<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/NCT04468243</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201902145</org_study_id>
    <secondary_id>OCR35482</secondary_id>
    <nct_id>NCT04468243</nct_id>
  </id_info>
  <brief_title>Pilot RCT Feasibility Study: Cancer and T2D</brief_title>
  <official_title>A Nurse-led Intervention in Patients With Newly Diagnosed Cancer and Type 2 Diabetes: A Pilot RCT Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>
      The purpose of this study is to test a nurse-led intervention for adults with newly diagnosed&#xD;
      cancer and undiagnosed/newly diagnosed Type-2 diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aim 1: To examine study feasibility of a nurse-led intervention for adults with&#xD;
      newly diagnosed cancer and T2D. We define feasibility indicators as: (a) efficient study&#xD;
      recruitment is possible given prevalence of T2D (diagnosed and undiagnosed) in UF patients&#xD;
      with newly diagnosed cancer; (b) retention rates in both groups ≥80% to indicate that the&#xD;
      study design and methods are adequately patient-centered; (c) identified barriers to and&#xD;
      facilitators of a nurse-led intervention are respectively modifiable or optimizable; and (d)&#xD;
      patient acceptability scores &gt;8 for the study procedures. We hypothesize that we will recruit&#xD;
      up to 40 patients within 18 months and retain ≥ 80% of patients in all groups; minor but&#xD;
      important revisions will be required to resolve issues identified with using the nurse-led&#xD;
      intervention; and 80% of patients from both groups who complete the study will report that&#xD;
      the burden of the study is acceptable through their retention in the study.&#xD;
&#xD;
      Specific Aim 2: To determine the variation in HbA1c at baseline and at the end of the&#xD;
      three-month intervention period in each of the two study groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow Accrual&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Actual">December 13, 2021</completion_date>
  <primary_completion_date type="Actual">December 13, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>At 3-month study visit</time_frame>
    <description>Study acceptability (scores&gt;8 indicate adequate acceptability) will be measured via the Study Acceptability Scale questionnaire for both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Point of Care HbA1c Test</measure>
    <time_frame>At baseline visit and at 3-month study visit</time_frame>
    <description>To determine the variation in HbA1c at baseline and at the end of the three-month intervention period in each of the two study groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Nurse-led</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nurse-led (group A). Patients randomized to group A will be taken to an available consultation room within the clinic and provided brief diabetes education which includes understanding what it means to have diabetes, healthy eating, and physical activity. Patients will also receive instructions on how to use a glucometer and how to take Metformin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care (Control; group B). Patients randomized to usual care will be informed of their HbA1c value, will continue to receive usual cancer care, and will be encouraged to follow-up with their PCP for T2D management. The RA will ensure that oncology visit clinic notes and the results of the HbA1c testing are relayed to the patient's PCP office. Patients who do not have a PCP identified will be referred to an appropriate provider.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nurse-led diabetes care</intervention_name>
    <description>Nurse-led brief diabetes education, instructions on glucometer and Metformin use, patients receive prescriptions for Metformin and blood glucose testing kit</description>
    <arm_group_label>Nurse-led</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a) 18 years and older&#xD;
&#xD;
          -  b) Using pathology reports, a new diagnosis of a solid tumor cancer or lymphoma within&#xD;
             the past 3 months&#xD;
&#xD;
          -  c) Patients being treated with curative intent or those with a prognosis estimated to&#xD;
             be &gt;2 years, as best assessed by the oncologist.&#xD;
&#xD;
          -  d) First medical oncology outpatient visit at UF within the past 3 months&#xD;
&#xD;
          -  e) Plans to continue cancer care at UF&#xD;
&#xD;
          -  f) Speaks and reads English&#xD;
&#xD;
          -  g) Can comply with study related procedures, per the treating oncologist or advanced&#xD;
             practice provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  a) Diagnosis of leukemia or pancreatic cancer as the new cancer diagnosis&#xD;
&#xD;
          -  b) Being treated for T2D for &gt; than 3 months&#xD;
&#xD;
          -  c) eGFR &lt;45mL/minute/1.73m2&#xD;
&#xD;
          -  d) Liver insufficiency (defined as liver enzymes over 5 times the upper limit of&#xD;
             normal or clinical sequelae of advanced cirrhosis as documented by the treating&#xD;
             oncologist or Advanced Practice Providers.&#xD;
&#xD;
          -  e) Active infection requiring systemic antibiotics&#xD;
&#xD;
          -  f) Taking systemic steroids of more than 1-week duration. Must have stopped &gt;3 days&#xD;
             prior to study enrollment. Note, inhaled or topical steroids are not exclusion&#xD;
             criteria.&#xD;
&#xD;
          -  g) Planning to receive cancer care at a location outside of UF&#xD;
&#xD;
          -  h) Enrolled in another study with similar outcomes.&#xD;
&#xD;
          -  i) Currently taking metformin or known inability to tolerate it&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lisa Scarton</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04468243
org study id: IRB201902145
secondary id: OCR35482
nct id: NCT04468243
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test a nurse-led intervention for adults with newly diagnosed
      cancer and undiagnosed/newly diagnosed Type-2 diabetes
Specific Aim 1: To examine study feasibility of a nurse-led intervention for adults with
      newly diagnosed cancer and T2D. We define feasibility indicators as: (a) efficient study
      recruitment is possible given prevalence of T2D (diagnosed and undiagnosed) in UF patients
      with newly diagnosed cancer; (b) retention rates in both groups ≥80% to indicate that the
      study design and methods are adequately patient-centered; (c) identified barriers to and
      facilitators of a nurse-led intervention are respectively modifiable or optimizable; and (d)
      patient acceptability scores >8 for the study procedures. We hypothesize that we will recruit
      up to 40 patients within 18 months and retain ≥ 80% of patients in all groups; minor but
      important revisions will be required to resolve issues identified with using the nurse-led
      intervention; and 80% of patients from both groups who complete the study will report that
      the burden of the study is acceptable through their retention in the study.

      Specific Aim 2: To determine the variation in HbA1c at baseline and at the end of the
      three-month intervention period in each of the two study groups.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Acceptability
time frame: At 3-month study visit
description: Study acceptability (scores>8 indicate adequate acceptability) will be measured via the Study Acceptability Scale questionnaire for both groups
measure: Point of Care HbA1c Test
time frame: At baseline visit and at 3-month study visit
description: To determine the variation in HbA1c at baseline and at the end of the three-month intervention period in each of the two study groups.
arm group label: Nurse-led
arm group type: Experimental
description: Nurse-led (group A). Patients randomized to group A will be taken to an available consultation room within the clinic and provided brief diabetes education which includes understanding what it means to have diabetes, healthy eating, and physical activity. Patients will also receive instructions on how to use a glucometer and how to take Metformin.
arm group label: Usual Care
arm group type: No Intervention
description: Usual Care (Control; group B). Patients randomized to usual care will be informed of their HbA1c value, will continue to receive usual cancer care, and will be encouraged to follow-up with their PCP for T2D management. The RA will ensure that oncology visit clinic notes and the results of the HbA1c testing are relayed to the patient's PCP office. Patients who do not have a PCP identified will be referred to an appropriate provider.
intervention type: Other
intervention name: Nurse-led diabetes care
description: Nurse-led brief diabetes education, instructions on glucometer and Metformin use, patients receive prescriptions for Metformin and blood glucose testing kit
arm group label: Nurse-led
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Lisa Scarton
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No