xml: <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/NCT06042023</url>
    </required_header>
    <id_info>
      <org_study_id>GS22/148530</org_study_id>
      <nct_id>NCT06042023</nct_id>
    </id_info>
    <brief_title>Remote Patient Monitoring for Preoperative Risk Assessment</brief_title>
    <acronym>REMOTES</acronym>
    <official_title>REmote Monitoring for preOperaTive Risk assEssment for Major Abdominal Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Leeds</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Leeds Teaching Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Leeds</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Preoperative risk assessment (an evaluation of overall health before surgery) is important to&#xD;
        determine the overall risk of mortality and complications for patients undergoing major&#xD;
        abdominal surgery to allow the appropriate allocation of sparse hospital resources. The&#xD;
        current gold standard for preoperative assessment is cardiopulmonary exercise testing (CPET).&#xD;
        CPET is, however, not available in all centres that perform major surgery, it is a costly&#xD;
        test, and therefore only high-risk patients are tested. Finding new ways of conducting&#xD;
        preoperative assessment could improve overall surgical safety, patient experience and reduce&#xD;
        cost.&#xD;
  &#xD;
        The preoperative use of remote vital signs monitoring can provide important information about&#xD;
        the patients' fitness and overall health and may be used for preoperative assessment. This&#xD;
        study will use a remote monitoring patch to monitor patients' vital signs before surgery. The&#xD;
        aim is to evaluate the utility and patient acceptability of the remote monitoring system and&#xD;
        the feasibility of a randomised controlled trial of this type of assessment. Additionally,&#xD;
        the study will assess the correlation between the data captured by the remote monitoring&#xD;
        system and the CPET results to evaluate the remote monitoring system's ability to predict&#xD;
        risk of surgery.&#xD;
  &#xD;
        The study will take place in Leeds Teaching hospitals. Adult patients undergoing major&#xD;
        abdominal surgery that require CPET before surgery are eligible. Participants will be&#xD;
        monitored at home with the patch monitor for 3-5 days before surgery, in addition to their&#xD;
        planned preoperative assessment. During remote monitoring, patients will be asked to complete&#xD;
        questionnaires on their general health and experience using the patch paired with the mobile&#xD;
        phone as part of the monitoring system. Clinical data from the electronic hospital records&#xD;
        and general practitioner records available on the trust system will then be collected after&#xD;
        surgery to assess complications and calculate risk scores.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The clinical research team will identify eligible participants from standard CPET booking&#xD;
        forms, which are received 1 - 2 weeks prior to the test. Researchers involved in this single&#xD;
        centre study are part of the clinical care team and have routine access to patient&#xD;
        identifiable information. Participants fulfilling the eligibility criteria will be sent a&#xD;
        Patient Information Sheet (PIS) explaining the study to accompany the routine appointment&#xD;
        letter. Participants attending their CPET appointment will be approached for inclusion in the&#xD;
        study by the clinical research team. Participants willing to take part in the study will be&#xD;
        asked to provide written, informed consent. CPET will be undertaken in the usual manner,&#xD;
        after which the patient will be fitted with a wearable patch and trained to use the remote&#xD;
        monitoring software/mobile device. A dedicated mobile device will be provided for the&#xD;
        duration of the remote monitoring and returned when the patient is admitted for surgery.&#xD;
  &#xD;
        The participants will wear the patch for 3 to 5 days and be provided with the mobile device&#xD;
        (modified smartphone), which records data transmitted wirelessly directly from the biosensor&#xD;
        patch. During the monitoring period, participants can continue their normal activities as&#xD;
        usual. The patch is water resistant, so participants can shower and pat dry the patch with a&#xD;
        towel.&#xD;
  &#xD;
        The system (patch - mobile device) is reliable and secure, using robust Wi-Fi radio&#xD;
        encryption and GDPR (General Data Protection Regulation) compliant data transfer to a&#xD;
        separate cloud server. The device cannot be used as a regular phone to make phone&#xD;
        calls/browse the web. In the unfortunate event that a device gets lost/ broken, or stolen,&#xD;
        the participant will not be liable.&#xD;
  &#xD;
        Remote monitoring will be undertaken using the LifeSignals wearable biosensor&#xD;
