<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/NCT03254836</url>
  </required_header>
  <id_info>
    <org_study_id>MTM-V3</org_study_id>
    <secondary_id>SJ-600</secondary_id>
    <nct_id>NCT03254836</nct_id>
  </id_info>
  <brief_title>Sleep and Survival in Colorectal Cancer</brief_title>
  <official_title>Sleep-wake Rhythm in the Perioperative Period in Patients Admitted for Elective Radical Surgery for Colorectal Cancer: an Observational Prospective Cohort Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Center of Surgical Science, Department of Surgery, Zealand University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zealand University Hospital</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>
      Objective The objective of the current trial is to investigate the effect of perioperative&#xD;
      sleep and circadian rhythm on the natural course of survival among patient diagnosed with&#xD;
      colorectal cancer. Concurrently, outcome measures like depression, fatigue, quality of life,&#xD;
      and co-morbidity will be measured continuously in the short-, intermediate- and long-term&#xD;
      period following diagnosis.&#xD;
&#xD;
      The a-priori hypothesis is that preoperative sleep and circadian disturbances is a prognostic&#xD;
      marker of reduced overall survival. Likewise, preoperative sleep-wake disturbances at&#xD;
      baseline are expected to result in overall universally reduced quality of life, increased&#xD;
      depression and fatigue. Furthermore, development of sleep-wake disturbances in the&#xD;
      postoperative period as compared to preoperative sleep-wake rhythm is expected to a&#xD;
      prognostic marker of negative outcomes.&#xD;
&#xD;
      Target and study population The study population are all patients diagnosed with colorectal&#xD;
      cancer in Region Zealand recruited consecutively from the trial initiation until study end&#xD;
      each patient with an intended 5 year follow-up period. All available cases will be included&#xD;
      in the trial.&#xD;
&#xD;
      Study design The study will be an observational prospective cohort study applying a&#xD;
      longituditional repeated measure design.&#xD;
&#xD;
      Exposures and outcomes of interest The primary outcomes in the trial are sleep and circadian&#xD;
      outcomes measured via actigraphy in the perioperative period.&#xD;
&#xD;
      Furthermore, cancer related survival and overall survival in the 5 year follow-up period is&#xD;
      considered primary outcomes.&#xD;
&#xD;
      Secondary outcomes consist of consecutively measured depression, fatigue, quality of life,&#xD;
      follow-up treatment and co-morbidity.&#xD;
&#xD;
      Exposure variables are primary related to the cancer, i.e. cancer stage, surgical treatment,&#xD;
      oncological treatment, baseline co-morbidity and pharmacological treatment. Some of the&#xD;
      secondary outcomes could be expected to serve as confounding or mediating factors.&#xD;
&#xD;
      Meaningful control for confounding will in the analysis phase be cancer stage and baseline&#xD;
      sleep-wake rhythm status.&#xD;
&#xD;
      Sampling methods All available cases will be sought included in the trial. No formal sample&#xD;
      size has been performed and continues inclusion into the trial will be performed during an&#xD;
      1,5 year period.&#xD;
&#xD;
      Statistical analyses The relationship between overall survival and baseline sleep-wake rhythm&#xD;
      will be investigated using survival statistics and/or multivariate logistic regression.&#xD;
&#xD;
      Expected results The investigators expect to see a marked difference in overall survival&#xD;
      among patients with sleep and circadian disturbances at baseline.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Actigraphy</measure>
    <time_frame>Approximately 1 week preoperatively to 2 weeks postoperatively</time_frame>
    <description>Assessment of activity using accelerometor - Sleep and circadian assesment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Depression Inventory</measure>
    <time_frame>Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.</time_frame>
    <description>Assesment of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.</time_frame>
    <description>Subjective sleep assesment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assesment</measure>
    <time_frame>Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.</time_frame>
    <description>EORCT-QLQ-C30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assesment</measure>
    <time_frame>Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.</time_frame>
    <description>EORCT-QLQ-CR29</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.</time_frame>
    <description>Baseline registration and follow-up assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Co-morbidity</measure>
    <time_frame>Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.</time_frame>
    <description>Baseline registration and follow-up assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug prescription history (Drug name and dosage)</measure>
    <time_frame>Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.</time_frame>
    <description>Baseline registration and follow-up assessments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Follow-up cancer treatment (Adjuvant chemotherapy, timing and duration)</measure>
    <time_frame>Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.</time_frame>
    <description>Baseline registration and follow-up assessments</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Colorectal Neoplasm</condition>
  <condition>Circadian Rhythm Sleep Disorder</condition>
  <condition>Depression</condition>
  <condition>Quality of Life</condition>
  <condition>Sleep</condition>
  <arm_group>
    <arm_group_label>Colorectal cancer undergoing elective surgery</arm_group_label>
    <description>All patients eligible for elective curative intended surgery for colonic adenocarcinoma at Zealand University Hospital.&#xD;
Patients will recieve treatment as per standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Elective radical surgery for adenocarcinoma.</description>
    <arm_group_label>Colorectal cancer undergoing elective surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients eligible for elective curative intended surgery for colonic or rectal&#xD;
        adenocarcinoma at Zealand University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of colorectal cancer as determined at the multi-disciplinary team&#xD;
             conference.&#xD;
&#xD;
          -  Admitted to elective radical surgery at the department of surgery at Zealand&#xD;
             University Hospital&#xD;
&#xD;
          -  Age above 18 years&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-ability to complete the study as assessed by the investigator&#xD;
&#xD;
          -  Non-fluent in Danish.&#xD;
&#xD;
          -  History of cognitive impairment (e.g. dementia)&#xD;
&#xD;
          -  Paralysis or inability to answer study questioners electronically.&#xD;
&#xD;
          -  Stadium 4 colonic adenocarcinoma with no surgical treatment options as determined at&#xD;
             the multi-disciplinary conference.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Michael T Madsen, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Surgery, Zealand University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Surgery, Zealand University Hospital</name>
      <address>
        <city>Roskilde</city>
        <state>Zealand</state>
        <zip>4000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zealand University Hospital</investigator_affiliation>
    <investigator_full_name>Michael Tvilling Madsen</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Actigraphy</keyword>
  <keyword>Major Depression Inventory (MDI)</keyword>
  <keyword>Insomnia Severity Index (ISI)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Sleep Wake Disorders</mesh_term>
    <mesh_term>Sleep Disorders, Circadian Rhythm</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Contact to study investigators avaliable at mitm@regionsjaelland.dk</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/NCT03254836
org study id: MTM-V3
secondary id: SJ-600
nct id: NCT03254836
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective The objective of the current trial is to investigate the effect of perioperative
      sleep and circadian rhythm on the natural course of survival among patient diagnosed with
      colorectal cancer. Concurrently, outcome measures like depression, fatigue, quality of life,
      and co-morbidity will be measured continuously in the short-, intermediate- and long-term
      period following diagnosis.

