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/NCT06027515</url>
    </required_header>
    <id_info>
      <org_study_id>23-085</org_study_id>
      <nct_id>NCT06027515</nct_id>
    </id_info>
    <brief_title>Esophageal Cancer Multimodal Prehabilitation Study</brief_title>
    <official_title>A Multimodal Prehabilitation Feasibility Study for Older Adult Patients at High Risk for Poor Postoperative Outcomes Prior to Esophageal Cancer Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</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>
        The goal of this research study is to investigate the feasibility of implementing a&#xD;
        prehabilitation program that aims to improve a patient's physical, nutritional, and sleep&#xD;
        health before surgery in an older, at-risk group with esophageal cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This research study is to test whether a novel, 4-week surgical multimodal prehabilitation&#xD;
        protocol is feasible in at-risk older adult patients who have previously undergone&#xD;
        neoadjuvant chemotherapy or radiotherapy and are scheduled for surgical removal of esophageal&#xD;
        cancer.&#xD;
  &#xD;
        Research study procedures include screening for eligibility, clinic visits, questionnaires,&#xD;
        blood tests, and Computed Tomography (CT) scans.&#xD;
  &#xD;
        Participation in this research study is expected to last 7 months.&#xD;
  &#xD;
        It is expected about 30 patients will participate in this study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 18, 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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Enrollment Rate (Feasibility)</measure>
      <time_frame>At screening</time_frame>
      <description>Number of eligible patients who enroll in study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Completion Rate (Feasibility)</measure>
      <time_frame>30 days</time_frame>
      <description>Defined as the number of patients who complete study procedures.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Nutrition Compliance Rate (Feasibility)</measure>
      <time_frame>5 days</time_frame>
      <description>Comparison of number of nutritional supplements consumed compared to number of nutritional supplements prescribed as determined from daily check-ins. A cut-off value of 80% will be used to indicate compliance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical Function Compliance Rate (Feasibility)</measure>
      <time_frame>30 days</time_frame>
      <description>Comparison of the total minutes of physical function completed compared to the total minutes of physical function prescribed as determined from daily check-ins and wearable device. A cut-off value of 80% will be used to indicate compliance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep Health Compliance Rate (Feasibility)</measure>
      <time_frame>30 days</time_frame>
      <description>Comparison of the average daily hours of sleep duration, minutes of wake after sleep onset, and variability in sleep timing, achieved compared to prescribed as determined from actigraphy. A cut-off value of 80% will be used to indicate compliance.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Actigraphy Compliance Rate (Feasibility)</measure>
      <time_frame>30 days</time_frame>
      <description>Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Sarcopenia</measure>
      <time_frame>At baseline</time_frame>
      <description>Assessed by baseline Computed Tomography (CT) scan of the thorax.</description>
    </other_outcome>
    <other_outcome>
      <measure>Malnutrition</measure>
      <time_frame>At baseline visit and second measure at post-operative 1 day visit</time_frame>
      <description>Assessed by the Perioperative Nutrition Screen (PONS) Risk Score, a modified version of the malnutrition universal screening tool, which determines the presence of nutrition risk based on BMI, recent body weight loss, decrement of dietary intake, and preoperative albumin concentration.</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient-Reported Sleep Measures</measure>
      <time_frame>At baseline visit and second measure at post-operative 1 day visit</time_frame>
      <description>Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Hand Grip Test</measure>
      <time_frame>At baseline visit and second measure at post-operative 1 day visit</time_frame>
      <description>Assessed by change in baseline and post-operative Hand Grip tests using a hand-held dynamometer. An average score is calculated using measurements from both hands.</description>
    </other_outcome>
    <other_outcome>
      <measure>BMI</measure>
      <time_frame>At baseline visit and second measure at post-operative 1 day visit</time_frame>
      <description>Assessed by change in baseline and post-operative height and weight.</description>
    </other_outcome>
    <other_outcome>
      <measure>Energy expenditure</measure>
      <time_frame>At baseline visit and second measure at post-operative 1 day visit</time_frame>
      <description>Assessed by change in baseline and post-operative Metabolic Cart, or indirect calorimetry.</description>
    </other_outcome>
    <other_outcome>
      <measure>6-Minute Walk Test</measure>
