<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/NCT03832686</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-48015</org_study_id>
    <secondary_id>ENT0070</secondary_id>
    <secondary_id>NCI-2019-04958</secondary_id>
    <nct_id>NCT03832686</nct_id>
  </id_info>
  <brief_title>Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer</brief_title>
  <official_title>Investigation of Two Swallowing Therapy Models During Radiation Therapy for Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</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>
      Vibrent Health is partnering with Stanford Cancer Center to conduct a randomized control&#xD;
      trial (RCT) using mobile health technology to enhance adherence and improve swallowing&#xD;
      outcomes in patients undergoing radiation therapy for head and neck cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Head and neck cancer (HNC) is the 6th most common type of cancer in the world and has&#xD;
      recently seen a dramatic rise in the United States due to a rise in the incidence of&#xD;
      oropharyngeal cancers related to the human papillomavirus (HPV) . The majority of patients&#xD;
      diagnosed with HNC receive radiation therapy at some point in their treatment, either in the&#xD;
      definitive or post-operative setting. Dysphagia is a common consequence of treatment for HNC,&#xD;
      experienced by approximately 50% of patients treated with radiation therapy. Post-treatment&#xD;
      dysphagia has been associated with increased risk of morbidity/mortality as well as&#xD;
      well-recognized deterioration of quality of life. Performance of swallowing exercises during&#xD;
      radiation significantly reduces dysphagia risk; however, patient adherence to swallowing&#xD;
      exercises during radiation treatment is limited. Thus, poor adherence stands as a major&#xD;
      obstacle to achieving the best swallowing outcomes. In response to this, a mobile health&#xD;
      application was developed to directly address barriers cited by patients as reasons for&#xD;
      non-adherence. The objective is to conduct a randomized controlled trial to test the impact&#xD;
      of the mobile application on adherence to prophylactic swallowing therapy during radiation&#xD;
      for HNC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 22, 2019</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">April 2023</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall adherence to prescribed exercise protocol measured as percentage of prescribed exercises completed</measure>
    <time_frame>up to 7 weeks</time_frame>
    <description>Percentage of prescribed exercises completed over a 7-week treatment period</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient perceived swallowing impairment as measured by the MD Anderson Dysphagia Inventory</measure>
    <time_frame>7 weeks</time_frame>
    <description>Mean MD Anderson Dysphagia Inventory score by treatment group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet level as defined by the Functional Oral Intake Scale</measure>
    <time_frame>7 weeks</time_frame>
    <description>Functional Oral Intake Scale (measure of diet restriction). Scores range from 1-7 with higher numbers indicating more normal diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet restrictions as measured by the Performance Status Scale Head and Neck</measure>
    <time_frame>7 weeks</time_frame>
    <description>Performance Status Scale Head and Neck provides a measure of eating in public (range 0-100; higher number is indicative of better function), understandability of speech (range 0-100, higher number is indicative of more normal function), and normalcy of diet (range 0-100, higher number is indicative of more normal function)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physiological oropharyngeal swallowing impairment as measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)</measure>
    <time_frame>7 weeks</time_frame>
    <description>Mean composite Modified Barium Swallow Impairment Profile score by treatment group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depth of bolus entry into the laryngeal vestibule as measured using the Penetration-Aspiration Scale (PAS)</measure>
    <time_frame>7 weeks</time_frame>
    <description>The Penetration Aspiration Scale measures the presence and depth of food/liquid material entering the airway and patient response to that material. This scale ranges from 1-8 with higher numbers indicating more abnormal function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of impairment of swallowing safety and efficiency as measured using the Dynamic Imaging Grade of Swallowing Toxicity scale</measure>
    <time_frame>7 weeks</time_frame>
