xml: <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/NCT06023654</url>
    </required_header>
    <id_info>
      <org_study_id>1926A</org_study_id>
      <nct_id>NCT06023654</nct_id>
    </id_info>
    <brief_title>Identifying Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer</brief_title>
    <official_title>Preliminary Validation of a Novel Screening Tool and Diagnostic Criteria to Identify Circadian Rest-Activity Rhythm Disorders in Patients With Advanced Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Dublin, Trinity College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Our Lady's Hospice and Care Services</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Dublin, Trinity College</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>
        Circadian rest-Activity Rhythm disorders (CARDs) are common in patients with cancer,&#xD;
        particularly in advanced disease. CARDs are associated with increased symptoms, poorer&#xD;
        quality of life, poorer response to anticancer treatments and shorter survival.&#xD;
  &#xD;
        The goal of this observational study is to see how common CARDs are in patients with advanced&#xD;
        cancer and to characterise their rest and activity patterns in more detail.&#xD;
  &#xD;
        A recent study has outlined a standard way to assess and diagnose a CARD.&#xD;
  &#xD;
        This study aims to assess patients with advanced cancer for a CARD using a novel screening&#xD;
        tool against this newly formed diagnostic criteria. Potentially modifiable risk factors will&#xD;
        be considered along with associations between CARDs and symptoms, sleep preferences, sleep&#xD;
        quality, daytime sleepiness, quality of life measures and predictors of survival.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 15, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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>To measure preliminary concurrent validity of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer against diagnostic criteria</measure>
      <time_frame>Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Assessing the sensitivity and specificity of the screening tool</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>To measure test-retest reliability of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer</measure>
      <time_frame>Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Assessing the correlation between scores from the screening tool at two time points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To measure acceptability and ease of use of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Patient ease of use, understandability, acceptability and time to complete.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To measure acceptability and ease of use of a novel sleep and activity diary in patients with advanced cancer</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Patient ease of use, understandability, and acceptability</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To identify the incidence of Circadian rest-activity Rhythm Disorders in patients with advanced cancer</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Incidence of Circadian rest-Activity Rhythm Disorders as identified by diagnostic criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess rest and physical activity patterns in patients with advanced cancer</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Combined assessment using wrist and thigh accelerometry alongside a sleep and activity diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the relationship between demographic details and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Baseline demographic details collected using a questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the relationship between past medical history and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Past medical history collected using a questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the relationship between current medication use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Current medication use collected using a questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the relationship between chronotype and the risk of develop a Circadian rest-Activity Rhythms in patients with cancer</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Chronotype assessed using the Morningness-Eveningness Questionnaire (MEQ)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the relationship between occupation and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Occupation provided by participant using a questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the relationship between cigarette use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer</measure>
      <time_frame>During 72 hours period of monitoring</time_frame>
      <description>Number and timing of last cigarette smoked each day assessed using a patient diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the relationship between alcohol consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer</measure>
      <time_frame>During 72 hours period of monitoring</time_frame>
      <description>Number and timing of alcoholic beverages consumed each day assessed using a patient diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess the relationship between caffeine consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer</measure>
      <time_frame>During 72 hours period of monitoring</time_frame>
      <description>Number and timing of last of caffeinated drink consumed each day assessed using a patient diary</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with symptoms</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Symptoms measured using the Memorial Symptom Assessment Scale - Short Form (MSAS-SF)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer and prognosis</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Prognosis measured using the Prognosis in Palliative Care tool (PiPS-B)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with quality of life</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Quality of Life measured using the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with sleep quality</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Sleep quality measured using the brief Pittsburgh Sleep Quality Instrument (bPSQI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with daytime sleepiness</measure>
      <time_frame>Time 2 (after 72 consecutive hours of accelerometry monitoring)</time_frame>
      <description>Daytime sleepiness assess using the Epworth Sleepiness Scale</description>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Cancer</condition>
    <condition>Circadian Rhythm Disorders</condition>
    <condition>Sleep Disturbance</condition>
    <condition>Activity, Motor</condition>
    <condition>Accelerometry</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with locally advanced or metastatic cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult (18 years of age or older)&#xD;
  &#xD;
            -  Locally advanced or metastatic cancer&#xD;
  &#xD;
            -  Outpatient&#xD;
  &#xD;
            -  Ambulatory&#xD;
  &#xD;
            -  Prognosis of 3 months or more&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inpatient&#xD;
  &#xD;
            -  Shiftworker&#xD;
  &#xD;
            -  Recent long-haul travel&#xD;
  &#xD;
            -  Cognitive impairment impacting on ability to complete questionnaires&#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_contact>
      <last_name>Craig Gouldthorpe</last_name>
      <phone>+35314986235</phone>
      <email>gouldthc@tcd.ie</email>
    </overall_contact>
    <location>
      <facility>
        <name>Our Lady's Hospice &amp; Care Services</name>
        <address>
          <city>Dublin</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Craig Gouldthorpe</last_name>
        <email>gouldthc@tcd.ie</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>St James's Hospital</name>
        <address>
          <city>Dublin</city>
          <country>Ireland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Craig Gouldthorpe</last_name>
        <email>gouldthc@tcd.ie</email>
      </contact>
    </location>
    <location_countries>
      <country>Ireland</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 9, 2022</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Dublin, Trinity College</investigator_affiliation>
      <investigator_full_name>Prof Andrew Davies</investigator_full_name>
      <investigator_title>Professor of Palliative Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyssomnias</mesh_term>
      <mesh_term>Parasomnias</mesh_term>
      <mesh_term>Chronobiology Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06023654
  org study id: 1926A
  nct id: NCT06023654
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Circadian rest-Activity Rhythm disorders (CARDs) are common in patients with cancer,
        particularly in advanced disease. CARDs are associated with increased symptoms, poorer
        quality of life, poorer response to anticancer treatments and shorter survival.
  
