<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/NCT03010150</url>
  </required_header>
  <id_info>
    <org_study_id>2016-0597</org_study_id>
    <secondary_id>NCI-2018-01260</secondary_id>
    <secondary_id>2016-0597</secondary_id>
    <secondary_id>R21DE019954</secondary_id>
    <nct_id>NCT03010150</nct_id>
  </id_info>
  <brief_title>Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer</brief_title>
  <official_title>Modeling Adherence to Preventive Swallowing Exercises in Head and Neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
      This trial uses blood tests and questionnaires to study how well participants with head and&#xD;
      neck cancer that has spread to other places in the body adhere to swallowing exercises to&#xD;
      prevent future disease. Using blood tests to study cytokines (proteins related to the immune&#xD;
      system) may help doctors learn if certain levels of cytokines affect whether or not side&#xD;
      effects occur and if they put participants at risk for future disease. Questionnaires may&#xD;
      help doctors learn about the reasons head and neck cancer participants may or may not follow&#xD;
      the swallowing exercises that they are asked to perform after receiving radiation treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine whether illness perceptions significantly predict adherence to swallowing&#xD;
      exercises at 6 months after the end of radiation.&#xD;
&#xD;
      II. To determine whether sickness behaviors (depression, fatigue, pain)'s effect on illness&#xD;
      perceptions are mediated by pro-inflammatory cytokines.&#xD;
&#xD;
      III. To determine whether social support moderates the impact of coping on appraisal of&#xD;
      coping.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. As a secondary aim, to determine the feasibility and utility of cardiac impedance&#xD;
      pre-ejection period measurement as a corollary measure for depression and distress.&#xD;
&#xD;
      II. As a secondary aim, to identify potential genetic markers for swallowing dysfunction&#xD;
      which has developed by the 6-month follow-up.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Participants provide blood samples prior to and at the 6-month visit after receiving&#xD;
      radiation therapy. Participants also complete questionnaires either at home, in clinic, or&#xD;
      via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood&#xD;
      sample collection.&#xD;
&#xD;
      After completion of study, participants are followed up periodically for up to 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2028</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence to swallowing exercises</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The primary analytic approach is to use linear mixed models to determine whether illness perceptions significantly predict adherence 6 months. The study will estimate and test the illness perception subscale scores' relationship to adherence using a linear mixed model. In the model, the dependent variable is the patient's self-reported adherence score and independent variables include illness perception, follow-up assessment time point and other covariates such as demographic and medical variables, depression, pain, fatigue, emotional coping, objective coping, appraisal of coping, stress, and lack of social well-being.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Illness perceptions</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The study's statistical tool is mediation analysis: the independent variables are the sickness behaviors (depression, fatigue, pain); the mediators are the cytokine levels, and the outcome variable is illness perception. The study will test the mediator effects based on the product of coefficients method, rather than the classical Baron &amp; Kenny causal steps tests, since the former approach has better statistical power. The study will conduct both single-mediator analysis for each of the mediators, and multiple-mediator analysis with all mediators in the mediating process</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of social support on coping</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>The moderating effect of social support on coping and appraisal of coping is the statistical equivalent of testing the two-way interaction between these variables and the social support variable. Multivariate linear regression will be used, in which the dependent variable is appraisal of coping at 6 months follow-up, and independent variables include the emotion-focused coping and action-focused sub scales, social support, and their two-way interactions. In the regression, the study will control for baseline variables. In addition, we will also apply the linear mixed model to investigate the moderating effect of these variables longitudinally. The mixed model naturally accounts for the correlation of repeated measures at baseline and 6 months follow-up.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">471</enrollment>
  <condition>Carcinoma of Unknown Primary</condition>
  <condition>Clinical Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8</condition>
  <condition>Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8</condition>
  <condition>Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8</condition>
  <condition>Metastatic Head and Neck Carcinoma</condition>
  <condition>Metastatic Malignant Neoplasm in the Uterine Cervix</condition>
  <condition>Pathologic Stage I HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8</condition>
  <condition>Pathologic Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage I Hypopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage I Nasopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage II Hypopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage II Laryngeal Cancer AJCC v8</condition>
  <condition>Stage II Nasopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8</condition>
  <condition>Stage III Hypopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage III Laryngeal Cancer AJCC v8</condition>
  <condition>Stage III Nasopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8</condition>
  <condition>Stage IV Hypopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage IV Laryngeal Cancer AJCC v8</condition>
  <condition>Stage IV Nasopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8</condition>
  <condition>Stage IVA Hypopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage IVA Laryngeal Cancer AJCC v8</condition>
  <condition>Stage IVA Nasopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8</condition>
  <condition>Stage IVB Hypopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage IVB Laryngeal Cancer AJCC v8</condition>
  <condition>Stage IVB Nasopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8</condition>
  <arm_group>
    <arm_group_label>Observational (blood tests, questionnaires)</arm_group_label>
    <description>Participants provide blood samples prior to and at the 6-month visit after receiving radiation therapy. Participants also complete questionnaires either at home, in clinic, or via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood sample collection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Provide blood samples</description>
    <arm_group_label>Observational (blood tests, questionnaires)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Observational (blood tests, questionnaires)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples obtained from participants&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with head and neck cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are dispositioned to receive radiation with curative intent for nasopharyngeal,&#xD;
             oropharyngeal, hypopharyngeal, laryngeal, or an unknown primary cancer with cervical&#xD;
             metastases&#xD;
&#xD;
          -  Are stage II-IVb for non- human papillomavirus (HPV)- related oropharyngeal cancer&#xD;
&#xD;
          -  Have HPV- related oropharynx cancer that is T1, have nodal involvement with no distant&#xD;
             metastasis or have HPV- related oropharynx cancer that is at least T2 with no distant&#xD;
             metastasis&#xD;
&#xD;
          -  Are stage II-IVb for laryngeal cancer&#xD;
&#xD;
          -  Are stage I-IVb for hypopharyngeal&#xD;
&#xD;
          -  Are stage I-IVb for nasopharyngeal cancer&#xD;
&#xD;
          -  Have stage I-III unknown primary cancer with cervical&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have other cancer diagnoses, except non-melanoma skin cancer&#xD;
&#xD;
          -  Had treatment for previous head and neck cancer or radiation to the head and neck&#xD;
&#xD;
          -  Have a history of previous head and neck surgery (excluding biopsy and/or&#xD;
             tonsillectomy and/or tracheotomy)&#xD;
&#xD;
          -  Have a current oropharyngeal dysphagia unrelated to cancer diagnosis (e.g., dysphagia&#xD;
             due to underlying neurogenic disorder)&#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>Eileen H Shinn</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eileen H. Shinn</last_name>
      <phone>713-745-0870</phone>
    </contact>
    <investigator>
      <last_name>Eileen H. Shinn</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>M D Anderson Cancer Center</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 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>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Laryngeal Neoplasms</mesh_term>
    <mesh_term>Oropharyngeal Neoplasms</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/NCT03010150
org study id: 2016-0597
secondary id: NCI-2018-01260
secondary id: 2016-0597
secondary id: R21DE019954
nct id: NCT03010150
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial uses blood tests and questionnaires to study how well participants with head and
      neck cancer that has spread to other places in the body adhere to swallowing exercises to
      prevent future disease. Using blood tests to study cytokines (proteins related to the immune
      system) may help doctors learn if certain levels of cytokines affect whether or not side
      effects occur and if they put participants at risk for future disease. Questionnaires may
      help doctors learn about the reasons head and neck cancer participants may or may not follow
      the swallowing exercises that they are asked to perform after receiving radiation treatments.
PRIMARY OBJECTIVES:

      I. To determine whether illness perceptions significantly predict adherence to swallowing
      exercises at 6 months after the end of radiation.

      II. To determine whether sickness behaviors (depression, fatigue, pain)'s effect on illness
      perceptions are mediated by pro-inflammatory cytokines.

      III. To determine whether social support moderates the impact of coping on appraisal of
      coping.

      SECONDARY OBJECTIVES:

      I. As a secondary aim, to determine the feasibility and utility of cardiac impedance
      pre-ejection period measurement as a corollary measure for depression and distress.

      II. As a secondary aim, to identify potential genetic markers for swallowing dysfunction
      which has developed by the 6-month follow-up.

      OUTLINE:

      Participants provide blood samples prior to and at the 6-month visit after receiving
      radiation therapy. Participants also complete questionnaires either at home, in clinic, or
      via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood
      sample collection.

      After completion of study, participants are followed up periodically for up to 2 years.
observational model: Cohort
time perspective: Prospective
measure: Adherence to swallowing exercises
time frame: Up to 6 months
description: The primary analytic approach is to use linear mixed models to determine whether illness perceptions significantly predict adherence 6 months. The study will estimate and test the illness perception subscale scores' relationship to adherence using a linear mixed model. In the model, the dependent variable is the patient's self-reported adherence score and independent variables include illness perception, follow-up assessment time point and other covariates such as demographic and medical variables, depression, pain, fatigue, emotional coping, objective coping, appraisal of coping, stress, and lack of social well-being.
measure: Illness perceptions
time frame: Up to 6 months
description: The study's statistical tool is mediation analysis: the independent variables are the sickness behaviors (depression, fatigue, pain); the mediators are the cytokine levels, and the outcome variable is illness perception. The study will test the mediator effects based on the product of coefficients method, rather than the classical Baron & Kenny causal steps tests, since the former approach has better statistical power. The study will conduct both single-mediator analysis for each of the mediators, and multiple-mediator analysis with all mediators in the mediating process
measure: Effect of social support on coping
time frame: Up to 6 months
description: The moderating effect of social support on coping and appraisal of coping is the statistical equivalent of testing the two-way interaction between these variables and the social support variable. Multivariate linear regression will be used, in which the dependent variable is appraisal of coping at 6 months follow-up, and independent variables include the emotion-focused coping and action-focused sub scales, social support, and their two-way interactions. In the regression, the study will control for baseline variables. In addition, we will also apply the linear mixed model to investigate the moderating effect of these variables longitudinally. The mixed model naturally accounts for the correlation of repeated measures at baseline and 6 months follow-up.
arm group label: Observational (blood tests, questionnaires)
description: Participants provide blood samples prior to and at the 6-month visit after receiving radiation therapy. Participants also complete questionnaires either at home, in clinic, or via internet over 30 minutes prior to receiving radiation therapy and within 14 days of blood sample collection.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Provide blood samples
arm group label: Observational (blood tests, questionnaires)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Observational (blood tests, questionnaires)
Blood samples obtained from participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eileen H Shinn
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: M D Anderson Cancer Center
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Head and Neck Neoplasms
mesh term: Nasopharyngeal Carcinoma
mesh term: Neoplasms
mesh term: Laryngeal Neoplasms
mesh term: Oropharyngeal Neoplasms