<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/NCT01684696</url>
  </required_header>
  <id_info>
    <org_study_id>12-09184</org_study_id>
    <secondary_id>(pC ID): 237290</secondary_id>
    <nct_id>NCT01684696</nct_id>
  </id_info>
  <brief_title>Virtual Intervention for Lung Cancer</brief_title>
  <acronym>VILC</acronym>
  <official_title>Virtual Intervention for Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lung cancer is the leading cause of cancer death in both men and women. Lung cancer is unique&#xD;
      because of racial disparity, persistent mortality rate, and social stigma. Lung cancer stigma&#xD;
      (LCS) and difficult patient-clinician communication may be an underlying factor in health&#xD;
      disparities in lung cancer. The purpose of this study is to PILOT test, in a diverse sample&#xD;
      of lung cancer patients the effectiveness of the mHealth Tool for Lung Cancer patients&#xD;
      (mHealthTLC), an interactive, immersive 3-dimensional iPad application that allows&#xD;
      individuals to experience first person virtual visits with their clinicians, to improve&#xD;
      patient-clinician communication, decrease LCS, and promote optimal self-management. The study&#xD;
      hypotheses are that patients who receive the mHealth TLC will improve their ability to&#xD;
      communicate effectively with their clinicians and will report decreased stigma related to&#xD;
      their lung cancer diagnosis compared to the attention control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two arm experimental design PILOT test of the mHealth Tool for Lung Cancer patients&#xD;
      (mHealthTLC) an intervention to improve patient-clinician communication, decrease lung cancer&#xD;
      stigma, and decrease lung cancer symptom scores. Patients will be assigned to either the&#xD;
      mHealth TLC group or the Attention Control Group (ACG). Interventions in both groups will be&#xD;
      delivered online or by iPad in a research office in the clinician's building prior to each&#xD;
      visit. Assessments will be done immediately after each visit in the same research room.&#xD;
      Intervention and assessment pre-visit is expected to take less than one hour, the&#xD;
      intervention is expected to take 30mins, and post assessment is expected to take 30 minutes.&#xD;
      A follow-up assessment will be done at 3 months from enrollment.&#xD;
&#xD;
      mhealth TLC group will meet with a nurse just before each of 4 clinician visits and use the&#xD;
      mHealth TLC on an iPad with an interactive, immersive 3-dimensional (3-D) intervention that&#xD;
      allows individuals to experience virtual visits with their clinicians. The mHealth TLC&#xD;
      provides engagement and experiential learning by delivering important information about&#xD;
      symptom management and provides the opportunity to practice a new communication strategy in&#xD;
      ever increasing complex situations with a virtual coach, receptionist, assistant, and&#xD;
      clinician.During the mHealthTLC the patient will enter a virtual clinic office, travel&#xD;
      through the different aspects of a typical clinic visit, and interact with office staff and&#xD;
      clinicians that are represented by avatars. The avatars will be designed to reflect ethnic&#xD;
      and cultural diversity. First person is the preferred format for health teaching because the&#xD;
      patient is active as self and not represented as an avatar. The first person vantage point&#xD;
      facilitates the immersion and immediacy of the experience. Key aspects of mHealthTLC include&#xD;
      informational videos about lung cancer (i.e. etiology, diagnosis, treatment, symptoms) and&#xD;
      LCS. Blame and self-blame will be addressed, information about the role of addiction,&#xD;
      social/cultural factors, and tobacco industry influence on smoking behaviors will be&#xD;
      highlighted. Information and training will be provided and patients will be able to&#xD;
      experience practiced interaction in ever increasing complex situations with avatars (i.e.,&#xD;
      receptionist, medical assistant, and clinician). A &quot;virtual coach&quot; will accompany the patient&#xD;
      through the virtual visit and will provide information and coaching (as needed). The&#xD;
      advantages to adding a virtual coach or avatar include the availability of an always-live&#xD;
      agent and the capability of customizing the coach to represent an ideal social model for a&#xD;
      particular user or group of users.Flexibility exists in how to design not only how the coach&#xD;
      will appear but also how the coach will sound - with an appropriate voice and engaging&#xD;
      non-verbal communication). This approach contributes to cultural and ethnic sensitivity. As&#xD;
      the patient attempts to communicate and receive information appropriate for a self-management&#xD;
      plan, they will receive &quot;points&quot; for successful communication. A cumulative score and&#xD;
      explanation will be given at the end of the virtual visit. During the visit the participant&#xD;
      will identify specific topics and questions that they want to address during their visit with&#xD;
      their real clinician; they will receive a printout of their priority questions that they can&#xD;
      take into the visit with their real clinician. The research nurse will review the score, the&#xD;
      priority questions, and the overall virtual experience. Virtual environments for learning are&#xD;
