<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/NCT03022032</url>
  </required_header>
  <id_info>
    <org_study_id>16-477</org_study_id>
    <secondary_id>1R21NR018532</secondary_id>
    <nct_id>NCT03022032</nct_id>
  </id_info>
  <brief_title>The HOPE Trial and the SMART Study</brief_title>
  <official_title>The HOPE Trial: Helping Our Patients Excel, and The SMART Study: Symptom Management and Reporting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</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 research study is evaluating a new smartphone application named the &quot;Helping Our&#xD;
      Patients Excel (HOPE)&quot; app with a Fitbit device. The SMART Study is a sub-study of the HOPE&#xD;
      Trial. Both studies evaluate an almost identical intervention using a Fitbit device and&#xD;
      smartphone app(s) with the goal of improving quality-of-life for women with gynecologic&#xD;
      cancers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The HOPE Trial:&#xD;
&#xD;
      The first goal of this study is to adapt and refine an existing smartphone app, paired with a&#xD;
      wearable accelerometer, to assess patients' symptoms in a population of patients with&#xD;
      gynecologic cancers receiving palliative chemotherapy. An existing app will be customized to&#xD;
      collect patient-reported toxicities using the Patient-Reported Outcome (PRO) version of the&#xD;
      Common Terminology Criteria for Adverse Events (PRO-CTCAE) and offer patients feedback about&#xD;
      how to manage their symptoms. Patient symptoms will be risk-stratified. Patients with&#xD;
      low-risk toxicities (grades 1 &amp; 2) will receive tailored educational information, while&#xD;
      patients with serious toxicities (grades 3 &amp; 4) will receive alerts to call their clinician.&#xD;
      In the first phase of the study, we will conduct an initial assessment of the app with a&#xD;
      diverse group of 10 patients to refine the app and test two different wearable accelerometers&#xD;
      (i.e. Fitbit Zip and Fitbit Charge 2) before pilot testing.&#xD;
&#xD;
      The second goal of this study is to conduct a pilot randomized controlled trial (RCT) of the&#xD;
      smartphone app and/or wearable accelerometer (i.e. Fitbit Zip or Fitbit Charge 2) to assess&#xD;
      the feasibility, acceptability, and preliminary efficacy of our intervention. During the&#xD;
      second phase of the study, we will conduct a 4-arm pilot RCT in 100 patients with gynecologic&#xD;
      cancers receiving palliative chemotherapy to establish preliminary effect sizes. Participants&#xD;
      will be randomized to: 1) Fitbit+active app, 2) Fitbit+passive app, 3) Active app, or 4)&#xD;
      Passive app.&#xD;
&#xD;
      We expect that the results of this pilot RCT, which is supported by the National Cancer&#xD;
      Institute, National Palliative Care Research Center, and the Dana-Farber Cancer Institute&#xD;
      Department of Medical Oncology, will provide a low-cost, scalable system to assess patients'&#xD;
      symptoms, address low-risk toxicities, and alert clinicians when patients have toxicities&#xD;
      that require intervention with the goal of reducing patient suffering and the use of&#xD;
      high-intensity, hospital-based health care.&#xD;
&#xD;
      The SMART Study:&#xD;
&#xD;
      The overall goals of this study are to test the combination of two smartphone research&#xD;
      platforms and a wearable accelerometer for use in NCI Community Oncology Research Program&#xD;
      (NCORP) sites to improve cancer patients' quality of life and symptom management. The SMART&#xD;
      Study (Symptom Management and Reporting Toxicities) has a single-arm research design and aims&#xD;
      to assess the feasibility, acceptability, and perceived efficacy of a wearable accelerometer&#xD;
      and two smartphone apps in 30 patients receiving chemotherapy to treat recurrent gynecologic&#xD;
      cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 12, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Actual">January 4, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; &lt;30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)</measure>
    <time_frame>30 days</time_frame>
    <description>This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.&#xD;
Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) &quot;Participating in this study placed a substantial burden on me.&quot; (2) &quot;I wish I had not agreed to participate in this study.&quot; and (3) &quot;I would recommend the application to a friend going through treatment.&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)</measure>
    <time_frame>30 days</time_frame>
    <description>This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.&#xD;
This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study</measure>
    <time_frame>90 days</time_frame>
    <description>SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.&#xD;
Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and &lt;30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study</measure>
    <time_frame>90 days</time_frame>
    <description>SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.&#xD;
Acceptability defined as responses to three questions: (1) &quot;Participating in this study placed a substantial burden on me.&quot;; (2) &quot;I wish I had not agreed to participate in this study.&quot;; and (3) &quot;I would recommend the application to a friend going through treatment.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety as Assessed by GAD-7 (HOPE RCT)</measure>
