<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/NCT04503681</url>
  </required_header>
  <id_info>
    <org_study_id>20-009</org_study_id>
    <nct_id>NCT04503681</nct_id>
  </id_info>
  <brief_title>Pre-consultation Compassion Among Patients Referred to a Cancer Center</brief_title>
  <official_title>A Pre-consultation Compassion Intervention to Reduce Anxiety Among Patients Referred to a Cancer Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cooper Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cooper Health System</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>
      Patients diagnosed with cancer commonly have a high degree of anxiety during an initial&#xD;
      oncology consultation, which may interfere with a patient's ability to retain information&#xD;
      required to make informed treatment decisions. A previous study randomized breast cancer&#xD;
      survivors (volunteers) to view either (a) a brief video depicting a standard initial&#xD;
      consultation from an oncologist or (b) an identical consultation with the addition of&#xD;
      compassionate statements from the oncologist, and found the compassionate statements reduced&#xD;
      anxiety among the volunteers. However, it is currently unknown if watching a video containing&#xD;
      compassionate statements from an oncologist prior to an actual initial oncology consultation&#xD;
      will reduce anxiety among patients referred to a cancer center. The aim of this randomized&#xD;
      control trial is to test if watching a brief video containing compassionate statements from&#xD;
      an oncologist, compared to watching a standard introduction video, prior to an initial&#xD;
      oncology consultation will reduce the degree of anxiety among patients referred to a cancer&#xD;
      center.&#xD;
&#xD;
      This is a prospective, randomized controlled clinical trial at an academic cancer center. The&#xD;
      investigators will enroll adult patients scheduled for an initial oncology consultation.&#xD;
      Subjects will be randomly assigned to receive a &quot;standard introduction video&quot; or &quot;enhanced&#xD;
      compassion video&quot; for viewing prior to the initial oncology consultation. On arrival to the&#xD;
      cancer center anxiety severity will be measured using the Hospital Anxiety and Depression&#xD;
      scale (HADS). The HADS has two 7-item subscales (HADS Anxiety and HADS Depression) and is&#xD;
      well-validated among oncology patients. Wilcoxon rank-sum test will be used to test for a&#xD;
      difference in the HADS subscales between the two video groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design This study is a prospective, randomized, controlled, parallel-group clinical&#xD;
      trial at a single university-based cancer center (MD Anderson Cancer Center at Cooper, Cooper&#xD;
      University Health Care, Camden, New Jersey, USA). Potential subjects will be enrolled at the&#xD;
      time of scheduling an initial cancer consultation. The Cooper University Hospital&#xD;
      Institutional Review Board allowed alteration of the requirements of obtaining informed&#xD;
      consent under 45 CFR 46.116(d) given the intervention was deemed no greater than minimal&#xD;
      risk. All new adult patients scheduled for an initial cancer consultation at MD Anderson&#xD;
      Cancer Center at Cooper will be randomized to receive an email containing a link for either&#xD;
      the &quot;standard introduction video&quot; or the &quot;enhanced compassion video.&quot; Emails will be sent to&#xD;
      patients prior to obtaining informed consent to allow for viewing of the video prior to the&#xD;
      initial oncology consultation and to keep the patients masked to the study hypotheses prior&#xD;
      to the consultation. When the patients arrive to the MD Anderson Cancer Center waiting room&#xD;
      for his/her initial cancer consultation they will be approached by research staff to obtain&#xD;
      written informed consent to complete the research questionnaire and for use of data.&#xD;
&#xD;
      Randomization and masking Patients will be randomly assigned to one of two groups, &quot;standard&#xD;
      introduction video&quot; or &quot;enhanced compassion video.&quot; An independent statistician will generate&#xD;
      the group assignment sequence using a parallel design, 1:1 randomization schedule. Standard&#xD;
      measures will be used to ensure appropriate concealment of group assignment. The&#xD;
      randomization assignments will be kept in a sequential list and maintained in the scheduling&#xD;
      operator office. At the time of scheduling an initial consultation, appointment operators&#xD;
      will identify the next assignment in the series, which will be labeled either &quot;Video A&quot; or&#xD;
      &quot;Video B.&quot; The operators will then send the appropriate email containing a link to a website&#xD;
      for the matching video. The independent statistician will maintain the code link for the&#xD;
      videos. Thus, the operators, investigators, and research statistician will be blinded to&#xD;
      video allocation until after all study analyses have been completed.&#xD;
&#xD;
