<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/NCT03279055</url>
  </required_header>
  <id_info>
    <org_study_id>17-276</org_study_id>
    <nct_id>NCT03279055</nct_id>
  </id_info>
  <brief_title>Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors</brief_title>
  <official_title>Web-based Insomnia Treatment for Adolescent and Young Adult Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dana-Farber Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alex's Lemonade Stand Foundation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Dana-Farber Cancer Institute</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 research study is evaluating a six-session online program designed to help insomnia&#xD;
      (difficulty falling or staying asleep) in adolescent and young adult cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to learn whether an adapted version of SHUTi (Sleep Healthy&#xD;
      Using the Internet), a six-session online program which has been found to be effective in&#xD;
      other groups of people, will be useful in treating insomnia in adolescent and young adult&#xD;
      cancer survivors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2018</start_date>
  <completion_date type="Actual">December 20, 2019</completion_date>
  <primary_completion_date type="Actual">December 20, 2019</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>Insomnia symptoms</measure>
    <time_frame>8 weeks</time_frame>
    <description>Insomnia symptom severity will be assessed using the Insomnia Severity Index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sleep efficiency</measure>
    <time_frame>6 weeks</time_frame>
    <description>Sleep diary calculated sleep efficiency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured with PedsQL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daytime sleepiness</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measured with Pediatric Daytime Sleepiness Scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>SHUTi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be provided with an individual access code for SHUTi&#xD;
SHUTi is delivered over 6 sessions, each taking 20-30 minutes&#xD;
SHUTi is delivered by a virtual therapist&#xD;
Participants will learn about the etiology and maintenance of their insomnia&#xD;
Participants will learn how to maintain their sleep log&#xD;
Participants will learn how to address lifestyle barriers that impact their sleep&#xD;
Participants will be taught stimulus control techniques targeting non-sleep behaviors in the bedroom&#xD;
Participants will learn a range of cognitive techniques that address the key cognitive factors that perpetuate poor sleep behavior&#xD;
Participants will be taught how to gradually expand their restricted sleep</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SHUTi</intervention_name>
    <description>Sleep Healthy Using the Internet (SHUTi) is a publicly available insomnia intervention program. It focuses on 5 treatment components that form the core of CBT-I: sleep restriction, stimulus control, cognitive restructuring, sleep behaviors, and relapse prevention.</description>
    <arm_group_label>SHUTi</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  14-25 years of age&#xD;
&#xD;
          -  History of a cancer diagnosis&#xD;
&#xD;
          -  No active cancer therapy (excluding chemoprevention) in the past three months, and no&#xD;
             cancer therapy currently planned in the next 6 months&#xD;
&#xD;
          -  No surgery planned in the next 6 months&#xD;
&#xD;
          -  Significant insomnia as evidenced by an Insomnia Severity Index score ≥12&#xD;
&#xD;
          -  Able to read and write in English&#xD;
&#xD;
          -  Has internet access at home&#xD;
&#xD;
          -  Motivated and able to follow the demands of the SHUTi program, to keep sleep records,&#xD;
             complete self-report symptom reports and make changes in their sleep schedule,&#xD;
             including restricting their sleep&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior attempt(s) to treat insomnia using cognitive-behavioral treatment for insomnia&#xD;
&#xD;
          -  History of Bipolar Disorder diagnosis&#xD;
&#xD;
          -  History of a Seizure Disorder diagnosis or have experienced a seizure in the past 12&#xD;
             months&#xD;
&#xD;
          -  Intention to adjust (decrease or increase) use of sedative, hypnotic, or&#xD;
             over-the-counter (e.g., Benadryl, Unisom) medications that can affect sleep during the&#xD;
             study period&#xD;
&#xD;
          -  Diagnosed, untreated sleep apnea or sleep apnea suspected by a physician but which has&#xD;
             not been unevaluated, or other sleep disorder&#xD;
&#xD;
          -  Employment that involves irregular sleep patterns, such as shift-work or frequent&#xD;
             long-distance travel that involves adjusting to different time zones, or employment in&#xD;
             a position that could impact public safety (such as operating heavy machinery)&#xD;
&#xD;
          -  Refusal to modify or reduce excessive alcohol use that is likely to interfere with an&#xD;
             individual's sleep&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Zhou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dana-Farber Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dana-Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Zhou ES, Recklitis CJ. Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors. Pediatr Blood Cancer. 2020 Sep;67(9):e28506. doi: 10.1002/pbc.28506. Epub 2020 Jun 22.</citation>
    <PMID>32568460</PMID>
  </results_reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>October 27, 2020</last_update_submitted>
  <last_update_submitted_qc>October 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
    <investigator_full_name>Eric Zhou</investigator_full_name>
    <investigator_title>Eric Zhou, PhD</investigator_title>
  </responsible_party>
  <keyword>Insomnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Initiation and Maintenance Disorders</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/NCT03279055
org study id: 17-276
nct id: NCT03279055
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research study is evaluating a six-session online program designed to help insomnia
      (difficulty falling or staying asleep) in adolescent and young adult cancer survivors.
The purpose of this study is to learn whether an adapted version of SHUTi (Sleep Healthy
      Using the Internet), a six-session online program which has been found to be effective in
      other groups of people, will be useful in treating insomnia in adolescent and young adult
      cancer survivors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Insomnia symptoms
time frame: 8 weeks
description: Insomnia symptom severity will be assessed using the Insomnia Severity Index
measure: Sleep efficiency
time frame: 6 weeks
description: Sleep diary calculated sleep efficiency
measure: Quality of life
time frame: 8 weeks
description: Measured with PedsQL
measure: Daytime sleepiness
time frame: 8 weeks
description: Measured with Pediatric Daytime Sleepiness Scale
arm group label: SHUTi
arm group type: Experimental
description: Participants will be provided with an individual access code for SHUTi
SHUTi is delivered over 6 sessions, each taking 20-30 minutes
SHUTi is delivered by a virtual therapist
Participants will learn about the etiology and maintenance of their insomnia
Participants will learn how to maintain their sleep log
Participants will learn how to address lifestyle barriers that impact their sleep
Participants will be taught stimulus control techniques targeting non-sleep behaviors in the bedroom
Participants will learn a range of cognitive techniques that address the key cognitive factors that perpetuate poor sleep behavior
Participants will be taught how to gradually expand their restricted sleep
intervention type: Behavioral
intervention name: SHUTi
description: Sleep Healthy Using the Internet (SHUTi) is a publicly available insomnia intervention program. It focuses on 5 treatment components that form the core of CBT-I: sleep restriction, stimulus control, cognitive restructuring, sleep behaviors, and relapse prevention.
arm group label: SHUTi
criteria: 
gender: All
minimum age: 14 Years
maximum age: 25 Years
healthy volunteers: No
last name: Eric Zhou, PhD
role: Principal Investigator
affiliation: Dana-Farber Cancer Institute
facility: 
country: United States
citation: Zhou ES, Recklitis CJ. Internet-delivered insomnia intervention improves sleep and quality of life for adolescent and young adult cancer survivors. Pediatr Blood Cancer. 2020 Sep;67(9):e28506. doi: 10.1002/pbc.28506. Epub 2020 Jun 22.
PMID: 32568460
responsible party type: Principal Investigator
investigator affiliation: Dana-Farber Cancer Institute
investigator full name: Eric Zhou
investigator title: Eric Zhou, PhD
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No