    <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
    <description>Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression as Assessed by PHQ-9 (HOPE RCT)</measure>
    <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
    <description>Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Well-being as Assessed by FACT-O (HOPE RCT)</measure>
    <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
    <description>Patients' FACT-O measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Symptoms (Reported by Patients) as Assessed by PRO-CTCAE (HOPE RCT)</measure>
    <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
    <description>Patients' PRO-CTCAE measurements (reported by patients) taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)</measure>
    <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
    <description>Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Gynecologic Cancer</condition>
  <arm_group>
    <arm_group_label>Comparing Steps Collected by Accelerometer (HOPE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 patients will be enrolled in stage 1 to refine the HOPE App intervention&#xD;
All participants will receive :&#xD;
HOPE App&#xD;
The Fitbit Zip&#xD;
The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care (HOPE)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.&#xD;
Usual care&#xD;
The app will also collect passive data from the smartphone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wearable accelerometer (HOPE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be asked to wear the Fitbit&#xD;
The Hope App will measure daily steps&#xD;
The app will also collect passive data from the smartphone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Refined smartphone app (HOPE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be prompted to answer questions about their quality of life and physical health daily&#xD;
The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.&#xD;
The app will also collect passive data from the smartphone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Refined smartphone app and accelerometer (HOPE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be prompted to answer questions about their quality of life and physical health daily&#xD;
The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.&#xD;
Participants will be asked to wear the Fitbit&#xD;
-The Hope App will measure daily steps The app will also collect passive data from the smartphone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SMART Study Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites.&#xD;
The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit).&#xD;
The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response).&#xD;
The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fitbit Zip</intervention_name>
    <description>Fitbit Zip</description>
    <arm_group_label>Comparing Steps Collected by Accelerometer (HOPE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>HOPE App</intervention_name>
    <description>HOPE App</description>
    <arm_group_label>Comparing Steps Collected by Accelerometer (HOPE)</arm_group_label>
    <arm_group_label>Refined smartphone app (HOPE)</arm_group_label>
    <arm_group_label>Refined smartphone app and accelerometer (HOPE)</arm_group_label>
    <arm_group_label>Usual care (HOPE)</arm_group_label>
    <arm_group_label>Wearable accelerometer (HOPE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of Care</description>
    <arm_group_label>Usual care (HOPE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fitbit Charge 2</intervention_name>
    <description>Fitbit Charge 2</description>
    <arm_group_label>Comparing Steps Collected by Accelerometer (HOPE)</arm_group_label>
    <arm_group_label>Wearable accelerometer (HOPE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMART Study Intervention</intervention_name>
    <description>SMART study app + Beiwe study app + Fitbit</description>
    <arm_group_label>SMART Study Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women ≥18 years of age&#xD;
&#xD;
          -  Who plan to receive chemotherapy at DFCI to treat recurrent, incurable gynecologic&#xD;
             cancers (ovarian, uterine, cervical) that have recurred despite ≥1 prior treatments.&#xD;
&#xD;
          -  Own a smart-phone (Android or iOS)&#xD;
&#xD;
          -  Capable of downloading and running the study app without assistance&#xD;
&#xD;
          -  Can read and provide informed consent in English&#xD;
&#xD;
          -  Do not have cognitive or visual impairments that would preclude use of the app.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be ineligible if they are participating in an investigational drug&#xD;
             treatment trial that requires structured symptom or toxicity reporting at the time of&#xD;
             enrollment.&#xD;
&#xD;
          -  Patients with severe cognitively impairments&#xD;
&#xD;
          -  Who appear too weak&#xD;
&#xD;
          -  Emotionally distraught&#xD;
&#xD;
          -  Agitated or ill to participate, as judged by either the research study staff or an&#xD;
             oncology provider, will be excluded.&#xD;
&#xD;
          -  Patients who are unable to provide informed consent in English will be excluded&#xD;
             because the smartphone app intervention is only available in English at this time.&#xD;
&#xD;
