<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/NCT02246725</url>
  </required_header>
  <id_info>
    <org_study_id>MS01</org_study_id>
    <nct_id>NCT02246725</nct_id>
  </id_info>
  <brief_title>Observational Study of Early Contact With Palliative Care Unit for Patients Receiving First Line Palliative Chemotherapy With Cancer in Upper Gastrointestinal Canal, or Second Line Palliative Chemotherapy in Patients With Colorectal Cancer - an Open, Randomised Investigator Initiated Trial.</brief_title>
  <acronym>ALLAN</acronym>
  <official_title>Observational Study of Early Contact With Palliative Care Unit for Patients Receiving First Line Palliative Chemotherapy With Cancer in Upper Gastrointestinal Canal, or Second Line Palliative Chemotherapy in Patients With Colorectal Cancer - an Open, Randomised Investigator Initiated Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lund University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lund University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this trial, patients with cancer in the upper gastrointestinal canal who are going to&#xD;
      receive first line palliative chemotherapy and patients with colorectal cancer who are going&#xD;
      to receive second line palliative chemotherapy will be included. Participating patients will&#xD;
      be randomized between early contact with a palliative care unit, or contact with a palliative&#xD;
      care unit when needed. The objectives with the trial is to investigate if an early&#xD;
      establishment with a palliative care unit will have a positive impact on the patients quality&#xD;
      of life, this also applies for the nearest relative, survival, and if a difference in numbers&#xD;
      of chemotherapy cycles can be detected.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Quality of Life, such as pain, anxiety.</measure>
    <time_frame>At baseline, every 6th week until death (approximately 1 year). The patients relative will be followed similarly until patients death and then every 12th week for 1 year.</time_frame>
    <description>Evaluation will be performed by different quality of life forms sent to the patient every 6th week, and by telephone contact with a study nurse every 6th week until patients death. The same also applies for the patients nearest relative; quality of life forms will be sent every 12th week for additional 1 year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>Approximately 12 months.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Numbers of chemotherapy cycles</measure>
    <time_frame>Approximately 12 months.</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">108</enrollment>
  <condition>Tumor in Upper Gastrointestinal Canal or Patients With Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Contact with palliative care unit versus contact when needed.</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Contact with palliative care unit.</intervention_name>
    <arm_group_label>Contact with palliative care unit versus contact when needed.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with tumor in esophagus, stomach, pancreas liver-biliary passage receiving first&#xD;
        line palliative chemotherapy, or patients with colorectal cancer receiving second line&#xD;
        palliative chemotherapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with tumor in upper gastrointestinal canal, who is going to start treatment&#xD;
             with first line palliative chemotherapy&#xD;
&#xD;
          -  Patients with colorectal cancer, who is going to start treatment with second line&#xD;
             palliative chemotherapy&#xD;
&#xD;
          -  Signed written informed concent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with neuroendocrine tumor&#xD;
&#xD;
          -  Patients with already ongoing chemotherapy&#xD;
&#xD;
          -  Patients with already established contact with palliative care unit&#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>Mikael Segerlantz, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Palliative Care and Advanced Home Health Care, Primary Health Care Skåne, Sankt lars väg 81, SE-221 85 LUND, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lund University Hospital</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>May 17, 2021</last_update_submitted>
  <last_update_submitted_qc>May 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colorectal Neoplasms</keyword>
  <keyword>Depression</keyword>
  <keyword>Intestinal Neoplasms</keyword>
  <keyword>Gastrointestinal Neoplasms</keyword>
  <keyword>Digestive System Neoplasms</keyword>
  <keyword>Digestive System Diseases</keyword>
  <keyword>Gastrointestinal Diseases</keyword>
  <keyword>Intestinal Diseases</keyword>
  <keyword>Palliative chemotherapy</keyword>
  <keyword>Palliative care</keyword>
  <keyword>Palliative treatment</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Quality of life for relatives</keyword>
  <keyword>Survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02246725
org study id: MS01
nct id: NCT02246725
lead sponsor: 
has dmc: No
In this trial, patients with cancer in the upper gastrointestinal canal who are going to
      receive first line palliative chemotherapy and patients with colorectal cancer who are going
      to receive second line palliative chemotherapy will be included. Participating patients will
      be randomized between early contact with a palliative care unit, or contact with a palliative
      care unit when needed. The objectives with the trial is to investigate if an early
      establishment with a palliative care unit will have a positive impact on the patients quality
      of life, this also applies for the nearest relative, survival, and if a difference in numbers
      of chemotherapy cycles can be detected.
observational model: Other
time perspective: Prospective
measure: Quality of Life, such as pain, anxiety.
time frame: At baseline, every 6th week until death (approximately 1 year). The patients relative will be followed similarly until patients death and then every 12th week for 1 year.
description: Evaluation will be performed by different quality of life forms sent to the patient every 6th week, and by telephone contact with a study nurse every 6th week until patients death. The same also applies for the patients nearest relative; quality of life forms will be sent every 12th week for additional 1 year.
measure: Survival
time frame: Approximately 12 months.
measure: Numbers of chemotherapy cycles
time frame: Approximately 12 months.
arm group label: Contact with palliative care unit versus contact when needed.
intervention type: Other
intervention name: Contact with palliative care unit.
arm group label: Contact with palliative care unit versus contact when needed.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mikael Segerlantz, MD, PhD
role: Principal Investigator
affiliation: Palliative Care and Advanced Home Health Care, Primary Health Care Skåne, Sankt lars väg 81, SE-221 85 LUND, Sweden
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Colorectal Neoplasms