      <time_frame>At baseline visit and second measure at post-operative 1 day visit</time_frame>
      <description>Assessed by a baseline and a post-operative 6-Minute Walk Test, a sub-maximal exercise test used to assess aerobic capacity and endurance.</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient-Reported Measures on Physical Function Score</measure>
      <time_frame>At baseline visit and second measure at post-operative 1 day visit</time_frame>
      <description>Assessed by Activity Measure for Post-Acute Care (AM-PAC), a standardized assessment used to measure the physical function and functional status of patients. The AM-PAC consists of 13 tests that divided into lower and upper extremity function, gait and balance and activities of daily living and instrumental activities of daily living. Also assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), a 45-item self-reported measure to evaluate physical function.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Esophageal Cancer</condition>
    <condition>Esophageal Neoplasms</condition>
    <arm_group>
      <arm_group_label>Prehabilitation Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>30 participants will be enrolled and will complete study procedures as follows:&#xD;
  Enrollment at least 4 weeks prior to esophageal cancer surgery.&#xD;
  In-person clinic visit with dietitian and physical therapist for assessments, and completion of baseline questionnaires with study coordinator.&#xD;
  Adherence to daily physical function, dietary, and sleep recommendations and consumption of 5-day immunonutrition supplement.&#xD;
  Regular electronic/phone-call check-ins with study staff.&#xD;
  Telehealth appointment with physical therapist and dietitian prior to surgery.&#xD;
  After surgery and during hospital admission, final visit with dietitian and physical therapist for assessments, and completion of questionnaires.&#xD;
  6-month follow-up period.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Prehabilitation Program</intervention_name>
      <description>Multimodal prehabilitation program consisting of pre-surgical optimization of nutrition, physical function, and sleep health via individualized plans. Participants will also be supplied with Nestle Impact Advances Recovery Immunonutrition Drink.</description>
      <arm_group_label>Prehabilitation Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  65 years of age and over&#xD;
  &#xD;
            -  Adult male or non-pregnant female volunteers&#xD;
  &#xD;
            -  Completed neoadjuvant chemotherapy or radiotherapy for esophageal cancer&#xD;
  &#xD;
            -  At least four weeks to esophageal cancer surgery&#xD;
  &#xD;
            -  Without skin conditions that preclude wearing sensors&#xD;
  &#xD;
            -  Able to speak English and consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants in any other interventional study that may bias results or limit study&#xD;
               adherence during our study&#xD;
  &#xD;
            -  Dietary restrictions that prevent consumption of nutritional supplements&#xD;
  &#xD;
            -  Women who are pregnant, nursing, or at risk of becoming pregnant&#xD;
  &#xD;
            -  Profound physical disability (for example, quadriplegia) that precludes participation&#xD;
               in any aerobic or strength training.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hassan Dashti, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hassan Dashti, PhD</last_name>
      <phone>6177269132</phone>
      <email>Hassan.dashti@mgh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Federico Ciardi, MBBS</last_name>
      <phone>646-574-7682</phone>
      <email>fciardi@mgh.harvard.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Hassan Dashti, PhD</last_name>
        <phone>617-726-9132</phone>
        <email>Hassan.dashti@mgh.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Federico Ciardi, MBBS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Hassan Dashti</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Esophageal Cancer</keyword>
    <keyword>Esophageal Neoplasms</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
      <ipd_access_criteria>Contact the Partners Innovations team at http://www.partners.org/innovation</ipd_access_criteria>
      <ipd_url>http://www.partners.org/innovation</ipd_url>
    </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/NCT06027515
  org study id: 23-085
  nct id: NCT06027515
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this research study is to investigate the feasibility of implementing a
        prehabilitation program that aims to improve a patient's physical, nutritional, and sleep
        health before surgery in an older, at-risk group with esophageal cancer.
  This research study is to test whether a novel, 4-week surgical multimodal prehabilitation
        protocol is feasible in at-risk older adult patients who have previously undergone
        neoadjuvant chemotherapy or radiotherapy and are scheduled for surgical removal of esophageal
        cancer.
  
        Research study procedures include screening for eligibility, clinic visits, questionnaires,
        blood tests, and Computed Tomography (CT) scans.
  
        Participation in this research study is expected to last 7 months.
