<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/NCT03283683</url>
  </required_header>
  <id_info>
    <org_study_id>16ONCN0004</org_study_id>
    <nct_id>NCT03283683</nct_id>
  </id_info>
  <brief_title>A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer</brief_title>
  <acronym>AIPACa</acronym>
  <official_title>A Feasibility Study of the Use of Actigraphy to Determine Prognosis in Patients With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Surrey County Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Surrey County Hospital NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the use of actigraphy-derived measures to improve prognostication in&#xD;
      patients with advanced cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An accurate assessment of prognosis (life expectancy) is important for cancer patients, their&#xD;
      carers, and their health care professionals. In the case of patients / their carers, it&#xD;
      allows them to plan for the future, and to make more informed decisions about further&#xD;
      anti-cancer treatments, and about referral to supportive and palliative care services.&#xD;
      However, previous research suggests that health care professionals are not particularly good&#xD;
      at estimating prognosis, and frequently over-estimate prognosis.&#xD;
&#xD;
      The aim of this project is to assess the usefulness of measuring physical activity, and&#xD;
      differences between daytime and nighttime physical activity, in determining prognosis in&#xD;
      patients with cancer. Studies suggest that these measures may be useful in determining&#xD;
      prognosis in certain groups of patients with cancer (e.g. patients receiving chemotherapy for&#xD;
      colon / rectum cancer). However, these studies need to be repeated in patients with different&#xD;
      types of cancer, and also patients receiving other types of treatment (including supportive&#xD;
      and palliative care). The aim of this small scale (&quot;feasibility&quot;) study is to determine&#xD;
      whether or not a large scale (&quot;definitive&quot;) study can be done.&#xD;
&#xD;
      The feasibility study will include 50 patients with cancer, who will be asked to rate their&#xD;
      performance status (physical activity) on a well-used scale, and then to wear a watch-like&#xD;
      device for one week that measures physical activity and sleep patterns. The researcher will&#xD;
      collect a blood sample: some of which will be used for analysis of parameters, which have&#xD;
      previously been identified as prognostic indicators and will collect and store some blood for&#xD;
      future transcriptome analysis. Participants will also be asked to complete a sleep diary&#xD;
      during the week, and a questionnaire about their symptoms at the beginning and end of the&#xD;
      week. The study will last one week in total and is collaboration between the Royal Surrey&#xD;
      County Hospital, and the University of Surrey (Surrey Sleep Research Centre).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 25, 2016</start_date>
  <completion_date type="Actual">October 19, 2018</completion_date>
  <primary_completion_date type="Actual">October 19, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Dichotomy Index (I&lt;O)</measure>
    <time_frame>7 days.</time_frame>
    <description>Compares the amount of activity of the patient when in bed to when the patient is out of bed. An actigraphy-derived percentage of the activity counts, measured when the patient is in bed, that are inferior to (lower than) the median of the activity counts measured when the patient is out of bed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>r24</measure>
    <time_frame>upto 7 days</time_frame>
    <description>An actigraphy-derived 24hr correlation coefficient that reports on how reproducible the patient's activity is every 24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mean or average activity</measure>
    <time_frame>7 days.</time_frame>
    <description>calculated as the average number of wrist movements per minute throughout the recording time</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Actigraphy-derived sleep parameters</measure>
    <time_frame>7 days</time_frame>
    <description>Parameters during the presumed sleep phase of the circadian cycle; eg: Time in bed, sleep efficiency e.t.c</description>
  </other_outcome>
  <other_outcome>
    <measure>Physician ECOG-PS</measure>
    <time_frame>Day 0 actigraphy and Day 8 actigraphy</time_frame>
    <description>Physician's assessment of the patient's ECOG-Performance Status. The Eastern Cooperative Oncology Group performance scale (ECOG-PS) is a standardised measure for quantifying the functional status of patients with cancer and includes a numerical / categorical scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient ECOG-PS</measure>
    <time_frame>Day 0 actigraphy and Day 8 actigraphy</time_frame>
    <description>Patient's assessment of their own ECOG-Performance Status</description>
  </other_outcome>
  <other_outcome>