    <description>Dynamic Imaging Grade of Swallowing Toxicity rates the safety and efficiency of the swallow. Each parameter is rated on a scale of 0-4 with higher numbers indicating more abnormality. This scale includes the safety score, the efficiency score, and an overall impairment score which takes into consideration the safety and efficiency grade.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">176</enrollment>
  <condition>Head Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Virtual Coach App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the experimental arm (Group A) will receive a comprehensive swallowing rehabilitation app. This study seeks to determine if a mobile application may enhance adherence to swallowing therapy in patients undergoing radiation therapy for head and neck cancer. No devices - outside of the Smartphone already owned by the participant - will be used in this study. Similarly, no drugs, biological materials, or other substances will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The paper group (Group B) will be given paper exercise logs to fill out Participants will be educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP. The paper log treatment group will serve as a standard treatment group. As adherence is a primary goal of the target intervention, paper logging will be necessary to determine relative adherence while minimizing reporting bias.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual Coach</intervention_name>
    <description>The smartphone application, tailored to patients with HNC, will monitor patient progress while also providing a direct line to health care providers should any questions or concerns arise concerning their treatment. The mobile application will also feature instructional videos that describe the swallowing exercises in detail, providing patients with another resource to help improve their overall rehabilitation experience. Finally, home practice reminders and prompts will be used to help patients integrate the exercises into their daily routine.</description>
    <arm_group_label>Virtual Coach App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Study subjects ≥ 18 years of age.&#xD;
&#xD;
          -  Fluent English speaking subjects.&#xD;
&#xD;
          -  Study subjects capable of providing informed consent.&#xD;
&#xD;
          -  Patients with newly diagnosed non-metastatic head and neck cancer of the oral cavity,&#xD;
             oropharynx, nasopharynx, hypopharynx, and larynx that require bilateral neck&#xD;
             radiation. Individuals with unknown primary head and neck cancer with nodal disease&#xD;
             necessitating bilateral radiation will also be included.&#xD;
&#xD;
          -  Study subjects with a previously untreated head and neck cancer diagnosis requiring a&#xD;
             definitive course of radiotherapy requiring a prescribed dose of 60Gy or greater.&#xD;
&#xD;
          -  Study subjects who have either an Android or Apple iOS-based smartphone or tablet&#xD;
             compatible with the Vibrent application.&#xD;
&#xD;
          -  Study subjects who have access to a sufficient monthly data plan (approximately 200&#xD;
             MB/month), or Internet connection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking, or incapable of providing informed consent.&#xD;
&#xD;
          -  Lack of smartphone, tablet, or Internet connection.&#xD;
&#xD;
          -  Inability to use the Vibrent application.&#xD;
&#xD;
          -  Patients being treated for head and neck cancer who do not receive some form of&#xD;
             primary, adjuvant, or neo-adjuvant radiation therapy will not be considered for the&#xD;
             study.&#xD;
&#xD;
          -  Patients with recurrent disease.&#xD;
&#xD;
          -  Pregnant women.&#xD;
&#xD;
          -  Individuals under the age of 18.&#xD;
&#xD;
          -  Individuals with contraindications to radiation therapy.&#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>Heather Starmer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford Universiy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Cancer Institute</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 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>Head and Neck Neoplasms</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/NCT03832686
org study id: IRB-48015
secondary id: ENT0070
secondary id: NCI-2019-04958
nct id: NCT03832686
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Vibrent Health is partnering with Stanford Cancer Center to conduct a randomized control
      trial (RCT) using mobile health technology to enhance adherence and improve swallowing
      outcomes in patients undergoing radiation therapy for head and neck cancer.