  
        It is expected about 30 patients will participate in this study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Enrollment Rate (Feasibility)
  time frame: At screening
  description: Number of eligible patients who enroll in study
  measure: Completion Rate (Feasibility)
  time frame: 30 days
  description: Defined as the number of patients who complete study procedures.
  measure: Nutrition Compliance Rate (Feasibility)
  time frame: 5 days
  description: Comparison of number of nutritional supplements consumed compared to number of nutritional supplements prescribed as determined from daily check-ins. A cut-off value of 80% will be used to indicate compliance.
  measure: Physical Function Compliance Rate (Feasibility)
  time frame: 30 days
  description: Comparison of the total minutes of physical function completed compared to the total minutes of physical function prescribed as determined from daily check-ins and wearable device. A cut-off value of 80% will be used to indicate compliance.
  measure: Sleep Health Compliance Rate (Feasibility)
  time frame: 30 days
  description: Comparison of the average daily hours of sleep duration, minutes of wake after sleep onset, and variability in sleep timing, achieved compared to prescribed as determined from actigraphy. A cut-off value of 80% will be used to indicate compliance.
  measure: Actigraphy Compliance Rate (Feasibility)
  time frame: 30 days
  description: Total daily hours of actiwatch/wearable device wear-time. A cut-off value of 80% will be used to indicate compliance.
  measure: Sarcopenia
  time frame: At baseline
  description: Assessed by baseline Computed Tomography (CT) scan of the thorax.
  measure: Malnutrition
  time frame: At baseline visit and second measure at post-operative 1 day visit
  description: Assessed by the Perioperative Nutrition Screen (PONS) Risk Score, a modified version of the malnutrition universal screening tool, which determines the presence of nutrition risk based on BMI, recent body weight loss, decrement of dietary intake, and preoperative albumin concentration.
  measure: Patient-Reported Sleep Measures
  time frame: At baseline visit and second measure at post-operative 1 day visit
  description: Assessed by the International Physical Activity Questionnaire (IPAQ), a 27-item self-reported measure of physical activity.
  measure: Hand Grip Test
  time frame: At baseline visit and second measure at post-operative 1 day visit
  description: Assessed by change in baseline and post-operative Hand Grip tests using a hand-held dynamometer. An average score is calculated using measurements from both hands.
  measure: BMI
  time frame: At baseline visit and second measure at post-operative 1 day visit
  description: Assessed by change in baseline and post-operative height and weight.
  measure: Energy expenditure
  time frame: At baseline visit and second measure at post-operative 1 day visit
  description: Assessed by change in baseline and post-operative Metabolic Cart, or indirect calorimetry.
  measure: 6-Minute Walk Test
  time frame: At baseline visit and second measure at post-operative 1 day visit
  description: Assessed by a baseline and a post-operative 6-Minute Walk Test, a sub-maximal exercise test used to assess aerobic capacity and endurance.
  measure: Patient-Reported Measures on Physical Function Score
  time frame: At baseline visit and second measure at post-operative 1 day visit
  description: Assessed by Activity Measure for Post-Acute Care (AM-PAC), a standardized assessment used to measure the physical function and functional status of patients. The AM-PAC consists of 13 tests that divided into lower and upper extremity function, gait and balance and activities of daily living and instrumental activities of daily living. Also assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF), a 45-item self-reported measure to evaluate physical function.
  arm group label: Prehabilitation Program
  arm group type: Experimental
  description: 30 participants will be enrolled and will complete study procedures as follows:
  Enrollment at least 4 weeks prior to esophageal cancer surgery.
  In-person clinic visit with dietitian and physical therapist for assessments, and completion of baseline questionnaires with study coordinator.
  Adherence to daily physical function, dietary, and sleep recommendations and consumption of 5-day immunonutrition supplement.
  Regular electronic/phone-call check-ins with study staff.
  Telehealth appointment with physical therapist and dietitian prior to surgery.
  After surgery and during hospital admission, final visit with dietitian and physical therapist for assessments, and completion of questionnaires.
  6-month follow-up period.
  intervention type: Behavioral
  intervention name: Prehabilitation Program
  description: Multimodal prehabilitation program consisting of pre-surgical optimization of nutrition, physical function, and sleep health via individualized plans. Participants will also be supplied with Nestle Impact Advances Recovery Immunonutrition Drink.
  arm group label: Prehabilitation Program
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hassan Dashti, PhD
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Hassan Dashti, PhD
  phone: 6177269132
  email: Hassan.dashti@mgh.harvard.edu
  last name: Federico Ciardi, MBBS
  phone: 646-574-7682
  email: fciardi@mgh.harvard.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Hassan Dashti
  investigator title: Principal Investigator
  mesh term: Esophageal Neoplasms
  sharing ipd: Yes
  ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data can be shared no earlier than 1 year following the date of publication
  ipd access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
  ipd url: http://www.partners.org/innovation