      Interventions As part of a currently ongoing clinical quality initiative at the study&#xD;
      institution, when a new patient schedules an appointment for an initial cancer consultation&#xD;
      the scheduling operator sends an email to the patient containing a link for a standard&#xD;
      introduction video. For the purposes of this study a second &quot;enhanced compassion video&quot; was&#xD;
      developed, which added five additional sentences to the standard introduction video. Those&#xD;
      five sentences were compassion-focused statements. Both videos feature the same oncologist&#xD;
      (i.e. Medical Director of MD Anderson Cancer Center at Cooper) and are identical aside from&#xD;
      the additional compassionate statements. The compassionate statements added to the &quot;enhanced&#xD;
      compassion video&quot; were based on the results of a recent systematic review of clinician&#xD;
      compassionate behaviors, which found incorporating statements of support, acknowledgement,&#xD;
      patient's perspective, emotion naming, and validation increased patient perception of&#xD;
      compassion.&#xD;
&#xD;
      Measurements and Data Collection After obtaining written informed consent a research&#xD;
      questionnaire will be administered to patients at the cancer center prior to the initial&#xD;
      cancer consultation. The questionnaire will assess the patients' perception of the video&#xD;
      oncologist's compassion using the 5-item compassion measure, a previously validated&#xD;
      patient-assessed measure of perceived compassion during patient care. Subject demographics,&#xD;
      as well as clinical information pertaining to cancer diagnosis will be abstracted from the&#xD;
      medical record.&#xD;
&#xD;
      Outcome measures The primary outcome measure will be anxiety severity on arrival to the&#xD;
      cancer center for the initial consultation. As part of the research questionnaire subjects&#xD;
      will be asked to complete the Hospital Anxiety and Depression scale (HADS). The HADS is a&#xD;
      14-item self-reported instrument that assesses anxiety and depressive symptoms in populations&#xD;
      with medical conditions (both in- and out-patients). It has two 7-item subscales: HADS&#xD;
      Anxiety and HADS Depression. Each item is scored on a 4-point scale (0=not at all to 3=nearly&#xD;
      all the time); thus, each sub-scale can range from 0-21. The HADS has been extensively&#xD;
      validated in oncology populations, and is a commonly used measure of anxiety and depression&#xD;
      in oncology studies. The HADS Depression score will be analyzed as a secondary outcome. An&#xD;
      additional secondary outcome measure will be the no-show rate for the initial consultation&#xD;
      among each group. All data will be entered into Research Electronic Data Capture (REDCap), a&#xD;
      secure, web-based application designed to support data capture for research studies, and&#xD;
      export the data into Stata/SE 16.0 for Mac, StataCorp LP (College Station, TX, USA) for&#xD;
      analysis.&#xD;
&#xD;
      Statistical analysis For descriptive statistics categorical data will be reported as&#xD;
      proportions with 95% confidence intervals and continuous data as means with standard&#xD;
      deviations or medians with interquartile ranges as appropriate. As part of the CONSORT&#xD;
      diagram the proportion of patients who do not attend their initial cancer consultation, as&#xD;
      well as the proportion of patients who attend their initial consultation, but decline to&#xD;
      participate in the study, will be recored and stratified by video group. The investigators&#xD;
      will test if the &quot;enhanced compassion video&quot; reduced the no-show rate to the initial&#xD;
      consultation, as well as increased participation in research using the Fisher exact test.&#xD;
      Cronbach's alpha will be used to separately test the internal reliability of the HADS anxiety&#xD;
      scale, HADS depression scale, and the 5-item compassion measure among our cohort. The&#xD;
      investigators will test if the &quot;enhanced compassion video&quot; group perceived the video&#xD;
      oncologist as more (or less) compassionate, as measured by the 5-item compassion measure,&#xD;
      than the &quot;standard introduction video&quot; group using the Wilcoxon rank-sum test.&#xD;
&#xD;
      For the primary outcome, the Wilcoxon rank-sum test will be used to test for a difference in&#xD;
      the HADS anxiety scale between the two video groups. Sensitivity analysis dichotomizing the&#xD;
      HADS anxiety scale into low (&lt; 8) and moderate/high (≥ 8) will be performed. A cut point of 8&#xD;
      on the HADS subscales has been defined as the optimal cut point for diagnosis screening and&#xD;
      is commonly used to define clinically significant symptoms in research studies. The Fisher&#xD;
      exact test will be used to test if the proportion of subjects with clinically significant&#xD;
      symptoms differed between the two video groups. For the secondary outcome measure the&#xD;
      investigators will repeat the same analyses described above using the HADS depression scale&#xD;