      sufficiently promising that further investment and development of this type of research is&#xD;
      warranted.&#xD;
&#xD;
      Attention control group (ACG)- Patients assigned to the ACG will meet with a nurse and&#xD;
      receive the informational videos from the mHealth TLC on an iPad before 4 clinician visits&#xD;
      with assessments after each clinician visit. An effort will be made to match the intervention&#xD;
      condition on salience, credibility, and contact time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    unable to secure funding&#xD;
  </why_stopped>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">August 2017</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient-clinician communication scores</measure>
    <time_frame>3 months</time_frame>
    <description>The Medical Communication Competence Scale (MCCS) measures patients' perceptions of their competence to effectively communicate. The Patients' Self-Competence Subscale of the MCCS has 16-items with a 5 point Likert-type scaling of 5 (important) to 1 (unimportant). Higher scores indicate greater perceived self-competence. The Quality of Physician-Patient Interaction (QQPPI) measures distinct domains that establish a high quality clinician-provider interaction (i.e.,information exchange, patient involvement, and sharing in the decision making process). Fourteen items are summed to yield a total score; higher scores indicate increased quality of communication as perceived by the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived lung cancer stigma</measure>
    <time_frame>3 months</time_frame>
    <description>The Cataldo Lung Cancer Stigma Scale (CLCSS) will be used to assess stigma. The CLCSS is a 31 item measure with each item rated on a 4-point Likert-type scale (strongly disagree to strongly agree). Higher values indicate higher levels of LCS.The CLCSS was found to be a reliable and valid measure with a diverse sample of people with lung cancer. Construct validity was supported by expected relationships with related constructs: self-esteem, depression, social support, and social conflict. The total scale Cronbach alpha coefficient was 0.96, the Cronbach alphas for the four subscales were: stigma/shame, 0.96; social isolation, 0.95; discrimination, 0.92; and smoking 0.76.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung Cancer symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>Lung Cancer Symptoms - Lung Cancer Symptom Scale (LCSS) measures the physical and functional dimensions of persons with lung cancer. The scale has 9 items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and three summary items related to total symptoms. The item scale is 0 (best) and 100 (worst). An average of all 9 items is the total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>3 months</time_frame>
    <description>Depression - Center for Epidemiologic Studies-Depression (CES-D) is a 20-item scale that is widely used for self-ratings of depression in clinical populations, including people with cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QOL)</measure>
    <time_frame>3 months</time_frame>
    <description>QOL - The QOL Inventory is a 33-item instrument that measures four dimensions of QOL in cancer patients (i.e., symptoms, social concerns, psychological well-being, and physical well being).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Lung Neoplasms</condition>
  <arm_group>
    <arm_group_label>mHealth TLC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The mhealth TLC group will meet with a nurse before each of 4 clinician visits and use the mHealth TLC on an iPad with an interactive 3-dimensional intervention that allows individuals to experience virtual visits with their clinicians. Key aspects of mHealthTLC include informational videos about lung cancer and LCS. Blame and self-blame will be addressed, information about the role of addiction, social/cultural factors, and tobacco industry influence on smoking behaviors will be highlighted. Patients will experience practiced interaction in ever increasing complex situations with avatars (i.e., receptionist, medical assistant, and clinician). A &quot;virtual coach&quot; will accompany the patient through the virtual visit and will provide information and coaching (as needed).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Attention control group (ACG) - Patients assigned to the ACG will meet with a nurse and receive only the informational videos on an iPad before 4 clinician visits with assessments after each clinician visit. An effort will be made to match the intervention condition on salience, credibility, and contact time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual experience</intervention_name>
    <arm_group_label>mHealth TLC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Videos</intervention_name>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria are &gt;21 years old with a diagnosis of lung cancer (any type or&#xD;
             stage), able to read and write English at 5th grade level, able to sign an IRB&#xD;
             approved consent form, and expects to have 4 visits with the same clinician in the&#xD;
             next 2 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand or tolerate the battery of questionnaires due to physical or&#xD;
