<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/NCT03281447</url>
  </required_header>
  <id_info>
    <org_study_id>020-2016-NQ</org_study_id>
    <secondary_id>2008-58-0035</secondary_id>
    <nct_id>NCT03281447</nct_id>
  </id_info>
  <brief_title>Nurse Navigation Versus Current Care Coordination During Colorectal Cancer Trajectories</brief_title>
  <acronym>NaviCan</acronym>
  <official_title>NaviCan. Navigation and Support to Cancer Patients - A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Slagelse Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Region Zealand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Odense Patient Data Explorative Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In western countries, the number of cancer survivors increases, and current cancer care seems&#xD;
      insufficient with both patients' experiences of lack of help in transitions and up to 60 % of&#xD;
      the patients having psychological problems after treatment. Further, Denmark shall have new&#xD;
      hospitals, where researchers and healthcare professionals are expected to merge tasks and&#xD;
      reach a higher patient experienced quality of care, without additional costs, so a better way&#xD;
      to provide cancer care, which benefits the patients and supports the ideas within the new&#xD;
      hospitals in Denmark, is needed.&#xD;
&#xD;
      In a randomized controlled trial, the organizational structure of the healthcare system is&#xD;
      challenged and the impact of a coherent nurse navigation practice compared to the currently&#xD;
      existing department-specific care coordination is tested. The primary data are changes in&#xD;
      patients' self-reported cancer-related self-efficacy from inclusion till one week after&#xD;
      receipt of the information that they have reached the end of treatment, or in case of&#xD;
      prolonged treatment, till not later than one year after inclusion.&#xD;
&#xD;
      Patients can participate if they are 18 years of age or older, speak and understand Danish,&#xD;
      and have a proven lesion suspected of cancer in the colon or rectum after colonoscopy or&#xD;
      sigmoidoscopy at the Danish endoscopy centers at Odense University Hospital (the cities:&#xD;
      Nyborg, Svendborg and Odense) or at Slagelse Hospital. Furthermore, participants must not be&#xD;
      mentally retarded, they must not suffer from a constant life-threatening disease, and they&#xD;
      must not suffer from, or be in the diagnostic phase of, dementia or severe psychiatric&#xD;
      disease.&#xD;
&#xD;
      Participants are allocated to support from nurse navigation or to current care coordination,&#xD;
      and fill in four questionnaires during their cancer trajectory: 1) At inclusion, 2) Three&#xD;
      days before treatment start, 3) One week after receipt of information about treatment end or&#xD;
      not later than one year after inclusion, and 4) Six weeks after measure point 3. Data is&#xD;
      analyzed using suitable statistical models.&#xD;
&#xD;
      With positive results, participants in nurse navigation are better helped during their cancer&#xD;
      trajectory and have a better psychological start on the rest of their lives after cancer&#xD;
      treatment. Focus will be on colon and rectum cancer care, but the results will be&#xD;
      transferable to similar settings. Furthermore, positive results will support changes in the&#xD;
      onset of rehabilitation initiatives.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary hypothesis in this study is:&#xD;
&#xD;
      Nurse navigation, as a specific, defined concept of coherent help through cancer&#xD;
      trajectories, will prove superior to current care coordination with regard to patients'&#xD;
      self-evaluated self-efficacy for cancer from inclusion to one week after receipt of&#xD;
      information about treatment end or not later than one year after inclusion.&#xD;
&#xD;
      Allocation The randomization will be stratified by age and gender. The rational is that age&#xD;
      and gender is differently associated with benefit by a given care.&#xD;
&#xD;
      Data collection Participants fill in questionnaires at four measurements, and supplements to&#xD;
      sociodemographic information as well as information for an economic evaluation is collected&#xD;
      from provider side.&#xD;
&#xD;
      The questionnaires for participants are available in paper and electronically, and&#xD;
      participants are allowed to discuss the individual questions with a person whom they trust&#xD;
      before filling in their answers. If a participant is blind or dyslexic and has no one to help&#xD;
      them fill in the questionnaires, a trained study nurse will read out loud the questions and&#xD;
      fill in the participant's answers, and eventually in this process, listen to the&#xD;
      participant's pros and cons, acknowledge that they are heard, ask for an answer and read out&#xD;
      loud the question again. All data are stored in Research Electronic Data Capture (RedCap).&#xD;
&#xD;
      Blinding The trial is not blinded but all participants are told, there is no favorite group.&#xD;
