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/NCT06001268</url>
    </required_header>
    <id_info>
      <org_study_id>MCC-22476</org_study_id>
      <nct_id>NCT06001268</nct_id>
    </id_info>
    <brief_title>Support Through Remote Observation and Nutrition Guidance Program (STRONG-PCS)</brief_title>
    <acronym>STRONG-PCS</acronym>
    <official_title>Support Through Remote Observation and Nutrition Guidance Program for Individuals With Pancreatic Cancer Undergoing Surgery (STRONG-PCS)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>United States Department of Defense</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>H. Lee Moffitt Cancer Center and Research Institute</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 the study is to assess the feasibility and participant satisfaction with the&#xD;
        Support through Remote Observation and Nutrition Guidance program. The program provides&#xD;
        enhanced dietician access and nutrition support for participants living with pancreatic&#xD;
        cancer who are undergoing surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 14, 2023</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2027</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>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment Rate - Feasibility</measure>
      <time_frame>Up to 48 months</time_frame>
      <description>The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention Rate - Feasibility</measure>
      <time_frame>at 8 weeks</time_frame>
      <description>The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Data Collection - Feasibility</measure>
      <time_frame>at 8 weeks</time_frame>
      <description>The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participant Satisfaction - Acceptability</measure>
      <time_frame>at 8 weeks</time_frame>
      <description>The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20, score &gt;/= 12).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Participant Rating on Ease of Use the Mobile Application - Usability</measure>
      <time_frame>at 8 weeks</time_frame>
      <description>The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100, score of &gt;/=60).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Malnutrition-Significant weight loss</measure>
      <time_frame>90 days</time_frame>
      <description>Significant weight loss is defined as &gt;5% and &gt;10% of body weight at 30, 60, and 90 days after discharge. This will be calculated based on weight obtained during clinic visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Malnutrition - Low BMI</measure>
      <time_frame>at Baseline, 30, 60 and 90 days</time_frame>
      <description>Low BMI will be defined as &lt;20kg/m² for individuals &lt;70 years old and &lt;22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Malnutrition - Low Skeletal Muscle Mass</measure>
      <time_frame>At baseline, 30, 60 and 90 days</time_frame>
      <description>Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline and 90 days after discharge (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.9 cm2 /m2 for females and SMI ≤55.4 cm2 /m2 for males.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life</measure>
      <time_frame>at Baseline, 4, 8 and 12 weeks</time_frame>
      <description>Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes questions about the participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher score indicates a better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital Readmissions</measure>
      <time_frame>30, 60 and 90 days post-hospital discharge</time_frame>
      <description>Hospital readmissions will be measured using a self-reported survey item to determine whether the patient was admitted to the index hospital or another hospital after hospital discharge.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Malnutrition -Nutritional Status</measure>
      <time_frame>at Baseline, 30, 60 and 90 days</time_frame>
      <description>Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, = 9 severely malnourished).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Pancreatic Cancer</condition>
    <arm_group>
      <arm_group_label>STRONG-PCS Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Fitbit Data Collection</intervention_name>
      <description>Participants will log food intake while sharing their data with a dietician in real time for 12 weeks</description>
      <arm_group_label>STRONG-PCS Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Nutrition Counseling</intervention_name>
      <description>Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.</description>
      <arm_group_label>STRONG-PCS Intervention</arm_group_label>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Survey</intervention_name>
      <description>Participants will take a survey at baseline and weeks 4,8,&amp; 12. (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.</description>
      <arm_group_label>STRONG-PCS Intervention</arm_group_label>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  ≥18 years old&#xD;
  &#xD;
            -  Diagnosis of pancreatic cancer&#xD;
  &#xD;
            -  Completed open pancreatic surgery (e.g., Whipple, distal/subtotal pancreatectomy,&#xD;
               total pancreatectomy) for treatment at Moffitt Cancer Center&#xD;
  &#xD;
            -  Discharged on an oral diet&#xD;
  &#xD;
            -  Able to speak and read English or Spanish&#xD;
  &#xD;
            -  Able to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Determined to be ineligible for surgery during evaluation (e.g., cancer metastasis)&#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>Kea Turner, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Moffitt Cancer Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Pamela J Hodul, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Moffitt Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emma Hume</last_name>
      <phone>813-745-6426</phone>
      <email>emma.hume@moffitt.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Kea L Turner, PhD</last_name>
      <phone>813-745-5213</phone>
      <email>Kea.Turner@moffitt.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Moffitt Cancer Center</name>
        <address>
          <city>Tampa</city>
          <state>Florida</state>
          <zip>33612</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emma Hume</last_name>
        <phone>813-745-6426</phone>
        <email>Emma.Hume@moffitt.org</email>
      </contact>
      <investigator>
        <last_name>Kea L Turner, PhD, MPH, MA</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Pamela J Hodul, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Amir Alishahi Tabriz, MD, PhD, MPH</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Brian D Gonzalez, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nate H Parker, MPH, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Laurence R Gore, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.moffitt.org/clinical-trials-research/clinical-trials/</url>
      <description>Moffitt Cancer Center Clinical Trial Search</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Nutrition Support</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pancreatic Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06001268
  org study id: MCC-22476
  nct id: NCT06001268
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of the study is to assess the feasibility and participant satisfaction with the
        Support through Remote Observation and Nutrition Guidance program. The program provides
        enhanced dietician access and nutrition support for participants living with pancreatic
        cancer who are undergoing surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Recruitment Rate - Feasibility
  time frame: Up to 48 months
  description: The study will be deemed feasible if ≥ 50% of eligible participants are enrolled.
