<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/NCT04465214</url>
  </required_header>
  <id_info>
    <org_study_id>170158</org_study_id>
    <secondary_id>17-C-0158</secondary_id>
    <nct_id>NCT04465214</nct_id>
  </id_info>
  <brief_title>Mobile Sensor Technologies to Assess General Symptomology of People With Cancer</brief_title>
  <official_title>A Feasibility Study of Mobile Sensor Technologies to Assess General Symptomology of Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Many digital devices, such as smartphones and activity monitors, have sensors to collect and&#xD;
      track health data. Researchers believe these devices may be able to transform the quality of&#xD;
      clinical research and healthcare. They believe they may be able to help assess the symptoms,&#xD;
      response to therapy, and quality of life of people with cancer.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      To collect data from people with cancer using an Apple iPhone alone or together with an Apple&#xD;
      Watch in order to assess their symptoms and activity levels.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      People ages 18 years and over who have cancer and receiving treatment for their cancer in&#xD;
      another NIH protocol&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Participants will be screened with their medical records.&#xD;
&#xD;
      Participants will have a baseline visit. They will have visits every 2 4 weeks based on the&#xD;
      treatment protocol in which they are co-enrolled. Then they will have a follow-up visit 4&#xD;
      months after the baseline visit. Visits include:&#xD;
&#xD;
      Medical history&#xD;
&#xD;
      Physical exam&#xD;
&#xD;
      Karnofsky Performance Scale/Eastern Cooperative Oncology Group performance status to see how&#xD;
      their disease affects daily activities&#xD;
&#xD;
      The study team will use an iPhone to collect data. This includes a 6-minute walk test and&#xD;
      tests of hearing, reaction time, and cognitive status.&#xD;
&#xD;
      Questionnaires&#xD;
&#xD;
      If participants have an iPhone, an Apple Watch will be provided to them after training at the&#xD;
      baseline visit. Continuous measurement of their activity will be recorded by the watch&#xD;
      between 2 visits. They will wear the watch while they are on study. They will wear the watch&#xD;
      while it is not being charged. They should charge the watch at night time. They will have the&#xD;
      watch for 4 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        -  A growing number of mobile health solutions are enabling the tracking, diagnosis, and&#xD;
           management of various physiological processes and disease conditions, and many common&#xD;
           devices such as smartphones (e.g., iPhone) have integrated robust sensors to collect and&#xD;
           track this data.&#xD;
&#xD;
        -  The two most commonly used tools in oncology include the Eastern Cooperative Oncology&#xD;
           Group Performance Status (ECOG PS) and Karnofsky Performance Status (KPS) scales that&#xD;
           were invented more than 50 years ago.&#xD;
&#xD;
        -  Although standard performance status (PS) measurements are simple to implement in the&#xD;
           clinic, they are retrospective, subject to bias and limitations including intra- or&#xD;
           inter- observer variability, they are intermittent, providing a snapshot of the&#xD;
           participants status at the time of assessment, and they are largely subjective, relying&#xD;
           on physician judgement and participants ability to recall events and describe their&#xD;
           symptoms. The inability to retrospectively verify or confirm the accuracy of PS&#xD;
           assessment is another limitation.&#xD;
&#xD;
        -  The benefits to participant care of knowing the accurate PS are extensive, including&#xD;
           making the right treatment decision based on the side effect profile, survival benefit&#xD;
           and eligibility on clinical trials.&#xD;
&#xD;
        -  Biometric data can also play a role in empowering participants to become active&#xD;
           participants in their own care, by providing them with quantitative feedback on&#xD;
           activities of daily living and other functions.&#xD;
&#xD;
        -  There are some studies exploring the accuracy of available electronic activity&#xD;
           monitoring (EAM) systems, but the available data on use of EAM systems in oncology&#xD;
           participants is limited.&#xD;
&#xD;
        -  Continuous biometric data can provide actionable insights into fluctuations in not only&#xD;
           the activity level of cancer participants, but also their cognitive function and mood&#xD;
           throughout treatment cycles.&#xD;
&#xD;
        -  Given the current limitations in the overall clinical evaluation of cancer participants,&#xD;
           the use of remote sensor technologies can provide an objective, frequent, and near-real&#xD;
           time stream of data in a machine-readable format that is free of human bias and can&#xD;
           greatly enhance the ability of both clinicians and participants to manage the&#xD;
           complexities of cancer care.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      This study will evaluate the feasibility of collecting data to assess fatigue, reaction time,&#xD;
      and cognitive functioning, in participants with cancer, using an Apple iPhone and Apple Watch&#xD;
      in the clinic setting and with or without additional activity monitoring in the home setting.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Inclusion criteria: Male or female subjects aged &gt;= 18 years with a diagnosis of&#xD;
           malignant tumors who are under active treatment for cancer.&#xD;
&#xD;
        -  Exclusion Criteria: Active central nervous system (CNS) metastases, known current&#xD;
           alcohol or drug abuse, any psychiatric condition that would prohibit the understanding&#xD;
           or rendering of informed consent.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      This pilot study will be done in two arms (enrolled concurrently) with the goal of 60&#xD;
      evaluable participants across both arms (accrual ceiling will be set at 80).&#xD;
&#xD;
      Participants assigned to Arm 1 will have all assessments done in the clinic. A specially&#xD;
      programmed iPhone, Apple Watch, an NIH iPad, and investigator conducted assessments will be&#xD;
      used to collect data assessing participant fatigue, reaction time, and cognitive functioning.&#xD;
      These data will be compared with data collected from questionnaires including: patient&#xD;
      reported outcome (PRO)-CTCAE fatigue and mood grading, ECOG/KPS, Neuro-QOL Ability to&#xD;
      Participate in Social Roles and Activities short form, the Delis-Kaplan Executive Functioning&#xD;
      System, and The NIH Toolbox.&#xD;
&#xD;
      Arm 2 of this study will be a subset of enrolled participants who have a personally owned&#xD;
      iPhone. Participants in Arm 2 will complete the same battery of assessments in the clinic as&#xD;
      those in Arm 1, with additional continuous measurement of their activity recorded by an Apple&#xD;
      Watch at home, between clinic visits. Participants in Arm 2 will have the option of having&#xD;
      the apps designed for this study installed on their personally owned iPhones so they can&#xD;
      complete the app assessments at home. The Apple Watch will be given to these participants (or&#xD;
      they may use a personally owned Apple Watch) who will be trained by study staff on using the&#xD;
      device for continuous monitoring. Participants who agree to have the study apps installed on&#xD;
      their personally owned iPhone will be trained by study staff on the use of the apps.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 23, 2020</start_date>
  <completion_date type="Anticipated">April 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2024</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>Outcomes from: PRO-CTCAE, Neuro-QOL, Numeric Rating Scale for Pain, 6-Minute Walking Test, Stroop Test, and Normalized Reaction Time Tests</measure>
    <time_frame>4 months</time_frame>
    <description>Percentage of patients successfully assessed for fatigue, reaction time, and cognitive status using an iPhone and Apple Watch.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between biometric monitoring system measures of activity and function with KPS, ECOG performance status and Neuro-QOL</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association of patient reported outcomes, including fatigue and ability to participate in social role and activities questions, with iPhone tests that assess mobility, fatigability and cognitive function</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of iPhone based tests of cognitive functioning and reaction time for reliability and validity</measure>
    <time_frame>4 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Neoplasms</condition>
  <condition>Solid Tumors</condition>
  <condition>Prostate Cancer</condition>
  <condition>Lung Cancer</condition>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>1/Cohort 1</arm_group_label>
    <description>Participants with a diagnosis of cancer who are under active treatment on a protocol at NIH</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a diagnosis of cancer who are under active treatment on a protocol at NIH&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Signed written informed consent.&#xD;
&#xD;
          -  Male or female subjects aged greater than or equal to 18 years.&#xD;
&#xD;
          -  A cancer diagnosis.&#xD;
&#xD;
          -  Participant should be under active treatment for cancer on a protocol at NIH.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Active central nervous system (CNS) metastases.&#xD;
&#xD;
          -  Known current alcohol or drug abuse.&#xD;
&#xD;
          -  Current marijuana use, including for medicinal purposes.&#xD;
&#xD;
          -  Any psychiatric condition that would prohibit the understanding or rendering of&#xD;
             informed consent.&#xD;
&#xD;
          -  Color blindness to any of the following colors: green, yellow, and/or red.&#xD;
&#xD;
          -  Legal incapacity or limited legal capacity.&#xD;
&#xD;
          -  Cancer survivors who are not actively receiving treatment.&#xD;
&#xD;
          -  Non-English speaking subjects.&#xD;
&#xD;
          -  Resting heart rate at screening, higher than 120 beats per minute.&#xD;
&#xD;
          -  Systolic blood pressure at screening, higher than 180 mmHg.&#xD;
&#xD;
          -  Diastolic blood pressure at screening, higher than 100 mmHg.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James L Gulley, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-C-0158.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>August 1, 2023</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Apple iPhone</keyword>
  <keyword>Apple Watch</keyword>
  <keyword>Data Collection</keyword>
  <keyword>acoustic neurotoxicity</keyword>
  <keyword>cognitive status</keyword>
  <keyword>Natural History</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>.All IPD recorded in the medical record will be shared with intramural investigators upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Clinical data available during the study and indefinitely.</ipd_time_frame>
    <ipd_access_criteria>Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.</ipd_access_criteria>
  </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/NCT04465214
org study id: 170158
secondary id: 17-C-0158
nct id: NCT04465214
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      Many digital devices, such as smartphones and activity monitors, have sensors to collect and
      track health data. Researchers believe these devices may be able to transform the quality of
      clinical research and healthcare. They believe they may be able to help assess the symptoms,
      response to therapy, and quality of life of people with cancer.

      Objective:

      To collect data from people with cancer using an Apple iPhone alone or together with an Apple
      Watch in order to assess their symptoms and activity levels.

      Eligibility:

      People ages 18 years and over who have cancer and receiving treatment for their cancer in
      another NIH protocol

      Design:

      Participants will be screened with their medical records.

      Participants will have a baseline visit. They will have visits every 2 4 weeks based on the
      treatment protocol in which they are co-enrolled. Then they will have a follow-up visit 4
      months after the baseline visit. Visits include:

      Medical history

      Physical exam

      Karnofsky Performance Scale/Eastern Cooperative Oncology Group performance status to see how
      their disease affects daily activities

      The study team will use an iPhone to collect data. This includes a 6-minute walk test and
      tests of hearing, reaction time, and cognitive status.

      Questionnaires

      If participants have an iPhone, an Apple Watch will be provided to them after training at the
      baseline visit. Continuous measurement of their activity will be recorded by the watch
      between 2 visits. They will wear the watch while they are on study. They will wear the watch
      while it is not being charged. They should charge the watch at night time. They will have the
      watch for 4 months.
Background:

        -  A growing number of mobile health solutions are enabling the tracking, diagnosis, and
           management of various physiological processes and disease conditions, and many common
           devices such as smartphones (e.g., iPhone) have integrated robust sensors to collect and
           track this data.

        -  The two most commonly used tools in oncology include the Eastern Cooperative Oncology
           Group Performance Status (ECOG PS) and Karnofsky Performance Status (KPS) scales that
           were invented more than 50 years ago.

        -  Although standard performance status (PS) measurements are simple to implement in the
           clinic, they are retrospective, subject to bias and limitations including intra- or
           inter- observer variability, they are intermittent, providing a snapshot of the
           participants status at the time of assessment, and they are largely subjective, relying
           on physician judgement and participants ability to recall events and describe their
           symptoms. The inability to retrospectively verify or confirm the accuracy of PS
           assessment is another limitation.

        -  The benefits to participant care of knowing the accurate PS are extensive, including
           making the right treatment decision based on the side effect profile, survival benefit
           and eligibility on clinical trials.

        -  Biometric data can also play a role in empowering participants to become active
           participants in their own care, by providing them with quantitative feedback on
           activities of daily living and other functions.

        -  There are some studies exploring the accuracy of available electronic activity
           monitoring (EAM) systems, but the available data on use of EAM systems in oncology
           participants is limited.

        -  Continuous biometric data can provide actionable insights into fluctuations in not only
           the activity level of cancer participants, but also their cognitive function and mood
           throughout treatment cycles.

        -  Given the current limitations in the overall clinical evaluation of cancer participants,
           the use of remote sensor technologies can provide an objective, frequent, and near-real
           time stream of data in a machine-readable format that is free of human bias and can
           greatly enhance the ability of both clinicians and participants to manage the
           complexities of cancer care.

      Objective:

      This study will evaluate the feasibility of collecting data to assess fatigue, reaction time,
      and cognitive functioning, in participants with cancer, using an Apple iPhone and Apple Watch
      in the clinic setting and with or without additional activity monitoring in the home setting.

      Eligibility:

        -  Inclusion criteria: Male or female subjects aged >= 18 years with a diagnosis of
           malignant tumors who are under active treatment for cancer.

        -  Exclusion Criteria: Active central nervous system (CNS) metastases, known current
           alcohol or drug abuse, any psychiatric condition that would prohibit the understanding
           or rendering of informed consent.

      Design:

      This pilot study will be done in two arms (enrolled concurrently) with the goal of 60
      evaluable participants across both arms (accrual ceiling will be set at 80).

      Participants assigned to Arm 1 will have all assessments done in the clinic. A specially
      programmed iPhone, Apple Watch, an NIH iPad, and investigator conducted assessments will be
      used to collect data assessing participant fatigue, reaction time, and cognitive functioning.
      These data will be compared with data collected from questionnaires including: patient
      reported outcome (PRO)-CTCAE fatigue and mood grading, ECOG/KPS, Neuro-QOL Ability to
      Participate in Social Roles and Activities short form, the Delis-Kaplan Executive Functioning
      System, and The NIH Toolbox.

      Arm 2 of this study will be a subset of enrolled participants who have a personally owned
      iPhone. Participants in Arm 2 will complete the same battery of assessments in the clinic as
      those in Arm 1, with additional continuous measurement of their activity recorded by an Apple
      Watch at home, between clinic visits. Participants in Arm 2 will have the option of having
      the apps designed for this study installed on their personally owned iPhones so they can
      complete the app assessments at home. The Apple Watch will be given to these participants (or
      they may use a personally owned Apple Watch) who will be trained by study staff on using the
      device for continuous monitoring. Participants who agree to have the study apps installed on
      their personally owned iPhone will be trained by study staff on the use of the apps.
observational model: Cohort
time perspective: Prospective
measure: Outcomes from: PRO-CTCAE, Neuro-QOL, Numeric Rating Scale for Pain, 6-Minute Walking Test, Stroop Test, and Normalized Reaction Time Tests
time frame: 4 months
description: Percentage of patients successfully assessed for fatigue, reaction time, and cognitive status using an iPhone and Apple Watch.
measure: Correlation between biometric monitoring system measures of activity and function with KPS, ECOG performance status and Neuro-QOL
time frame: 4 months
measure: Association of patient reported outcomes, including fatigue and ability to participate in social role and activities questions, with iPhone tests that assess mobility, fatigability and cognitive function
time frame: 4 months
measure: Evaluation of iPhone based tests of cognitive functioning and reaction time for reliability and validity
time frame: 4 months
arm group label: 1/Cohort 1
description: Participants with a diagnosis of cancer who are under active treatment on a protocol at NIH
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: James L Gulley, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2017-C-0158.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Colonic Neoplasms
sharing ipd: Yes
ipd description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Clinical data available during the study and indefinitely.
ipd access criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.