<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/NCT02238951</url>
  </required_header>
  <id_info>
    <org_study_id>551190</org_study_id>
    <nct_id>NCT02238951</nct_id>
  </id_info>
  <brief_title>Cancer Care Coordination for Chemotherapy Patients</brief_title>
  <acronym>4CP</acronym>
  <official_title>Use of mHealth to Support Nurse-directed Care Coordination for Chemotherapy Patients: Improving Health, Healthcare Delivery, and Healthcare Utilization.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McKesson Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare nurse-led care coordination for persons receiving&#xD;
      cancer chemotherapy treatment incorporating mobile health technology to nurse-led care&#xD;
      coordination without any mobile health enhancements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will randomize sixty (60) participants receiving cancer chemotherapy treatment to&#xD;
      receive nurse-led care coordination using a HIPAA-compliant mobile health platform compared&#xD;
      to no technology-enhanced care coordination.&#xD;
&#xD;
      All participants receive nurse-led care coordination throughout chemotherapy treatment.&#xD;
&#xD;
      RESEARCH AIMS:&#xD;
&#xD;
        -  Demonstration of a HIPAA-compliant social networking platform;&#xD;
&#xD;
        -  Facilitate communication and collaboration among patients with cancer and their care&#xD;
           team;&#xD;
&#xD;
        -  Assess patient health outcomes (chemotherapy-related physical and psychological side&#xD;
           effects; pain, quality of life and patient satisfaction)&#xD;
&#xD;
        -  Assessment of healthcare utilization including emergency department visits, unplanned&#xD;
           clinic visits and hospitalization;&#xD;
&#xD;
        -  For patients assigned to the mobile health care coordination, understanding their&#xD;
           experience of use of the technology&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 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>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Patient Health Outcome</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Pain</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Demonstration of a HIPAA-compliant platform to coordinate care overtime</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Technology Usability and Acceptance&#xD;
Patient engagement with technology&#xD;
Use of electronic medical record features to communicate with providers</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Patient Health Outcomes</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Treatment related symptoms&#xD;
Psychological Distress&#xD;
Quality of Life</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Healthcare Outcomes</measure>
    <time_frame>Baseline, 6 months</time_frame>
    <description>Processes of care coordination&#xD;
Patient engagement&#xD;
Patient satisfaction</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Healthcare Utilization</measure>
    <time_frame>Baseline, 3 months, 6 months</time_frame>
    <description>Emergency department visits&#xD;
Unplanned hospitalizations&#xD;
Unplanned clinic visits</description>
  </other_outcome>
  <other_outcome>
    <measure>Mobile health usability overtime</measure>
    <time_frame>2 weeks, 8 weeks</time_frame>
    <description>Guided interviews with technology group to assess understanding and usability of the mobile technology platform to communicate and coordinate care</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Mobile Health (mHealth)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Care coordination using mHealth technology enhancements</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No mHealth</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Care coordination without mHealth enhancements</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobile Health (mHealth)</intervention_name>
    <description>Participants receive care coordination throughout their chemotherapy treatment using mHealth technology</description>
    <arm_group_label>Mobile Health (mHealth)</arm_group_label>
    <other_name>Android-based device</other_name>
    <other_name>Mobile health</other_name>
    <other_name>Patient Health Network</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No mHealth</intervention_name>
    <description>Participants receive the same evidence-based care coordination without mHealth technology</description>
    <arm_group_label>No mHealth</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Newly diagnosed cancer - any site or stage&#xD;
&#xD;
          -  Initiating chemotherapy&#xD;
&#xD;
          -  Ability to read and write English&#xD;
&#xD;
          -  Manual dexterity sufficient to use a tablet technology&#xD;
&#xD;
          -  Cognitive capacity to participate&#xD;
&#xD;
          -  Preferential recruitment of publicly insured and/or living in rural communities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Oral chemotherapy&#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_official>
    <last_name>Jill G Joseph, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis Betty Irene Moore School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Davis Comprehensive Cancer Care Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>November 15, 2018</last_update_submitted>
  <last_update_submitted_qc>November 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>care coordination, mobile health, chemotherapy, technology</keyword>
  <!-- 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/NCT02238951
org study id: 551190
nct id: NCT02238951
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to compare nurse-led care coordination for persons receiving
      cancer chemotherapy treatment incorporating mobile health technology to nurse-led care
      coordination without any mobile health enhancements.
This study will randomize sixty (60) participants receiving cancer chemotherapy treatment to
      receive nurse-led care coordination using a HIPAA-compliant mobile health platform compared
      to no technology-enhanced care coordination.

      All participants receive nurse-led care coordination throughout chemotherapy treatment.

      RESEARCH AIMS:

        -  Demonstration of a HIPAA-compliant social networking platform;

        -  Facilitate communication and collaboration among patients with cancer and their care
           team;

        -  Assess patient health outcomes (chemotherapy-related physical and psychological side
           effects; pain, quality of life and patient satisfaction)

        -  Assessment of healthcare utilization including emergency department visits, unplanned
           clinic visits and hospitalization;

        -  For patients assigned to the mobile health care coordination, understanding their
           experience of use of the technology
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Change in Patient Health Outcome
time frame: Baseline, 3 months, 6 months
description: Pain
measure: Demonstration of a HIPAA-compliant platform to coordinate care overtime
time frame: Baseline, 6 months
description: Technology Usability and Acceptance
Patient engagement with technology
Use of electronic medical record features to communicate with providers
measure: Change in Patient Health Outcomes
time frame: Baseline, 3 months, 6 months
description: Treatment related symptoms
Psychological Distress
Quality of Life
measure: Change in Healthcare Outcomes
time frame: Baseline, 6 months
description: Processes of care coordination
Patient engagement
Patient satisfaction
measure: Change in Healthcare Utilization
time frame: Baseline, 3 months, 6 months
description: Emergency department visits
Unplanned hospitalizations
Unplanned clinic visits
measure: Mobile health usability overtime
time frame: 2 weeks, 8 weeks
description: Guided interviews with technology group to assess understanding and usability of the mobile technology platform to communicate and coordinate care
arm group label: Mobile Health (mHealth)
arm group type: Experimental
description: Care coordination using mHealth technology enhancements
arm group label: No mHealth
arm group type: Active Comparator
description: Care coordination without mHealth enhancements
intervention type: Other
intervention name: Mobile Health (mHealth)
description: Participants receive care coordination throughout their chemotherapy treatment using mHealth technology
arm group label: Mobile Health (mHealth)
other name: Android-based device
other name: Mobile health
other name: Patient Health Network
intervention type: Other
intervention name: No mHealth
description: Participants receive the same evidence-based care coordination without mHealth technology
arm group label: No mHealth
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jill G Joseph, MD, PhD
role: Principal Investigator
affiliation: University of California, Davis Betty Irene Moore School of Nursing
facility: 
country: United States
responsible party type: Sponsor