<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/NCT04479605</url>
  </required_header>
  <id_info>
    <org_study_id>20-241</org_study_id>
    <nct_id>NCT04479605</nct_id>
  </id_info>
  <brief_title>Communication Training for Cancer Patients, Their Caregivers, and Their Doctors</brief_title>
  <official_title>Values and Options in Cancer Care 2.0 (VOICE 2.0): Building on Lessons Learned to Improve Communication and Illness Understanding in Cancer Patients and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to develop and test a new communication intervention, &quot;Values&#xD;
      and Options in Cancer Care 2.0&quot; (VOICE 2.0), which involves oncologist training, patient and&#xD;
      caregiver coaching, and caregiver support.&#xD;
&#xD;
      The VOICE 2.0 intervention was developed by members of the study team to improve&#xD;
      communication among oncologists, patients with cancer, and caregivers. Researchers have found&#xD;
      that clear communication about the patient's disease can help with the planning of that&#xD;
      patient's future care and improve the well-being of both the patient and his or her&#xD;
      caregiver. The long-term goals of developing and testing VOICE 2.0 include improving the care&#xD;
      and respecting the wishes of cancer patients, and helping those patients and their caregivers&#xD;
      have an improved quality of life during their experience with cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility will be assessed by rates of accrual, retention, and intervention completion</measure>
    <time_frame>10 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Acceptability</measure>
    <time_frame>7 weeks</time_frame>
    <description>Intervention Acceptability will be assessed with Likert scale items with responses that range from 1 to 5 with higher scores indicating greater acceptability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concordant illness understanding (oncologists, patients, caregivers)</measure>
    <time_frame>7 weeks</time_frame>
    <description>will be measured using two items assessing participants' beliefs about the patient's chances of living two or more years and chances of being cured. Items are rated on a seven-point scale: 100%, 90% 75%, 50-50, 25%, 10%, 0%. Patient, caregiver, and oncologist responses that differ by two or more response categories will be categorized as discordant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Communicational self-efficacy</measure>
    <time_frame>7 weeks</time_frame>
    <description>will be measured with the 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI) survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-caregiver communication quality</measure>
    <time_frame>7 weeks</time_frame>
    <description>will be assessed with the 5-item Family Communication subscale of the Cancer Communication Assessment Tool for Patients and Families, a valid measure in cancer patients and caregivers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient/caregiver-oncologist relationship strength</measure>
    <time_frame>7 weeks</time_frame>
    <description>will be measured with the 16-item Human Connection scale Each item is rated on Likert scale from 1 to 4 with higher scores indicating a stronger relationship with the oncologist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological distress</measure>
    <time_frame>7 weeks</time_frame>
    <description>will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report measure45 commonly used with cancer patients46-51 and caregivers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Meaning and purpose (patients, caregivers)</measure>
    <time_frame>7 weeks</time_frame>
    <description>will be assessed with the 48-item Life Attitude Profile-Revised, a self-report measure of discovered meaning and the motivation to find purpose that has been used with advanced cancer patients and caregivers.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">47</enrollment>
  <condition>Communication and Illness Understanding</condition>
  <arm_group>
    <arm_group_label>Patients with advanced cancer</arm_group_label>
    <description>Patient and caregiver coaching is facilitated by a booklet titled Our Cancer Care (Appendices E &amp; F) that includes a Question Prompt List (QPL) and resources for a Values Affirmation Exercise (Appendices G &amp; H). The QPL and Values Affirmation Exercises will be provided with a cover letter (Appendix I). The QPL consists of example questions to discuss with oncologists about diagnosis, prognosis, treatments, symptom management, transitions in care, self-care, family needs, and life goals. Patients and caregivers meet over video-conferencing with a study interventionist for one hour to review the QPL. The interventionist makes three follow-up phone calls to each dyad bi-weekly to evaluate use of the QPL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers</arm_group_label>
    <description>Caregivers will participate in three 45-minute sessions with the interventionist over the telephone or video-conferencing (per caregiver preference) approximately bi-weekly. These sessions take place while the patient and caregiver are completing the three follow-up dyadic sessions. Efforts will be made to schedule the caregiver support sessions during weeks that fall between dyadic coaching sessions to minimize intervention burden on caregivers (i.e., avoiding scheduling two sessions for the caregiver in the same week).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oncologists</arm_group_label>
    <description>The Oncologist training will be conducted online using Bridge, an internet-based platform designed to facilitate communication between instructors and learners. The training includes written information on and videos demonstrating target communication skills (Table 1) and knowledge acquisition checks. Five of the online modules are required and the remaining six modules are optional. The required modules are estimated to take oncologists approximately one hour to complete; the optional modules are estimated to take 90 minutes total (i.e., for all modules) to complete. Oncologists' logging history will be tracked in Bridge.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Voice 2.0 consists of Oncologist training, patient and caregiver coaching, and caregiver&#xD;
