 weeks
description: Toxicities will also be formally assessed in-office every 3-4 months using CTCAE scoring. The categories chosen are common toxicities that occur with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, appetite, mouth sores, cough and shortness of breath
measure: Quality of Life Determination Using the FKSI-DRS Survey
time frame: 48 weeks
description: Subjects will be asked to fill out the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) at baseline and approximately every 3 months in-office.
measure: Distress Level Using the NCCN Distress Thermometer
time frame: 48 weeks
description: The subject will be asked to rate their distress level in-office using the NCCN Distress Thermometer, which is a 1 to 10 numerical scale. This will be delivered during routine office visits approximately every 3 months on a tablet.
measure: • Health Care Utilization Assessment By Quantification of Health Care Visits or Hospitalizations
time frame: 48 weeks
description: Health care utilization will be self-reported by the subject through CareVive software monthly, in addition at the end of the study or at time of withdrawal, a search of the electronic medical record will be performed to determine the number of calls made to oncology care providers and the number of visits to the oncologist during the study period.
arm group label: Use of Carevive software
arm group type: Experimental
description: Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC).
intervention type: Other
intervention name: Carevive software
description: In this study, Carevive will deliver a link to subjects so that an online survey can be completed. The survey will occur weekly for the first 12 weeks of the study and will be spaced out to every other week thereafter. The questions will mostly focus on side effects from their cancer therapy, as well as a few questions about drug compliance and healthcare utilization. After completion of the survey, the subject will be given a care plan with at home self-management options for drug-related toxicities.
arm group label: Use of Carevive software
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Chunkit Fung
investigator title: Doctor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
sharing ipd: No