             mental health issues (i.e., dementia, active psychosis).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janine Cataldo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UCSF Department of Physiological Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSF Helen Diller Family Comprehensive Cancer Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>October 9, 2018</last_update_submitted>
  <last_update_submitted_qc>October 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer</keyword>
  <keyword>stigma</keyword>
  <keyword>virtual intervention</keyword>
  <keyword>mHealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01684696
org study id: 12-09184
secondary id: (pC ID): 237290
nct id: NCT01684696
lead sponsor: 
has dmc: Yes
Lung cancer is the leading cause of cancer death in both men and women. Lung cancer is unique
      because of racial disparity, persistent mortality rate, and social stigma. Lung cancer stigma
      (LCS) and difficult patient-clinician communication may be an underlying factor in health
      disparities in lung cancer. The purpose of this study is to PILOT test, in a diverse sample
      of lung cancer patients the effectiveness of the mHealth Tool for Lung Cancer patients
      (mHealthTLC), an interactive, immersive 3-dimensional iPad application that allows
      individuals to experience first person virtual visits with their clinicians, to improve
      patient-clinician communication, decrease LCS, and promote optimal self-management. The study
      hypotheses are that patients who receive the mHealth TLC will improve their ability to
      communicate effectively with their clinicians and will report decreased stigma related to
      their lung cancer diagnosis compared to the attention control group.
This is a two arm experimental design PILOT test of the mHealth Tool for Lung Cancer patients
      (mHealthTLC) an intervention to improve patient-clinician communication, decrease lung cancer
      stigma, and decrease lung cancer symptom scores. Patients will be assigned to either the
      mHealth TLC group or the Attention Control Group (ACG). Interventions in both groups will be
      delivered online or by iPad in a research office in the clinician's building prior to each
      visit. Assessments will be done immediately after each visit in the same research room.
      Intervention and assessment pre-visit is expected to take less than one hour, the
      intervention is expected to take 30mins, and post assessment is expected to take 30 minutes.
      A follow-up assessment will be done at 3 months from enrollment.

      mhealth TLC group will meet with a nurse just before each of 4 clinician visits and use the
      mHealth TLC on an iPad with an interactive, immersive 3-dimensional (3-D) intervention that
      allows individuals to experience virtual visits with their clinicians. The mHealth TLC
      provides engagement and experiential learning by delivering important information about
      symptom management and provides the opportunity to practice a new communication strategy in
      ever increasing complex situations with a virtual coach, receptionist, assistant, and
      clinician.During the mHealthTLC the patient will enter a virtual clinic office, travel
      through the different aspects of a typical clinic visit, and interact with office staff and
      clinicians that are represented by avatars. The avatars will be designed to reflect ethnic
      and cultural diversity. First person is the preferred format for health teaching because the
      patient is active as self and not represented as an avatar. The first person vantage point
      facilitates the immersion and immediacy of the experience. Key aspects of mHealthTLC include
      informational videos about lung cancer (i.e. etiology, diagnosis, treatment, symptoms) and
      LCS. Blame and self-blame will be addressed, information about the role of addiction,
      social/cultural factors, and tobacco industry influence on smoking behaviors will be
      highlighted. Information and training will be provided and patients will be able to
      experience practiced interaction in ever increasing complex situations with avatars (i.e.,
      receptionist, medical assistant, and clinician). A "virtual coach" will accompany the patient
      through the virtual visit and will provide information and coaching (as needed). The
      advantages to adding a virtual coach or avatar include the availability of an always-live
      agent and the capability of customizing the coach to represent an ideal social model for a
      particular user or group of users.Flexibility exists in how to design not only how the coach
      will appear but also how the coach will sound - with an appropriate voice and engaging
      non-verbal communication). This approach contributes to cultural and ethnic sensitivity. As
      the patient attempts to communicate and receive information appropriate for a self-management
      plan, they will receive "points" for successful communication. A cumulative score and
      explanation will be given at the end of the virtual visit. During the visit the participant
      will identify specific topics and questions that they want to address during their visit with
      their real clinician; they will receive a printout of their priority questions that they can
      take into the visit with their real clinician. The research nurse will review the score, the
      priority questions, and the overall virtual experience. Virtual environments for learning are
      sufficiently promising that further investment and development of this type of research is
      warranted.

