<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/NCT03267524</url>
  </required_header>
  <id_info>
    <org_study_id>17277</org_study_id>
    <secondary_id>NCI-2017-01565</secondary_id>
    <nct_id>NCT03267524</nct_id>
  </id_info>
  <brief_title>Walking for Recovery From Surgery in Improving Quality of Life in Older Adults With Lung or Gastrointestinal Cancer and Their Family Caregivers</brief_title>
  <official_title>Walking for Recovery From Surgery: Pilot Study of a Prehabilitation Intervention for Older Adults With Cancer and Their Family Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>City of Hope Medical Center</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 pilot clinical trial studies how well Walking for Recovery from Surgery works in&#xD;
      improving quality of life in older adults with lung or gastrointestinal cancer and their&#xD;
      family caregivers. A walking program, such as Walking for Recovery from Surgery may help&#xD;
      support overall well-being as a caregiver, and may help improve family member or friend's&#xD;
      recovery from surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To examine whether the intervention and telehealth approach would be feasible and&#xD;
      acceptable.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To examine patient outcome patterns suggesting the potential efficacy of the intervention&#xD;
      on self-efficacy, functional status (daily steps, 6-minute walk time, timed up and go),&#xD;
      psychological distress, symptoms, and global health status.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients and caregivers receive Walking for Recovery from Surgery prehabilitation&#xD;
      intervention in 4 sessions 3-7 days before surgery, before discharge, and at 2 and 7 days&#xD;
      post-discharge.&#xD;
&#xD;
      After completion of study, patients and caregivers are followed up for 2 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 9, 2017</start_date>
  <completion_date type="Anticipated">November 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">November 28, 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>Pedometer-assessed daily steps (patients)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>6-minute walking time (patients)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timed-up and go (patients)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short Physical Performance Battery (patients)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (patients)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptoms (patients)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distress level assessed using Distress Thermometer (patients)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-efficacy (caregivers)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy-Short Form. Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distress assessed using Distress thermometer (caregivers)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (caregivers)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional status (caregivers)</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geriatric assessment</measure>
    <time_frame>Up to 2 months</time_frame>
    <description>Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Adult Liver Carcinoma</condition>
  <condition>Caregiver</condition>
  <condition>Colorectal Carcinoma</condition>
  <condition>Lung Carcinoma</condition>
  <condition>Malignant Digestive System Neoplasm</condition>
  <condition>Pancreatic Carcinoma</condition>
  <arm_group>
    <arm_group_label>Supportive Care (Walking for Recovery from Surgery)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients and caregivers receive Walking for Recovery from Surgery prehabilitation intervention in 4 sessions 3-7 days before surgery, before discharge, and at 2 and 7 days post-discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Exercise Intervention</intervention_name>
    <description>Receive Walking for Recovery from Surgery prehabilitation intervention</description>
    <arm_group_label>Supportive Care (Walking for Recovery from Surgery)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (Walking for Recovery from Surgery)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive Care (Walking for Recovery from Surgery)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -Inclusion:&#xD;
&#xD;
          -  PATIENT: Diagnosis of lung or GI (colorectal, pancreas, liver) cancers&#xD;
&#xD;
          -  PATIENT: Scheduled to undergo surgery&#xD;
&#xD;
          -  PATIENT: &gt;= 65 years&#xD;
&#xD;
          -  PATIENT: Able to read and understand English&#xD;
&#xD;
          -  CAREGIVER: Family member/friend identified by the patient as the primary caregiver&#xD;
             before and after surgery&#xD;
&#xD;
          -  CAREGIVER: &gt;= 21 years&#xD;
&#xD;
          -  CAREGIVER: Able to read and understand English&#xD;
&#xD;
          -  This study will be conducted in patients and family caregivers who are scheduled to&#xD;
             undergo lung or GI cancer surgery treatment&#xD;
&#xD;
          -  There are no restrictions related to performance status or life expectancy&#xD;
&#xD;
          -  All subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
        • Subjects, who in the opinion of the investigator, may not be able to comply with the&#xD;
        safety monitoring requirements of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Virginia Sun, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2023</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>Carcinoma</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
    <mesh_term>Digestive System Neoplasms</mesh_term>
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
  </condition_browse>
  <!-- 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/NCT03267524
org study id: 17277
secondary id: NCI-2017-01565
nct id: NCT03267524
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot clinical trial studies how well Walking for Recovery from Surgery works in
      improving quality of life in older adults with lung or gastrointestinal cancer and their
      family caregivers. A walking program, such as Walking for Recovery from Surgery may help
      support overall well-being as a caregiver, and may help improve family member or friend's
      recovery from surgery.
PRIMARY OBJECTIVES:

      I. To examine whether the intervention and telehealth approach would be feasible and
      acceptable.

      SECONDARY OBJECTIVES:

      I. To examine patient outcome patterns suggesting the potential efficacy of the intervention
      on self-efficacy, functional status (daily steps, 6-minute walk time, timed up and go),
      psychological distress, symptoms, and global health status.

      OUTLINE:

      Patients and caregivers receive Walking for Recovery from Surgery prehabilitation
      intervention in 4 sessions 3-7 days before surgery, before discharge, and at 2 and 7 days
      post-discharge.

      After completion of study, patients and caregivers are followed up for 2 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pedometer-assessed daily steps (patients)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: 6-minute walking time (patients)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: Timed-up and go (patients)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: Short Physical Performance Battery (patients)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (patients)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: Symptoms (patients)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: Distress level assessed using Distress Thermometer (patients)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: Self-efficacy (caregivers)
time frame: Up to 2 months
description: Will be assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy-Short Form. Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: Distress assessed using Distress thermometer (caregivers)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: General health status assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) General Physical and Mental Health-Short Form (caregivers)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: Functional status (caregivers)
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
measure: Geriatric assessment
time frame: Up to 2 months
description: Descriptive statistics will be used to summarize all outcome measure scores using validated scoring procedures, and to evaluate patterns suggesting potential intervention efficacy on outcomes.
arm group label: Supportive Care (Walking for Recovery from Surgery)
arm group type: Experimental
description: Patients and caregivers receive Walking for Recovery from Surgery prehabilitation intervention in 4 sessions 3-7 days before surgery, before discharge, and at 2 and 7 days post-discharge.
intervention type: Behavioral
intervention name: Exercise Intervention
description: Receive Walking for Recovery from Surgery prehabilitation intervention
arm group label: Supportive Care (Walking for Recovery from Surgery)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive Care (Walking for Recovery from Surgery)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Survey Administration
description: Ancillary studies
arm group label: Supportive Care (Walking for Recovery from Surgery)
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Virginia Sun, RN, PhD
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Colorectal Neoplasms
mesh term: Pancreatic Neoplasms
mesh term: Digestive System Neoplasms
mesh term: Gastrointestinal Neoplasms
mesh term: Carcinoma, Hepatocellular