<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/NCT02204631</url>
  </required_header>
  <id_info>
    <org_study_id>14-244</org_study_id>
    <nct_id>NCT02204631</nct_id>
  </id_info>
  <brief_title>2 Phase Use Of Educational Materials In Head And Neck Cancer Center</brief_title>
  <official_title>A Two-phase Study to Evaluate the Use of Educational Materials in the Head and Neck Cancer Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this study is to assess the experience of our patients with head and neck cancer&#xD;
      in regard to the information they receive, their symptoms, and their understanding of their&#xD;
      diagnosis, to determine ways to improve upon these aspects of patient care in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There will be two phases of the study. In &quot;Phase I&quot;, 30 participants will be recruited for&#xD;
      assessment of information satisfaction, psychological stress, illness perception, and symptom&#xD;
      burden throughout their head and neck cancer treatment without any intervention. This group&#xD;
      will represent the current standard of care in the head and neck group and serve as a&#xD;
      &quot;historical control&quot; for the second group. In &quot;Phase II&quot;, which will occur after &quot;Phase I&quot;&#xD;
      group, 30 new participants will be recruited to receive a handbook and to have it integrated&#xD;
      into their cancer care. The same participant reported outcome measures of information&#xD;
      satisfaction, psychological stress, illness perception, and symptom burden will be assessed&#xD;
      such that comparisons between phases can be made. This will serve as a pilot study of the&#xD;
      implementation and maintenance of an educational intervention in clinical practice and how it&#xD;
      affects participant-reported outcomes. Comparison of these two groups of participants will&#xD;
      provide the baseline data to plan future interventions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2014</start_date>
  <completion_date type="Actual">December 22, 2016</completion_date>
  <primary_completion_date type="Actual">December 22, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Information Satisfaction Questionnaire (ISQ)</measure>
    <time_frame>Baseline, 4 Months, 6 Months</time_frame>
    <description>The primary endpoint will be the difference in scores on the Information Satisfaction Questionnaire (ISQ) between participants in Phase I and Phase II at 3 weeks into their treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of participant change of scores of psychological distress</measure>
    <time_frame>Baseline, 4 Months, 6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of change participant symptom burden</measure>
    <time_frame>Baseline, 4 Months, 6 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participant illness perception</measure>
    <time_frame>Baseline, 4 Months, 6 Months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Head and Neck Educational Handbook</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception).&#xD;
After enrollment and baseline data collection, the participant will be given the handbook. The clinician giving out the handbook will give an overview of the handbook and flip through the important sections. The clinician will encourage the participant to bring it back and forth.&#xD;
Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non Head and Neck Educational Handbook</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception).&#xD;
The first group of participants will not receive the handbook but will receive the current standard care in the head and neck disease center.&#xD;
Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception).&#xD;
At completion of &quot;Phase I&quot;, all 30 participants will also be given a copy of the handbook and an accompanying questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Head and Neck Educational Handbook</intervention_name>
    <arm_group_label>Head and Neck Educational Handbook</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (greater than 18 years old) with a new diagnosis of head and neck&#xD;
             cancer.&#xD;
&#xD;
          -  Patients who have a treatment plan including both chemotherapy and radiation.&#xD;
&#xD;
          -  Patients who will be undergoing treatment at Massachusetts General Hospital Cancer&#xD;
             Center.&#xD;
&#xD;
          -  Ability to speak and read in English in order to be able to complete questionnaires&#xD;
             with minimal assistance required from a family member.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with head and neck cancer who have a treatment plan only including single&#xD;
             modality therapy (ie just radiation, just surgery, or just systemic therapy)&#xD;
&#xD;
          -  Patients who cannot speak, read and write in English with minimal assistance from a&#xD;
             family member.&#xD;
&#xD;
          -  Patients with cognitive impairment that would preclude the patient signing informed&#xD;
             consent or understanding the materials.&#xD;
&#xD;
          -  Patients who will not be receiving their cancer treatment at MGH.&#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>Lori Wirth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>May 24, 2017</last_update_submitted>
  <last_update_submitted_qc>May 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Lori J. Wirth, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Head and Neck Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck 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/NCT02204631
org study id: 14-244
nct id: NCT02204631
lead sponsor: 
has dmc: Yes
The goal of this study is to assess the experience of our patients with head and neck cancer
      in regard to the information they receive, their symptoms, and their understanding of their
      diagnosis, to determine ways to improve upon these aspects of patient care in the future.
There will be two phases of the study. In "Phase I", 30 participants will be recruited for
      assessment of information satisfaction, psychological stress, illness perception, and symptom
      burden throughout their head and neck cancer treatment without any intervention. This group
      will represent the current standard of care in the head and neck group and serve as a
      "historical control" for the second group. In "Phase II", which will occur after "Phase I"
      group, 30 new participants will be recruited to receive a handbook and to have it integrated
      into their cancer care. The same participant reported outcome measures of information
      satisfaction, psychological stress, illness perception, and symptom burden will be assessed
      such that comparisons between phases can be made. This will serve as a pilot study of the
      implementation and maintenance of an educational intervention in clinical practice and how it
      affects participant-reported outcomes. Comparison of these two groups of participants will
      provide the baseline data to plan future interventions.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Information Satisfaction Questionnaire (ISQ)
time frame: Baseline, 4 Months, 6 Months
description: The primary endpoint will be the difference in scores on the Information Satisfaction Questionnaire (ISQ) between participants in Phase I and Phase II at 3 weeks into their treatment.
measure: Percentage of participant change of scores of psychological distress
time frame: Baseline, 4 Months, 6 Months
measure: Percentage of change participant symptom burden
time frame: Baseline, 4 Months, 6 Months
measure: Percentage of Participant illness perception
time frame: Baseline, 4 Months, 6 Months
arm group label: Head and Neck Educational Handbook
arm group type: Experimental
description: Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception).
After enrollment and baseline data collection, the participant will be given the handbook. The clinician giving out the handbook will give an overview of the handbook and flip through the important sections. The clinician will encourage the participant to bring it back and forth.
Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception).
arm group label: Non Head and Neck Educational Handbook
arm group type: No Intervention
description: Prior to starting treatment, patients will be approached for trial participation and baseline questionnaires (demographics, psychological distress, symptom burden, and illness perception).
The first group of participants will not receive the handbook but will receive the current standard care in the head and neck disease center.
Participants will complete questionnaires at 3 weeks into treatment and 2 weeks after treatment has ended (information satisfaction, psychological distress, symptom burden, and illness perception).
At completion of "Phase I", all 30 participants will also be given a copy of the handbook and an accompanying questionnaire.
intervention type: Other
intervention name: Head and Neck Educational Handbook
arm group label: Head and Neck Educational Handbook
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lori Wirth, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Lori J. Wirth, MD
investigator title: Principal Investigator
mesh term: Head and Neck Neoplasms