        support.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ONCOLOGISTS:&#xD;
&#xD;
          -  As per self-report, medical oncologist providing care to patients with&#xD;
             gastrointestinal, genitourinary, gynecologic, lung, or hematologic cancers at MSK&#xD;
&#xD;
          -  As per self-report, not planning to leave MSK in the next six months&#xD;
&#xD;
          -  As per self-report, willing to be audio-recorded for Post-Training Follow-Up Interview&#xD;
&#xD;
        PATIENTS:&#xD;
&#xD;
          -  Per medical record and/or self-report, a patient of an oncologist participating in&#xD;
             this study&#xD;
&#xD;
          -  As per medical record and/or self-report, diagnosis of:&#xD;
&#xD;
               -  a hematologic cancer with disease progression following second-line treatment&#xD;
                  that is not eligible for transplant; OR&#xD;
&#xD;
               -  stage III or IV gastrointestinal, genitourinary, gynecologic, or lung cancer&#xD;
&#xD;
          -  As per medical record and/or self-report, fluent in English&#xD;
&#xD;
          -  As per medical record and/or self-report, age 18 or older&#xD;
&#xD;
          -  As per self-report, has a primary informal caregiver (as defined by an unpaid&#xD;
             individual who provides the patient with emotional, physical, and/or practical&#xD;
             support) who is willing and able to participate in the study&#xD;
&#xD;
          -  As per self-report, residency in New York or ability to complete sessions in New York&#xD;
             to ensure that provision of intervention is covered by the professional licenses of&#xD;
             interventionists (i.e., social workers licensed in New York State)&#xD;
&#xD;
          -  As per self-report, able to communicate over video-conference and phone for sessions&#xD;
&#xD;
          -  As per self-report, willing to be audio-recorded for assessments and study sess&#xD;
&#xD;
        CAREGIVERS:&#xD;
&#xD;
          -  As per patient report, is a primary informal caregiver (&quot;a family member, partner,&#xD;
             friend, or other individual involved with your health care issues, preferably someone&#xD;
             who comes to physician appointments with you&quot;) for an MSK patient&#xD;
&#xD;
          -  As per self-report, fluent in English&#xD;
&#xD;
          -  As per self-report, age 18 or older&#xD;
&#xD;
          -  As per self-report, ability to complete sessions in a state the interventionists are&#xD;
             legally allowed to practice in (i.e., social workers licensed in New York or New&#xD;
             Jersey State; states with shared license laws)&#xD;
&#xD;
          -  As per self-report, able to communicate over video-conference and phone for sessions&#xD;
&#xD;
          -  As per self-report, willing to be audio-recorded for assessments and study sessions **&#xD;
             Language verification: For both patients and caregivers, prior to enrollment, all will&#xD;
             be asked the following two questions by an CRC to verify English fluency necessary for&#xD;
             participation in the study:&#xD;
&#xD;
               1. How well do you speak English? (must respond &quot;Very well&quot; when given the choices&#xD;
                  of Very well, Well, Not well, Not at all, Don't know, or Refused)&#xD;
&#xD;
               2. What is your preferred language for healthcare? (must respond English)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        PATIENTS:&#xD;
&#xD;
          -  Score &gt;4 on Short Portable Mental Status Questionnaire&#xD;
&#xD;
          -  As per self-report, feels too weak or cognitively impaired to participate in the&#xD;
             intervention and complete the assessments&#xD;
&#xD;
          -  As per medical record or self-report, receiving hospice care at the time of enrollment&#xD;
&#xD;
        CAREGIVERS:&#xD;
&#xD;
          -  Score &gt;4 on Short Portable Mental Status Questionnaire&#xD;
&#xD;
          -  As per self-report, feels too weak or cognitively impaired to participate in the&#xD;
             intervention and complete the assessments&#xD;
&#xD;
          -  As per medical record or self-report, receiving hospice care at the time of enrollment&#xD;
&#xD;
          -  As per patient or self-report, supports the patient in a professional role&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelly Trevino, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kelly Trevino, PhD</last_name>
    <phone>646-888-0026</phone>
    <email>trevinok@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrew Epstein, MD</last_name>
    <phone>646-888-4313</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Trevino, PhD</last_name>
      <phone>646-888-0026</phone>
      <email>trevinok@mskcc.org</email>
    </contact>
    <contact_backup>
      <last_name>Andrew Epstein, MD</last_name>
      <phone>646-888-4313</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>June 7, 2023</last_update_submitted>
  <last_update_submitted_qc>June 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caregiver Support Sessions</keyword>
  <keyword>Patient &amp; Caregiver Coaching</keyword>
  <keyword>20-241</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </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/NCT04479605
org study id: 20-241
nct id: NCT04479605
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to develop and test a new communication intervention, "Values
      and Options in Cancer Care 2.0" (VOICE 2.0), which involves oncologist training, patient and
      caregiver coaching, and caregiver support.

