<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/NCT04475354</url>
  </required_header>
  <id_info>
    <org_study_id>NL.67509.028.18</org_study_id>
    <nct_id>NCT04475354</nct_id>
  </id_info>
  <brief_title>Distress In CErvical Cancer Patients and Partners</brief_title>
  <acronym>DICE</acronym>
  <official_title>Mechanisms Explaining Psychological Distress In CErvical Cancer Patients and Partners (DICE): a Population-based Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Comprehensive Cancer Centre The Netherlands</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tilburg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Netherlands Organisation for Scientific Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Comprehensive Cancer Centre The Netherlands</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>
      Rationale: A growing number of cervical cancer patients live years beyond their cancer&#xD;
      diagnosis and ultimately survive their disease. Cervical cancer patients report higher levels&#xD;
      of psychological distress compared to other (gynecological) cancer types, resulting in&#xD;
      physical and psychosocial limitations. The mechanisms explaining why some patients do, and&#xD;
      others do not experience persistent psychological distress after cervical cancer remain&#xD;
      unclear.&#xD;
&#xD;
      Objective: Gain insight into the mechanisms explaining psychological distress (i.e. anxiety,&#xD;
      depression, cancer worry, perceived stress) in a prospective population-based sample of&#xD;
      cervical cancer patients. Factors to be studied include characteristics of the individual&#xD;
      (demographical and clinical, including comorbidities), characteristics of the environment&#xD;
      ((sexual) relationships), biological function (cortisol, melatonin and sex hormone production&#xD;
      assessed in scalp hair, inflammation and telomere length assessed in blood, overall quality&#xD;
      of life (EORTC QLQ-C30), symptoms (EORTC QLQ-CX24), functional status (physical activity and&#xD;
      sleep measured using the Actigraph activity tracker, and food intake measured using the&#xD;
      online 'Eetmeter'), and general health perceptions (B-IPQ). The second aim is to assess the&#xD;
      impact of cervical cancer on partners' distress (cancer worry, illness perceptions,&#xD;
      relationship quality, dyadic coping).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: Prospective population-based study in which cervical cancer patients and their&#xD;
      partners are included shortly after diagnosis and followed until 10 years after diagnosis.&#xD;
      Patients from treatment centres in the Netherlands and their partners will be asked to&#xD;
      complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 year.&#xD;
      Clinical data like disease stage, initial treatment and mortality will be extracted from the&#xD;
      Netherlands Cancer Registry. In a subsample of patients, additionally objective lifestyle&#xD;
      (actigraph, biosensor) and biological (blood, hair) measures are assessed at diagnosis and&#xD;
      after 6, 12 and 24 months. .&#xD;
&#xD;
      Study population: Newly diagnosed stage 1-3 cervical cancer patients (N=520) and their&#xD;
      partners (N=312, expected) from any treatment centre in the Netherlands will be asked to fill&#xD;
      out questionnaires. In a subsample of patients (N=116) additionally lifestyle and biological&#xD;
      measures are assessed at all time-points.&#xD;
&#xD;
      Main study parameters/endpoints: psychological distress (anxiety, depression, perceived&#xD;
      stress, cancer worry)&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: Patients and partners are asked to complete a questionnaire at 6 points in time:&#xD;
      after diagnosis, after 6 months, and after 1, 2, 5 and 10 year. Patients will additionally be&#xD;
      asked to complete an online food diary for 3 days. A subsample of patients will be asked to&#xD;
      donate blood samples (2X10 ml, 10 minutes) to assess inflammation markers and telomere&#xD;
      length, to donate a scalp hair sample (10 mg) to assess hormone production after diagnosis&#xD;
      and after 6, 12 and 24 months, and to wear an Actigraph activity tracker to assess physical&#xD;
      activity and sleep and a Philips Biosensor to assess heart rate variability as a marker of&#xD;
      vagal nerve function at 6, 12 and 24 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Anticipated">January 2030</completion_date>
  <primary_completion_date type="Anticipated">January 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>Anxiety/ depression</measure>
    <time_frame>24 months</time_frame>
    <description>Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cancer worry</measure>
    <time_frame>24 months</time_frame>
    <description>Impact of Cancer version 2 (Worry Scale) (0-5, higher scores indicate more worry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>24 months</time_frame>
    <description>Perceived Stress Scale (0-40, higher scores indicate more perceived stress)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life</measure>
    <time_frame>24 months</time_frame>
    <description>EORTC Quality of Life Questionnaire (QLQC30) (0-100, higher scores indicate better quality of life or more symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical cancer health-related quality of life</measure>
    <time_frame>24 months</time_frame>
    <description>EORTC Cervical Cancer Module (CX24) (0-100, higher scores indicate better quality of life or more symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Health</measure>
    <time_frame>24 months</time_frame>
