<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/NCT04432818</url>
  </required_header>
  <id_info>
    <org_study_id>20252</org_study_id>
    <secondary_id>NCI-2020-04166</secondary_id>
    <nct_id>NCT04432818</nct_id>
  </id_info>
  <brief_title>Digital Life Coaching for Myeloma Patients Undergoing Transplantation</brief_title>
  <official_title>Digital Life Coaching in Multiple Myeloma Patients Undergoing Hematopoietic Stem Cell Transplantation</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>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>
      This is the first study of digital life coaching (DLC) to engage patients during the peri-HCT&#xD;
      period that is punctuated by intensive life changes. DLC may circumvent these limitations by&#xD;
      combining the integrative cross-dimensional nature of life coaching with the advantages of&#xD;
      mobile health technology. The purpose of this study is to evaluate whether ongoing&#xD;
      participant engagement with a DLC platform is feasible for multiple myeloma (MM) patients&#xD;
      actively undergoing hematopoietic stem cell transplantation (HCT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will receive unlimited access to Pack Health's DLC platform during a 16-week&#xD;
      period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day&#xD;
      follow-up. Participants will engage with Pack Health's DLC platform and complete quality of&#xD;
      life assessments for 16 weeks beginning from enrollment. At the conclusion of the treatment&#xD;
      period, participants will be asked to rate their satisfaction with the DLC platform&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To evaluate the rate of ongoing participant engagement with a DLC platform during the study&#xD;
      period&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To assess quality of life among participants during the study period&#xD;
&#xD;
        -  To assess psychosocial distress among participants during the study period&#xD;
&#xD;
        -  To assess sleep disturbances among participants during the study period&#xD;
&#xD;
        -  To assess participant satisfaction with the DLC platform at the end of the study period&#xD;
&#xD;
      Exploratory Objectives:&#xD;
&#xD;
        -  To assess benzodiazepine and zolpidem-class drug usage for anxiety or insomnia among&#xD;
           participants during the study period&#xD;
&#xD;
        -  To assess communications with treatment teams among participants during the study period&#xD;
&#xD;
        -  To assess 100-day clinical outcomes among participants at the end of the study period&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2020</start_date>
  <completion_date type="Actual">February 25, 2021</completion_date>
  <primary_completion_date type="Actual">February 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants displaying ongoing engagement with DLC</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>Ongoing participant engagement is defined as at least 4 or more participant-initiated interactions with the DLC platform, including at least 1 interaction in each of four 4-week study sub-periods</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Median PRO Measurement Information System (PROMIS) Global Health (GH) Score</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>The PROMIS GH instrument v1.2 will be used to assess quality of life. This 10-item inventory with scores ranging from 1 to 5 with higher scores indicating a a greater quality of life. Raw PROMIS scores will subsequently be transformed to T-score metrics as per the scoring manual to reflect a population mean of 50 and standard deviation of 10. Among cancer patients, a T-score change of 5 points on any PROMIS inventory is generally considered to be clinically meaningful.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) Score</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>The NCCN DT will be used to assess psychosocial distress. This single-item inventory uses a graphic of a thermometer to allow patients to assess their overall distress on a scale of 0=No Distress to 10= Extreme distress. The NCCN considers a cutoff score of 4 to differentiate clinically significant distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median PROMIS Sleep Disturbance (SD) Short Form (SF) 4a Score</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>The PROMIS SD SF 4a inventory will be used to measure overall sleep disturbance in past 7 days. This assessment consists of 4 items which measure sleep quality and sleep disturbances using a 5 point likert scale ranging in value from 1 to 5 with higher scores indicating greater sleep quality. Raw PROMIS scores will subsequently be transformed to T-score metrics as per the scoring manual to reflect a population mean of 50 and standard deviation of 10. Among cancer patients, a T-score change of 5 points on any PROMIS inventory is generally considered to be clinically meaningful</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Participant Satisfaction Score</measure>
    <time_frame>Up to 16 weeks</time_frame>
    <description>Participants will be asked to provide a response, on a scale from 0 (not at all likely) to 10 (extremely likely), to the following single question: &quot;How likely are you to recommend this life coaching tool to other patients undergoing stem cell transplantation?&quot;</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Pack Health's digital life coaching (DLC)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to the DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pack Health's digital life coaching (DLC)</intervention_name>
    <description>Pack Health smartphone-based DLC platform will be provided for 16-week subscription which allows unlimited bidirectional communication between enrolled participants and their life coach</description>
    <arm_group_label>Pack Health's digital life coaching (DLC)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of one of the following (all referred to as MM in this protocol):&#xD;
&#xD;
               -  Multiple myeloma (ICD-10 code: C90.0)&#xD;
&#xD;
               -  Extramedullary plasmacytoma (ICD-10 code: C90.2)&#xD;
&#xD;
          -  Planned receipt of autologous HCT at our institution&#xD;
&#xD;
               -  Patients undergoing outpatient HCT will be eligible&#xD;
&#xD;
               -  Patients who received chemomobilization will be eligible&#xD;
&#xD;
          -  Age ≥ 18, as life coaches employed by the DLC vendor are not currently trained to work&#xD;
             with pediatric patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior autologous HCT for any indication&#xD;
&#xD;
          -  Physician-assessed lack of sufficient English proficiency&#xD;
&#xD;
          -  Lack of ownership of a personal smartphone&#xD;
&#xD;
          -  Any serious and/or unstable pre-existing medical, psychiatric, or other condition that&#xD;
             could interfere with participant's safety, provision of informed consent, or&#xD;
             compliance with study procedures&#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>Rahul Banerjee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 1, 2021</last_update_submitted>
  <last_update_submitted_qc>June 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Digital life coaching</keyword>
  <keyword>Hematopoietic stem cell transplantation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04432818
org study id: 20252
secondary id: NCI-2020-04166
nct id: NCT04432818
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is the first study of digital life coaching (DLC) to engage patients during the peri-HCT
      period that is punctuated by intensive life changes. DLC may circumvent these limitations by
      combining the integrative cross-dimensional nature of life coaching with the advantages of
      mobile health technology. The purpose of this study is to evaluate whether ongoing
      participant engagement with a DLC platform is feasible for multiple myeloma (MM) patients
      actively undergoing hematopoietic stem cell transplantation (HCT).
Participants will receive unlimited access to Pack Health's DLC platform during a 16-week
      period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day
      follow-up. Participants will engage with Pack Health's DLC platform and complete quality of
      life assessments for 16 weeks beginning from enrollment. At the conclusion of the treatment
      period, participants will be asked to rate their satisfaction with the DLC platform

