<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/NCT04448041</url>
  </required_header>
  <id_info>
    <org_study_id>CRANE</org_study_id>
    <nct_id>NCT04448041</nct_id>
  </id_info>
  <brief_title>CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries</brief_title>
  <acronym>CRANE</acronym>
  <official_title>A Cluster Randomised Feasibility Study of a Sustainable Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Edinburgh</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>
      Aims: The CRANE feasibility study (A mixed methods study of malnutrition and sustainable&#xD;
      nutritional intervention for patients undergoing cancer surgery in low- and middle-income&#xD;
      countries) aims to investigate the identification of pre-operative malnourishment, data&#xD;
      collection methods and acceptability of a nutritional intervention for a future trial to&#xD;
      improve outcomes after cancer surgery in low- and middle-income countries (LMICs).&#xD;
&#xD;
        1. To identify and validate the most relevant nutritional screening tool for patients in&#xD;
           LMICs undergoing surgery for cancer;&#xD;
&#xD;
        2. To identify a low cost sustainable nutritional intervention for patients in LMICs&#xD;
           undergoing surgery for cancer;&#xD;
&#xD;
        3. To establish the feasibility of delivering a randomised trial of a sustainable&#xD;
           nutritional intervention for patients in LMICs undergoing surgery for cancer.&#xD;
&#xD;
      Design: A mixed-methods study comprising of qualitative work including focus groups and&#xD;
      interviews, trial of data collection and validation to test feasibility in clinical practice&#xD;
&#xD;
      Participants: Patients undergoing elective surgery for suspected cancer in LMICs&#xD;
&#xD;
      Outcomes Work package (WP) 1: The primary deliverable is the identification of a relevant,&#xD;
      pragmatic, and acceptable nutritional screening tool.&#xD;
&#xD;
      WP 2: The primary deliverable is the identification of a low-cost and sustainable nutritional&#xD;
      intervention. Focus groups and interviews will be held with patients and clinicians to&#xD;
      explore the sustainability, implementation and acceptability of screening and interventions.&#xD;
&#xD;
      WP 3: The primary outcome will be to determine feasibility and acceptability of trial design.&#xD;
      A number of outcome assessments and data collection instruments will be evaluated for&#xD;
      feasibility, including anthropometric parameters and patient outcomes (30-day mortality,&#xD;
      major post-operative complications, length of hospital stay and quality of life). A final&#xD;
      study design, analysis plan, and health economic plan will be developed.&#xD;
&#xD;
      Sample size: For this feasibility study, the investigators will conduct multidisciplinary&#xD;
      focus groups and interviews, perform and validate malnutrition screening in 200 patients&#xD;
      across four countries and record patient 30-day outcomes. This will also include the time&#xD;
      taken to collect data on 200 eligible patients. This sample size has been informed from&#xD;
      previous malnutrition data originating from a large prospective international multicentre&#xD;
      observational cancer study (GlobalSurg 3).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 2020</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</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>Prevalence of malnutrition</measure>
    <time_frame>Immediately prior to surgery</time_frame>
    <description>Malnutrition as measured using validated screening tools</description>
  </primary_outcome>
  <primary_outcome>
    <measure>30-day mortality rate</measure>
    <time_frame>30 days from surgery</time_frame>
    <description>Death within 30 days of surgical procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30-day complication rate</measure>
    <time_frame>30 days from surgery</time_frame>
    <description>Defined with by Clavien-Dindo grade III or IV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>30 days from surgery</time_frame>
    <description>Length of hospital admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operation rate</measure>
    <time_frame>30 days from surgery</time_frame>
    <description>Re-operation within 30 days of surgical procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life following surgery (EQ-5D / WHODAS questionnaire)</measure>
    <time_frame>30 days from surgery</time_frame>
    <description>Short-term quality of life for patients following surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission rates</measure>
    <time_frame>30 days from surgery</time_frame>
    <description>Readmission within 30 days of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>Through study duration, up to one year</time_frame>
    <description>Time taken to recruit 200 patients</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Malnutrition</condition>
  <condition>Surgery</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Ghana</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>India</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Philippines</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Zambia</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Malnutrition screening</intervention_name>
    <description>Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer</description>
    <arm_group_label>Ghana</arm_group_label>
    <arm_group_label>India</arm_group_label>
    <arm_group_label>Philippines</arm_group_label>
    <arm_group_label>Zambia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing surgery for cancer in four partner LMIC countries are eligible&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitals in LMICs who undertake planned (elective) cancer surgery for cancer.&#xD;
&#xD;
          -  Patients over 18 years of age (or the age of majority for the country);&#xD;
&#xD;
          -  Patients undergoing planned (elective) surgery for cancer;&#xD;
&#xD;
          -  Patients undergoing surgery where the intent is either curative or palliative;&#xD;
&#xD;
          -  Patients must be able and willing to provide written informed consent (signature or a&#xD;
             fingerprint).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children (below age of majority for the country);&#xD;
&#xD;
          -  Patients undergoing emergency surgery;&#xD;
&#xD;
          -  Any operative indication other than cancer;&#xD;
&#xD;
          -  Patients unable to provide written informed consent;&#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>Ewen Harrison</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Edinburgh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stephen Knight</last_name>
    <phone>+44 (0)131 242 3616</phone>
    <email>stephenknight@doctors.org.uk</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 22, 2020</last_update_submitted>
  <last_update_submitted_qc>June 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Edinburgh</investigator_affiliation>
    <investigator_full_name>Ewen Harrison</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Malnutrition</keyword>
  <keyword>Screening tools</keyword>
  <keyword>Cancer surgery</keyword>
  <keyword>Low and middle-income countries (LMIC)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Derived anonymised data at the patient-level may be able to be made available for sharing</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </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/NCT04448041
org study id: CRANE
nct id: NCT04448041
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aims: The CRANE feasibility study (A mixed methods study of malnutrition and sustainable
      nutritional intervention for patients undergoing cancer surgery in low- and middle-income
      countries) aims to investigate the identification of pre-operative malnourishment, data
      collection methods and acceptability of a nutritional intervention for a future trial to
      improve outcomes after cancer surgery in low- and middle-income countries (LMICs).

        1. To identify and validate the most relevant nutritional screening tool for patients in
           LMICs undergoing surgery for cancer;

        2. To identify a low cost sustainable nutritional intervention for patients in LMICs
           undergoing surgery for cancer;

        3. To establish the feasibility of delivering a randomised trial of a sustainable
           nutritional intervention for patients in LMICs undergoing surgery for cancer.

      Design: A mixed-methods study comprising of qualitative work including focus groups and
      interviews, trial of data collection and validation to test feasibility in clinical practice

      Participants: Patients undergoing elective surgery for suspected cancer in LMICs

      Outcomes Work package (WP) 1: The primary deliverable is the identification of a relevant,
      pragmatic, and acceptable nutritional screening tool.

      WP 2: The primary deliverable is the identification of a low-cost and sustainable nutritional
      intervention. Focus groups and interviews will be held with patients and clinicians to
      explore the sustainability, implementation and acceptability of screening and interventions.

      WP 3: The primary outcome will be to determine feasibility and acceptability of trial design.
      A number of outcome assessments and data collection instruments will be evaluated for
      feasibility, including anthropometric parameters and patient outcomes (30-day mortality,
      major post-operative complications, length of hospital stay and quality of life). A final
      study design, analysis plan, and health economic plan will be developed.

      Sample size: For this feasibility study, the investigators will conduct multidisciplinary
      focus groups and interviews, perform and validate malnutrition screening in 200 patients
      across four countries and record patient 30-day outcomes. This will also include the time
      taken to collect data on 200 eligible patients. This sample size has been informed from
      previous malnutrition data originating from a large prospective international multicentre
      observational cancer study (GlobalSurg 3).
observational model: Cohort
time perspective: Prospective
measure: Prevalence of malnutrition
time frame: Immediately prior to surgery
description: Malnutrition as measured using validated screening tools
measure: 30-day mortality rate
time frame: 30 days from surgery
description: Death within 30 days of surgical procedure
measure: 30-day complication rate
time frame: 30 days from surgery
description: Defined with by Clavien-Dindo grade III or IV
measure: Length of stay
time frame: 30 days from surgery
description: Length of hospital admission
measure: Re-operation rate
time frame: 30 days from surgery
description: Re-operation within 30 days of surgical procedure
measure: Quality of life following surgery (EQ-5D / WHODAS questionnaire)
time frame: 30 days from surgery
description: Short-term quality of life for patients following surgery
measure: Readmission rates
time frame: 30 days from surgery
description: Readmission within 30 days of surgery
measure: Recruitment rate
time frame: Through study duration, up to one year
description: Time taken to recruit 200 patients
arm group label: Ghana
arm group label: India
arm group label: Philippines
arm group label: Zambia
intervention type: Other
intervention name: Malnutrition screening
description: Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer
arm group label: Ghana
arm group label: India
arm group label: Philippines
arm group label: Zambia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ewen Harrison
role: Principal Investigator
affiliation: University of Edinburgh
last name: Stephen Knight
phone: +44 (0)131 242 3616
email: stephenknight@doctors.org.uk
responsible party type: Principal Investigator
investigator affiliation: University of Edinburgh
investigator full name: Ewen Harrison
investigator title: Professor
mesh term: Malnutrition
sharing ipd: Yes
ipd description: Derived anonymised data at the patient-level may be able to be made available for sharing
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code