    <description>EORTC Sexual Health Questionnaire (SHQ22) (0-100, higher scores indicate better quality of life or more symptoms)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">832</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Psychologic Stress</condition>
  <condition>Psychological Distress</condition>
  <condition>Survivorship</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Cervical cancer patients and their partners</arm_group_label>
    <description>520 cervical cancer patients will complete questionnaires, online food diary and wear a fitbit after diagnosis, after 6 months, and after 1, 2, 5 and 10 years. In addition, a subsample (n=116) will donate blood samples and a scalp hair sample after diagnosis and 6, 12 and 24 months. We expect 312 partners of cervical cancer patients to included in the study and complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 years</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood: pro-and anti-inflammatory cytokines, telomere length Scalp hair: cortisol, melatonin&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All newly diagnosed I-III stage cervical cancer patients that receive primary treatment in&#xD;
        one of the treatment centres will be identified by their treating gynaecologist. Patients&#xD;
        will be invited before the start of treatment and will be followed until 10 years after&#xD;
        diagnosis. Additionally, patients will be asked to invite their partner to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patients&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed with cervical cancer stage I, II or III&#xD;
&#xD;
          -  &gt;18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with cognitive impairment will not be included because of expected&#xD;
             difficulties in completing the questionnaires without assistance.&#xD;
&#xD;
          -  Participants who are not able to read or write Dutch will be excluded, as they are not&#xD;
             able to complete a Dutch questionnaire.&#xD;
&#xD;
        Partners&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Partner of patient participating in the study&#xD;
&#xD;
          -  &gt;18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with cognitive impairment will not be included because of expected&#xD;
             difficulties in completing the questionnaires without assistance.&#xD;
&#xD;
          -  Participants who are not able to read or write Dutch will be excluded, as they are not&#xD;
             able to complete a Dutch questionnaire.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Nicole Ezendam</last_name>
    <role>Principal Investigator</role>
    <affiliation>Netherlands Comprehensive Cancer Organisation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicole Ezendam, PhD</last_name>
    <phone>+31 88 234 6096</phone>
    <email>N.Ezendam@iknl.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Belle de Rooij, PhD</last_name>
    <phone>+31 88 234 6057</phone>
    <email>B.deRooij@iknl.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Amphia</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Catharina Hospital</name>
      <address>
        <city>Eindhoven</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>UMC Utrecht</name>
      <address>
        <city>Utrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eleonora van Dorst, Dr.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <link>
    <url>https://www.profilesregistry.nl/</url>
    <description>https://www.nvog.nl/organisatie/pijler-oncologie/dgog/studies/dice-2/</description>
  </link>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Comprehensive Cancer Centre The Netherlands</investigator_affiliation>
    <investigator_full_name>Nicole Ezendam</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Neoplasms</mesh_term>
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Questionnaire data will be dissiminated 1 year after conclusion of the study. Data from the PROFILES registry are freely available for non-commercial scientific research, subject to study question, privacy and confidentiality restrictions, and registration (www.profileregistry.nl).</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/NCT04475354
org study id: NL.67509.028.18
nct id: NCT04475354
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rationale: A growing number of cervical cancer patients live years beyond their cancer
      diagnosis and ultimately survive their disease. Cervical cancer patients report higher levels
      of psychological distress compared to other (gynecological) cancer types, resulting in
      physical and psychosocial limitations. The mechanisms explaining why some patients do, and
      others do not experience persistent psychological distress after cervical cancer remain
      unclear.

      Objective: Gain insight into the mechanisms explaining psychological distress (i.e. anxiety,
      depression, cancer worry, perceived stress) in a prospective population-based sample of
      cervical cancer patients. Factors to be studied include characteristics of the individual
      (demographical and clinical, including comorbidities), characteristics of the environment
      ((sexual) relationships), biological function (cortisol, melatonin and sex hormone production
      assessed in scalp hair, inflammation and telomere length assessed in blood, overall quality
      of life (EORTC QLQ-C30), symptoms (EORTC QLQ-CX24), functional status (physical activity and
      sleep measured using the Actigraph activity tracker, and food intake measured using the
      online 'Eetmeter'), and general health perceptions (B-IPQ). The second aim is to assess the
      impact of cervical cancer on partners' distress (cancer worry, illness perceptions,
      relationship quality, dyadic coping).