      The statistician is blinded to randomization group and this blinding will be unveiled after&#xD;
      the data is analyzed.&#xD;
&#xD;
      Statistics Data are analyzed following the modified intention-to-treat principle, which is&#xD;
      carried out by a senior statistician in close collaboration with the research group. Usual&#xD;
      descriptive statistics will be used to summarize baseline and subject characteristics. The&#xD;
      analyses of the primary endpoint, i.e. change in self-evaluated self-efficacy for cancer from&#xD;
      inclusion (measurement 1) to end of treatment (measurement 3), and the secondary outcomes are&#xD;
      done using analysis of covariance of the measure at measurement 3 with randomization group as&#xD;
      a factor and measure at measurement 1 as covariate. In secondary analyses for all endpoints&#xD;
      (measurement 1-4), the change over time will be investigated by mixed effects repeated&#xD;
      measures analysis with randomization group as factor and random effects for subjects. These&#xD;
      analyses are repeated within the subgroup of all cancer patients and the subgroup of cancer&#xD;
      patients treated with curative aim. In the subgroup analyses, the influence of relevant&#xD;
      subject-level confounders such as age, disease-stage, treatment, etc. will be explored, and&#xD;
      appropriate adjustment will be performed. An economic evaluation will be performed for each&#xD;
      randomized group and compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 26, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 23, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self evaluated Self Efficacy for Cancer</measure>
    <time_frame>Change in &quot;Cancer Behaviour Inventory - Brief&quot; from inclusion to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.</time_frame>
    <description>Cancer Behaviour Inventory - Brief</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self evaluated Self Efficacy for Cancer</measure>
    <time_frame>Change in &quot;Cancer Behaviour Inventory - Brief&quot; from inclusion to three days before treatment start.</time_frame>
    <description>Cancer Behaviour Inventory - Brief</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self evaluated Self Efficacy for Cancer</measure>
    <time_frame>Change in &quot;Cancer Behaviour Inventory - Brief&quot; from inclusion to six weeks after measurement 3.</time_frame>
    <description>Cancer Behaviour Inventory - Brief</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self evaluated Self Efficacy for Cancer</measure>
    <time_frame>Change in &quot;Cancer Behaviour Inventory - Brief&quot; from three days before treatment start to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.</time_frame>
    <description>Cancer Behaviour Inventory - Brief</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self evaluated Self Efficacy for Cancer</measure>
    <time_frame>Change in &quot;Cancer Behaviour Inventory - Brief&quot; from three days before treatment start to six weeks after measurement 3.</time_frame>
    <description>Cancer Behaviour Inventory - Brief</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self evaluated Self Efficacy for Cancer</measure>
    <time_frame>Change in &quot;Cancer Behaviour Inventory - Brief&quot; from one week after measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion to six weeks after measure point 3.</time_frame>
    <description>Cancer Behaviour Inventory - Brief</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuity of care</measure>
    <time_frame>Change in &quot;Continuity of care&quot; from inclusion to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.</time_frame>
    <description>Qualitatively validated questions answered by participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuity of care</measure>
    <time_frame>Change in &quot;Continuity of care&quot; from inclusion to three days before treatment start.</time_frame>
    <description>Qualitatively validated questions answered by participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuity of care</measure>
    <time_frame>Change in &quot;Continuity of care&quot; from inclusion to six weeks after measurement 3.</time_frame>
    <description>Qualitatively validated questions answered by participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuity of care</measure>
    <time_frame>Change in &quot;Continuity of care&quot; from three days before treatment start to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.</time_frame>
    <description>Qualitatively validated questions answered by participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuity of care</measure>
    <time_frame>Change in &quot;Continuity of care&quot; from three days before treatment start to six weeks after measurement 3.</time_frame>
    <description>Qualitatively validated questions answered by participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuity of care</measure>
    <time_frame>Change in &quot;Continuity of care&quot; from one week after measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion to six weeks after measure point 3.</time_frame>
    <description>Qualitatively validated questions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unmet needs</measure>
    <time_frame>Change in &quot;Unmet needs&quot; from three days before treatment start to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.</time_frame>
    <description>Patients experienced needs and degree of fulfilled support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unmet needs</measure>
    <time_frame>Change in &quot;Unmet needs&quot; from three days before treatment start to six weeks after measurement 3.</time_frame>
    <description>Patients experienced needs and degree of fulfilled support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unmet needs</measure>
    <time_frame>Change in &quot;Cancer Behaviour Inventory - Brief&quot; from one week after measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion to six weeks after measure point 3.</time_frame>
    <description>Patients experienced needs and degree of fulfilled support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life</measure>
    <time_frame>Change in &quot;Health-related Quality of Life&quot; from three days before treatment start to six weeks after measurement 3.</time_frame>
    <description>European Organisation for Research and Treatment of Cancer Quality of life questionnaire with 30 questions (EORCT QLQ-c30).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Self Efficacy</condition>
  <condition>Continuity of Care</condition>
  <condition>Quality of Life</condition>
  <condition>Colorectal Neoplasms</condition>
  <condition>Case Management</condition>
  <arm_group>
    <arm_group_label>Nurse navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Coherent navigation and support from a family-centred viewpoint throughout the cancer trajectory, despite the individual patient's affiliation to any department.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Current care coordination</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Department-specific coordination and answers to questions from a patient-centred viewpoint.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nurse navigation</intervention_name>
    <arm_group_label>Nurse navigation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Current care coordination</intervention_name>
    <arm_group_label>Current care coordination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Lesions suspected for cancer in the colon or rectum recognized through colonoscopy or&#xD;
             sigmoidoscopy found at scopy centres in Odense, Nyborg, Svendborg or Slagelse, all in&#xD;
             Denmark&#xD;
&#xD;
          -  Can speak and understand Danish.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Life-threatening disease: score 4 in the American Society of Anaesthesiologists status&#xD;
             classification system.&#xD;
&#xD;
          -  Dementia ( Diagnosed or in a diagnostic phase).&#xD;
&#xD;
          -  Severe psychiatric disease ( Diagnosed or in a diagnostic phase).&#xD;
&#xD;
          -  Mentally retarded ( Diagnosed or in a diagnostic phase).&#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>Lise Fillion, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Nursing Faculty, Laval University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jens Søndergaard, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Research Unit of General Practice, Faculty of Health Sciences, University of Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marianne K Thygesen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark and OPEN at Region of Southern Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Niels Qvist, DMSc</last_name>
    <role>Study Director</role>
    <affiliation>Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark</affiliation>
  </overall_official>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>April 2, 2019</last_update_submitted>
  <last_update_submitted_qc>April 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Marianne K. Thygesen</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Nurse navigation</keyword>
  <keyword>Family</keyword>
  <keyword>Self Efficacy</keyword>
  <keyword>Needs assessment</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Case Management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03281447
org study id: 020-2016-NQ
secondary id: 2008-58-0035
nct id: NCT03281447
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
In western countries, the number of cancer survivors increases, and current cancer care seems
      insufficient with both patients' experiences of lack of help in transitions and up to 60 % of
      the patients having psychological problems after treatment. Further, Denmark shall have new
      hospitals, where researchers and healthcare professionals are expected to merge tasks and
      reach a higher patient experienced quality of care, without additional costs, so a better way
      to provide cancer care, which benefits the patients and supports the ideas within the new
      hospitals in Denmark, is needed.

      In a randomized controlled trial, the organizational structure of the healthcare system is
      challenged and the impact of a coherent nurse navigation practice compared to the currently
      existing department-specific care coordination is tested. The primary data are changes in
      patients' self-reported cancer-related self-efficacy from inclusion till one week after
      receipt of the information that they have reached the end of treatment, or in case of
      prolonged treatment, till not later than one year after inclusion.

      Patients can participate if they are 18 years of age or older, speak and understand Danish,
      and have a proven lesion suspected of cancer in the colon or rectum after colonoscopy or
      sigmoidoscopy at the Danish endoscopy centers at Odense University Hospital (the cities:
      Nyborg, Svendborg and Odense) or at Slagelse Hospital. Furthermore, participants must not be
      mentally retarded, they must not suffer from a constant life-threatening disease, and they
      must not suffer from, or be in the diagnostic phase of, dementia or severe psychiatric
      disease.

      Participants are allocated to support from nurse navigation or to current care coordination,
      and fill in four questionnaires during their cancer trajectory: 1) At inclusion, 2) Three
      days before treatment start, 3) One week after receipt of information about treatment end or
      not later than one year after inclusion, and 4) Six weeks after measure point 3. Data is
      analyzed using suitable statistical models.

      With positive results, participants in nurse navigation are better helped during their cancer
      trajectory and have a better psychological start on the rest of their lives after cancer
      treatment. Focus will be on colon and rectum cancer care, but the results will be
      transferable to similar settings. Furthermore, positive results will support changes in the
      onset of rehabilitation initiatives.
The primary hypothesis in this study is:

      Nurse navigation, as a specific, defined concept of coherent help through cancer
      trajectories, will prove superior to current care coordination with regard to patients'
      self-evaluated self-efficacy for cancer from inclusion to one week after receipt of
      information about treatment end or not later than one year after inclusion.

      Allocation The randomization will be stratified by age and gender. The rational is that age
      and gender is differently associated with benefit by a given care.

      Data collection Participants fill in questionnaires at four measurements, and supplements to
      sociodemographic information as well as information for an economic evaluation is collected
      from provider side.

      The questionnaires for participants are available in paper and electronically, and
      participants are allowed to discuss the individual questions with a person whom they trust
      before filling in their answers. If a participant is blind or dyslexic and has no one to help
      them fill in the questionnaires, a trained study nurse will read out loud the questions and
      fill in the participant's answers, and eventually in this process, listen to the
      participant's pros and cons, acknowledge that they are heard, ask for an answer and read out
      loud the question again. All data are stored in Research Electronic Data Capture (RedCap).

      Blinding The trial is not blinded but all participants are told, there is no favorite group.
      The statistician is blinded to randomization group and this blinding will be unveiled after
      the data is analyzed.

