<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/NCT03814213</url>
  </required_header>
  <id_info>
    <org_study_id>90-days mortality</org_study_id>
    <nct_id>NCT03814213</nct_id>
  </id_info>
  <brief_title>Effect of Comprehensive Geriatric Assessment on Short-time Mortality in Elderly Cancer Patients</brief_title>
  <official_title>Effect of Comprehensive Geriatric Assessment on Short-time Mortality in Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Danish Cancer Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Older cancer patients referred to Oncology outpatient Clinic at Aarhus University Hospital&#xD;
      have for a period been offered Comprehensive geriatric Assessment (CGA) as part of a routine&#xD;
      practice. Oncology Department was responsible for planning the CGA. A number of patients did&#xD;
      however not recieve this offer as planning failed. This Group of patients will be compared to&#xD;
      patients recieving Geriatric assessment.&#xD;
&#xD;
      Patients recieving CGA is part of a Randomised controlled study (ID: NCT02837679) comparing&#xD;
      CGA without 90 days follow-up to CGA with 90 days of Comprehensive geriatric care.&#xD;
&#xD;
      Patients are identified from electronic medical files. Data regarding death is obtained from&#xD;
      Medical files.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria:&#xD;
&#xD;
        -  70 years or more&#xD;
&#xD;
        -  Cancer of the head and neck (HNC), lung (LC), upper gastro-intestinal- tract (UGI) or&#xD;
           colo-rectal cancer (CRC)&#xD;
&#xD;
        -  Referred to the Outpatient Clinic at department of oncology at Aarhus University&#xD;
           Hospital for cancer treatment.&#xD;
&#xD;
        -  Living in Aarhus, Favrskov, Odder or Skanderborg Municipalities&#xD;
&#xD;
      Exclusion:&#xD;
&#xD;
      - Referred for specialised palliative care&#xD;
&#xD;
      Patients with both newly diagnosed cancer disease and patients with a relapse of previously&#xD;
      treated cancer disease are included. Patients qualify for participation regardless of the&#xD;
      stage of the cancer disease and regardless if specific cancer treatment is initiated.&#xD;
&#xD;
      The oncology department is responsible for identifying patients and informing of the planned&#xD;
      CGA.&#xD;
&#xD;
      All potential patients referred to the oncology outpatient clinic are identified by&#xD;
      retrospective review of lists of planned consultations in the oncology department out patient&#xD;
      clinic available in the electronic medical file approximately once a week. By this procedure&#xD;
      patients who were not informed of the possibility of having a CGA are identified (Group1)&#xD;
      Patients who are referred for geriatric evaluation have a complete CGA at baseline. The CGA&#xD;
      comprises 7 instruments for assessing health: Activities of Daily Living (ADL) and&#xD;
      Instrumental Activities of Daily Living (IADL) for autonomy, Mini Nutritional Status (MNA)&#xD;
      for nutritional state, Mini Mental State Examination (MMSE) for Cognitive state, Geriatric&#xD;
      Depression Scale 15-item (GDS) for mood and Cumulative Illness Rating Scale - Geriatrics&#xD;
      (CIRS-G) for comorbidity and number of daily medication for polypharmacy as previously&#xD;
      published. According to CGA, patients were given a CGA-status of &quot;fit&quot;, &quot;vulnerable&quot; or&#xD;
      &quot;frail&quot;. In order to be &quot;fit&quot; all of the following should be present: Independence in ADL and&#xD;
      IADL, less than 5 daily medications, no severe comorbidity and no more than 2 well controlled&#xD;
      comorbidities, normal cognitive ability and no indications of depression or malnutrition.&#xD;
      Information on whether or not the multidisciplinary team initiated any individual&#xD;
      action/advice based on the CGA in group 1 and group 2 was registered as well. Interventions&#xD;
      initiated by the multidisciplinary team were recorded in four categories: medical changes,&#xD;
      nutritional intervention, physical intervention or social intervention. These interventions&#xD;
      were registered before randomization was performed Frail and vulnerable patients are offered&#xD;
      participation in a controlled randomized study (Clinical trialsID: NCT02837679). Patients are&#xD;
      randomly and 1:1 assigned to either: No tailored follow-up (Group 2) or 90 days tailored&#xD;
      follow up (group 3). Randomization were performed by REDcap and allocated equally by&#xD;
      CGA-status (frail/vulnerable), gender and index tumor site (CRC or no-CRC).&#xD;
&#xD;
      It is not possible to blind patients or the multidisciplinary team of the randomization.&#xD;
&#xD;
      Group 2 has no tailored follow up on the problems found during CGA. Group 3 has 90 days&#xD;
      tailored follow-up on problems that were identified during CGA and problems that evolved&#xD;
      during the follow-up period.&#xD;
&#xD;
      Tailored follow-up The tailored intervention consists of phone calls, home visits, or contact&#xD;
      to community care-takers. A multidisciplinary team consisting of a trained geriatric nurse&#xD;
      and a geriatrician specialist performs the follow up. The team can perform clinical&#xD;
      investigation of patients, initiate changes in medication, or referral to further&#xD;
      investigation. Furthermore transfusion of blood, fluids or i.v. antibiotics could be&#xD;
      performed either at home or in the geriatric out patient clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2019</start_date>
  <completion_date type="Actual">April 25, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>short time mortality</measure>
    <time_frame>90 days</time_frame>
    <description>dead within 90 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1 year mortality</measure>
    <time_frame>365 days</time_frame>
    <description>dead within 1 year</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">781</enrollment>
  <condition>Geriatric Assessment</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>No-CGA</arm_group_label>
    <description>Patients were not initially offered CGA due to no booking for CGA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CGA alone</arm_group_label>
    <description>Patients had CGA, but no tailored follow-up upon identified problems</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CGA with tailored care</arm_group_label>
    <description>CGA and a tailored follow-up and care for 90 days following the CGA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CGA</intervention_name>
    <description>Multi-level Health assessment</description>
    <arm_group_label>CGA alone</arm_group_label>
    <arm_group_label>CGA with tailored care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>tailored care</intervention_name>
    <description>Tailored care based on problems identified by CGA</description>
    <arm_group_label>CGA with tailored care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        older cancer patients referred for oncology out patient Clinic for evaluaation regarding&#xD;
        initialisation of treatment All stages of cancer is included, all kind of treatment is&#xD;
        accepted including best supportive care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        cancer of head and neck, lung, upper or lower gastro intestinal Canal Referred for&#xD;
        evaluation in oncology department out patient Clinic Living in Aarhus, Odder, Favrskov or&#xD;
        Skanderborg municipality&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Referred for specialised palliative care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Else M Damsgaard, DMsc</last_name>
    <role>Study Chair</role>
    <affiliation>Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geriatric Department Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000 C</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 25, 2019</last_update_submitted>
  <last_update_submitted_qc>April 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Aarhus</investigator_affiliation>
    <investigator_full_name>Marianne Ørum</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Comprehensive geriatric assessment</keyword>
  <keyword>Cancer</keyword>
  <keyword>Short time mortality</keyword>
  <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/NCT03814213
org study id: 90-days mortality
nct id: NCT03814213
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Older cancer patients referred to Oncology outpatient Clinic at Aarhus University Hospital
      have for a period been offered Comprehensive geriatric Assessment (CGA) as part of a routine
      practice. Oncology Department was responsible for planning the CGA. A number of patients did
      however not recieve this offer as planning failed. This Group of patients will be compared to
      patients recieving Geriatric assessment.

      Patients recieving CGA is part of a Randomised controlled study (ID: NCT02837679) comparing
      CGA without 90 days follow-up to CGA with 90 days of Comprehensive geriatric care.

      Patients are identified from electronic medical files. Data regarding death is obtained from
      Medical files.
Inclusion criteria:

        -  70 years or more

        -  Cancer of the head and neck (HNC), lung (LC), upper gastro-intestinal- tract (UGI) or
           colo-rectal cancer (CRC)

        -  Referred to the Outpatient Clinic at department of oncology at Aarhus University
           Hospital for cancer treatment.

        -  Living in Aarhus, Favrskov, Odder or Skanderborg Municipalities

      Exclusion:

      - Referred for specialised palliative care

      Patients with both newly diagnosed cancer disease and patients with a relapse of previously
      treated cancer disease are included. Patients qualify for participation regardless of the
      stage of the cancer disease and regardless if specific cancer treatment is initiated.

      The oncology department is responsible for identifying patients and informing of the planned
      CGA.

      All potential patients referred to the oncology outpatient clinic are identified by
      retrospective review of lists of planned consultations in the oncology department out patient
      clinic available in the electronic medical file approximately once a week. By this procedure
      patients who were not informed of the possibility of having a CGA are identified (Group1)
      Patients who are referred for geriatric evaluation have a complete CGA at baseline. The CGA
      comprises 7 instruments for assessing health: Activities of Daily Living (ADL) and
      Instrumental Activities of Daily Living (IADL) for autonomy, Mini Nutritional Status (MNA)
      for nutritional state, Mini Mental State Examination (MMSE) for Cognitive state, Geriatric
      Depression Scale 15-item (GDS) for mood and Cumulative Illness Rating Scale - Geriatrics
      (CIRS-G) for comorbidity and number of daily medication for polypharmacy as previously
      published. According to CGA, patients were given a CGA-status of "fit", "vulnerable" or
      "frail". In order to be "fit" all of the following should be present: Independence in ADL and
      IADL, less than 5 daily medications, no severe comorbidity and no more than 2 well controlled
      comorbidities, normal cognitive ability and no indications of depression or malnutrition.
      Information on whether or not the multidisciplinary team initiated any individual
      action/advice based on the CGA in group 1 and group 2 was registered as well. Interventions
      initiated by the multidisciplinary team were recorded in four categories: medical changes,
      nutritional intervention, physical intervention or social intervention. These interventions
      were registered before randomization was performed Frail and vulnerable patients are offered
      participation in a controlled randomized study (Clinical trialsID: NCT02837679). Patients are
      randomly and 1:1 assigned to either: No tailored follow-up (Group 2) or 90 days tailored
      follow up (group 3). Randomization were performed by REDcap and allocated equally by
      CGA-status (frail/vulnerable), gender and index tumor site (CRC or no-CRC).

      It is not possible to blind patients or the multidisciplinary team of the randomization.

      Group 2 has no tailored follow up on the problems found during CGA. Group 3 has 90 days
      tailored follow-up on problems that were identified during CGA and problems that evolved
      during the follow-up period.

      Tailored follow-up The tailored intervention consists of phone calls, home visits, or contact
      to community care-takers. A multidisciplinary team consisting of a trained geriatric nurse
      and a geriatrician specialist performs the follow up. The team can perform clinical
      investigation of patients, initiate changes in medication, or referral to further
      investigation. Furthermore transfusion of blood, fluids or i.v. antibiotics could be
      performed either at home or in the geriatric out patient clinic.
observational model: Other
time perspective: Prospective
measure: short time mortality
time frame: 90 days
description: dead within 90 days
measure: 1 year mortality
time frame: 365 days
description: dead within 1 year
arm group label: No-CGA
description: Patients were not initially offered CGA due to no booking for CGA
arm group label: CGA alone
description: Patients had CGA, but no tailored follow-up upon identified problems
arm group label: CGA with tailored care
description: CGA and a tailored follow-up and care for 90 days following the CGA
intervention type: Other
intervention name: CGA
description: Multi-level Health assessment
arm group label: CGA alone
arm group label: CGA with tailored care
intervention type: Other
intervention name: tailored care
description: Tailored care based on problems identified by CGA
arm group label: CGA with tailored care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Else M Damsgaard, DMsc
role: Study Chair
affiliation: Aarhus University Hospital
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Aarhus
investigator full name: Marianne Ørum
investigator title: Principal Investigator
sharing ipd: No