      The a-priori hypothesis is that preoperative sleep and circadian disturbances is a prognostic
      marker of reduced overall survival. Likewise, preoperative sleep-wake disturbances at
      baseline are expected to result in overall universally reduced quality of life, increased
      depression and fatigue. Furthermore, development of sleep-wake disturbances in the
      postoperative period as compared to preoperative sleep-wake rhythm is expected to a
      prognostic marker of negative outcomes.

      Target and study population The study population are all patients diagnosed with colorectal
      cancer in Region Zealand recruited consecutively from the trial initiation until study end
      each patient with an intended 5 year follow-up period. All available cases will be included
      in the trial.

      Study design The study will be an observational prospective cohort study applying a
      longituditional repeated measure design.

      Exposures and outcomes of interest The primary outcomes in the trial are sleep and circadian
      outcomes measured via actigraphy in the perioperative period.

      Furthermore, cancer related survival and overall survival in the 5 year follow-up period is
      considered primary outcomes.

      Secondary outcomes consist of consecutively measured depression, fatigue, quality of life,
      follow-up treatment and co-morbidity.

      Exposure variables are primary related to the cancer, i.e. cancer stage, surgical treatment,
      oncological treatment, baseline co-morbidity and pharmacological treatment. Some of the
      secondary outcomes could be expected to serve as confounding or mediating factors.

      Meaningful control for confounding will in the analysis phase be cancer stage and baseline
      sleep-wake rhythm status.

      Sampling methods All available cases will be sought included in the trial. No formal sample
      size has been performed and continues inclusion into the trial will be performed during an
      1,5 year period.

      Statistical analyses The relationship between overall survival and baseline sleep-wake rhythm
      will be investigated using survival statistics and/or multivariate logistic regression.

      Expected results The investigators expect to see a marked difference in overall survival
      among patients with sleep and circadian disturbances at baseline.
observational model: Cohort
time perspective: Prospective
measure: Actigraphy
time frame: Approximately 1 week preoperatively to 2 weeks postoperatively
description: Assessment of activity using accelerometor - Sleep and circadian assesment.
measure: Major Depression Inventory
time frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.
description: Assesment of depression
measure: Insomnia Severity Index
time frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.
description: Subjective sleep assesment
measure: Quality of life assesment
time frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.
description: EORCT-QLQ-C30
measure: Quality of life assesment
time frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.
description: EORCT-QLQ-CR29
measure: Mortality
time frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.
description: Baseline registration and follow-up assessments
measure: Co-morbidity
time frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.
description: Baseline registration and follow-up assessments
measure: Drug prescription history (Drug name and dosage)
time frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.
description: Baseline registration and follow-up assessments
measure: Follow-up cancer treatment (Adjuvant chemotherapy, timing and duration)
time frame: Baseline (approx. 1 week preoperatively), 2 weeks postoperatively, 3 months postoperatively, 6 months postoperatively, 12 months postoperativly, 24 months postoperatively, 36 months postoperatively, 60 months postoperatively.
description: Baseline registration and follow-up assessments
arm group label: Colorectal cancer undergoing elective surgery
description: All patients eligible for elective curative intended surgery for colonic adenocarcinoma at Zealand University Hospital.
Patients will recieve treatment as per standard of care.
intervention type: Other
intervention name: Standard of care
description: Elective radical surgery for adenocarcinoma.
arm group label: Colorectal cancer undergoing elective surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Michael T Madsen, M.D.
role: Principal Investigator
affiliation: Department of Surgery, Zealand University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Zealand University Hospital
investigator full name: Michael Tvilling Madsen
investigator title: M.D.
mesh term: Colorectal Neoplasms
mesh term: Sleep Wake Disorders
mesh term: Sleep Disorders, Circadian Rhythm
mesh term: Depression
sharing ipd: Undecided
ipd description: Contact to study investigators avaliable at mitm@regionsjaelland.dk