<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/NCT03243188</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS ID 225027</org_study_id>
    <nct_id>NCT03243188</nct_id>
  </id_info>
  <brief_title>Palliative Care in General Practice: Cancer Patient/Carer Experience</brief_title>
  <official_title>Palliative Care in General Practice: Cancer Patients' and Carers' Experience of Their General Practitioner's (GP's) Role</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King's College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King's College London</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>
      Study Title: Palliative care in general practice: cancer patients' and carers' experience of&#xD;
      their GP's role&#xD;
&#xD;
      Study Design: Qualitative interview study&#xD;
&#xD;
      Study Participants: Adult patients with cancer and palliative care needs, accompanied by&#xD;
      their carers&#xD;
&#xD;
      Planned Sample Size: Up to 30 interviews with patients +/- their carers&#xD;
&#xD;
      Planned Study Period: October 2017 - December 2018&#xD;
&#xD;
      Research Question: What experience do adults with cancer, and carers, have of their GP's&#xD;
      involvement in palliative care provision?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be invited and recruited to the study from St Joseph's Hospice in Hackney&#xD;
      (single centre study). Patients with cancer that are either attending the day centre service&#xD;
      at St Joseph's or being visited at home by the community specialist palliative care&#xD;
      nursing/medical team based at St Joseph's Hospice; will be approached by their direct&#xD;
      clinical care staff. (Some of the direct clinical care team are National Health Service (NHS)&#xD;
      staff and some care is commissioned by the NHS despite St Joseph's Hospice being a non-NHS&#xD;
      site). Staff will initiate discussion about the project, and will assess for both mental and&#xD;
      physical capacity to participate.&#xD;
&#xD;
      Dr Emilie Green (EG) will then contact the potential participants by phone or in person (if&#xD;
      they have previously given verbal consent for her to join their usual clinical staff on a&#xD;
      home visit or when they are attending the day centre). The project will be discussed with&#xD;
      each potential participant, and EG will answer any questions they may have, will assess for&#xD;
      mental and physical capacity, and will arrange a mutually convenient time and location to&#xD;
      meet for the interview.&#xD;
&#xD;
      Before starting the interview, EG will again make time to clarify any questions each&#xD;
      participant may have. She will ask each participant to date/sign three consent forms before&#xD;
      starting the interview (one for EG, one for the participant, and one for their notes at St&#xD;
      Joseph's Hospice). If a joint interview is undertaken with a patient and their carer; both&#xD;
      parties will individually sign their own consent forms. She will then ask questions relating&#xD;
      to sociodemographic data (recording this on the Personal Information Sheet) e.g. age, living&#xD;
      situation and diagnosis before starting the interview. The interviews will each last at least&#xD;
      30 minutes.&#xD;
&#xD;
      If participants decide that they would like a telephone interview, the process will be&#xD;
      slightly different. EG will send three consent forms to each prospective participant (one for&#xD;
      them to keep, and two for them to date/sign and send back by post) in a stamped addressed&#xD;
      envelope. If the forms are not received within 3 weeks, EG will follow up with a phone call&#xD;
      to the prospective participant, to clarify whether they still wish to participate. Only after&#xD;
      she receives the two dated/signed consent forms will EG arrange a time with them for the&#xD;
      telephone interview. She will then phone the participant from a private location that she&#xD;
      does not share with other colleagues. She will collect sociodemographic information (which&#xD;
      will be recorded on the Personal Information Sheet) before starting the interview (which will&#xD;
      last at least 30 minutes.)&#xD;
&#xD;
      Qualitative data will be obtained through semi-structured interviews with adults with cancer&#xD;
      and palliative care needs. Patients will be invited to bring their carer to the interview. EG&#xD;
      will conduct and transcribe up to 30 audio-recorded semi-structured interviews, which will be&#xD;
      carried out at the patient's preferred location (either at home, over the phone, or in a&#xD;
      pre-booked room at St Joseph's Hospice). EG will ask questions relating to sociodemographic&#xD;
      data (recording this on the Personal Information Sheet) prior to starting the interview.&#xD;
&#xD;
      EG will transcribe all interviews verbatim. Data will be analysed thematically and will&#xD;
      adhere to the principles of the Framework Analysis developed by Ritchie and Spencer.&#xD;
      Recurring themes and concepts will be identified using a constant comparative approach. Any&#xD;
      contributions made by carers will be included and analysed as 'added value' data.This will&#xD;
      enable us to explore if and how carers' perspectives contribute to our understanding of&#xD;
      patient experience of their GP's involvement in palliative care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To explore the experience/perspectives of adults with cancer, and carers, of the role of their GP in providing palliative care, using a qualitative semi-structured interview schedule</measure>
    <time_frame>October 2017 - December 2018</time_frame>
    <description>To explore patients' and carers' experience of:&#xD;
The role of the GP in providing palliative care to adult patients with cancer&#xD;
The facilitators and barriers to the GP's capacity to fulfill this perceived role</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Participants</arm_group_label>
    <description>Cancer patients with palliative care needs (+/- their carers)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qualitative interview</intervention_name>
    <description>Qualitative data will be obtained through semi-structured interviews with adults with cancer and palliative care needs. Patients will be invited to bring their carer to the interview. EG will conduct and transcribe up to 30 audio-recorded semi-structured interviews, which will be carried out at the patient's preferred location (either at home, over the phone, or in a pre-booked room at St Joseph's Hospice). EG will ask questions relating to sociodemographic data (recording this on the Personal Information Sheet) prior to starting the interview.</description>
    <arm_group_label>Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be invited and recruited to the study from St Joseph's Hospice in Hackney&#xD;
        (single centre study). Patients and their carers from all three geographical areas, served&#xD;
        by St Joseph's, will be invited to participate: City &amp; Hackney, Tower Hamlets and Newham.&#xD;
        The Principal Investigator Jane Naismith (JN) working at St Joseph's Hospice will assist&#xD;
        with and coordinate the recruitment process.&#xD;
&#xD;
        This setting was chosen as it permits access to a varied group of patients and carers. A&#xD;
        purposive sampling will ensure recruitment of patients across a breadth of&#xD;
        socio-demographics, cancer diagnoses and experience of different GP practices.&#xD;
&#xD;
        A target sample size of up to 30 interviews has been chosen, taking into account available&#xD;
        time and resources.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for participants&#xD;
&#xD;
          -  Patients either attending the St Joseph's Hospice day centre or being visited at home&#xD;
             by their community specialist palliative care nursing/medical team and their carers&#xD;
&#xD;
          -  Adult patients with a cancer diagnosis and their carers&#xD;
&#xD;
          -  Able to understand and communicate in written and spoken English&#xD;
&#xD;
          -  With mental and physical capacity to consent Exclusion criteria for participants&#xD;
&#xD;
          -  Paediatric patients&#xD;
&#xD;
          -  Patients without a cancer diagnosis&#xD;
&#xD;
          -  Unable to understand written or spoken English&#xD;
&#xD;
          -  Without mental and physical capacity to 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>Jane Naismith</last_name>
    <role>Principal Investigator</role>
    <affiliation>St Joseph's Hospice</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Patrick White</last_name>
    <role>Study Director</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Heidi Lempp</last_name>
    <role>Study Director</role>
    <affiliation>King's College London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Emilie Green</last_name>
    <phone>02078488679</phone>
    <email>emilie.green@kcl.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Patrick White</last_name>
    <phone>02078488679</phone>
    <email>patrick.white@kcl.ac.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>King's College London</name>
      <address>
        <city>London</city>
        <zip>SE1 1UL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Palliative Care</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/NCT03243188
org study id: IRAS ID 225027
nct id: NCT03243188
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Study Title: Palliative care in general practice: cancer patients' and carers' experience of
      their GP's role

      Study Design: Qualitative interview study

      Study Participants: Adult patients with cancer and palliative care needs, accompanied by
      their carers

      Planned Sample Size: Up to 30 interviews with patients +/- their carers

      Planned Study Period: October 2017 - December 2018

      Research Question: What experience do adults with cancer, and carers, have of their GP's
      involvement in palliative care provision?
Participants will be invited and recruited to the study from St Joseph's Hospice in Hackney
      (single centre study). Patients with cancer that are either attending the day centre service
      at St Joseph's or being visited at home by the community specialist palliative care
      nursing/medical team based at St Joseph's Hospice; will be approached by their direct
      clinical care staff. (Some of the direct clinical care team are National Health Service (NHS)
      staff and some care is commissioned by the NHS despite St Joseph's Hospice being a non-NHS
      site). Staff will initiate discussion about the project, and will assess for both mental and
      physical capacity to participate.

      Dr Emilie Green (EG) will then contact the potential participants by phone or in person (if
      they have previously given verbal consent for her to join their usual clinical staff on a
      home visit or when they are attending the day centre). The project will be discussed with
      each potential participant, and EG will answer any questions they may have, will assess for
      mental and physical capacity, and will arrange a mutually convenient time and location to
      meet for the interview.

      Before starting the interview, EG will again make time to clarify any questions each
      participant may have. She will ask each participant to date/sign three consent forms before
      starting the interview (one for EG, one for the participant, and one for their notes at St
      Joseph's Hospice). If a joint interview is undertaken with a patient and their carer; both
      parties will individually sign their own consent forms. She will then ask questions relating
      to sociodemographic data (recording this on the Personal Information Sheet) e.g. age, living
      situation and diagnosis before starting the interview. The interviews will each last at least
      30 minutes.

      If participants decide that they would like a telephone interview, the process will be
      slightly different. EG will send three consent forms to each prospective participant (one for
      them to keep, and two for them to date/sign and send back by post) in a stamped addressed
      envelope. If the forms are not received within 3 weeks, EG will follow up with a phone call
      to the prospective participant, to clarify whether they still wish to participate. Only after
      she receives the two dated/signed consent forms will EG arrange a time with them for the
      telephone interview. She will then phone the participant from a private location that she
      does not share with other colleagues. She will collect sociodemographic information (which
      will be recorded on the Personal Information Sheet) before starting the interview (which will
      last at least 30 minutes.)

      Qualitative data will be obtained through semi-structured interviews with adults with cancer
      and palliative care needs. Patients will be invited to bring their carer to the interview. EG
      will conduct and transcribe up to 30 audio-recorded semi-structured interviews, which will be
      carried out at the patient's preferred location (either at home, over the phone, or in a
      pre-booked room at St Joseph's Hospice). EG will ask questions relating to sociodemographic
      data (recording this on the Personal Information Sheet) prior to starting the interview.

      EG will transcribe all interviews verbatim. Data will be analysed thematically and will
      adhere to the principles of the Framework Analysis developed by Ritchie and Spencer.
      Recurring themes and concepts will be identified using a constant comparative approach. Any
      contributions made by carers will be included and analysed as 'added value' data.This will
      enable us to explore if and how carers' perspectives contribute to our understanding of
      patient experience of their GP's involvement in palliative care.
observational model: Other
time perspective: Other
measure: To explore the experience/perspectives of adults with cancer, and carers, of the role of their GP in providing palliative care, using a qualitative semi-structured interview schedule
time frame: October 2017 - December 2018
description: To explore patients' and carers' experience of:
The role of the GP in providing palliative care to adult patients with cancer
The facilitators and barriers to the GP's capacity to fulfill this perceived role
arm group label: Participants
description: Cancer patients with palliative care needs (+/- their carers)
intervention type: Other
intervention name: Qualitative interview
description: Qualitative data will be obtained through semi-structured interviews with adults with cancer and palliative care needs. Patients will be invited to bring their carer to the interview. EG will conduct and transcribe up to 30 audio-recorded semi-structured interviews, which will be carried out at the patient's preferred location (either at home, over the phone, or in a pre-booked room at St Joseph's Hospice). EG will ask questions relating to sociodemographic data (recording this on the Personal Information Sheet) prior to starting the interview.
arm group label: Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jane Naismith
role: Principal Investigator
affiliation: St Joseph's Hospice
last name: Patrick White
role: Study Director
affiliation: King's College London
last name: Heidi Lempp
role: Study Director
affiliation: King's College London
last name: Emilie Green
phone: 02078488679
email: emilie.green@kcl.ac.uk
last name: Patrick White
phone: 02078488679
email: patrick.white@kcl.ac.uk
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No