        (www.LifeSignals.com) and the Asclepius software platform. The biosensor communicates with a&#xD;
        commercially available mobile device, which relays data to a secure Cloud server. The&#xD;
        biosensor is CE-marked and has been used in other clinical settings for remote patient&#xD;
        monitoring. The device is currently not routinely used in the NHS.&#xD;
  &#xD;
        Participants will subsequently undergo their planned surgery in the usual way. Data captured&#xD;
        from the remote monitoring will not be used or made accessible to inform decisions about&#xD;
        clinical care.&#xD;
  &#xD;
        All decisions regarding perioperative care will be based on the standard preoperative&#xD;
        assessment per routine care. The remote monitoring data will not be monitored in real-time.&#xD;
        There will be no clinical intervention from the researchers if abnormalities in vital signs&#xD;
        are picked up by the monitoring patch, as all data will be analysed retrospectively 90 days&#xD;
        after the participant's operation. Any clinical concerns about the device that arise will be&#xD;
        reported to the relevant clinical team. In the unlikely event that patient safety is&#xD;
        considered at risk in any way as a result of the study intervention, the patient will be&#xD;
        withdrawn from the study, and the clinical team and Chief Investigator will be notified, who&#xD;
        will escalate the concern to the Sponsor as necessary. The Sponsor or Chief Investigator may&#xD;
        take appropriate safety measures to protect research participants against any immediate&#xD;
        hazard to their health or safety. In the event of a safety breach, the main REC will be&#xD;
        notified within three days on why such measures have been taken. Any other unexpected events&#xD;
        will be reported to the REC within 15 days of the research team becoming aware and to the&#xD;
        Sponsor within one working day.&#xD;
  &#xD;
        Interviews The investigators aim to interview both main study participants and&#xD;
        non-participants (CPET only group). Participants fulfilling the eligibility criteria for the&#xD;
        main study will be sent an additional Interview Patient Information Sheet to accompany the&#xD;
        main study PIS and the routine appointment letter. The approach will take place at the&#xD;
        scheduled CPET appointment. A purposive approach to sampling will be used, accounting for&#xD;
        age, sex, ethnicity, indication for surgery, and type of surgery. A maximum of 20 study&#xD;
        participants and 5 non-participants will be interviewed. Main study participants will be&#xD;
        invited to keep a diary of their experiences with the device. For this group, the interview&#xD;
        will be scheduled after discharge from the hospital when convenient for the participant.&#xD;
  &#xD;
        For the CPET-only group, the timing of the interview will coincide with the timing of&#xD;
        approach at the CPET appointment.&#xD;
  &#xD;
        The interviews will be semi-structured and last 30-60 min. They will be facilitated by&#xD;
        telephone or face-to-face according to the current guidelines on social distancing,&#xD;
        investigating participants' attitudes and experiences with the device or what reasons have&#xD;
        influenced their decision to decline participation.&#xD;
  &#xD;
        The investigators also aim to interview clinicians who are considered to be opinion holders.&#xD;
        The participants will be employed by Leeds Teaching Hospitals Trust and will also be provided&#xD;
        with a PIS and asked to sign an informed consent form. Again the interview will be&#xD;
        facilitated by telephone or face-to-face according to the current guidelines on social&#xD;
        distancing, when convenient for the clinician. The interviews will be semi-structured, last&#xD;
        30-60 min, and investigate clinicians' attitudes towards the device.&#xD;
  &#xD;
        All interviews will be audio recorded and transcribed verbatim for content analysis.&#xD;
  &#xD;
        Data management&#xD;
  &#xD;
        Data collection during the study will be handled in accordance with Data Protection Act 2018.&#xD;
        An agreement will be in place between the University of Leeds and Asclepius for the provision&#xD;
        of the biosensor patches and mobile phones and to cover data transfer, storage, and&#xD;
        processing. All information collected will be kept strictly confidential. Information will be&#xD;
        held securely on paper and/or electronically at Leeds Teaching Hospitals NHS Trust. A site&#xD;
        file and study master file will be held securely within the Clinical Research Office at St&#xD;
        James's University Hospital. The study master file will contain all participant information,&#xD;
        including the contact information for potential participants from the clinical teams, consent&#xD;
        forms, and copies of completed case report forms (CRFs) for the study.&#xD;
  &#xD;