      Statistics Data are analyzed following the modified intention-to-treat principle, which is
      carried out by a senior statistician in close collaboration with the research group. Usual
      descriptive statistics will be used to summarize baseline and subject characteristics. The
      analyses of the primary endpoint, i.e. change in self-evaluated self-efficacy for cancer from
      inclusion (measurement 1) to end of treatment (measurement 3), and the secondary outcomes are
      done using analysis of covariance of the measure at measurement 3 with randomization group as
      a factor and measure at measurement 1 as covariate. In secondary analyses for all endpoints
      (measurement 1-4), the change over time will be investigated by mixed effects repeated
      measures analysis with randomization group as factor and random effects for subjects. These
      analyses are repeated within the subgroup of all cancer patients and the subgroup of cancer
      patients treated with curative aim. In the subgroup analyses, the influence of relevant
      subject-level confounders such as age, disease-stage, treatment, etc. will be explored, and
      appropriate adjustment will be performed. An economic evaluation will be performed for each
      randomized group and compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Self evaluated Self Efficacy for Cancer
time frame: Change in "Cancer Behaviour Inventory - Brief" from inclusion to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.
description: Cancer Behaviour Inventory - Brief
measure: Self evaluated Self Efficacy for Cancer
time frame: Change in "Cancer Behaviour Inventory - Brief" from inclusion to three days before treatment start.
description: Cancer Behaviour Inventory - Brief
measure: Self evaluated Self Efficacy for Cancer
time frame: Change in "Cancer Behaviour Inventory - Brief" from inclusion to six weeks after measurement 3.
description: Cancer Behaviour Inventory - Brief
measure: Self evaluated Self Efficacy for Cancer
time frame: Change in "Cancer Behaviour Inventory - Brief" from three days before treatment start to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.
description: Cancer Behaviour Inventory - Brief
measure: Self evaluated Self Efficacy for Cancer
time frame: Change in "Cancer Behaviour Inventory - Brief" from three days before treatment start to six weeks after measurement 3.
description: Cancer Behaviour Inventory - Brief
measure: Self evaluated Self Efficacy for Cancer
time frame: Change in "Cancer Behaviour Inventory - Brief" from one week after measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion to six weeks after measure point 3.
description: Cancer Behaviour Inventory - Brief
measure: Continuity of care
time frame: Change in "Continuity of care" from inclusion to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.
description: Qualitatively validated questions answered by participants
measure: Continuity of care
time frame: Change in "Continuity of care" from inclusion to three days before treatment start.
description: Qualitatively validated questions answered by participants
measure: Continuity of care
time frame: Change in "Continuity of care" from inclusion to six weeks after measurement 3.
description: Qualitatively validated questions answered by participants
measure: Continuity of care
time frame: Change in "Continuity of care" from three days before treatment start to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.
description: Qualitatively validated questions answered by participants
measure: Continuity of care
time frame: Change in "Continuity of care" from three days before treatment start to six weeks after measurement 3.
description: Qualitatively validated questions answered by participants
measure: Continuity of care
time frame: Change in "Continuity of care" from one week after measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion to six weeks after measure point 3.
description: Qualitatively validated questions
measure: Unmet needs
time frame: Change in "Unmet needs" from three days before treatment start to measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion.
description: Patients experienced needs and degree of fulfilled support
measure: Unmet needs
time frame: Change in "Unmet needs" from three days before treatment start to six weeks after measurement 3.
description: Patients experienced needs and degree of fulfilled support
measure: Unmet needs
time frame: Change in "Cancer Behaviour Inventory - Brief" from one week after measurement 3: one week after receipt of information about treatment end or not later than one year after inclusion to six weeks after measure point 3.
description: Patients experienced needs and degree of fulfilled support
measure: Health-related Quality of Life
time frame: Change in "Health-related Quality of Life" from three days before treatment start to six weeks after measurement 3.
description: European Organisation for Research and Treatment of Cancer Quality of life questionnaire with 30 questions (EORCT QLQ-c30).
arm group label: Nurse navigation
arm group type: Experimental
description: Coherent navigation and support from a family-centred viewpoint throughout the cancer trajectory, despite the individual patient's affiliation to any department.
arm group label: Current care coordination
arm group type: Active Comparator
description: Department-specific coordination and answers to questions from a patient-centred viewpoint.
intervention type: Other
intervention name: Nurse navigation
arm group label: Nurse navigation
intervention type: Other
intervention name: Current care coordination
arm group label: Current care coordination
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lise Fillion, PhD
role: Study Chair
affiliation: Nursing Faculty, Laval University
last name: Jens Søndergaard, PhD
role: Study Chair
affiliation: Research Unit of General Practice, Faculty of Health Sciences, University of Southern Denmark
last name: Marianne K Thygesen, PhD
role: Principal Investigator
affiliation: Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark and OPEN at Region of Southern Denmark
last name: Niels Qvist, DMSc
role: Study Director
affiliation: Surgery department A, Clinical Institute, Faculty of Health Sciences, University of Southern Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Marianne K. Thygesen
investigator title: Associate professor
mesh term: Colorectal Neoplasms
sharing ipd: No