<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/NCT01672684</url>
  </required_header>
  <id_info>
    <org_study_id>BRSADJ0023</org_study_id>
    <secondary_id>NCI-2012-01357</secondary_id>
    <secondary_id>21349</secondary_id>
    <nct_id>NCT01672684</nct_id>
  </id_info>
  <brief_title>Phase I: At-Home Support for Rural Women Using Group Video Calling</brief_title>
  <official_title>At-Home Support for Rural Women Using Group Video Calling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California Breast Cancer Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized phase I trial studies at-home group video calling sessions in quality of life&#xD;
      in rural patients with breast cancer. At-home group video calling support sessions may&#xD;
      improve the well-being and quality of life of women who have breast cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To examine whether delivering at-home professionally-led breast cancer support using group&#xD;
      video calling is feasible, acceptable and satisfactory for women in rural northern&#xD;
      California.&#xD;
&#xD;
      II. To evaluate the feasibility of using on-line tools to recruit, screen, treat, and assess&#xD;
      this population for a subsequent randomized clinical trial.&#xD;
&#xD;
      III. Assess whether the rate of recruitment of women in this region in this study using&#xD;
      predominantly on-line means of recruitment can be improved over that of the previous study&#xD;
      using predominantly face-to-face means of recruitment.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Estimate effect size changes in measures of quality of life (post-traumatic stress&#xD;
      disorder symptoms, depression symptoms, perceived stress, and positive states of mind),&#xD;
      satisfaction with social support, and self-efficacy for coping with cancer.&#xD;
&#xD;
      II. Prescribe sample size. III. Perform I and II for all of these outcomes.&#xD;
&#xD;
      OUTLINE: Participants are randomized to 1 of 2 treatment arms.&#xD;
&#xD;
      ARM I (experimental arm): Participants complete at-home group video calling sessions for 1&#xD;
      1/2 hours once weekly for 8 weeks.&#xD;
&#xD;
      ARM II (control arm): Participants receive an educational workbook journal.&#xD;
&#xD;
      After completion of study treatment, participants are followed up for 1 week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 1</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data</measure>
    <time_frame>At 1 week post-intervention</time_frame>
    <description>The major criterion for determining feasibility is to determine whether we can recruit rural women with breast cancer more rapidly using predominantly on-line procedures in this study than in our previous study that predominantly used face-to-face procedures. The qualitative data for determining the feasibility will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data</measure>
    <time_frame>At 1 week post-intervention</time_frame>
    <description>The qualitative data for determining the acceptability will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life (posttraumatic stress, depression symptoms, perceived stress, and positive states of mind)</measure>
    <time_frame>From baseline to 1 week post-intervention</time_frame>
    <description>Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in satisfaction with social support</measure>
    <time_frame>From baseline to 1 week post-intervention</time_frame>
    <description>Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in self-efficacy for coping with cancer</measure>
    <time_frame>From baseline to 1 week post-intervention</time_frame>
    <description>Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Depression</condition>
  <condition>Post-traumatic Stress Disorder</condition>
  <condition>Recurrent Breast Cancer</condition>
  <condition>Stage IA Breast Cancer</condition>
  <condition>Stage IB Breast Cancer</condition>
  <condition>Stage II Breast Cancer</condition>
  <condition>Stage IIIA Breast Cancer</condition>
  <condition>Stage IIIB Breast Cancer</condition>
  <condition>Stage IIIC Breast Cancer</condition>
  <condition>Stage IV Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Arm I (experimental arm)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (control arm)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive an educational workbook journal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>support group therapy</intervention_name>
    <description>Complete at-home group video calling support sessions</description>
    <arm_group_label>Arm I (experimental arm)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>educational intervention</intervention_name>
    <description>Receive an educational workbook journal</description>
    <arm_group_label>Arm II (control arm)</arm_group_label>
    <other_name>intervention, educational</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be eligible for this study, the participant must have been diagnosed with breast&#xD;
             cancer within the previous 5 years prior to study entry; individuals who have been&#xD;
             diagnosed with any stage of breast cancer are eligible&#xD;
&#xD;
          -  There are no limitations regarding allowable type and amount of prior therapy&#xD;
&#xD;
          -  There are no race/ethnic restrictions&#xD;
&#xD;
          -  There are no life expectancy restrictions&#xD;
&#xD;
          -  Neither Eastern Cooperative Oncology Group (ECOG) nor Karnofsky performance status&#xD;
             will be employed&#xD;
&#xD;
          -  There are no requirements for organ and marrow function&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document;&#xD;
             this will be assessed in the telephone screen conducted by Lisa Frankel as she will&#xD;
             review each section of the consent form with the participant and ask if she has any&#xD;
             questions about it; this telephone screen will have been approved by the Stanford&#xD;
             University Institutional Review Board (IRB), and Lisa Frankel will conduct the&#xD;
             interviews in a private location to ensure confidentiality&#xD;
&#xD;
          -  Eligibility for this study requires that a woman be a resident of one of 27 rural&#xD;
             counties in California (Alpine, Amador, Butte, Calaveras, Colusa, Del Norte, El&#xD;
             Dorado, Glenn, Imperial, Inyo, Lake, Lassen, Madera, Mariposa, Modoc, Mono, Nevada,&#xD;
             Placer, Plumas, Shasta, Sierra, Siskiyou, Sutter, Tehama, Trinity, Tuolumne, or Yuba,&#xD;
             except we will not include women living within the following cities: Chico, Madera,&#xD;
             Redding, Rocklin, Roseville or Yuba City, due to this study's more rural focus)&#xD;
&#xD;
          -  Eligibility for this study requires that a woman has sufficient hearing to be able to&#xD;
             engage in conversation over the phone&#xD;
&#xD;
          -  Eligibility for this study requires that a woman has a private place available where&#xD;
             she can access the internet&#xD;
&#xD;
          -  Eligibility for this study requires that a woman is potentially available to meet at&#xD;
             the day of the week and time of the day that the group intervention is scheduled Ã¢ in&#xD;
             the event that she is randomly assigned to receive the at-home group calling&#xD;
             intervention&#xD;
&#xD;
          -  Eligibility for this study requires that women have broadband or digital subscriber&#xD;
             line (DSL) internet access&#xD;
&#xD;
          -  Eligibility for this study requires that women have a computer with a webcam and&#xD;
             either a microphone or a phone available to call into the video conference&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There are no therapy restrictions&#xD;
&#xD;
          -  There are no restrictions regarding use of other investigational agents&#xD;
&#xD;
          -  There are no exclusion requirements due to co-morbid disease or incurrent illness&#xD;
&#xD;
          -  Requirements regarding history of allergic reactions attributed to compounds of&#xD;
             similar chemical or biologic composition to investigational agent or device are not&#xD;
             applicable to this study&#xD;
&#xD;
          -  There are no exclusion criteria relating to concomitant medications or substances that&#xD;
             have the potential to affect the activity or pharmacokinetics of the study agent&#xD;
&#xD;
          -  There are no other agent-specific exclusion criteria&#xD;
&#xD;
          -  Pregnancy or nursing patients will not be excluded from the study&#xD;
&#xD;
          -  Patients who are cancer survivors or those who are human immunodeficiency virus&#xD;
             (HIV)-positive will not be excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheryl Koopman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sierra Streams Institute</name>
      <address>
        <city>Nevada City</city>
        <state>California</state>
        <zip>95959</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University Cancer Institute</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>October 15, 2014</last_update_submitted>
  <last_update_submitted_qc>October 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Cheryl Koopman</investigator_full_name>
    <investigator_title>Professor (Research) of Psychiatry and Behavioral Sciences</investigator_title>
  </responsible_party>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT01672684
org study id: BRSADJ0023
secondary id: NCI-2012-01357
secondary id: 21349
nct id: NCT01672684
lead sponsor: 
collaborator: 
has dmc: No
This randomized phase I trial studies at-home group video calling sessions in quality of life
      in rural patients with breast cancer. At-home group video calling support sessions may
      improve the well-being and quality of life of women who have breast cancer
PRIMARY OBJECTIVES:

      I. To examine whether delivering at-home professionally-led breast cancer support using group
      video calling is feasible, acceptable and satisfactory for women in rural northern
      California.

      II. To evaluate the feasibility of using on-line tools to recruit, screen, treat, and assess
      this population for a subsequent randomized clinical trial.

      III. Assess whether the rate of recruitment of women in this region in this study using
      predominantly on-line means of recruitment can be improved over that of the previous study
      using predominantly face-to-face means of recruitment.

      SECONDARY OBJECTIVES:

      I. Estimate effect size changes in measures of quality of life (post-traumatic stress
      disorder symptoms, depression symptoms, perceived stress, and positive states of mind),
      satisfaction with social support, and self-efficacy for coping with cancer.

      II. Prescribe sample size. III. Perform I and II for all of these outcomes.

      OUTLINE: Participants are randomized to 1 of 2 treatment arms.

      ARM I (experimental arm): Participants complete at-home group video calling sessions for 1
      1/2 hours once weekly for 8 weeks.

      ARM II (control arm): Participants receive an educational workbook journal.

      After completion of study treatment, participants are followed up for 1 week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Feasibility of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data
time frame: At 1 week post-intervention
description: The major criterion for determining feasibility is to determine whether we can recruit rural women with breast cancer more rapidly using predominantly on-line procedures in this study than in our previous study that predominantly used face-to-face procedures. The qualitative data for determining the feasibility will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods.
measure: Acceptability of the study protocol as determined primarily through qualitative analysis of the group sessions and the interview data
time frame: At 1 week post-intervention
description: The qualitative data for determining the acceptability will be collected during the at-home group video calling sessions and from women's interviews conducted at the end of the study. Will be assessed using mixed methods.
measure: Changes in quality of life (posttraumatic stress, depression symptoms, perceived stress, and positive states of mind)
time frame: From baseline to 1 week post-intervention
description: Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.
measure: Changes in satisfaction with social support
time frame: From baseline to 1 week post-intervention
description: Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.
measure: Changes in self-efficacy for coping with cancer
time frame: From baseline to 1 week post-intervention
description: Treatment effect size will be estimated for each measure for the purpose of prescribing the sample size for a subsequent larger randomized clinical trial examining efficacy of the intervention. Will be analyzed using generalized linear mixed models.
arm group label: Arm I (experimental arm)
arm group type: Experimental
description: Participants complete at-home group video calling sessions for 1 1/2 hours once weekly for 8 weeks.
arm group label: Arm II (control arm)
arm group type: Active Comparator
description: Participants receive an educational workbook journal.
intervention type: Procedure
intervention name: support group therapy
description: Complete at-home group video calling support sessions
arm group label: Arm I (experimental arm)
intervention type: Other
intervention name: educational intervention
description: Receive an educational workbook journal
arm group label: Arm II (control arm)
other name: intervention, educational
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Cheryl Koopman
role: Principal Investigator
affiliation: Stanford University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Cheryl Koopman
investigator title: Professor (Research) of Psychiatry and Behavioral Sciences
mesh term: Breast Neoplasms
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic