<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/NCT03838627</url>
  </required_header>
  <id_info>
    <org_study_id>WHOOPHPP</org_study_id>
    <secondary_id>NCI-2021-05183</secondary_id>
    <nct_id>NCT03838627</nct_id>
  </id_info>
  <brief_title>Feasibility and Agreement of Remote Evaluation of Resting Heart Rate and Heart Rate Variability in Survivors of Hodgkin Lymphoma Treated With Chest Radiation (PILOT STUDY-SURVIVOR)</brief_title>
  <official_title>Feasibility and Agreement of Remote Evaluation of Resting Heart Rate and Heart Rate Variability in Survivors of Hodgkin Lymphoma Treated With Chest Radiation (PILOT STUDY-SURVIVOR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Jude Children's Research Hospital</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>
      Primary Objective The objective is to determine the feasibility and agreement of remote&#xD;
      evaluation of resting heart rate and HRV using the commercially available WHOOP® wrist&#xD;
      monitor, compared to in-office measurements using AtCor Medical SphygmoCor HRV Software, in a&#xD;
      cohort of 40 St. Jude Life Study participants with a history of mantle radiation for&#xD;
      management of Hodgkin lymphoma.&#xD;
&#xD;
      Elucidating the mechanisms that contribute to adverse cardiovascular outcomes and reduced&#xD;
      quality of life among the growing population of childhood cancer survivors is paramount.&#xD;
      Cancer, certain cancer drugs, radiation therapy, cancer-associated lifestyle disturbances,&#xD;
      and cancer-independent comorbidities combine to predispose cancer survivors to autonomic&#xD;
      dysfunction (AD). Reduced heart rate variability (HRV) has been described in various cancer&#xD;
      cohorts. Furthermore, these markers of AD have been implicated in adverse outcomes in&#xD;
      oncology patients, including increased mortality, exercise limitation, and fatigue. However,&#xD;
      data are largely derived from small studies with methodological limitations, and the&#xD;
      contribution of AD to overall morbidity and mortality in cancer survivors is not well&#xD;
      understood.&#xD;
&#xD;
      The objective is to determine the feasibility and agreement of remote evaluation of resting&#xD;
      heart rate and HRV using the commercially available WHOOP® wrist monitor, compared to&#xD;
      in-office measurements using AtCor Medical SphygmoCor HRV Software, in a cohort of 40 St.&#xD;
      Jude Life Study participants with a history of mantle radiation for management of Hodgkin&#xD;
      lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At St. Jude Children's Research Hospital survivors who meet the eligibility criteria will be&#xD;
      identified from SJLIFE participants and contacted for potential participation via phone. If&#xD;
      the SJLIFE participant expresses interest they will be e-mailed or faxed a copy of the&#xD;
      consent form; the consent conference will occur via phone and e-mail or facsimile will be&#xD;
      used to document informed consent. Once the consent signature page is received and the&#xD;
      participant is enrolled on study, a WHOOP® wrist monitor and directions for wearing the&#xD;
      device will be mailed to the participant. Feasibility will be assessed by evaluating how many&#xD;
      participants wear and return the device with enough data for analysis. The investigator will&#xD;
      consider the project feasible if 30 of 40 participants have 3 hours of usable data after&#xD;
      removal of noise. Upon arrival at St. Jude for the St Jude LIFE study, the participant will&#xD;
      undergo in-office measurement of HRV while also wearing the WHOOP® device. A standard&#xD;
      10-minute electrocardiogram recording will be performed with the participant in a supine&#xD;
      position, with a regular and calm breathing pattern in a quiet room. The standard deviation&#xD;
      of normal RR intervals (SDNN, msec) will be derived from SphygmoCor HRV Software. SDNN during&#xD;
      this 10-minute time period will be derived from WHOOP® HRV software. Agreement between&#xD;
      measures of SDNN derived by the two techniques will be assessed. A mean discrepancy of &lt;20&#xD;
      msec for SDNN measured by the two methods will be considered acceptable agreement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 5, 2019</start_date>
  <completion_date type="Actual">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">January 19, 2021</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>The number of patients who wear, return and have sufficient data for analysis of resting heart rate and HRV after removal of noise by WHOOP® HRV software data analysis algorithms.</measure>
    <time_frame>48 hours</time_frame>
    <description>Feasibility will be considered adequate if 30 of 40 participants have at least 3 hours of HRV data from the home wearing period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The degree of agreement between measurements of continuous HRV parameters derived from the two methods will be assessed using linear regression, Pearson's correlation coefficient and Bland Altman analysis.</measure>
    <time_frame>10 minute electrocardiogram recording</time_frame>
    <description>A mean discrepancy of &lt;20 msec for SDNN measured by the two methods will be considered acceptable agreement.</description>
  </primary_outcome>
  <enrollment type="Actual">34</enrollment>
  <condition>Hodgkin Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        St. Jude Patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in the SJLIFE study.&#xD;
&#xD;
          -  Survivor of childhood Hodgkin lymphoma.&#xD;
&#xD;
          -  Exposure to ≥ 20 Gy chest radiation&#xD;
&#xD;
          -  Is 18 years of age and older.&#xD;
&#xD;
          -  No evidence of cancer recurrence.&#xD;
&#xD;
          -  Non-smoker at time of study participation.&#xD;
&#xD;
          -  Willingness to avoid caffeine for 3-4 hours and alcohol for 8 hours prior to testing.&#xD;
&#xD;
          -  No history of allergic reactions to ECG electrodes.&#xD;
&#xD;
          -  Has a smart phone and is willing to download the WHOOP app to their smartphone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        NA&#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>Kirsten K Ness, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kirsten Ness</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Childen's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>Clinical Trials Open at St.Jude</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 23, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hodgkin Disease</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03838627/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03838627
org study id: WHOOPHPP
secondary id: NCI-2021-05183
nct id: NCT03838627
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Primary Objective The objective is to determine the feasibility and agreement of remote
      evaluation of resting heart rate and HRV using the commercially available WHOOP® wrist
      monitor, compared to in-office measurements using AtCor Medical SphygmoCor HRV Software, in a
      cohort of 40 St. Jude Life Study participants with a history of mantle radiation for
      management of Hodgkin lymphoma.

      Elucidating the mechanisms that contribute to adverse cardiovascular outcomes and reduced
      quality of life among the growing population of childhood cancer survivors is paramount.
      Cancer, certain cancer drugs, radiation therapy, cancer-associated lifestyle disturbances,
      and cancer-independent comorbidities combine to predispose cancer survivors to autonomic
      dysfunction (AD). Reduced heart rate variability (HRV) has been described in various cancer
      cohorts. Furthermore, these markers of AD have been implicated in adverse outcomes in
      oncology patients, including increased mortality, exercise limitation, and fatigue. However,
      data are largely derived from small studies with methodological limitations, and the
      contribution of AD to overall morbidity and mortality in cancer survivors is not well
      understood.

      The objective is to determine the feasibility and agreement of remote evaluation of resting
      heart rate and HRV using the commercially available WHOOP® wrist monitor, compared to
      in-office measurements using AtCor Medical SphygmoCor HRV Software, in a cohort of 40 St.
      Jude Life Study participants with a history of mantle radiation for management of Hodgkin
      lymphoma.
At St. Jude Children's Research Hospital survivors who meet the eligibility criteria will be
      identified from SJLIFE participants and contacted for potential participation via phone. If
      the SJLIFE participant expresses interest they will be e-mailed or faxed a copy of the
      consent form; the consent conference will occur via phone and e-mail or facsimile will be
      used to document informed consent. Once the consent signature page is received and the
      participant is enrolled on study, a WHOOP® wrist monitor and directions for wearing the
      device will be mailed to the participant. Feasibility will be assessed by evaluating how many
      participants wear and return the device with enough data for analysis. The investigator will
      consider the project feasible if 30 of 40 participants have 3 hours of usable data after
      removal of noise. Upon arrival at St. Jude for the St Jude LIFE study, the participant will
      undergo in-office measurement of HRV while also wearing the WHOOP® device. A standard
      10-minute electrocardiogram recording will be performed with the participant in a supine
      position, with a regular and calm breathing pattern in a quiet room. The standard deviation
      of normal RR intervals (SDNN, msec) will be derived from SphygmoCor HRV Software. SDNN during
      this 10-minute time period will be derived from WHOOP® HRV software. Agreement between
      measures of SDNN derived by the two techniques will be assessed. A mean discrepancy of <20
      msec for SDNN measured by the two methods will be considered acceptable agreement.
observational model: Cohort
time perspective: Prospective
measure: The number of patients who wear, return and have sufficient data for analysis of resting heart rate and HRV after removal of noise by WHOOP® HRV software data analysis algorithms.
time frame: 48 hours
description: Feasibility will be considered adequate if 30 of 40 participants have at least 3 hours of HRV data from the home wearing period.
measure: The degree of agreement between measurements of continuous HRV parameters derived from the two methods will be assessed using linear regression, Pearson's correlation coefficient and Bland Altman analysis.
time frame: 10 minute electrocardiogram recording
description: A mean discrepancy of <20 msec for SDNN measured by the two methods will be considered acceptable agreement.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kirsten K Ness, PhD
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Childen's Research Hospital
url: http://www.stjude.org/protocols
description: Clinical Trials Open at St.Jude
responsible party type: Sponsor
mesh term: Hodgkin Disease
provided document: 