      in place of the HADS anxiety scale. The investigators will perform the above analyses using&#xD;
      intention to treat methodology. The analyses will be repeated in a per protocol fashion&#xD;
      excluding patients who state they did not watch the video prior to presentation to the cancer&#xD;
      center.&#xD;
&#xD;
      To test if the relationship between video group and anxiety severity differs among&#xD;
      pre-specified subgroups the investigators will perform separate multivariable linear&#xD;
      regression models with the HADS anxiety scale as the dependent variable, and entering the&#xD;
      following patient characteristic along with an interaction term between video group and the&#xD;
      characteristic as independent variables: (1) age (decile), (2) sex (male vs. female), (3)&#xD;
      race (white vs. non-white), (4) ethnicity (Hispanic vs. non-Hispanic), (5) suspected primary&#xD;
      cancer (breast vs. gastrointestinal vs. pulmonary vs. skin vs. central nervous system vs.&#xD;
      gynecologic vs. other).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2021</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">July 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety subscale of the Hospital Anxiety and Depression scale (HADS)</measure>
    <time_frame>Baseline (on arrival to the cancer center for an initial oncology consultant).</time_frame>
    <description>Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Depression subscale of the Hospital Anxiety and Depression scale</measure>
    <time_frame>Baseline (on arrival to the cancer center for an initial oncology consultant).</time_frame>
    <description>Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">470</enrollment>
  <condition>Cancer</condition>
  <condition>Anxiety</condition>
  <condition>Compassion</condition>
  <condition>Empathy</condition>
  <arm_group>
    <arm_group_label>Standard introduction video</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced compassion video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced compassion video</intervention_name>
    <description>Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the &quot;enhanced compassion video&quot; were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion.</description>
    <arm_group_label>Enhanced compassion video</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard introduction video</intervention_name>
    <description>Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.</description>
    <arm_group_label>Standard introduction video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  scheduled for an initial oncology consultation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who do not have an active email address or are medically unable to complete&#xD;
             the research questionnaire at the time of the initial cancer consultation.&#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_contact>
    <last_name>Brian Roberts</last_name>
    <phone>856-342-2352</phone>
    <email>roberts-brian-w@cooperhealth.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cooper University Health Care</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brian Roberts</last_name>
      <email>roberts-brian-w@cooperhealth.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 12, 2023</last_update_submitted>
  <last_update_submitted_qc>July 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cooper Health System</investigator_affiliation>
    <investigator_full_name>Brian Roberts</investigator_full_name>
    <investigator_title>Study Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After review and approval by our study data use committee, we will allow other researchers who submit to us a suitable protocol to have access to the complete de-identified datasets used and/or analyzed during the study, in comma separated value format together with a data dictionary.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </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/NCT04503681
org study id: 20-009
nct id: NCT04503681
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients diagnosed with cancer commonly have a high degree of anxiety during an initial
      oncology consultation, which may interfere with a patient's ability to retain information
      required to make informed treatment decisions. A previous study randomized breast cancer
      survivors (volunteers) to view either (a) a brief video depicting a standard initial
      consultation from an oncologist or (b) an identical consultation with the addition of
      compassionate statements from the oncologist, and found the compassionate statements reduced
      anxiety among the volunteers. However, it is currently unknown if watching a video containing
      compassionate statements from an oncologist prior to an actual initial oncology consultation
      will reduce anxiety among patients referred to a cancer center. The aim of this randomized
      control trial is to test if watching a brief video containing compassionate statements from
      an oncologist, compared to watching a standard introduction video, prior to an initial
      oncology consultation will reduce the degree of anxiety among patients referred to a cancer
      center.