          -  Children and young adults up to age 18 will be excluded because the diagnosis of&#xD;
             metastatic gynecologic cancers in this age group is rare and the proposed instruments&#xD;
             are not designed for people of those ages.&#xD;
&#xD;
          -  Patients with a life expectancy of ≤6 months, as determined by their oncology&#xD;
             providers, will be excluded since they cannot participate in all of the required data&#xD;
             collection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexi A Wright, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>March 3, 2023</results_first_submitted>
  <results_first_submitted_qc>April 14, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2023</results_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Alexi A. Wright, MD</investigator_full_name>
    <investigator_title>Alexi. A Wright, MD, MPH</investigator_title>
  </responsible_party>
  <keyword>Gynecologic cancer</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03022032/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>HOPE Pre-Pilot</title>
          <description>10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.</description>
        </group>
        <group group_id="P2">
          <title>Refined Smartphone App and Accelerometer (HOPE)</title>
          <description>Participants received the FitBit Charge 2 and access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.</description>
        </group>
        <group group_id="P3">
          <title>Wearable Accelerometer (HOPE)</title>
          <description>Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.</description>
        </group>
        <group group_id="P4">
          <title>Refined Smartphone App (HOPE)</title>
          <description>Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.</description>
        </group>
        <group group_id="P5">
          <title>Usual Care (HOPE)</title>
          <description>The HOPE app will collect passive data from the smartphone.</description>
        </group>
        <group group_id="P6">
          <title>SMART Study Arm</title>
          <description>Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="22"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="22"/>
                <participants group_id="P6" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Comparing Steps Collected by Accelerometer (HOPE)</title>
          <description>10 patients will be enrolled in stage 1 to refine the HOPE App intervention&#xD;
All participants will receive :&#xD;
HOPE App&#xD;
The Fitbit Zip&#xD;
The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2&#xD;
Fitbit Zip: Fitbit Zip&#xD;
HOPE App: HOPE App&#xD;
Fitbit Charge 2: Fitbit Charge 2</description>
        </group>
        <group group_id="B2">
          <title>Refined Smartphone App and Accelerometer (HOPE)</title>
          <description>Participants will be prompted to answer questions about their quality of life and physical health daily&#xD;
The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.&#xD;
Participants will be asked to wear the Fitbit&#xD;
-The Hope App will measure daily steps The app will also collect passive data from the smartphone&#xD;
HOPE App: HOPE App</description>
        </group>
        <group group_id="B3">
          <title>Wearable Accelerometer (HOPE)</title>
          <description>Participants will be asked to wear the Fitbit&#xD;
The Hope App will measure daily steps&#xD;
The app will also collect passive data from the smartphone&#xD;
HOPE App: HOPE App&#xD;
Fitbit Charge 2: Fitbit Charge 2</description>
        </group>
        <group group_id="B4">
          <title>Refined Smartphone App (HOPE)</title>
          <description>Participants will be prompted to answer questions about their quality of life and physical health daily&#xD;
The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.&#xD;
The app will also collect passive data from the smartphone&#xD;
HOPE App: HOPE App</description>
        </group>
        <group group_id="B5">
          <title>Usual Care (HOPE)</title>
          <description>Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.&#xD;
Usual care&#xD;
The app will also collect passive data from the smartphone&#xD;
HOPE App: HOPE App&#xD;
Standard of Care: Standard of Care</description>
        </group>
        <group group_id="B6">
          <title>SMART Study Arm</title>
          <description>Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites.&#xD;
The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit).&#xD;
The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response).&#xD;
The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement.&#xD;
SMART Study Intervention: SMART study app + Beiwe study app + Fitbit</description>
        </group>
        <group group_id="B7">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="21"/>
            <count group_id="B4" value="22"/>
            <count group_id="B5" value="22"/>
            <count group_id="B6" value="4"/>
            <count group_id="B7" value="102"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.9" spread="11.29"/>
                    <measurement group_id="B2" value="61.52" spread="13.36"/>
                    <measurement group_id="B3" value="63.76" spread="8.43"/>
                    <measurement group_id="B4" value="62.09" spread="8.19"/>
                    <measurement group_id="B5" value="59.64" spread="9.31"/>
                    <measurement group_id="B6" value="65.50" spread="8.85"/>