Head and neck cancer (HNC) is the 6th most common type of cancer in the world and has
      recently seen a dramatic rise in the United States due to a rise in the incidence of
      oropharyngeal cancers related to the human papillomavirus (HPV) . The majority of patients
      diagnosed with HNC receive radiation therapy at some point in their treatment, either in the
      definitive or post-operative setting. Dysphagia is a common consequence of treatment for HNC,
      experienced by approximately 50% of patients treated with radiation therapy. Post-treatment
      dysphagia has been associated with increased risk of morbidity/mortality as well as
      well-recognized deterioration of quality of life. Performance of swallowing exercises during
      radiation significantly reduces dysphagia risk; however, patient adherence to swallowing
      exercises during radiation treatment is limited. Thus, poor adherence stands as a major
      obstacle to achieving the best swallowing outcomes. In response to this, a mobile health
      application was developed to directly address barriers cited by patients as reasons for
      non-adherence. The objective is to conduct a randomized controlled trial to test the impact
      of the mobile application on adherence to prophylactic swallowing therapy during radiation
      for HNC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Overall adherence to prescribed exercise protocol measured as percentage of prescribed exercises completed
time frame: up to 7 weeks
description: Percentage of prescribed exercises completed over a 7-week treatment period
measure: Patient perceived swallowing impairment as measured by the MD Anderson Dysphagia Inventory
time frame: 7 weeks
description: Mean MD Anderson Dysphagia Inventory score by treatment group
measure: Diet level as defined by the Functional Oral Intake Scale
time frame: 7 weeks
description: Functional Oral Intake Scale (measure of diet restriction). Scores range from 1-7 with higher numbers indicating more normal diet
measure: Diet restrictions as measured by the Performance Status Scale Head and Neck
time frame: 7 weeks
description: Performance Status Scale Head and Neck provides a measure of eating in public (range 0-100; higher number is indicative of better function), understandability of speech (range 0-100, higher number is indicative of more normal function), and normalcy of diet (range 0-100, higher number is indicative of more normal function)
measure: Physiological oropharyngeal swallowing impairment as measured by the Modified Barium Swallow Impairment Profile (MBS-ImP)
time frame: 7 weeks
description: Mean composite Modified Barium Swallow Impairment Profile score by treatment group
measure: Depth of bolus entry into the laryngeal vestibule as measured using the Penetration-Aspiration Scale (PAS)
time frame: 7 weeks
description: The Penetration Aspiration Scale measures the presence and depth of food/liquid material entering the airway and patient response to that material. This scale ranges from 1-8 with higher numbers indicating more abnormal function.
measure: Severity of impairment of swallowing safety and efficiency as measured using the Dynamic Imaging Grade of Swallowing Toxicity scale
time frame: 7 weeks
description: Dynamic Imaging Grade of Swallowing Toxicity rates the safety and efficiency of the swallow. Each parameter is rated on a scale of 0-4 with higher numbers indicating more abnormality. This scale includes the safety score, the efficiency score, and an overall impairment score which takes into consideration the safety and efficiency grade.
arm group label: Virtual Coach App
arm group type: Experimental
description: Participants in the experimental arm (Group A) will receive a comprehensive swallowing rehabilitation app. This study seeks to determine if a mobile application may enhance adherence to swallowing therapy in patients undergoing radiation therapy for head and neck cancer. No devices - outside of the Smartphone already owned by the participant - will be used in this study. Similarly, no drugs, biological materials, or other substances will be used.
arm group label: Standard of Care
arm group type: No Intervention
description: The paper group (Group B) will be given paper exercise logs to fill out Participants will be educated regarding potential radiation-related side effects and trained in the same series of swallowing exercises by the SLP. The paper log treatment group will serve as a standard treatment group. As adherence is a primary goal of the target intervention, paper logging will be necessary to determine relative adherence while minimizing reporting bias.
intervention type: Other
intervention name: Virtual Coach
description: The smartphone application, tailored to patients with HNC, will monitor patient progress while also providing a direct line to health care providers should any questions or concerns arise concerning their treatment. The mobile application will also feature instructional videos that describe the swallowing exercises in detail, providing patients with another resource to help improve their overall rehabilitation experience. Finally, home practice reminders and prompts will be used to help patients integrate the exercises into their daily routine.
arm group label: Virtual Coach App
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Heather Starmer
role: Principal Investigator
affiliation: Stanford Universiy
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Head and Neck Neoplasms
sharing ipd: No