      This is a prospective, randomized controlled clinical trial at an academic cancer center. The
      investigators will enroll adult patients scheduled for an initial oncology consultation.
      Subjects will be randomly assigned to receive a "standard introduction video" or "enhanced
      compassion video" for viewing prior to the initial oncology consultation. On arrival to the
      cancer center anxiety severity will be measured using the Hospital Anxiety and Depression
      scale (HADS). The HADS has two 7-item subscales (HADS Anxiety and HADS Depression) and is
      well-validated among oncology patients. Wilcoxon rank-sum test will be used to test for a
      difference in the HADS subscales between the two video groups.
Study design This study is a prospective, randomized, controlled, parallel-group clinical
      trial at a single university-based cancer center (MD Anderson Cancer Center at Cooper, Cooper
      University Health Care, Camden, New Jersey, USA). Potential subjects will be enrolled at the
      time of scheduling an initial cancer consultation. The Cooper University Hospital
      Institutional Review Board allowed alteration of the requirements of obtaining informed
      consent under 45 CFR 46.116(d) given the intervention was deemed no greater than minimal
      risk. All new adult patients scheduled for an initial cancer consultation at MD Anderson
      Cancer Center at Cooper will be randomized to receive an email containing a link for either
      the "standard introduction video" or the "enhanced compassion video." Emails will be sent to
      patients prior to obtaining informed consent to allow for viewing of the video prior to the
      initial oncology consultation and to keep the patients masked to the study hypotheses prior
      to the consultation. When the patients arrive to the MD Anderson Cancer Center waiting room
      for his/her initial cancer consultation they will be approached by research staff to obtain
      written informed consent to complete the research questionnaire and for use of data.

      Randomization and masking Patients will be randomly assigned to one of two groups, "standard
      introduction video" or "enhanced compassion video." An independent statistician will generate
      the group assignment sequence using a parallel design, 1:1 randomization schedule. Standard
      measures will be used to ensure appropriate concealment of group assignment. The
      randomization assignments will be kept in a sequential list and maintained in the scheduling
      operator office. At the time of scheduling an initial consultation, appointment operators
      will identify the next assignment in the series, which will be labeled either "Video A" or
      "Video B." The operators will then send the appropriate email containing a link to a website
      for the matching video. The independent statistician will maintain the code link for the
      videos. Thus, the operators, investigators, and research statistician will be blinded to
      video allocation until after all study analyses have been completed.

      Interventions As part of a currently ongoing clinical quality initiative at the study
      institution, when a new patient schedules an appointment for an initial cancer consultation
      the scheduling operator sends an email to the patient containing a link for a standard
      introduction video. For the purposes of this study a second "enhanced compassion video" was
      developed, which added five additional sentences to the standard introduction video. Those
      five sentences were compassion-focused statements. Both videos feature the same oncologist
      (i.e. Medical Director of MD Anderson Cancer Center at Cooper) and are identical aside from
      the additional compassionate statements. The compassionate statements added to the "enhanced
      compassion video" were based on the results of a recent systematic review of clinician
      compassionate behaviors, which found incorporating statements of support, acknowledgement,
      patient's perspective, emotion naming, and validation increased patient perception of
      compassion.

      Measurements and Data Collection After obtaining written informed consent a research
      questionnaire will be administered to patients at the cancer center prior to the initial
      cancer consultation. The questionnaire will assess the patients' perception of the video
      oncologist's compassion using the 5-item compassion measure, a previously validated
      patient-assessed measure of perceived compassion during patient care. Subject demographics,
      as well as clinical information pertaining to cancer diagnosis will be abstracted from the
      medical record.

