<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/NCT03030859</url>
  </required_header>
  <id_info>
    <org_study_id>IRB# 828744</org_study_id>
    <secondary_id>NCI-2016-01901</secondary_id>
    <nct_id>NCT03030859</nct_id>
  </id_info>
  <brief_title>Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis</brief_title>
  <official_title>Self-Care for Head and Neck Cancer Survivors With Lymphedema and Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</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 randomized pilot clinical trial studies how well the self-care program works in head and&#xD;
      neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care&#xD;
      activities for managing chronic swelling and tough/tight tissues in the head and neck region.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To complete development of a self-care program focusing on lymphedema and fibrosis (LEF)&#xD;
      in head and neck cancer (HNC) survivors (LEF-self-care program [SCP]) with the goal of&#xD;
      improving LEF associated outcomes when compared to usual care alone. (Stage I)&#xD;
&#xD;
      II. To determine the feasibility of a program of LEF-SCP with or without follow-up to usual&#xD;
      care for HNC survivors with LEF, specifically to: 1) obtain recruitment estimates and&#xD;
      determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety;&#xD;
      and 4) evaluate patient satisfaction. (Stage II)&#xD;
&#xD;
      III. To determine if the LEF-SCP with or without follow-up enhances self-efficacy and&#xD;
      adherence compared to usual care in HNC survivors with LEF. (Stage II)&#xD;
&#xD;
      IV. To determine the preliminary efficacy of the LEF-SCP with or without follow-up as&#xD;
      compared to usual care for the following outcomes: 1) LEF progression; 2) symptom burden; and&#xD;
      3) functional status. (Stage II)&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      STAGE I: Patients undergo a training session with the study lymphedema therapist and review&#xD;
      the educational manual and videos for the development of all three components of the LEF&#xD;
      self-care program.&#xD;
&#xD;
      STAGE II: Patients are randomized to 1 of 3 groups.&#xD;
&#xD;
      GROUP I: Patients receive monthly automated system telephone call for 12 month.&#xD;
&#xD;
      GROUP II: Patients undergo LEF-SCP training comprising of motivational interview (MI) session&#xD;
      over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients&#xD;
      receive monthly automated system telephone call for 12 months. Patients also review LEF&#xD;
      self-care educational manual and watch self-care videos monthly or more frequently as needed.&#xD;
&#xD;
      GROUP III: Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF&#xD;
      self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated&#xD;
      system telephone call for 12 months. Patients review LEF self-care educational manual and&#xD;
      watch self-care videos monthly or more frequently as needed. Patients also meet with the&#xD;
      study lymphedema therapist over 1 hour at 3, 6, and 9 months.&#xD;
&#xD;
      After completion of study, patients are followed up at 3, 6, 9, and 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</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>Feasibility of the LEF-SCP evaluated by Recruitment Log</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Descriptive statistical methods will be used to summarize the rates of participation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-efficacy assessed by Perceived Medical Condition Self-Management Scale (PMCSMS)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Descriptive statistical methods will be used to summarize the PMCSMS score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-care adherence evaluated by Self-Care Checklist</measure>
    <time_frame>Up to 12 months.</time_frame>
    <description>Descriptive statistical and graphical methods will be used to describe the number and types of self-care activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preliminary efficacy assessed by LEF status</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Mixed effects generalized linear models with the appropriate link function for the nature of the specific outcome variable being analyzed will be used to generate estimates of the effect of the LEF-SCP on the progression of head and neck LEF.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Head and Neck Cancer</condition>
  <condition>Lymphedema</condition>
  <condition>Fibrosis</condition>
  <arm_group>
    <arm_group_label>Group I (Usual Care)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive monthly automated system telephone call for 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (Usual Care plus LEF-SCP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III (Usual Care plus LEF-SCP plus Follow-Up)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Undergo usual care only</description>
    <arm_group_label>Group I (Usual Care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care plus LEF-SCP</intervention_name>
    <description>Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos</description>
    <arm_group_label>Group II (Usual Care plus LEF-SCP)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care plus LEF-SCP plus Follow-up</intervention_name>
    <description>Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist</description>
    <arm_group_label>Group III (Usual Care plus LEF-SCP plus Follow-Up)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  STAGE I&#xD;
&#xD;
          -  Post HNC primary treatment&#xD;
&#xD;
          -  No evidence of cancer (NED)&#xD;
&#xD;
          -  No more than 6 weeks after completion of initial lymphedema therapy for head and neck&#xD;
             lymphedema&#xD;
&#xD;
          -  &gt; 21 years of age&#xD;
&#xD;
          -  Ability to understand English in order to complete questionnaires&#xD;
&#xD;
          -  Able to complete the onsite training and home self-care activities for LEF management&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients will be excluded if they have any of the following medical conditions that&#xD;
             would prohibit the safe implementation of self-care of LEF: recurrent or metastatic&#xD;
             cancer; any other active cancer; acute infection; congestive heart failure; renal&#xD;
             failure; cardiac or pulmonary edema; sensitive carotid sinus; severe carotid blockage;&#xD;
             and uncontrolled hypertension&#xD;
&#xD;
          -  STAGE II&#xD;
&#xD;
          -  Eligibility criteria same as stage I&#xD;
&#xD;
          -  Stage I participants are ineligible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Deng, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Jie Deng</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 27, 2023</submitted>
    <returned>March 23, 2023</returned>
  </pending_results>
  <!-- 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/NCT03030859
org study id: IRB# 828744
secondary id: NCI-2016-01901
nct id: NCT03030859
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This randomized pilot clinical trial studies how well the self-care program works in head and
      neck cancer survivors with lymphedema and fibrosis. A self-care program may promote self-care
      activities for managing chronic swelling and tough/tight tissues in the head and neck region.
PRIMARY OBJECTIVES:

      I. To complete development of a self-care program focusing on lymphedema and fibrosis (LEF)
      in head and neck cancer (HNC) survivors (LEF-self-care program [SCP]) with the goal of
      improving LEF associated outcomes when compared to usual care alone. (Stage I)

      II. To determine the feasibility of a program of LEF-SCP with or without follow-up to usual
      care for HNC survivors with LEF, specifically to: 1) obtain recruitment estimates and
      determine barriers to recruitment; 2) identify barriers to implementation; 3) assess safety;
      and 4) evaluate patient satisfaction. (Stage II)

      III. To determine if the LEF-SCP with or without follow-up enhances self-efficacy and
      adherence compared to usual care in HNC survivors with LEF. (Stage II)

      IV. To determine the preliminary efficacy of the LEF-SCP with or without follow-up as
      compared to usual care for the following outcomes: 1) LEF progression; 2) symptom burden; and
      3) functional status. (Stage II)

      OUTLINE:

      STAGE I: Patients undergo a training session with the study lymphedema therapist and review
      the educational manual and videos for the development of all three components of the LEF
      self-care program.

      STAGE II: Patients are randomized to 1 of 3 groups.

      GROUP I: Patients receive monthly automated system telephone call for 12 month.

      GROUP II: Patients undergo LEF-SCP training comprising of motivational interview (MI) session
      over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients
      receive monthly automated system telephone call for 12 months. Patients also review LEF
      self-care educational manual and watch self-care videos monthly or more frequently as needed.

      GROUP III: Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF
      self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated
      system telephone call for 12 months. Patients review LEF self-care educational manual and
      watch self-care videos monthly or more frequently as needed. Patients also meet with the
      study lymphedema therapist over 1 hour at 3, 6, and 9 months.

      After completion of study, patients are followed up at 3, 6, 9, and 12 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of the LEF-SCP evaluated by Recruitment Log
time frame: Up to 12 months
description: Descriptive statistical methods will be used to summarize the rates of participation.
measure: Self-efficacy assessed by Perceived Medical Condition Self-Management Scale (PMCSMS)
time frame: Up to 12 months
description: Descriptive statistical methods will be used to summarize the PMCSMS score.
measure: Self-care adherence evaluated by Self-Care Checklist
time frame: Up to 12 months.
description: Descriptive statistical and graphical methods will be used to describe the number and types of self-care activities.
measure: Preliminary efficacy assessed by LEF status
time frame: Up to 12 months
description: Mixed effects generalized linear models with the appropriate link function for the nature of the specific outcome variable being analyzed will be used to generate estimates of the effect of the LEF-SCP on the progression of head and neck LEF.
arm group label: Group I (Usual Care)
arm group type: Experimental
description: Patients receive monthly automated system telephone call for 12 months.
arm group label: Group II (Usual Care plus LEF-SCP)
arm group type: Experimental
description: Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients also review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed.
arm group label: Group III (Usual Care plus LEF-SCP plus Follow-Up)
arm group type: Experimental
description: Patients undergo LEF-SCP training comprising of MI session over 1 hour and LEF self-care training session over 1 hour weekly for 3 weeks. Patients receive monthly automated system telephone call for 12 months. Patients review LEF self-care educational manual and watch self-care videos monthly or more frequently as needed. Patients also meet with the study lymphedema therapist over 1 hour at 3, 6, and 9 months.
intervention type: Other
intervention name: Usual Care
description: Undergo usual care only
arm group label: Group I (Usual Care)
intervention type: Other
intervention name: Usual Care plus LEF-SCP
description: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos
arm group label: Group II (Usual Care plus LEF-SCP)
intervention type: Other
intervention name: Usual Care plus LEF-SCP plus Follow-up
description: Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist
arm group label: Group III (Usual Care plus LEF-SCP plus Follow-Up)
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Jie Deng, PhD, RN
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Jie Deng
investigator title: Associate Professor
mesh term: Head and Neck Neoplasms
mesh term: Lymphedema
mesh term: Fibrosis
sharing ipd: Undecided
submitted: February 27, 2023
returned: March 23, 2023