    <measure>Memorial Symptom Assessment Scale - Short Form (MSAS-SF)</measure>
    <time_frame>Day 0 actigraphy and Day 8 actigraphy</time_frame>
    <description>The MSAS-SF is a validated symptom assessment tool that has been used extensively in oncology / palliative care research and includes questions on both physical and psychological symptoms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Day 8 actigraphy</time_frame>
    <description>This is a validated, self-rated questionnaire, which measures sleep quality and disturbances over a 1-month time period</description>
  </other_outcome>
  <other_outcome>
    <measure>Prognosis in Palliative Care Study predictor model (PiPS-B model)</measure>
    <time_frame>Day 0 actigraphy</time_frame>
    <description>Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators</description>
  </other_outcome>
  <other_outcome>
    <measure>modified Glasgow Prognostic Score (mGPS)</measure>
    <time_frame>Day 0 actigraphy</time_frame>
    <description>Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators</description>
  </other_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Cancer</condition>
  <condition>Sleep</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      On first visit (Day 1 of the study), the researcher will collect total 7.5mls (1½ teaspoons)&#xD;
      of blood from a vein in the participant's arm. 5 mL of the venous blood sample will be sent&#xD;
      for analysis at the Royal Surrey County Hospital of haematological and biochemical&#xD;
      parameters, i.e. white blood cell count (WBC), neutrophil count, lymphocyte count, platelet&#xD;
      count, urea, alanine aminotransferase (ALT), alkaline phosphatase (ALP), albumin, C-reactive&#xD;
      protein (CRP). 2.5 mL of the venous blood sample will be sent for bio-banking at the Surrey&#xD;
      Clinical Research Centre at the University of Surrey (for future transcriptome analysis i.e.&#xD;
      RNA analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The number of participants in the feasibility study will be 50. Participants will be&#xD;
        outpatients at the site, who meet all of the inclusion criteria and none of the exclusion&#xD;
        criteria of the study (see above).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Diagnosis of locally advanced / metastatic cancer.&#xD;
&#xD;
          -  No curative treatment available.&#xD;
&#xD;
          -  Patient receiving supportive and palliative care.&#xD;
&#xD;
          -  Negative response from palliative medicine physician to the &quot;surprise&quot; question (i.e.&#xD;
             &quot;would you be surprised if this patient were to die in the next 12 months&quot;).&#xD;
&#xD;
          -  (Estimated) prognosis of &gt; 2 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inpatients.&#xD;
&#xD;
          -  Age &lt; 18 years.&#xD;
&#xD;
          -  Diagnosis of local (non-advanced) cancer.&#xD;
&#xD;
          -  Curative treatment available.&#xD;
&#xD;
          -  Presence of a physical disability that affects daytime activity (e.g. metastatic&#xD;
             spinal cord compression).&#xD;
&#xD;
          -  Presence of a physical disability that affects movement of the non-dominant arm (e.g.&#xD;
             lymphoedema).&#xD;
&#xD;
          -  Cognitive impairment (clinical judgement).&#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>Derk-Jan Dijk</last_name>
    <role>Study Director</role>
    <affiliation>Supervisor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrew Davies</last_name>
    <role>Study Director</role>
    <affiliation>Supervisor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shuchita D Patel</last_name>
    <role>Principal Investigator</role>
    <affiliation>PhD student</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>March 27, 2019</last_update_submitted>
  <last_update_submitted_qc>March 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Royal Surrey County Hospital NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Shuchita Dhwiren Patel</investigator_full_name>
    <investigator_title>Dr Shuchita Dhwiren Patel</investigator_title>
  </responsible_party>
  <keyword>rest-activity rhythm</keyword>
  <keyword>survival</keyword>
  <keyword>actigraphy</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/NCT03283683
org study id: 16ONCN0004
nct id: NCT03283683
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study evaluates the use of actigraphy-derived measures to improve prognostication in
      patients with advanced cancer.
An accurate assessment of prognosis (life expectancy) is important for cancer patients, their
      carers, and their health care professionals. In the case of patients / their carers, it
      allows them to plan for the future, and to make more informed decisions about further
      anti-cancer treatments, and about referral to supportive and palliative care services.
      However, previous research suggests that health care professionals are not particularly good
      at estimating prognosis, and frequently over-estimate prognosis.