  measure: Retention Rate - Feasibility
  time frame: at 8 weeks
  description: The study will be deemed feasible if ≥ 70% of participants enrolled at baseline will be retained at 8 weeks.
  measure: Data Collection - Feasibility
  time frame: at 8 weeks
  description: The study will be deemed feasible if ≥ 70% of participants log food for greater than 80% of study days.
  measure: Participant Satisfaction - Acceptability
  time frame: at 8 weeks
  description: The study will be deemed acceptable if ≥ 70% of participants rate the overall intervention as satisfactory using a validated 4-item scale (score range 0-20, score >/= 12).
  measure: Participant Rating on Ease of Use the Mobile Application - Usability
  time frame: at 8 weeks
  description: The study will be deemed usable if ≥ 60% of participants rate the mobile application as easy-to-use for logging dietary intake using a validated 10-item scale (score range from 0-100, score of >/=60).
  measure: Malnutrition-Significant weight loss
  time frame: 90 days
  description: Significant weight loss is defined as >5% and >10% of body weight at 30, 60, and 90 days after discharge. This will be calculated based on weight obtained during clinic visits.
  measure: Malnutrition - Low BMI
  time frame: at Baseline, 30, 60 and 90 days
  description: Low BMI will be defined as <20kg/m² for individuals <70 years old and <22kg/m2 for individuals ≥70 years old. This will be calculated based on weight and height measurements from clinic visits.
  measure: Malnutrition - Low Skeletal Muscle Mass
  time frame: At baseline, 30, 60 and 90 days
  description: Low muscle mass will be estimated by calculating skeletal muscle index (SMI) from routinely collected CT scans at baseline and 90 days after discharge (CT scans are conducted every 3 months). Low muscle mass will be defined as SMI ≤38.9 cm2 /m2 for females and SMI ≤55.4 cm2 /m2 for males.
  measure: Quality of Life
  time frame: at Baseline, 4, 8 and 12 weeks
  description: Quality of Life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire includes questions about the participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher score indicates a better quality of life.
  measure: Hospital Readmissions
  time frame: 30, 60 and 90 days post-hospital discharge
  description: Hospital readmissions will be measured using a self-reported survey item to determine whether the patient was admitted to the index hospital or another hospital after hospital discharge.
  measure: Malnutrition -Nutritional Status
  time frame: at Baseline, 30, 60 and 90 days
  description: Nutritional status will be measured using the Patient-Generated Subjective Global Assessment (PG-SGA) Short Form (score range: 0-35) and categorized based on a prior validation study (0-1 well nourished, 2-8 at-risk, = 9 severely malnourished).
  arm group label: STRONG-PCS Intervention
  arm group type: Experimental
  description: Participants will receive an initial in-person consultation with a dietician within 2 weeks of hospital discharge. Then participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person and remote monitoring through a smart phone app and wearable sensor to allow participants to log food intake while sharing their data with a dietician.
  arm group label: Usual Care
  arm group type: Active Comparator
  description: Participants will be referred for nutrition counseling from a dietitian based on clinical discretion.
  intervention type: Behavioral
  intervention name: Fitbit Data Collection
  description: Participants will log food intake while sharing their data with a dietician in real time for 12 weeks
  arm group label: STRONG-PCS Intervention
  intervention type: Behavioral
  intervention name: Nutrition Counseling
  description: Participants will receive individually tailored, bi-weekly nutrition counseling from a dietician via telehealth or in person.
  arm group label: STRONG-PCS Intervention
  arm group label: Usual Care
  intervention type: Behavioral
  intervention name: Survey
  description: Participants will take a survey at baseline and weeks 4,8,& 12. (FACT-G) Questionnaire includes questions about participant's physical, social, emotional and functional well being over the past 7 days. This questionnaire uses a 5 point Likert-type scale, 0=not at all, 4=very much. A higher total score indicates better quality of life.
  arm group label: STRONG-PCS Intervention
  arm group label: Usual Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kea Turner, PhD
  role: Principal Investigator
  affiliation: Moffitt Cancer Center
  last name: Pamela J Hodul, MD
  role: Principal Investigator
  affiliation: Moffitt Cancer Center
  last name: Emma Hume
  phone: 813-745-6426
  email: emma.hume@moffitt.org
  last name: Kea L Turner, PhD
  phone: 813-745-5213
  email: Kea.Turner@moffitt.org
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  url: https://www.moffitt.org/clinical-trials-research/clinical-trials/
  description: Moffitt Cancer Center Clinical Trial Search
  responsible party type: Sponsor
  mesh term: Pancreatic Neoplasms
  sharing ipd: Undecided