        The goal of this observational study is to see how common CARDs are in patients with advanced
        cancer and to characterise their rest and activity patterns in more detail.
  
        A recent study has outlined a standard way to assess and diagnose a CARD.
  
        This study aims to assess patients with advanced cancer for a CARD using a novel screening
        tool against this newly formed diagnostic criteria. Potentially modifiable risk factors will
        be considered along with associations between CARDs and symptoms, sleep preferences, sleep
        quality, daytime sleepiness, quality of life measures and predictors of survival.
  observational model: Cohort
  time perspective: Prospective
  measure: To measure preliminary concurrent validity of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer against diagnostic criteria
  time frame: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Assessing the sensitivity and specificity of the screening tool
  measure: To measure test-retest reliability of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
  time frame: Time 1 (baseline), Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Assessing the correlation between scores from the screening tool at two time points
  measure: To measure acceptability and ease of use of a novel screening tool to identify Circadian rest-Activity Rhythm Disorders in patients with advanced cancer
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Patient ease of use, understandability, acceptability and time to complete.
  measure: To measure acceptability and ease of use of a novel sleep and activity diary in patients with advanced cancer
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Patient ease of use, understandability, and acceptability
  measure: To identify the incidence of Circadian rest-activity Rhythm Disorders in patients with advanced cancer
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Incidence of Circadian rest-Activity Rhythm Disorders as identified by diagnostic criteria
  measure: To assess rest and physical activity patterns in patients with advanced cancer
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Combined assessment using wrist and thigh accelerometry alongside a sleep and activity diary
  measure: To assess the relationship between demographic details and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Baseline demographic details collected using a questionnaire
  measure: To assess the relationship between past medical history and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Past medical history collected using a questionnaire
  measure: To assess the relationship between current medication use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Current medication use collected using a questionnaire
  measure: To assess the relationship between chronotype and the risk of develop a Circadian rest-Activity Rhythms in patients with cancer
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Chronotype assessed using the Morningness-Eveningness Questionnaire (MEQ)
  measure: To assess the relationship between occupation and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Occupation provided by participant using a questionnaire
  measure: To assess the relationship between cigarette use and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
  time frame: During 72 hours period of monitoring
  description: Number and timing of last cigarette smoked each day assessed using a patient diary
  measure: To assess the relationship between alcohol consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
  time frame: During 72 hours period of monitoring
  description: Number and timing of alcoholic beverages consumed each day assessed using a patient diary
  measure: To assess the relationship between caffeine consumption and the risk of developing a Circadian rest-Activity Rhythms in patients with cancer
  time frame: During 72 hours period of monitoring
  description: Number and timing of last of caffeinated drink consumed each day assessed using a patient diary
  measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with symptoms
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Symptoms measured using the Memorial Symptom Assessment Scale - Short Form (MSAS-SF)
  measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer and prognosis
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Prognosis measured using the Prognosis in Palliative Care tool (PiPS-B)
  measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with quality of life
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Quality of Life measured using the EORTC Quality of Life Questionnaire (EORTC-QLQ-C30)
  measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with sleep quality
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Sleep quality measured using the brief Pittsburgh Sleep Quality Instrument (bPSQI)
  measure: To assess associations between Circadian rest-activity Rhythm Disorders in patients with advanced cancer with daytime sleepiness
  time frame: Time 2 (after 72 consecutive hours of accelerometry monitoring)
  description: Daytime sleepiness assess using the Epworth Sleepiness Scale
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Craig Gouldthorpe
  phone: +35314986235
  email: gouldthc@tcd.ie
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Ireland
  responsible party type: Principal Investigator
  investigator affiliation: University of Dublin, Trinity College
  investigator full name: Prof Andrew Davies
  investigator title: Professor of Palliative Medicine
  mesh term: Dyssomnias
  mesh term: Parasomnias
  mesh term: Chronobiology Disorders