      The VOICE 2.0 intervention was developed by members of the study team to improve
      communication among oncologists, patients with cancer, and caregivers. Researchers have found
      that clear communication about the patient's disease can help with the planning of that
      patient's future care and improve the well-being of both the patient and his or her
      caregiver. The long-term goals of developing and testing VOICE 2.0 include improving the care
      and respecting the wishes of cancer patients, and helping those patients and their caregivers
      have an improved quality of life during their experience with cancer.
observational model: Cohort
time perspective: Prospective
measure: Feasibility will be assessed by rates of accrual, retention, and intervention completion
time frame: 10 weeks
measure: Intervention Acceptability
time frame: 7 weeks
description: Intervention Acceptability will be assessed with Likert scale items with responses that range from 1 to 5 with higher scores indicating greater acceptability.
measure: Concordant illness understanding (oncologists, patients, caregivers)
time frame: 7 weeks
description: will be measured using two items assessing participants' beliefs about the patient's chances of living two or more years and chances of being cured. Items are rated on a seven-point scale: 100%, 90% 75%, 50-50, 25%, 10%, 0%. Patient, caregiver, and oncologist responses that differ by two or more response categories will be categorized as discordant.
measure: Communicational self-efficacy
time frame: 7 weeks
description: will be measured with the 10-item Perceived Efficacy in Patient-Physician Interactions (PEPPI) survey.
measure: Patient-caregiver communication quality
time frame: 7 weeks
description: will be assessed with the 5-item Family Communication subscale of the Cancer Communication Assessment Tool for Patients and Families, a valid measure in cancer patients and caregivers.
measure: Patient/caregiver-oncologist relationship strength
time frame: 7 weeks
description: will be measured with the 16-item Human Connection scale Each item is rated on Likert scale from 1 to 4 with higher scores indicating a stronger relationship with the oncologist.
measure: Psychological distress
time frame: 7 weeks
description: will be measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report measure45 commonly used with cancer patients46-51 and caregivers
measure: Meaning and purpose (patients, caregivers)
time frame: 7 weeks
description: will be assessed with the 48-item Life Attitude Profile-Revised, a self-report measure of discovered meaning and the motivation to find purpose that has been used with advanced cancer patients and caregivers.
arm group label: Patients with advanced cancer
description: Patient and caregiver coaching is facilitated by a booklet titled Our Cancer Care (Appendices E & F) that includes a Question Prompt List (QPL) and resources for a Values Affirmation Exercise (Appendices G & H). The QPL and Values Affirmation Exercises will be provided with a cover letter (Appendix I). The QPL consists of example questions to discuss with oncologists about diagnosis, prognosis, treatments, symptom management, transitions in care, self-care, family needs, and life goals. Patients and caregivers meet over video-conferencing with a study interventionist for one hour to review the QPL. The interventionist makes three follow-up phone calls to each dyad bi-weekly to evaluate use of the QPL.
arm group label: Caregivers
description: Caregivers will participate in three 45-minute sessions with the interventionist over the telephone or video-conferencing (per caregiver preference) approximately bi-weekly. These sessions take place while the patient and caregiver are completing the three follow-up dyadic sessions. Efforts will be made to schedule the caregiver support sessions during weeks that fall between dyadic coaching sessions to minimize intervention burden on caregivers (i.e., avoiding scheduling two sessions for the caregiver in the same week).
arm group label: Oncologists
description: The Oncologist training will be conducted online using Bridge, an internet-based platform designed to facilitate communication between instructors and learners. The training includes written information on and videos demonstrating target communication skills (Table 1) and knowledge acquisition checks. Five of the online modules are required and the remaining six modules are optional. The required modules are estimated to take oncologists approximately one hour to complete; the optional modules are estimated to take 90 minutes total (i.e., for all modules) to complete. Oncologists' logging history will be tracked in Bridge.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kelly Trevino, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Kelly Trevino, PhD
phone: 646-888-0026
email: trevinok@mskcc.org
last name: Andrew Epstein, MD
phone: 646-888-4313
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.