      Primary Objective:

      To evaluate the rate of ongoing participant engagement with a DLC platform during the study
      period

      Secondary Objectives:

        -  To assess quality of life among participants during the study period

        -  To assess psychosocial distress among participants during the study period

        -  To assess sleep disturbances among participants during the study period

        -  To assess participant satisfaction with the DLC platform at the end of the study period

      Exploratory Objectives:

        -  To assess benzodiazepine and zolpidem-class drug usage for anxiety or insomnia among
           participants during the study period

        -  To assess communications with treatment teams among participants during the study period

        -  To assess 100-day clinical outcomes among participants at the end of the study period
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of participants displaying ongoing engagement with DLC
time frame: Up to 16 weeks
description: Ongoing participant engagement is defined as at least 4 or more participant-initiated interactions with the DLC platform, including at least 1 interaction in each of four 4-week study sub-periods
measure: Median PRO Measurement Information System (PROMIS) Global Health (GH) Score
time frame: Up to 16 weeks
description: The PROMIS GH instrument v1.2 will be used to assess quality of life. This 10-item inventory with scores ranging from 1 to 5 with higher scores indicating a a greater quality of life. Raw PROMIS scores will subsequently be transformed to T-score metrics as per the scoring manual to reflect a population mean of 50 and standard deviation of 10. Among cancer patients, a T-score change of 5 points on any PROMIS inventory is generally considered to be clinically meaningful.
measure: Median National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) Score
time frame: Up to 16 weeks
description: The NCCN DT will be used to assess psychosocial distress. This single-item inventory uses a graphic of a thermometer to allow patients to assess their overall distress on a scale of 0=No Distress to 10= Extreme distress. The NCCN considers a cutoff score of 4 to differentiate clinically significant distress.
measure: Median PROMIS Sleep Disturbance (SD) Short Form (SF) 4a Score
time frame: Up to 16 weeks
description: The PROMIS SD SF 4a inventory will be used to measure overall sleep disturbance in past 7 days. This assessment consists of 4 items which measure sleep quality and sleep disturbances using a 5 point likert scale ranging in value from 1 to 5 with higher scores indicating greater sleep quality. Raw PROMIS scores will subsequently be transformed to T-score metrics as per the scoring manual to reflect a population mean of 50 and standard deviation of 10. Among cancer patients, a T-score change of 5 points on any PROMIS inventory is generally considered to be clinically meaningful
measure: Median Participant Satisfaction Score
time frame: Up to 16 weeks
description: Participants will be asked to provide a response, on a scale from 0 (not at all likely) to 10 (extremely likely), to the following single question: "How likely are you to recommend this life coaching tool to other patients undergoing stem cell transplantation?"
arm group label: Pack Health's digital life coaching (DLC)
arm group type: Experimental
description: Access to the DLC platform during a 16-week period encompassing pre-HCT conditioning chemotherapy, post-HCT recovery, and 100-day follow-up
intervention type: Behavioral
intervention name: Pack Health's digital life coaching (DLC)
description: Pack Health smartphone-based DLC platform will be provided for 16-week subscription which allows unlimited bidirectional communication between enrolled participants and their life coach
arm group label: Pack Health's digital life coaching (DLC)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rahul Banerjee, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: No