      Attention control group (ACG)- Patients assigned to the ACG will meet with a nurse and
      receive the informational videos from the mHealth TLC on an iPad before 4 clinician visits
      with assessments after each clinician visit. An effort will be made to match the intervention
      condition on salience, credibility, and contact time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Patient-clinician communication scores
time frame: 3 months
description: The Medical Communication Competence Scale (MCCS) measures patients' perceptions of their competence to effectively communicate. The Patients' Self-Competence Subscale of the MCCS has 16-items with a 5 point Likert-type scaling of 5 (important) to 1 (unimportant). Higher scores indicate greater perceived self-competence. The Quality of Physician-Patient Interaction (QQPPI) measures distinct domains that establish a high quality clinician-provider interaction (i.e.,information exchange, patient involvement, and sharing in the decision making process). Fourteen items are summed to yield a total score; higher scores indicate increased quality of communication as perceived by the patient.
measure: Perceived lung cancer stigma
time frame: 3 months
description: The Cataldo Lung Cancer Stigma Scale (CLCSS) will be used to assess stigma. The CLCSS is a 31 item measure with each item rated on a 4-point Likert-type scale (strongly disagree to strongly agree). Higher values indicate higher levels of LCS.The CLCSS was found to be a reliable and valid measure with a diverse sample of people with lung cancer. Construct validity was supported by expected relationships with related constructs: self-esteem, depression, social support, and social conflict. The total scale Cronbach alpha coefficient was 0.96, the Cronbach alphas for the four subscales were: stigma/shame, 0.96; social isolation, 0.95; discrimination, 0.92; and smoking 0.76.
measure: Lung Cancer symptoms
time frame: 3 months
description: Lung Cancer Symptoms - Lung Cancer Symptom Scale (LCSS) measures the physical and functional dimensions of persons with lung cancer. The scale has 9 items: six measuring major symptoms for lung cancer (appetite loss, fatigue, cough, dyspnea, hemoptysis, pain) and three summary items related to total symptoms. The item scale is 0 (best) and 100 (worst). An average of all 9 items is the total score.
measure: Depression
time frame: 3 months
description: Depression - Center for Epidemiologic Studies-Depression (CES-D) is a 20-item scale that is widely used for self-ratings of depression in clinical populations, including people with cancer.
measure: Quality of Life (QOL)
time frame: 3 months
description: QOL - The QOL Inventory is a 33-item instrument that measures four dimensions of QOL in cancer patients (i.e., symptoms, social concerns, psychological well-being, and physical well being).
arm group label: mHealth TLC
arm group type: Experimental
description: The mhealth TLC group will meet with a nurse before each of 4 clinician visits and use the mHealth TLC on an iPad with an interactive 3-dimensional intervention that allows individuals to experience virtual visits with their clinicians. Key aspects of mHealthTLC include informational videos about lung cancer and LCS. Blame and self-blame will be addressed, information about the role of addiction, social/cultural factors, and tobacco industry influence on smoking behaviors will be highlighted. Patients will experience practiced interaction in ever increasing complex situations with avatars (i.e., receptionist, medical assistant, and clinician). A "virtual coach" will accompany the patient through the virtual visit and will provide information and coaching (as needed).
arm group label: Attention Control
arm group type: Active Comparator
description: Attention control group (ACG) - Patients assigned to the ACG will meet with a nurse and receive only the informational videos on an iPad before 4 clinician visits with assessments after each clinician visit. An effort will be made to match the intervention condition on salience, credibility, and contact time.
intervention type: Behavioral
intervention name: Virtual experience
arm group label: mHealth TLC
intervention type: Behavioral
intervention name: Videos
arm group label: Attention Control
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Janine Cataldo, PhD
role: Principal Investigator
affiliation: UCSF Department of Physiological Nursing
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms