<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/NCT04499872</url>
  </required_header>
  <id_info>
    <org_study_id>RLBUHT5869</org_study_id>
    <secondary_id>261984</secondary_id>
    <nct_id>NCT04499872</nct_id>
  </id_info>
  <brief_title>Planning for Future Care With Patients With Advanced Cancer</brief_title>
  <official_title>Planning for Future Care With Patients With Advanced Cancer: Examining the Feasibility of Using the Trajectory Touchpoint Technique for Advance Care Planning.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool University Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Liverpool</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Liverpool University Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</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>
      Advance Care Planning (ACP) is a process where patients (and their families if appropriate)&#xD;
      discuss with their doctors and nurses what may happen as their illness progresses, including&#xD;
      how they (and their family) would like to be supported and cared for. The discussion of&#xD;
      expectations and choices for care can then be formally recorded and used to guide and inform&#xD;
      future care. Well documented benefits of ACP include empowering patients and their families&#xD;
      to better understand available choices and make informed decisions regarding future care;&#xD;
      This ensures care is based on what is important to that patient (and their family) and&#xD;
      prepares all for the end of life. However, few people with a life limiting illness (such as&#xD;
      cancer) have an ACP. Patients and families often find future and end of life care a difficult&#xD;
      subject to discuss, as do doctors/nurses, who fear upsetting patients and families and who&#xD;
      may have limited training/experience in how to prompt and record ACP discussions.&#xD;
&#xD;
      This project aims to overcome the barriers in discussing ACP by using the Trajectory&#xD;
      Touchpoint Technique. The technique utilises a range of existing service evaluation and&#xD;
      service design methods found in &quot;service management&quot; and &quot;design systems&quot;. Rich pictures are&#xD;
      used in the form of cartoons on an electronic tablet or printed card, to enable&#xD;
      patients/families to lead discussions. The images are simple and enable people to raise&#xD;
      sensitive and potentially distressing topics at a pace they are comfortable with, rather than&#xD;
      responding to numerous pre-determined questions. The technique was originally designed to&#xD;
      explore the experiences of patients (and their families) of Hospice Care and has been&#xD;
      successfully used in over 200 interviews, demonstrating an ability to sensitively facilitate&#xD;
      difficult conversations whilst enabling rich and detailed discussion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1.1 BACKGROUND In 2014, academics at the University of Liverpool Management School who are&#xD;
      service quality researchers were approached by East Cheshire Hospice (ECH). ECH provides&#xD;
      specialist palliative care for people with progressive life-limiting illnesses, providing&#xD;
      services to patients, carers and families via inpatient and outpatient units and day&#xD;
      facilities. ECH strives for excellence in service and the patient experience. Anecdotal&#xD;
      stories and other forms of feedback provided plenty of evidence that the work of the hospice&#xD;
      was meaningful. However, ECH did not have any systematic, robust way of capturing these&#xD;
      experiences. Hence, while ECH was often told it had transformed the experience of patient's&#xD;
      at the most critical time in their lives and that it was needed and appreciated by many&#xD;
      service users, there was nothing but anecdotal evidence to back up this feedback. Worried&#xD;
      that such superb feedback could actually lead to complacency, the team at ECH commissioned&#xD;
      the University to undertake a 'deep-dive' of the impact of hospice services upon the&#xD;
      different inpatient and outpatient service users associated with ECH.&#xD;
&#xD;
      The team, comprising Prof Philippa Hunter-Jones and Dr. Lynn Sudbury-Riley, designed a new&#xD;
      qualitative research technique to follow the user's experience at every touchpoint in their&#xD;
      journey. In 2015, interviews with 38 in-patients, outpatients, visitors and bereaved families&#xD;
      enabled a 'deep-dive' to uncover perceptions of the whole service experience among these&#xD;
      diverse users. Results of this new approach suggested the technique fully captures the&#xD;
      hospice experience and suggests areas for improvements to hospice services. Indeed, the&#xD;
      results of the study have informed the strategy and operations of ECH, and, mindful of&#xD;
      continuous improvement, ECH have requested that the exercise is repeated.&#xD;
&#xD;
      Other hospices heard of the success of this work and the team were commissioned by Oakhaven&#xD;
      Hospice in Hampshire to work with them, too. Additionally, based on the success of the&#xD;
      project, the project was shortlisted by the school for a REF impact case, and the team were&#xD;
      awarded funding to repeat the project in further hospice and palliative care settings.&#xD;
&#xD;
      The Academic Palliative Care Unit on 4Y at RLBUHT was one of the palliative care units to be&#xD;
      evaluated next. From the service evaluation project on 4Y grew the novel idea to use the TTT&#xD;
      as part of the Advanced Care Planning (ACP) conversation lead by clinicians. ACP is not&#xD;
      consistently carried out for all patients that might have a need. There is also not a&#xD;
      consistent way in which ACP is conducted to ensure quality is maintained within the patient&#xD;
      centric approach.&#xD;
&#xD;
      1.2 RATIONALE FOR CURRENT STUDY Advance Care Planning (ACP) is the process of making choices&#xD;
      and plans in regards of future care for patients with life limiting disease, particularly&#xD;
      those who may lose the capacity to communicate. ACP has been shown to positively impact on&#xD;
      the quality of end-of-life care, yet few (only 6-8%) have a completed formal ACP: a result of&#xD;
      patients' anxieties about discussing future care issues and clinicians' concerns over&#xD;
      responsibility and starting a &quot;difficult&quot; conversation.&#xD;
&#xD;
      This project will test a new methodology, the Trajectory Touchpoint Technique - a&#xD;
      visual/pictorial technique - that aids difficult conversation. In a recent trial, the&#xD;
      technique has successfully enabled patients to direct in-depth and sensitive conversations&#xD;
      regarding their experiences of Hospice care. This technique exhibits the potential to&#xD;
      overcome barriers in ACP discussions, enabling patients to direct the conversation at their&#xD;
      pace/level of comfort, and empowering clinicians to sensitively facilitate depth and detail.&#xD;
      Therefore the research question is: Is the Trajectory Touchpoint Technique a feasible&#xD;
      intervention to support Advance Care Planning in patients/families with advanced cancer.&#xD;
&#xD;
      1.3 THE TRAJECTORY TOUCHPOINT TECHNIQUE The Trajectory Touchpoint Technique uses the concept&#xD;
      of touchpoints; anything that fosters or impacts experiences. Touchpoints are any potentially&#xD;
      important issue that a participant may wish to talk about. It is important to stress that a&#xD;
      touchpoint is only valid if it is considered to be so by the participant. Potential&#xD;
      touchpoints can be big or small, tangible or intangible. Rich pictures, in the form of&#xD;
      cartoons and easy to recognise signs and symbols are used to reference potentially important&#xD;
      touchpoints. Such rich picture methodologies are particularly appropriate for complex&#xD;
      research situations where multiple forces and interactions between those forces are present,&#xD;
      and can capture and elucidate potential influences that may otherwise remain hidden.&#xD;
&#xD;
      The technique uses a qualitative, narrative data collection method and touchpoints are&#xD;
      grouped together into key stages or themes. These groups of cartoon touchpoints are presented&#xD;
      on an I-Pad/Electronic Tablet or printed onto large laminated cards and used as a prompt/aide&#xD;
      memoire to guide discussion. Figure 1 provides an example of one group of touchpoints used to&#xD;
      collect data on the experiences of care in a children's hospice.&#xD;
&#xD;
      Prior use of the technique with over 200 palliative care patients and their families&#xD;
      demonstrates that the cartoons make people smile and help people to relax, even when the&#xD;
      content of the discussion is distressing. Patients and their families are free to choose from&#xD;
      the range of touchpoints, and to add anything else that they may see fit. Importantly, the&#xD;
      pictures guide the discussion, making difficult discussions easier as there is a greatly&#xD;
      reduced need for probing and/or pre-determined clinician led questioning. Touchpoints remind&#xD;
      people of things that they may have otherwise omitted from the discussion. Our experience&#xD;
      suggests that the technique enables a 'deep dive' into the feelings, fears and wishes of&#xD;
      palliative care patients and their families, aids systematic and comprehensive data&#xD;
      collection, yet is very easy to use and understand.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 10, 2019</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Interview question: please share in your own words your opinion of the ACP discussion</measure>
    <time_frame>within 72 hours of consent.</time_frame>
    <description>Participant is asked to join a 1:1 interview discussion. VERBAL DIALOGUE NO SCALE they talk about their ACP. Thematic Analysis will be conducted on the interview transcript to understand the common themes raised throughout the different interviews.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Advance Care Planning</condition>
  <arm_group>
    <arm_group_label>Patient/family Participant</arm_group_label>
    <description>Advance Care Plan with the Trajectory Touchpoint Technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Advance Care Plan with Trajectory Touchpoint Technique</intervention_name>
    <description>Advance Care Plan with Trajectory Touchpoint Technique</description>
    <arm_group_label>Patient/family Participant</arm_group_label>
    <other_name>ACP TTT</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who could benefit from an ACP discussion and are located on ward 4Y of the&#xD;
        Academic Palliative Care Unit of Royal Liverpool Broardgreen University Hospital NHS Trust.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cared for on the Academic Palliative Care Unit&#xD;
&#xD;
          -  Diagnosis of Cancer&#xD;
&#xD;
          -  No Advance Care Plan (or ACP needs updating)&#xD;
&#xD;
          -  Able to provide informed consent (has capacity)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of cancer&#xD;
&#xD;
          -  Has current ACP&#xD;
&#xD;
          -  Deemed to unwell by the APCU MDT&#xD;
&#xD;
          -  Unable to provide 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>Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Royal Liverpool Broadgreen University Hospital NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liverpool University Hospitals NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>June 21, 2019</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>October 7, 2021</last_update_submitted>
  <last_update_submitted_qc>October 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Palliative care</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>data will be anonymised and archived for use in other research projects in the future. After 10 years all data will be destroyed.</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Within 3 months of study completion</ipd_time_frame>
    <ipd_access_criteria>Only the named investigators will have access to the data.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 1, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/72/NCT04499872/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04499872
org study id: RLBUHT5869
secondary id: 261984
nct id: NCT04499872
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Advance Care Planning (ACP) is a process where patients (and their families if appropriate)
      discuss with their doctors and nurses what may happen as their illness progresses, including
      how they (and their family) would like to be supported and cared for. The discussion of
      expectations and choices for care can then be formally recorded and used to guide and inform
      future care. Well documented benefits of ACP include empowering patients and their families
      to better understand available choices and make informed decisions regarding future care;
      This ensures care is based on what is important to that patient (and their family) and
      prepares all for the end of life. However, few people with a life limiting illness (such as
      cancer) have an ACP. Patients and families often find future and end of life care a difficult
      subject to discuss, as do doctors/nurses, who fear upsetting patients and families and who
      may have limited training/experience in how to prompt and record ACP discussions.

      This project aims to overcome the barriers in discussing ACP by using the Trajectory
      Touchpoint Technique. The technique utilises a range of existing service evaluation and
      service design methods found in "service management" and "design systems". Rich pictures are
      used in the form of cartoons on an electronic tablet or printed card, to enable
      patients/families to lead discussions. The images are simple and enable people to raise
      sensitive and potentially distressing topics at a pace they are comfortable with, rather than
      responding to numerous pre-determined questions. The technique was originally designed to
      explore the experiences of patients (and their families) of Hospice Care and has been
      successfully used in over 200 interviews, demonstrating an ability to sensitively facilitate
      difficult conversations whilst enabling rich and detailed discussion.
1.1 BACKGROUND In 2014, academics at the University of Liverpool Management School who are
      service quality researchers were approached by East Cheshire Hospice (ECH). ECH provides
      specialist palliative care for people with progressive life-limiting illnesses, providing
      services to patients, carers and families via inpatient and outpatient units and day
      facilities. ECH strives for excellence in service and the patient experience. Anecdotal
      stories and other forms of feedback provided plenty of evidence that the work of the hospice
      was meaningful. However, ECH did not have any systematic, robust way of capturing these
      experiences. Hence, while ECH was often told it had transformed the experience of patient's
      at the most critical time in their lives and that it was needed and appreciated by many
      service users, there was nothing but anecdotal evidence to back up this feedback. Worried
      that such superb feedback could actually lead to complacency, the team at ECH commissioned
      the University to undertake a 'deep-dive' of the impact of hospice services upon the
      different inpatient and outpatient service users associated with ECH.

      The team, comprising Prof Philippa Hunter-Jones and Dr. Lynn Sudbury-Riley, designed a new
      qualitative research technique to follow the user's experience at every touchpoint in their
      journey. In 2015, interviews with 38 in-patients, outpatients, visitors and bereaved families
      enabled a 'deep-dive' to uncover perceptions of the whole service experience among these
      diverse users. Results of this new approach suggested the technique fully captures the
      hospice experience and suggests areas for improvements to hospice services. Indeed, the
      results of the study have informed the strategy and operations of ECH, and, mindful of
      continuous improvement, ECH have requested that the exercise is repeated.

      Other hospices heard of the success of this work and the team were commissioned by Oakhaven
      Hospice in Hampshire to work with them, too. Additionally, based on the success of the
      project, the project was shortlisted by the school for a REF impact case, and the team were
      awarded funding to repeat the project in further hospice and palliative care settings.

      The Academic Palliative Care Unit on 4Y at RLBUHT was one of the palliative care units to be
      evaluated next. From the service evaluation project on 4Y grew the novel idea to use the TTT
      as part of the Advanced Care Planning (ACP) conversation lead by clinicians. ACP is not
      consistently carried out for all patients that might have a need. There is also not a
      consistent way in which ACP is conducted to ensure quality is maintained within the patient
      centric approach.

      1.2 RATIONALE FOR CURRENT STUDY Advance Care Planning (ACP) is the process of making choices
      and plans in regards of future care for patients with life limiting disease, particularly
      those who may lose the capacity to communicate. ACP has been shown to positively impact on
      the quality of end-of-life care, yet few (only 6-8%) have a completed formal ACP: a result of
      patients' anxieties about discussing future care issues and clinicians' concerns over
      responsibility and starting a "difficult" conversation.

      This project will test a new methodology, the Trajectory Touchpoint Technique - a
      visual/pictorial technique - that aids difficult conversation. In a recent trial, the
      technique has successfully enabled patients to direct in-depth and sensitive conversations
      regarding their experiences of Hospice care. This technique exhibits the potential to
      overcome barriers in ACP discussions, enabling patients to direct the conversation at their
      pace/level of comfort, and empowering clinicians to sensitively facilitate depth and detail.
      Therefore the research question is: Is the Trajectory Touchpoint Technique a feasible
      intervention to support Advance Care Planning in patients/families with advanced cancer.

      1.3 THE TRAJECTORY TOUCHPOINT TECHNIQUE The Trajectory Touchpoint Technique uses the concept
      of touchpoints; anything that fosters or impacts experiences. Touchpoints are any potentially
      important issue that a participant may wish to talk about. It is important to stress that a
      touchpoint is only valid if it is considered to be so by the participant. Potential
      touchpoints can be big or small, tangible or intangible. Rich pictures, in the form of
      cartoons and easy to recognise signs and symbols are used to reference potentially important
      touchpoints. Such rich picture methodologies are particularly appropriate for complex
      research situations where multiple forces and interactions between those forces are present,
      and can capture and elucidate potential influences that may otherwise remain hidden.

      The technique uses a qualitative, narrative data collection method and touchpoints are
      grouped together into key stages or themes. These groups of cartoon touchpoints are presented
      on an I-Pad/Electronic Tablet or printed onto large laminated cards and used as a prompt/aide
      memoire to guide discussion. Figure 1 provides an example of one group of touchpoints used to
      collect data on the experiences of care in a children's hospice.

      Prior use of the technique with over 200 palliative care patients and their families
      demonstrates that the cartoons make people smile and help people to relax, even when the
      content of the discussion is distressing. Patients and their families are free to choose from
      the range of touchpoints, and to add anything else that they may see fit. Importantly, the
      pictures guide the discussion, making difficult discussions easier as there is a greatly
      reduced need for probing and/or pre-determined clinician led questioning. Touchpoints remind
      people of things that they may have otherwise omitted from the discussion. Our experience
      suggests that the technique enables a 'deep dive' into the feelings, fears and wishes of
      palliative care patients and their families, aids systematic and comprehensive data
      collection, yet is very easy to use and understand.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Interview question: please share in your own words your opinion of the ACP discussion
time frame: within 72 hours of consent.
description: Participant is asked to join a 1:1 interview discussion. VERBAL DIALOGUE NO SCALE they talk about their ACP. Thematic Analysis will be conducted on the interview transcript to understand the common themes raised throughout the different interviews.
arm group label: Patient/family Participant
description: Advance Care Plan with the Trajectory Touchpoint Technique
intervention type: Other
intervention name: Advance Care Plan with Trajectory Touchpoint Technique
description: Advance Care Plan with Trajectory Touchpoint Technique
arm group label: Patient/family Participant
other name: ACP TTT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Professor
role: Study Chair
affiliation: Royal Liverpool Broadgreen University Hospital NHS Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Yes
ipd description: data will be anonymised and archived for use in other research projects in the future. After 10 years all data will be destroyed.
ipd info type: Clinical Study Report (CSR)
ipd time frame: Within 3 months of study completion
ipd access criteria: Only the named investigators will have access to the data.
provided document: 