                    <measurement group_id="B7" value="60.75" spread="10.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="22"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="102"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="22"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="99"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Divorced/Separated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Widowed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="21"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="83"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refuse to answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Last grade level completed</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>8th grade or less</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>9 - 11th grade</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school graduate or GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Vocational or Technical training</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Associate degree or some college</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bachelor's degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Advanced degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Don't know</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refused</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; &lt;30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)</title>
        <description>This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.&#xD;
Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) &quot;Participating in this study placed a substantial burden on me.&quot; (2) &quot;I wish I had not agreed to participate in this study.&quot; and (3) &quot;I would recommend the application to a friend going through treatment.&quot;</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>HOPE Pre-pilot</title>
            <description>10 patients will be enrolled in stage 1 to refine the HOPE App intervention. All participants will receive the HOPE App and The Fitbit Zip or The Fitbit Charge 2. This will allow the team to identify which wearable accelerometer to use in stage 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; &lt;30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)</title>
          <description>This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.&#xD;
Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) &quot;Participating in this study placed a substantial burden on me.&quot; (2) &quot;I wish I had not agreed to participate in this study.&quot; and (3) &quot;I would recommend the application to a friend going through treatment.&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Feasibility - (1) greater than or equal to 60% enrollment rate among eligible patients approached</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feasibility - (2) greater than or equal to 70% adherence to daily smartphone surveys</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Feasibility - (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acceptability - (1) &quot;Participating in this study placed a substantial burden on me.&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acceptability - (2) &quot;I wish I had not agreed to participate in this study.&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)</title>
        <description>This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.&#xD;
This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.</description>
        <time_frame>30 days</time_frame>
        <population>This outcome was limited to the HOPE pilot, consisting of 10 patients.</population>
        <group_list>
          <group group_id="O1">
            <title>HOPE Pre-pilot</title>
            <description>Single arm pre-pilot of 10 participants.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)</title>
          <description>This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.&#xD;
This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.</description>
          <population>This outcome was limited to the HOPE pilot, consisting of 10 patients.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Preferred FitBit Charge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Preferred FitBit Zip</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study</title>
        <description>SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.&#xD;
Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SMART Study</title>
            <description>Single arm pre-pilot feasibility and acceptability testing of SMART at University of New Mexico and Sanford Health (Sioux Falls, South Dakota).</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study</title>
          <description>SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.&#xD;
Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and &lt;30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study</title>
        <description>SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.&#xD;
Acceptability defined as responses to three questions: (1) &quot;Participating in this study placed a substantial burden on me.&quot;; (2) &quot;I wish I had not agreed to participate in this study.&quot;; and (3) &quot;I would recommend the application to a friend going through treatment.&quot;</description>
        <time_frame>90 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SMART Study</title>
            <description>Single arm pre-pilot feasibility and acceptability testing of SMART at University of New Mexico and Sanford Health (Sioux Falls, South Dakota).</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and &lt;30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study</title>
          <description>SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.&#xD;
Acceptability defined as responses to three questions: (1) &quot;Participating in this study placed a substantial burden on me.&quot;; (2) &quot;I wish I had not agreed to participate in this study.&quot;; and (3) &quot;I would recommend the application to a friend going through treatment.&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Acceptability - (1) &quot;Participating in this study placed a substantial burden on me.&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acceptability - (2) &quot;I wish I had not agreed to participate in this study.&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acceptability - (3) &quot;I would recommend the application to a friend going through treatment.&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anxiety as Assessed by GAD-7 (HOPE RCT)</title>
        <description>Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
        <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression as Assessed by PHQ-9 (HOPE RCT)</title>
        <description>Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
        <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Well-being as Assessed by FACT-O (HOPE RCT)</title>
        <description>Patients' FACT-O measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
        <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Symptoms (Reported by Patients) as Assessed by PRO-CTCAE (HOPE RCT)</title>
        <description>Patients' PRO-CTCAE measurements (reported by patients) taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
        <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)</title>
        <description>Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.</description>
        <time_frame>Baseline, 30 days, 90 days, 180 days (Phase II)</time_frame>
        <posting_date>12/2023</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>HOPE Pre-Pilot: 30 days; HOPE RCT (4 arms): 180 days; SMART: 90 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>HOPE Pre-Pilot</title>
          <description>10 patients will be enrolled in stage 1 to refine the HOPE App intervention; All participants will receive: HOPE App, The Fitbit Zip, The Fitbit Charge 2&#xD;
The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2.&#xD;
Fitbit Zip: Fitbit Zip HOPE App: HOPE App Fitbit Charge 2: Fitbit Charge 2</description>
        </group>
        <group group_id="E2">
          <title>Refined Smartphone App and Accelerometer (HOPE)</title>
          <description>Participants received the Fitbit Charge 2 and access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.</description>
        </group>
        <group group_id="E3">
          <title>Wearable Accelerometer (HOPE)</title>
          <description>Participants were asked to wear the Fitbit Charge 2. The HOPE app will also collect passive smartphone data.</description>
        </group>
        <group group_id="E4">
          <title>Refined Smartphone App (HOPE)</title>
          <description>Participants received access to the HOPE smartphone app. The HOPE app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.</description>
        </group>
        <group group_id="E5">
          <title>Usual Care (HOPE)</title>
          <description>The HOPE app will collect passive data from the smartphone.</description>
        </group>
        <group group_id="E6">
          <title>SMART Study Arm</title>
          <description>Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Alexi Wright</name_or_title>
      <organization>Dana-Farber Cancer Institute</organization>
      <phone>617-632-2334</phone>
      <email>alexi_wright@dfci.harvard.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03022032
org study id: 16-477
secondary id: 1R21NR018532
nct id: NCT03022032
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research study is evaluating a new smartphone application named the "Helping Our
      Patients Excel (HOPE)" app with a Fitbit device. The SMART Study is a sub-study of the HOPE
      Trial. Both studies evaluate an almost identical intervention using a Fitbit device and
      smartphone app(s) with the goal of improving quality-of-life for women with gynecologic
      cancers.
The HOPE Trial:

      The first goal of this study is to adapt and refine an existing smartphone app, paired with a
      wearable accelerometer, to assess patients' symptoms in a population of patients with
      gynecologic cancers receiving palliative chemotherapy. An existing app will be customized to
      collect patient-reported toxicities using the Patient-Reported Outcome (PRO) version of the
      Common Terminology Criteria for Adverse Events (PRO-CTCAE) and offer patients feedback about
      how to manage their symptoms. Patient symptoms will be risk-stratified. Patients with
      low-risk toxicities (grades 1 & 2) will receive tailored educational information, while
      patients with serious toxicities (grades 3 & 4) will receive alerts to call their clinician.
      In the first phase of the study, we will conduct an initial assessment of the app with a
      diverse group of 10 patients to refine the app and test two different wearable accelerometers
      (i.e. Fitbit Zip and Fitbit Charge 2) before pilot testing.

      The second goal of this study is to conduct a pilot randomized controlled trial (RCT) of the
      smartphone app and/or wearable accelerometer (i.e. Fitbit Zip or Fitbit Charge 2) to assess
      the feasibility, acceptability, and preliminary efficacy of our intervention. During the
      second phase of the study, we will conduct a 4-arm pilot RCT in 100 patients with gynecologic
      cancers receiving palliative chemotherapy to establish preliminary effect sizes. Participants
      will be randomized to: 1) Fitbit+active app, 2) Fitbit+passive app, 3) Active app, or 4)
      Passive app.

      We expect that the results of this pilot RCT, which is supported by the National Cancer
      Institute, National Palliative Care Research Center, and the Dana-Farber Cancer Institute
      Department of Medical Oncology, will provide a low-cost, scalable system to assess patients'
      symptoms, address low-risk toxicities, and alert clinicians when patients have toxicities
      that require intervention with the goal of reducing patient suffering and the use of
      high-intensity, hospital-based health care.

      The SMART Study:

      The overall goals of this study are to test the combination of two smartphone research
      platforms and a wearable accelerometer for use in NCI Community Oncology Research Program
      (NCORP) sites to improve cancer patients' quality of life and symptom management. The SMART
      Study (Symptom Management and Reporting Toxicities) has a single-arm research design and aims
      to assess the feasibility, acceptability, and perceived efficacy of a wearable accelerometer
      and two smartphone apps in 30 patients receiving chemotherapy to treat recurrent gynecologic
      cancers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility (≥60% Enrollment Rate of Eligible Patients; ≥70% Survey Adherence; ≥80% FitBit Adherence) and Acceptability (≥60% Would Recommend the Intervention; <30% Rate the Study as Burdensome/Wish They Had Not Participated) in HOPE Pre-Pilot (n=10)
time frame: 30 days
description: This outcome was limited to the HOPE pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.
Feasibility defined as (1) greater than or equal to 60% enrollment rate among eligible patients approached, (2) greater than or equal to 70% adherence to daily smartphone surveys, (3) greater than or equal to 80% adherence to Fitbits at least 4 days per week. Acceptability defined as responses to 3 questions: (1) "Participating in this study placed a substantial burden on me." (2) "I wish I had not agreed to participate in this study." and (3) "I would recommend the application to a friend going through treatment."
measure: Number of Participants Who Preferred the FitBit Zip vs. Number of Participants Who Preferred the FitBit Charge HR in the HOPE Pre-Pilot Study (n=10)
time frame: 30 days
description: This outcome was limited to the HOPE Pre-pilot, consisting of 10 patients. This open pilot aimed to identify patient preference of Fitbit Zip or Fitbit Charge 2 and whether this study was burdensome. This outcome informed appropriate study procedures before launching to a larger study with four arms across multiple sites.
This outcome is participant preference of the Fitbit Zip vs. Fitbit Charge in the HOPE Pre-Pilot study.
measure: Feasibility (i.e. ≥50% 3-month Adherence Rates to Both Smartphone Apps and the Wearable Accelerometer) in the SMART Study
time frame: 90 days
description: SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
Feasibility will be defined as greater than or equal to 50% 3-month adherence rates to both smartphone apps and the wearable accelerometer.
measure: Acceptability (i.e. ≥60% of Study Participants Would Recommend the Intervention to Other Patients; and <30% of Patients Rate the Study as Burdensome or Wish They Had Not Participated) in the SMART Study
time frame: 90 days
description: SMART Study: Participants received the Fitbit Charge 2 and access to the smartphone app. The app presented tailored advice if one or more low-risk symptoms were reported and prompted the patient to call their clinician for high-risk symptoms.
