<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/NCT04495530</url>
  </required_header>
  <id_info>
    <org_study_id>CCR 5217</org_study_id>
    <nct_id>NCT04495530</nct_id>
  </id_info>
  <brief_title>Information Needs Around Parenteral nUTrition in Cancer</brief_title>
  <acronym>INPUT</acronym>
  <official_title>What Information do Patients and Carers Need to Make an Informed Decision to Commence and Discontinue Parenteral Nutrition, in Advanced Cancer?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Marsden NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St George's University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College London Hospitals</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London North West Healthcare NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Royal Marsden NHS Foundation Trust</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will explore the information needs of patient's with advanced cancer, and their&#xD;
      carers, when making a decision to commence or discontinue parenteral nutrition. Interviews&#xD;
      will be conducted with both patients with advanced cancer, and their carers to determine the&#xD;
      information they need to make a shared decision with the healthcare team.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parenteral nutrition (PN) is a type of nutritional liquid that is given directly into a vein,&#xD;
      and is usually given when a person does not have a working gut. This type of nutrition is&#xD;
      managed by a team of healthcare professionals and requires regular monitoring, such as bloods&#xD;
      tests, to allow the team to provide the right balance of nutrients to the individual patient.&#xD;
      This is an important decision, and the benefits, risks and consequences of having this type&#xD;
      of nutrition should be fully explained to the patient and carer, to make sure they can make&#xD;
      an informed decision. The aim of this study is to find out what information both patients and&#xD;
      carers feel they need to be able to make a decision to start, and a later date stop,&#xD;
      parenteral nutrition, with a diagnosis of advanced (incurable) cancer.&#xD;
&#xD;
      It is not clear if patients and carers get all the information they need before making this&#xD;
      decision, and often the decision is made by a doctor and other healthcare professionals.&#xD;
      However, patients and carers have a right to make decisions about their care. We will&#xD;
      therefore interview patients and carers who have experience of making this decision, or in&#xD;
      the process of making this decision, to find out what information is important to them. Our&#xD;
      aim is to use the results from this research to improve the experience that patients and&#xD;
      carers have in the future.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2021</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The type of information that patients and carers need to make an informed decision to commence or discontinue parenteral nutrition</measure>
    <time_frame>Through completion of study; expected 1 year</time_frame>
    <description>This exploratory study will provide insight into the information that patients with advanced cancer, and their carers need to make an informed decision to commence and discontinue parenteral nutrition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>How healthcare professionals should deliver information to patients and carers in order for them to make an informed decision to commence or discontinue parenteral nutrition</measure>
    <time_frame>Through completion of study; expected 1 year</time_frame>
    <description>Patients and carers will provide insight into how they would like to receive information regarding parenteral nutrition from the clinical team. This may be through verbal or written communication.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Cancer</condition>
  <condition>End Stage Cancer</condition>
  <condition>Terminal Cancer</condition>
  <condition>Neoplasms</condition>
  <condition>Tumor</condition>
  <condition>Malignancy</condition>
  <condition>Malignant Neoplasm</condition>
  <arm_group>
    <arm_group_label>Patient</arm_group_label>
    <description>Patients will be considering commencing or discontinuing parenteral nutrition, or will be receiving home parenteral nutrition</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carer</arm_group_label>
    <description>Carers will be those caring for a patient with advanced cancer who is considering commencing or discontinuing parenteral nutrition, or already receiving parenteral nutrition. Carers will also be recruited if they previously cared for a person with advanced cancer receiving parenteral nutrition in the last 12 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-interventional study</intervention_name>
    <description>semi-structured interviews will take place on one occasion with participants in this study. This is qualitative research, and does not involve any interventions</description>
    <arm_group_label>Carer</arm_group_label>
    <arm_group_label>Patient</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited from the inpatient and outpatient setting (intestinal failure&#xD;
        clinic). Carers may be recruited from participating hospitals if they are caring for a&#xD;
        patient under the care of that centre. Carers will also be recruited via social media, and&#xD;
        online support networks.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years and over&#xD;
&#xD;
          -  Fluent English speaker&#xD;
&#xD;
          -  Is aware of diagnosis of advanced cancer&#xD;
&#xD;
          -  Patient considering starting PN, is currently receiving PN or has previously received&#xD;
             PN OR&#xD;
&#xD;
          -  Carer of a patient considering, receiving or who has received PN&#xD;
&#xD;
          -  NHS patient&#xD;
&#xD;
          -  Assessed as having capacity to give consent and participate&#xD;
&#xD;
          -  Current patient at one of the recruiting hospital sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Private patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clare Shaw</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Marsden NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Mark's Hospital</name>
      <address>
        <city>London</city>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Marsden Hospital NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>SW3 6JJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 14, 2022</last_update_submitted>
  <last_update_submitted_qc>July 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT04495530
org study id: CCR 5217
nct id: NCT04495530
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study will explore the information needs of patient's with advanced cancer, and their
      carers, when making a decision to commence or discontinue parenteral nutrition. Interviews
      will be conducted with both patients with advanced cancer, and their carers to determine the
      information they need to make a shared decision with the healthcare team.
Parenteral nutrition (PN) is a type of nutritional liquid that is given directly into a vein,
      and is usually given when a person does not have a working gut. This type of nutrition is
      managed by a team of healthcare professionals and requires regular monitoring, such as bloods
      tests, to allow the team to provide the right balance of nutrients to the individual patient.
      This is an important decision, and the benefits, risks and consequences of having this type
      of nutrition should be fully explained to the patient and carer, to make sure they can make
      an informed decision. The aim of this study is to find out what information both patients and
      carers feel they need to be able to make a decision to start, and a later date stop,
      parenteral nutrition, with a diagnosis of advanced (incurable) cancer.

      It is not clear if patients and carers get all the information they need before making this
      decision, and often the decision is made by a doctor and other healthcare professionals.
      However, patients and carers have a right to make decisions about their care. We will
      therefore interview patients and carers who have experience of making this decision, or in
      the process of making this decision, to find out what information is important to them. Our
      aim is to use the results from this research to improve the experience that patients and
      carers have in the future.
observational model: Cohort
time perspective: Cross-Sectional
measure: The type of information that patients and carers need to make an informed decision to commence or discontinue parenteral nutrition
time frame: Through completion of study; expected 1 year
description: This exploratory study will provide insight into the information that patients with advanced cancer, and their carers need to make an informed decision to commence and discontinue parenteral nutrition
measure: How healthcare professionals should deliver information to patients and carers in order for them to make an informed decision to commence or discontinue parenteral nutrition
time frame: Through completion of study; expected 1 year
description: Patients and carers will provide insight into how they would like to receive information regarding parenteral nutrition from the clinical team. This may be through verbal or written communication.
arm group label: Patient
description: Patients will be considering commencing or discontinuing parenteral nutrition, or will be receiving home parenteral nutrition
arm group label: Carer
description: Carers will be those caring for a patient with advanced cancer who is considering commencing or discontinuing parenteral nutrition, or already receiving parenteral nutrition. Carers will also be recruited if they previously cared for a person with advanced cancer receiving parenteral nutrition in the last 12 months
intervention type: Other
intervention name: Non-interventional study
description: semi-structured interviews will take place on one occasion with participants in this study. This is qualitative research, and does not involve any interventions
arm group label: Carer
arm group label: Patient
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clare Shaw
role: Principal Investigator
affiliation: Royal Marsden NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No