      Outcome measures The primary outcome measure will be anxiety severity on arrival to the
      cancer center for the initial consultation. As part of the research questionnaire subjects
      will be asked to complete the Hospital Anxiety and Depression scale (HADS). The HADS is a
      14-item self-reported instrument that assesses anxiety and depressive symptoms in populations
      with medical conditions (both in- and out-patients). It has two 7-item subscales: HADS
      Anxiety and HADS Depression. Each item is scored on a 4-point scale (0=not at all to 3=nearly
      all the time); thus, each sub-scale can range from 0-21. The HADS has been extensively
      validated in oncology populations, and is a commonly used measure of anxiety and depression
      in oncology studies. The HADS Depression score will be analyzed as a secondary outcome. An
      additional secondary outcome measure will be the no-show rate for the initial consultation
      among each group. All data will be entered into Research Electronic Data Capture (REDCap), a
      secure, web-based application designed to support data capture for research studies, and
      export the data into Stata/SE 16.0 for Mac, StataCorp LP (College Station, TX, USA) for
      analysis.

      Statistical analysis For descriptive statistics categorical data will be reported as
      proportions with 95% confidence intervals and continuous data as means with standard
      deviations or medians with interquartile ranges as appropriate. As part of the CONSORT
      diagram the proportion of patients who do not attend their initial cancer consultation, as
      well as the proportion of patients who attend their initial consultation, but decline to
      participate in the study, will be recored and stratified by video group. The investigators
      will test if the "enhanced compassion video" reduced the no-show rate to the initial
      consultation, as well as increased participation in research using the Fisher exact test.
      Cronbach's alpha will be used to separately test the internal reliability of the HADS anxiety
      scale, HADS depression scale, and the 5-item compassion measure among our cohort. The
      investigators will test if the "enhanced compassion video" group perceived the video
      oncologist as more (or less) compassionate, as measured by the 5-item compassion measure,
      than the "standard introduction video" group using the Wilcoxon rank-sum test.

      For the primary outcome, the Wilcoxon rank-sum test will be used to test for a difference in
      the HADS anxiety scale between the two video groups. Sensitivity analysis dichotomizing the
      HADS anxiety scale into low (< 8) and moderate/high (≥ 8) will be performed. A cut point of 8
      on the HADS subscales has been defined as the optimal cut point for diagnosis screening and
      is commonly used to define clinically significant symptoms in research studies. The Fisher
      exact test will be used to test if the proportion of subjects with clinically significant
      symptoms differed between the two video groups. For the secondary outcome measure the
      investigators will repeat the same analyses described above using the HADS depression scale
      in place of the HADS anxiety scale. The investigators will perform the above analyses using
      intention to treat methodology. The analyses will be repeated in a per protocol fashion
      excluding patients who state they did not watch the video prior to presentation to the cancer
      center.

      To test if the relationship between video group and anxiety severity differs among
      pre-specified subgroups the investigators will perform separate multivariable linear
      regression models with the HADS anxiety scale as the dependent variable, and entering the
      following patient characteristic along with an interaction term between video group and the
      characteristic as independent variables: (1) age (decile), (2) sex (male vs. female), (3)
      race (white vs. non-white), (4) ethnicity (Hispanic vs. non-Hispanic), (5) suspected primary
      cancer (breast vs. gastrointestinal vs. pulmonary vs. skin vs. central nervous system vs.
      gynecologic vs. other).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Anxiety subscale of the Hospital Anxiety and Depression scale (HADS)
time frame: Baseline (on arrival to the cancer center for an initial oncology consultant).
description: Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21.
measure: Depression subscale of the Hospital Anxiety and Depression scale
time frame: Baseline (on arrival to the cancer center for an initial oncology consultant).
description: Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21.
arm group label: Standard introduction video
arm group type: Active Comparator
arm group label: Enhanced compassion video
arm group type: Experimental
intervention type: Other
intervention name: Enhanced compassion video
description: Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the "enhanced compassion video" were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion.
arm group label: Enhanced compassion video
intervention type: Other
intervention name: Standard introduction video
description: Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.
arm group label: Standard introduction video
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian Roberts
phone: 856-342-2352
email: roberts-brian-w@cooperhealth.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cooper Health System
investigator full name: Brian Roberts
investigator title: Study Director
mesh term: Anxiety Disorders
sharing ipd: Yes
ipd description: After review and approval by our study data use committee, we will allow other researchers who submit to us a suitable protocol to have access to the complete de-identified datasets used and/or analyzed during the study, in comma separated value format together with a data dictionary.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code