<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/NCT03757182</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2018-19-GRESH-DIGISTEP</org_study_id>
    <nct_id>NCT03757182</nct_id>
  </id_info>
  <brief_title>Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients</brief_title>
  <acronym>DigiSTEPS</acronym>
  <official_title>Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients: A Single Cohort, Prospective Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</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>
      The purpose of this study is to examine the relationships between objectively measured&#xD;
      physical activity and provider-assessed and patient-reported functional outcomes in patients&#xD;
      with advanced cancer. Findings from this study will help us better understand how change in&#xD;
      daily physical activity, as measured using the wearable activity monitor, is related to&#xD;
      change in a patient's functional status and clinical condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients diagnosed with stage 3/ 4 cancer will be enrolled. After providing informed consent,&#xD;
      patients will be asked to wear a FitBit Charge HR continuously for 8 weeks with the option to&#xD;
      continue wearing the monitor for up to a year after end-of-study. Baseline assessments&#xD;
      include a physical exam, medical history, and frailty assessment. The attending oncologist&#xD;
      will rate the patient's performance status (ECOG PS) at baseline and 8-weeks follow-up.&#xD;
      Patient-reported outcomes (self-reported physical function, fatigue, sleep, emotional&#xD;
      distress) will be assessed weekly using NIH PROMIS from baseline up to 8 weeks from&#xD;
      end-of-study. They will also be collected at 1 year follow-up. Wearable activity monitor data&#xD;
      will be summarized each week for 8 weeks, and then again at 1 year follow-up. Physical&#xD;
      activity data (number of steps, stairs climbed, active minutes, heart rate, and sleep&#xD;
      duration) will be collected and analyzed at end-of-study (up to 1 year from end-of-study).&#xD;
      Overall survival will also be assessed up to 1 year from end-of-study. Absolute change in&#xD;
      physical activity levels will be correlated with change in performance status and occurrence&#xD;
      of AEs and death to better understand the role of remote activity monitoring in cancer&#xD;
      patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute change in average step counts at 8 weeks from baseline</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in performance status will be calculated based on difference in provider-assessed Eastern Cooperative Oncology Group (ECOG) performance status at end-of-study visit and baseline ECOG. ECOG Performance Status is rated based on a 5-point scale where a score of 0 indicates best performance status and 5 indicates death. Only one rating of ECOG PS by provider is completed at each timepoint.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute change in patient-reported physical function at 8 weeks from baseline</measure>
    <time_frame>8 weeks</time_frame>
    <description>Physical function will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form, which includes 20 items and a range of 1 (low physical function) to 5 (high physical function). The total score will be calculated and converted into a standardized t-score will be calculated based on a standard cancer population with a mean of 50 and SD of 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient weekly distress levels up to 8 weeks from baseline</measure>
    <time_frame>8 weeks</time_frame>
    <description>Distress will be measured using using NIH Patient-Reported Outcomes Measurement Information System (PROMIS), which includes short forms: emotional distress, sleep quality, pain, and fatigue. Items range from 1 (worse outcome) and 5 (best outcome) where a total score will be calculated and converted into standardized t-scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to wearing the device for the specified study period</measure>
    <time_frame>8 weeks</time_frame>
    <description>A patient is considered adherent if they wear the device at least 10 hours per day for at least 4 of 7 days prior to each study timepoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Score calculated based on total number of frailty characteristics present using Fried's validated Frailty index. Characteristics of frailty include shrinking (weight loss), weakness (grip strength), poor endurance, exhaustion, slowness, and low activity. The minimal score is 0, indicating absence of frailty, and the highest is 5. Frailty index categories include absence of frailty (score of 0), pre-frail or intermediate frail (1-2 criteria) and frail (&gt;3 criteria present).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks</measure>
    <time_frame>up to 12 weeks</time_frame>
    <description>AEs will be rated using CTCAE v5</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival up to 1 year from end-of-study</measure>
    <time_frame>up to 1 year</time_frame>
    <description>Occurrence of death from any cause</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Cancer</condition>
  <condition>Cancer, Metastatic</condition>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Wearable activity monitor</arm_group_label>
    <description>Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Wearable activity monitor</intervention_name>
    <description>Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)</description>
    <arm_group_label>Wearable activity monitor</arm_group_label>
    <other_name>Fitness tracker</other_name>
    <other_name>Wearable device</other_name>
    <other_name>Biosensor</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Stage 3/4 advanced cancer patients being seen for treatment at Cedars-Sinai Medical Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of advanced (stage 3 or 4) cancer of any type&#xD;
&#xD;
          -  Ambulatory (use of walking aids, such as cane and rollator, is acceptable)&#xD;
&#xD;
          -  Access to a device that has the capability to sync to the Fitbit&#xD;
&#xD;
          -  Expected to have standard of care oncology appointments at least once every 8 weeks&#xD;
             (+/-7 days).&#xD;
&#xD;
          -  Have an understanding, ability, and willingness to fully comply with study procedures&#xD;
             and restrictions&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  Ability to consent&#xD;
&#xD;
          -  Informed consent obtained from subject and ability for subject to comply with the&#xD;
             requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to surgical steel or elastomer/rubber&#xD;
&#xD;
          -  Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable&#xD;
             hearing aids, cochlear implants, or other electronic medical equipment. However,&#xD;
             removable hearing aids are permitted.&#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>Gillian Gresham, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gillian Gresham, PhD</last_name>
    <phone>310-423-3341</phone>
    <email>gillian.gresham@cshs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eileen Liu</last_name>
    <phone>310-967-0699</phone>
    <email>Eileen.Liu@cshs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eileen Liu</last_name>
      <phone>310-967-0699</phone>
      <email>Eileen.Liu@cshs.org</email>
    </contact>
    <investigator>
      <last_name>Stephen Freedland, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>BJ Rimel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brennan Spiegel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jun Gong, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Arash Asher, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrew Hendifar, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Christine Walsh, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Edwin Posadas, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gillian Gresham, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Gillian Gresham</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Wearable device</keyword>
  <keyword>Fitness tracker</keyword>
  <keyword>Wearable activity monitor</keyword>
  <keyword>Biosensor</keyword>
  <keyword>Performance Status</keyword>
  <keyword>Activity Monitoring</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>IPD available upon request.</ipd_description>
  </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/NCT03757182
org study id: IIT2018-19-GRESH-DIGISTEP
nct id: NCT03757182
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the relationships between objectively measured
      physical activity and provider-assessed and patient-reported functional outcomes in patients
      with advanced cancer. Findings from this study will help us better understand how change in
      daily physical activity, as measured using the wearable activity monitor, is related to
      change in a patient's functional status and clinical condition.
Patients diagnosed with stage 3/ 4 cancer will be enrolled. After providing informed consent,
      patients will be asked to wear a FitBit Charge HR continuously for 8 weeks with the option to
      continue wearing the monitor for up to a year after end-of-study. Baseline assessments
      include a physical exam, medical history, and frailty assessment. The attending oncologist
      will rate the patient's performance status (ECOG PS) at baseline and 8-weeks follow-up.
      Patient-reported outcomes (self-reported physical function, fatigue, sleep, emotional
      distress) will be assessed weekly using NIH PROMIS from baseline up to 8 weeks from
      end-of-study. They will also be collected at 1 year follow-up. Wearable activity monitor data
      will be summarized each week for 8 weeks, and then again at 1 year follow-up. Physical
      activity data (number of steps, stairs climbed, active minutes, heart rate, and sleep
      duration) will be collected and analyzed at end-of-study (up to 1 year from end-of-study).
      Overall survival will also be assessed up to 1 year from end-of-study. Absolute change in
      physical activity levels will be correlated with change in performance status and occurrence
      of AEs and death to better understand the role of remote activity monitoring in cancer
      patients.
observational model: Cohort
time perspective: Prospective
measure: Absolute change in average step counts at 8 weeks from baseline
time frame: 8 weeks
description: Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit
measure: Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline
time frame: 8 weeks
description: Change in performance status will be calculated based on difference in provider-assessed Eastern Cooperative Oncology Group (ECOG) performance status at end-of-study visit and baseline ECOG. ECOG Performance Status is rated based on a 5-point scale where a score of 0 indicates best performance status and 5 indicates death. Only one rating of ECOG PS by provider is completed at each timepoint.
measure: Absolute change in patient-reported physical function at 8 weeks from baseline
time frame: 8 weeks
description: Physical function will be assessed using the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) short form, which includes 20 items and a range of 1 (low physical function) to 5 (high physical function). The total score will be calculated and converted into a standardized t-score will be calculated based on a standard cancer population with a mean of 50 and SD of 10.
measure: Patient weekly distress levels up to 8 weeks from baseline
time frame: 8 weeks
description: Distress will be measured using using NIH Patient-Reported Outcomes Measurement Information System (PROMIS), which includes short forms: emotional distress, sleep quality, pain, and fatigue. Items range from 1 (worse outcome) and 5 (best outcome) where a total score will be calculated and converted into standardized t-scores.
measure: Adherence to wearing the device for the specified study period
time frame: 8 weeks
description: A patient is considered adherent if they wear the device at least 10 hours per day for at least 4 of 7 days prior to each study timepoint
measure: Change in frailty status from baseline to end-of-study visit (up to 8 weeks from baseline)
time frame: 8 weeks
description: Score calculated based on total number of frailty characteristics present using Fried's validated Frailty index. Characteristics of frailty include shrinking (weight loss), weakness (grip strength), poor endurance, exhaustion, slowness, and low activity. The minimal score is 0, indicating absence of frailty, and the highest is 5. Frailty index categories include absence of frailty (score of 0), pre-frail or intermediate frail (1-2 criteria) and frail (>3 criteria present).
measure: Occurrence of grade 3 or 4 SOC cancer-related adverse events or chemotoxicities and hospitalizations occurring from baseline up to 12 weeks
time frame: up to 12 weeks
description: AEs will be rated using CTCAE v5
measure: Overall survival up to 1 year from end-of-study
time frame: up to 1 year
description: Occurrence of death from any cause
arm group label: Wearable activity monitor
description: Continuous activity monitoring with Fitbit Charge HR from baseline to up to 1 year from end-of-study.
intervention type: Other
intervention name: Wearable activity monitor
description: Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)
arm group label: Wearable activity monitor
other name: Fitness tracker
other name: Wearable device
other name: Biosensor
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gillian Gresham, PhD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Gillian Gresham, PhD
phone: 310-423-3341
email: gillian.gresham@cshs.org
last name: Eileen Liu
phone: 310-967-0699
email: Eileen.Liu@cshs.org
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Gillian Gresham
investigator title: Principal Investigator
sharing ipd: Undecided
ipd description: IPD available upon request.