        Data collected during the monitoring period will be filtered, compressed, and encrypted,&#xD;
        converting analogue biological sensor data to a digital format using the global standard of&#xD;
        Advanced Encryption Standard (AES) protocol. The data is then instantly communicated to a&#xD;
        central server in a pseudo-anonymised format and is password protected. No patient&#xD;
        identifiable data will be entered into the Asclepius platform. The Asclepius cloud database&#xD;
        system adheres to all hospital security procedures and data backup policies. At the end of&#xD;
        the study, the collected data (monitoring data and questionnaire responses) will be&#xD;
        downloaded and consequently erased from the cloud database. All downloaded data will be&#xD;
        entered into a secure, password-protected study database on University of Leeds computers&#xD;
        within the trust clinical research office. Only the clinical research team will have access&#xD;
        to the stored data. Information to link participant numbers and patch numbers to personal&#xD;
        data will be kept safely on paper in the study master file in the clinical research office at&#xD;
        St James's University Hospital. This information will not be stored in any other way. The&#xD;
        trial data will be securely archived for a minimum of 5 years at the end of the study, in&#xD;
        accordance with the Good Clinical Practice guidelines.&#xD;
  &#xD;
        If a participant withdraws, all data collected by the patch up to that point will be retained&#xD;
        unless they explicitly withdraw consent. In the unlikely event that, during the study, a&#xD;
        participant loses capacity, any intervention outside of standard care (such as the monitoring&#xD;
        patch) will be removed. No further information will be collected after this point in time.&#xD;
        Information collected previously to this will remain in the study.&#xD;
  &#xD;
        Audio recordings The electronic voice recordings will be transcribed by the research team for&#xD;
        content analysis (within three months from the interview), with personal details censored to&#xD;
        ensure anonymity (unique study ID). The investigators will only store these recordings for as&#xD;
        long as necessary on a secure University of Leeds server. The audio file will be deleted&#xD;
        permanently immediately after the recording gets transcribed. The transcribed recordings will&#xD;
        then be stored securely for 5 years on the University of Leeds servers before being&#xD;
        permanently deleted.&#xD;
  &#xD;
        With regards to the analysis of the interview content, a thematic framework approach to&#xD;
        analysing data will be used. This approach is widely used in applied health research. There&#xD;
        are five stages of data analysis summarised below:&#xD;
  &#xD;
        I) familiarisation with data; II) identifying a thematic framework; III) indexing; IV)&#xD;
        charting; and V) mapping and interpretation&#xD;
  &#xD;
        The process enables the researcher to identify emerging themes in the data. The thematic&#xD;
        analysis will be modified in light of new data, and a process of iterative comparison will be&#xD;
        used to examine across themes and cases, capturing the participant experience of being part&#xD;
        of the study and using the device.&#xD;
  &#xD;
        Participants are free to withdraw from the substudy up to 7 days after the interview. After&#xD;
        this time, transcriptions will be anonymised, and it may not be possible to identify the&#xD;
        participant. It is possible to withdraw from the optional study and continue in the main&#xD;
        study. The investigators will still keep records from the interview unless the participant&#xD;
        explicitly withdraws consent for this. In the unlikely event that, during the study, the&#xD;
        participant loses capacity, any intervention outside of standard care (for main study&#xD;
        participants) will be removed. No further information will be collected after this point in&#xD;
        time. Information collected previously to this will remain in the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 19, 2022</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 19, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rates</measure>
      <time_frame>up to 18 months</time_frame>
      <description>Ratio of patients recruited in the study to overall number of eligible patients approached</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Utility as measured by the System Usability Questionnaires.</measure>
      <time_frame>up to 18 months</time_frame>
      <description>Will be assessed with System Usability score questionnaires filled by participants</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability of the Remote monitoring system as evidenced by qualitative interviews.</measure>
      <time_frame>up to 18 months</time_frame>
      <description>Patients are invited to take part in an interview process if they are willing to elaborate and provide their thoughts and experiences on the system.&#xD;
  In addition all patients fill in specific questionnaire regarding their experience of the remote monitoring system at the end of the monitoring process.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Predictors extracted from the wearable data.</measure>
      <time_frame>up to 21 months</time_frame>
      <description>Feature extraction and machine learning analysis of the wearable raw data will determine which predictors might be significant during the development of a predictive model process. (Such predictors might include factors such as Heart rate, Heart rate variability, Heart rate reserve, foot step count, walking distance, walking speed, respiratory rate).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Abdominal Neoplasm</condition>
    <condition>Surgery</condition>
    <condition>Surgery-Complications</condition>
    <condition>Risk Assessment</condition>
    <arm_group>
      <arm_group_label>Remote monitoring</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants that consent to the study will undergo additional remote monitoring with the applied wearable sensor.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Lifesignals Wearable Sensor</intervention_name>
      <description>The participants will wear the patch for 3-5 days and be provided with the mobile device, which records data transmitted wirelessly directly from the biosensor patch. During the monitoring period, participants can continue their normal activities.&#xD;
  Remote monitoring will be undertaken using the CE-marked LifeSignals wearable biosensor. The biosensor communicates with a commercially available mobile device, which relays data to a secure Cloud server (GDPR compliant data transfer).&#xD;
  Participants will subsequently undergo their planned surgery in the usual way. Data captured from the remote monitoring will not be used or made accessible to inform decisions about clinical care.&#xD;
  There will be no clinical intervention from the researchers if abnormalities in vital signs are picked up by the monitoring patch, as all data will be analysed retrospectively after the participant's operation. Any clinical concerns about the device that arise will be reported to the relevant clinical team.</description>
      <arm_group_label>Remote monitoring</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing elective major abdominal surgery (BUPA classification: Major 1 to&#xD;
               +5) [36]&#xD;
  &#xD;
            -  Patients who can be trained to use the remote monitoring software on a dedicated&#xD;
               smartphone&#xD;
  &#xD;
            -  Patients who have the capacity to provide informed, written consent&#xD;
  &#xD;
            -  Patients referred for CPET as part of routine preoperative assessment&#xD;
  &#xD;
            -  Ages ≥ 18 years&#xD;
  &#xD;
            -  Patients who can comprehend verbal and written English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients allergic to skin adhesive&#xD;
  &#xD;
            -  Patients with a cardiac pacemaker&#xD;
  &#xD;
            -  Patients who do not need to undergo CPET for preoperative assessment&#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>Alexios Dosis, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Leeds institute of Medical Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>David Jane, MD</last_name>
      <phone>+44(0)1132065281</phone>
      <email>d.g.jayne@leeds.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Alexios Dosis, MD</last_name>
      <phone>+44(0)7754226212</phone>
      <email>a.dosis@leeds.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Leeds Teaching Hospitals</name>
        <address>
          <city>Leeds</city>
          <zip>LS9 7TF</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>C Moriarty</last_name>
        <phone>07909960597</phone>
        <email>Catherine.moriarty@nhs.net</email>
      </contact>
      <investigator>
        <last_name>Alexios Dosis, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Leeds</investigator_affiliation>
      <investigator_full_name>David Jayne</investigator_full_name>
      <investigator_title>Professor of Surgery</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abdominal Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042023
  org study id: GS22/148530
  nct id: NCT06042023
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  Preoperative risk assessment (an evaluation of overall health before surgery) is important to
        determine the overall risk of mortality and complications for patients undergoing major
        abdominal surgery to allow the appropriate allocation of sparse hospital resources. The
        current gold standard for preoperative assessment is cardiopulmonary exercise testing (CPET).
        CPET is, however, not available in all centres that perform major surgery, it is a costly
        test, and therefore only high-risk patients are tested. Finding new ways of conducting
        preoperative assessment could improve overall surgical safety, patient experience and reduce
        cost.
  
        The preoperative use of remote vital signs monitoring can provide important information about
        the patients' fitness and overall health and may be used for preoperative assessment. This
        study will use a remote monitoring patch to monitor patients' vital signs before surgery. The
        aim is to evaluate the utility and patient acceptability of the remote monitoring system and
        the feasibility of a randomised controlled trial of this type of assessment. Additionally,
        the study will assess the correlation between the data captured by the remote monitoring
        system and the CPET results to evaluate the remote monitoring system's ability to predict
        risk of surgery.
  
        The study will take place in Leeds Teaching hospitals. Adult patients undergoing major
        abdominal surgery that require CPET before surgery are eligible. Participants will be
        monitored at home with the patch monitor for 3-5 days before surgery, in addition to their
        planned preoperative assessment. During remote monitoring, patients will be asked to complete
        questionnaires on their general health and experience using the patch paired with the mobile
        phone as part of the monitoring system. Clinical data from the electronic hospital records
        and general practitioner records available on the trust system will then be collected after
        surgery to assess complications and calculate risk scores.
  The clinical research team will identify eligible participants from standard CPET booking
        forms, which are received 1 - 2 weeks prior to the test. Researchers involved in this single
        centre study are part of the clinical care team and have routine access to patient
        identifiable information. Participants fulfilling the eligibility criteria will be sent a
        Patient Information Sheet (PIS) explaining the study to accompany the routine appointment
        letter. Participants attending their CPET appointment will be approached for inclusion in the
        study by the clinical research team. Participants willing to take part in the study will be
        asked to provide written, informed consent. CPET will be undertaken in the usual manner,
        after which the patient will be fitted with a wearable patch and trained to use the remote
        monitoring software/mobile device. A dedicated mobile device will be provided for the
        duration of the remote monitoring and returned when the patient is admitted for surgery.
  
        The participants will wear the patch for 3 to 5 days and be provided with the mobile device
        (modified smartphone), which records data transmitted wirelessly directly from the biosensor
        patch. During the monitoring period, participants can continue their normal activities as
        usual. The patch is water resistant, so participants can shower and pat dry the patch with a
        towel.
  
        The system (patch - mobile device) is reliable and secure, using robust Wi-Fi radio
        encryption and GDPR (General Data Protection Regulation) compliant data transfer to a
        separate cloud server. The device cannot be used as a regular phone to make phone
        calls/browse the web. In the unfortunate event that a device gets lost/ broken, or stolen,
        the participant will not be liable.
  
        Remote monitoring will be undertaken using the LifeSignals wearable biosensor
        (www.LifeSignals.com) and the Asclepius software platform. The biosensor communicates with a
        commercially available mobile device, which relays data to a secure Cloud server. The
        biosensor is CE-marked and has been used in other clinical settings for remote patient
        monitoring. The device is currently not routinely used in the NHS.
  
        Participants will subsequently undergo their planned surgery in the usual way. Data captured
        from the remote monitoring will not be used or made accessible to inform decisions about
        clinical care.
  
        All decisions regarding perioperative care will be based on the standard preoperative
        assessment per routine care. The remote monitoring data will not be monitored in real-time.
        There will be no clinical intervention from the researchers if abnormalities in vital signs
        are picked up by the monitoring patch, as all data will be analysed retrospectively 90 days
        after the participant's operation. Any clinical concerns about the device that arise will be
        reported to the relevant clinical team. In the unlikely event that patient safety is
        considered at risk in any way as a result of the study intervention, the patient will be
        withdrawn from the study, and the clinical team and Chief Investigator will be notified, who
        will escalate the concern to the Sponsor as necessary. The Sponsor or Chief Investigator may
        take appropriate safety measures to protect research participants against any immediate
        hazard to their health or safety. In the event of a safety breach, the main REC will be
        notified within three days on why such measures have been taken. Any other unexpected events
        will be reported to the REC within 15 days of the research team becoming aware and to the
        Sponsor within one working day.
  
        Interviews The investigators aim to interview both main study participants and
        non-participants (CPET only group). Participants fulfilling the eligibility criteria for the
        main study will be sent an additional Interview Patient Information Sheet to accompany the
        main study PIS and the routine appointment letter. The approach will take place at the
        scheduled CPET appointment. A purposive approach to sampling will be used, accounting for
        age, sex, ethnicity, indication for surgery, and type of surgery. A maximum of 20 study
        participants and 5 non-participants will be interviewed. Main study participants will be
        invited to keep a diary of their experiences with the device. For this group, the interview
        will be scheduled after discharge from the hospital when convenient for the participant.
  
        For the CPET-only group, the timing of the interview will coincide with the timing of
        approach at the CPET appointment.
  
        The interviews will be semi-structured and last 30-60 min. They will be facilitated by
        telephone or face-to-face according to the current guidelines on social distancing,
        investigating participants' attitudes and experiences with the device or what reasons have
        influenced their decision to decline participation.
  
        The investigators also aim to interview clinicians who are considered to be opinion holders.
        The participants will be employed by Leeds Teaching Hospitals Trust and will also be provided
        with a PIS and asked to sign an informed consent form. Again the interview will be
        facilitated by telephone or face-to-face according to the current guidelines on social
        distancing, when convenient for the clinician. The interviews will be semi-structured, last
        30-60 min, and investigate clinicians' attitudes towards the device.
  
        All interviews will be audio recorded and transcribed verbatim for content analysis.
  
        Data management
  
        Data collection during the study will be handled in accordance with Data Protection Act 2018.
        An agreement will be in place between the University of Leeds and Asclepius for the provision
        of the biosensor patches and mobile phones and to cover data transfer, storage, and
        processing. All information collected will be kept strictly confidential. Information will be
        held securely on paper and/or electronically at Leeds Teaching Hospitals NHS Trust. A site
        file and study master file will be held securely within the Clinical Research Office at St
        James's University Hospital. The study master file will contain all participant information,
        including the contact information for potential participants from the clinical teams, consent
        forms, and copies of completed case report forms (CRFs) for the study.
  
        Data collected during the monitoring period will be filtered, compressed, and encrypted,
        converting analogue biological sensor data to a digital format using the global standard of
        Advanced Encryption Standard (AES) protocol. The data is then instantly communicated to a
        central server in a pseudo-anonymised format and is password protected. No patient
        identifiable data will be entered into the Asclepius platform. The Asclepius cloud database
        system adheres to all hospital security procedures and data backup policies. At the end of
        the study, the collected data (monitoring data and questionnaire responses) will be
        downloaded and consequently erased from the cloud database. All downloaded data will be
        entered into a secure, password-protected study database on University of Leeds computers
        within the trust clinical research office. Only the clinical research team will have access
        to the stored data. Information to link participant numbers and patch numbers to personal
        data will be kept safely on paper in the study master file in the clinical research office at
        St James's University Hospital. This information will not be stored in any other way. The
        trial data will be securely archived for a minimum of 5 years at the end of the study, in
        accordance with the Good Clinical Practice guidelines.
  
        If a participant withdraws, all data collected by the patch up to that point will be retained
        unless they explicitly withdraw consent. In the unlikely event that, during the study, a
        participant loses capacity, any intervention outside of standard care (such as the monitoring
        patch) will be removed. No further information will be collected after this point in time.
        Information collected previously to this will remain in the study.
  
        Audio recordings The electronic voice recordings will be transcribed by the research team for
        content analysis (within three months from the interview), with personal details censored to
        ensure anonymity (unique study ID). The investigators will only store these recordings for as
        long as necessary on a secure University of Leeds server. The audio file will be deleted
        permanently immediately after the recording gets transcribed. The transcribed recordings will
        then be stored securely for 5 years on the University of Leeds servers before being
        permanently deleted.
  
        With regards to the analysis of the interview content, a thematic framework approach to
        analysing data will be used. This approach is widely used in applied health research. There
        are five stages of data analysis summarised below:
  
        I) familiarisation with data; II) identifying a thematic framework; III) indexing; IV)
        charting; and V) mapping and interpretation
  
        The process enables the researcher to identify emerging themes in the data. The thematic
        analysis will be modified in light of new data, and a process of iterative comparison will be
        used to examine across themes and cases, capturing the participant experience of being part
        of the study and using the device.
  
        Participants are free to withdraw from the substudy up to 7 days after the interview. After
        this time, transcriptions will be anonymised, and it may not be possible to identify the
        participant. It is possible to withdraw from the optional study and continue in the main
        study. The investigators will still keep records from the interview unless the participant
        explicitly withdraws consent for this. In the unlikely event that, during the study, the
        participant loses capacity, any intervention outside of standard care (for main study
        participants) will be removed. No further information will be collected after this point in
        time. Information collected previously to this will remain in the study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Recruitment rates
  time frame: up to 18 months
  description: Ratio of patients recruited in the study to overall number of eligible patients approached
  measure: Utility as measured by the System Usability Questionnaires.
  time frame: up to 18 months
  description: Will be assessed with System Usability score questionnaires filled by participants
  measure: Acceptability of the Remote monitoring system as evidenced by qualitative interviews.
  time frame: up to 18 months
  description: Patients are invited to take part in an interview process if they are willing to elaborate and provide their thoughts and experiences on the system.
  In addition all patients fill in specific questionnaire regarding their experience of the remote monitoring system at the end of the monitoring process.
  measure: Number of Predictors extracted from the wearable data.
  time frame: up to 21 months
  description: Feature extraction and machine learning analysis of the wearable raw data will determine which predictors might be significant during the development of a predictive model process. (Such predictors might include factors such as Heart rate, Heart rate variability, Heart rate reserve, foot step count, walking distance, walking speed, respiratory rate).
  arm group label: Remote monitoring
  arm group type: Experimental
  description: Participants that consent to the study will undergo additional remote monitoring with the applied wearable sensor.
  intervention type: Device
  intervention name: Lifesignals Wearable Sensor
  description: The participants will wear the patch for 3-5 days and be provided with the mobile device, which records data transmitted wirelessly directly from the biosensor patch. During the monitoring period, participants can continue their normal activities.
  Remote monitoring will be undertaken using the CE-marked LifeSignals wearable biosensor. The biosensor communicates with a commercially available mobile device, which relays data to a secure Cloud server (GDPR compliant data transfer).
  Participants will subsequently undergo their planned surgery in the usual way. Data captured from the remote monitoring will not be used or made accessible to inform decisions about clinical care.
  There will be no clinical intervention from the researchers if abnormalities in vital signs are picked up by the monitoring patch, as all data will be analysed retrospectively after the participant's operation. Any clinical concerns about the device that arise will be reported to the relevant clinical team.
  arm group label: Remote monitoring
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alexios Dosis, MD
  role: Principal Investigator
  affiliation: Leeds institute of Medical Research
  last name: David Jane, MD
  phone: +44(0)1132065281
  email: d.g.jayne@leeds.ac.uk
  last name: Alexios Dosis, MD
  phone: +44(0)7754226212
  email: a.dosis@leeds.ac.uk
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: University of Leeds
  investigator full name: David Jayne
  investigator title: Professor of Surgery
  mesh term: Abdominal Neoplasms