Study design: Prospective population-based study in which cervical cancer patients and their
      partners are included shortly after diagnosis and followed until 10 years after diagnosis.
      Patients from treatment centres in the Netherlands and their partners will be asked to
      complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 year.
      Clinical data like disease stage, initial treatment and mortality will be extracted from the
      Netherlands Cancer Registry. In a subsample of patients, additionally objective lifestyle
      (actigraph, biosensor) and biological (blood, hair) measures are assessed at diagnosis and
      after 6, 12 and 24 months. .

      Study population: Newly diagnosed stage 1-3 cervical cancer patients (N=520) and their
      partners (N=312, expected) from any treatment centre in the Netherlands will be asked to fill
      out questionnaires. In a subsample of patients (N=116) additionally lifestyle and biological
      measures are assessed at all time-points.

      Main study parameters/endpoints: psychological distress (anxiety, depression, perceived
      stress, cancer worry)

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: Patients and partners are asked to complete a questionnaire at 6 points in time:
      after diagnosis, after 6 months, and after 1, 2, 5 and 10 year. Patients will additionally be
      asked to complete an online food diary for 3 days. A subsample of patients will be asked to
      donate blood samples (2X10 ml, 10 minutes) to assess inflammation markers and telomere
      length, to donate a scalp hair sample (10 mg) to assess hormone production after diagnosis
      and after 6, 12 and 24 months, and to wear an Actigraph activity tracker to assess physical
      activity and sleep and a Philips Biosensor to assess heart rate variability as a marker of
      vagal nerve function at 6, 12 and 24 months.
observational model: Cohort
time perspective: Prospective
measure: Anxiety/ depression
time frame: 24 months
description: Hospital Anxiety and Depression Scale (1-21, higher scores indicate more anxiety or depression)
measure: Cancer worry
time frame: 24 months
description: Impact of Cancer version 2 (Worry Scale) (0-5, higher scores indicate more worry)
measure: Perceived stress
time frame: 24 months
description: Perceived Stress Scale (0-40, higher scores indicate more perceived stress)
measure: Health-related quality of life
time frame: 24 months
description: EORTC Quality of Life Questionnaire (QLQC30) (0-100, higher scores indicate better quality of life or more symptoms)
measure: Cervical cancer health-related quality of life
time frame: 24 months
description: EORTC Cervical Cancer Module (CX24) (0-100, higher scores indicate better quality of life or more symptoms)
measure: Sexual Health
time frame: 24 months
description: EORTC Sexual Health Questionnaire (SHQ22) (0-100, higher scores indicate better quality of life or more symptoms)
arm group label: Cervical cancer patients and their partners
description: 520 cervical cancer patients will complete questionnaires, online food diary and wear a fitbit after diagnosis, after 6 months, and after 1, 2, 5 and 10 years. In addition, a subsample (n=116) will donate blood samples and a scalp hair sample after diagnosis and 6, 12 and 24 months. We expect 312 partners of cervical cancer patients to included in the study and complete questionnaires after diagnosis, after 6 months, and after 1, 2, 5 and 10 years
Blood: pro-and anti-inflammatory cytokines, telomere length Scalp hair: cortisol, melatonin
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Nicole Ezendam
role: Principal Investigator
affiliation: Netherlands Comprehensive Cancer Organisation
last name: Nicole Ezendam, PhD
phone: +31 88 234 6096
email: N.Ezendam@iknl.nl
last name: Belle de Rooij, PhD
phone: +31 88 234 6057
email: B.deRooij@iknl.nl
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
country: Netherlands
url: https://www.profilesregistry.nl/
description: https://www.nvog.nl/organisatie/pijler-oncologie/dgog/studies/dice-2/
responsible party type: Principal Investigator
investigator affiliation: Comprehensive Cancer Centre The Netherlands
investigator full name: Nicole Ezendam
investigator title: Principal Investigator
mesh term: Uterine Cervical Neoplasms
mesh term: Stress, Psychological
sharing ipd: No
ipd description: Questionnaire data will be dissiminated 1 year after conclusion of the study. Data from the PROFILES registry are freely available for non-commercial scientific research, subject to study question, privacy and confidentiality restrictions, and registration (www.profileregistry.nl).