      The aim of this project is to assess the usefulness of measuring physical activity, and
      differences between daytime and nighttime physical activity, in determining prognosis in
      patients with cancer. Studies suggest that these measures may be useful in determining
      prognosis in certain groups of patients with cancer (e.g. patients receiving chemotherapy for
      colon / rectum cancer). However, these studies need to be repeated in patients with different
      types of cancer, and also patients receiving other types of treatment (including supportive
      and palliative care). The aim of this small scale ("feasibility") study is to determine
      whether or not a large scale ("definitive") study can be done.

      The feasibility study will include 50 patients with cancer, who will be asked to rate their
      performance status (physical activity) on a well-used scale, and then to wear a watch-like
      device for one week that measures physical activity and sleep patterns. The researcher will
      collect a blood sample: some of which will be used for analysis of parameters, which have
      previously been identified as prognostic indicators and will collect and store some blood for
      future transcriptome analysis. Participants will also be asked to complete a sleep diary
      during the week, and a questionnaire about their symptoms at the beginning and end of the
      week. The study will last one week in total and is collaboration between the Royal Surrey
      County Hospital, and the University of Surrey (Surrey Sleep Research Centre).
observational model: Cohort
time perspective: Prospective
measure: Dichotomy Index (I<O)
time frame: 7 days.
description: Compares the amount of activity of the patient when in bed to when the patient is out of bed. An actigraphy-derived percentage of the activity counts, measured when the patient is in bed, that are inferior to (lower than) the median of the activity counts measured when the patient is out of bed.
measure: r24
time frame: upto 7 days
description: An actigraphy-derived 24hr correlation coefficient that reports on how reproducible the patient's activity is every 24 hours.
measure: mean or average activity
time frame: 7 days.
description: calculated as the average number of wrist movements per minute throughout the recording time
measure: Actigraphy-derived sleep parameters
time frame: 7 days
description: Parameters during the presumed sleep phase of the circadian cycle; eg: Time in bed, sleep efficiency e.t.c
measure: Physician ECOG-PS
time frame: Day 0 actigraphy and Day 8 actigraphy
description: Physician's assessment of the patient's ECOG-Performance Status. The Eastern Cooperative Oncology Group performance scale (ECOG-PS) is a standardised measure for quantifying the functional status of patients with cancer and includes a numerical / categorical scale
measure: Patient ECOG-PS
time frame: Day 0 actigraphy and Day 8 actigraphy
description: Patient's assessment of their own ECOG-Performance Status
measure: Memorial Symptom Assessment Scale - Short Form (MSAS-SF)
time frame: Day 0 actigraphy and Day 8 actigraphy
description: The MSAS-SF is a validated symptom assessment tool that has been used extensively in oncology / palliative care research and includes questions on both physical and psychological symptoms.
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: Day 8 actigraphy
description: This is a validated, self-rated questionnaire, which measures sleep quality and disturbances over a 1-month time period
measure: Prognosis in Palliative Care Study predictor model (PiPS-B model)
time frame: Day 0 actigraphy
description: Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators
measure: modified Glasgow Prognostic Score (mGPS)
time frame: Day 0 actigraphy
description: Compare actigraphy-derived circadian / sleep parameters against other validated prognostic indicators
On first visit (Day 1 of the study), the researcher will collect total 7.5mls (1½ teaspoons)
      of blood from a vein in the participant's arm. 5 mL of the venous blood sample will be sent
      for analysis at the Royal Surrey County Hospital of haematological and biochemical
      parameters, i.e. white blood cell count (WBC), neutrophil count, lymphocyte count, platelet
      count, urea, alanine aminotransferase (ALT), alkaline phosphatase (ALP), albumin, C-reactive
      protein (CRP). 2.5 mL of the venous blood sample will be sent for bio-banking at the Surrey
      Clinical Research Centre at the University of Surrey (for future transcriptome analysis i.e.
      RNA analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Derk-Jan Dijk
role: Study Director
affiliation: Supervisor
last name: Andrew Davies
role: Study Director
affiliation: Supervisor
last name: Shuchita D Patel
role: Principal Investigator
affiliation: PhD student
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Royal Surrey County Hospital NHS Foundation Trust
investigator full name: Shuchita Dhwiren Patel
investigator title: Dr Shuchita Dhwiren Patel
sharing ipd: No