Acceptability defined as responses to three questions: (1) "Participating in this study placed a substantial burden on me."; (2) "I wish I had not agreed to participate in this study."; and (3) "I would recommend the application to a friend going through treatment."
measure: Anxiety as Assessed by GAD-7 (HOPE RCT)
time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
description: Patients' GAD-7 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.
measure: Depression as Assessed by PHQ-9 (HOPE RCT)
time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
description: Patients' PHQ-9 measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.
measure: Patient Well-being as Assessed by FACT-O (HOPE RCT)
time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
description: Patients' FACT-O measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.
measure: Patient Symptoms (Reported by Patients) as Assessed by PRO-CTCAE (HOPE RCT)
time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
description: Patients' PRO-CTCAE measurements (reported by patients) taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.
measure: Correlation Between Patient and Physician Estimates of Performance Status as Assessed by ECOG-PS (HOPE RCT)
time frame: Baseline, 30 days, 90 days, 180 days (Phase II)
description: Patients' and their physicians' ECOG-PS measurements taken at baseline and post-baseline (30 days, 90 days, and 180 days) in the HOPE RCT.
arm group label: Comparing Steps Collected by Accelerometer (HOPE)
arm group type: Experimental
description: 10 patients will be enrolled in stage 1 to refine the HOPE App intervention
All participants will receive :
HOPE App
The Fitbit Zip
The Fitbit Charge 2 The amount of step collected by each device will be compared. This will allow the team to identify which wearable accelerometer to use in stage 2
arm group label: Usual care (HOPE)
arm group type: Other
description: Stage 2 will consist of arm 2-5 and will enroll 100 randomized patients.
Usual care
The app will also collect passive data from the smartphone
arm group label: Wearable accelerometer (HOPE)
arm group type: Experimental
description: Participants will be asked to wear the Fitbit
The Hope App will measure daily steps
The app will also collect passive data from the smartphone
arm group label: Refined smartphone app (HOPE)
arm group type: Experimental
description: Participants will be prompted to answer questions about their quality of life and physical health daily
The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
The app will also collect passive data from the smartphone
arm group label: Refined smartphone app and accelerometer (HOPE)
arm group type: Experimental
description: Participants will be prompted to answer questions about their quality of life and physical health daily
The HOPE App will present tailored advice to improve symptoms if one or more low-risk toxicities are reported. If the symptoms are determined to be high-risk, the App will prompt the patient to call their clinician.
Participants will be asked to wear the Fitbit
-The Hope App will measure daily steps The app will also collect passive data from the smartphone
arm group label: SMART Study Arm
arm group type: Experimental
description: Two smartphone apps and a wearable accelerometer (Fitbit) in 30 patients with gynecologic cancers receiving chemotherapy at two NCI Community Oncology sites.
The SMART intervention refers to the combination of both smartphone apps (SMART app and Beiwe app) and the accelerometer (Fitbit).
The SMART app is the technology that is actively collecting symptom reporting information from patients (e.g. patients are receiving surveys, recording their symptoms daily, and receiving tailored symptom management materials on their phone in response).
The Beiwe app is the technology involved in the passive data collection of participants' symptoms (GPS and accelerometer data) without their involvement.
intervention type: Device
intervention name: Fitbit Zip
description: Fitbit Zip
arm group label: Comparing Steps Collected by Accelerometer (HOPE)
intervention type: Other
intervention name: HOPE App
description: HOPE App
arm group label: Comparing Steps Collected by Accelerometer (HOPE)
arm group label: Refined smartphone app (HOPE)
arm group label: Refined smartphone app and accelerometer (HOPE)
arm group label: Usual care (HOPE)
arm group label: Wearable accelerometer (HOPE)
intervention type: Other
intervention name: Standard of Care
description: Standard of Care
arm group label: Usual care (HOPE)
intervention type: Device
intervention name: Fitbit Charge 2
description: Fitbit Charge 2
arm group label: Comparing Steps Collected by Accelerometer (HOPE)
arm group label: Wearable accelerometer (HOPE)
intervention type: Other
intervention name: SMART Study Intervention
description: SMART study app + Beiwe study app + Fitbit
arm group label: SMART Study Arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexi A Wright, MD MPH
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Alexi A. Wright, MD
investigator title: Alexi. A Wright, MD, MPH
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 