<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/NCT03810365</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00002898</org_study_id>
    <secondary_id>1R01NR018215</secondary_id>
    <nct_id>NCT03810365</nct_id>
  </id_info>
  <brief_title>Brief Behavioral Treatment for Insomnia in Cancer Survivors</brief_title>
  <official_title>Efficacy of Nurse-Delivered Brief Behavioral Treatment to Self-Manage Insomnia in Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>State University of New York at Buffalo</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>
      The purpose is to determine whether brief behavioral treatment is effective for insomnia in&#xD;
      cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized controlled clinical trial will be used to test the efficacy of this brief&#xD;
      behavioral treatment compared to attention control on sleep, mood, functional, status and&#xD;
      quality of life and determine predictors for efficacy of Brief Behavioral Treatment for&#xD;
      Insomnia (BBTI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 6, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">October 30, 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Insomnia Severity Index (ISI)</measure>
    <time_frame>One month</time_frame>
    <description>One month after the intervention, experimental group mean ISI will be compared to control group mean ISI.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Chronic Insomnia</condition>
  <arm_group>
    <arm_group_label>Behavioral: Brief behavioral treatment for insomnia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Behavioral: Healthy eating control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy eating control involves a 45 minute individual session with two follow up phone calls.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief behavioral treatment for insomnia</intervention_name>
    <description>Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.</description>
    <arm_group_label>Behavioral: Brief behavioral treatment for insomnia</arm_group_label>
    <arm_group_label>Behavioral: Healthy eating control</arm_group_label>
    <other_name>Brief behavioral treatment for insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month 3 month 12 month follow-up visits.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; or = 4 weeks from surgery for cancer treatment; chemotherapy and/or radiation&#xD;
             therapy; no wait for hormone therapy or targeted treatment for stage I, II, or III:&#xD;
             breast, colorectal, prostate, lung cancer&#xD;
&#xD;
          -  chronic insomnia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other preexisting sleep disorders except those with OSA stable on CPAP&#xD;
&#xD;
          -  Unstable medical illnesses&#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>Suzanne S. Dickerson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Buffalo, School of Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University at Buffalo</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Comprehensive Cancer Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/17326546?dopt=Abstract</url>
    <description>Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/12683477?dopt=Abstract</url>
    <description>A primary care &quot;friendly&quot; cognitive behavioral insomnia therapy.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/16777060?dopt=Abstract</url>
    <description>Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/18591549?dopt=Abstract</url>
    <description>Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/17352006?dopt=Abstract</url>
    <description>How to provide insomnia interventions to people with cancer: insights from patients.</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>May 11, 2023</last_update_submitted>
  <last_update_submitted_qc>May 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York at Buffalo</investigator_affiliation>
    <investigator_full_name>Suzanne Dickerson</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cancer Survivors</keyword>
  <keyword>Brief Behavioral Treatment</keyword>
  <keyword>Older Adults</keyword>
  <keyword>Attention Control</keyword>
  <keyword>Intervention</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/NCT03810365
org study id: STUDY00002898
secondary id: 1R01NR018215
nct id: NCT03810365
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose is to determine whether brief behavioral treatment is effective for insomnia in
      cancer survivors.
A randomized controlled clinical trial will be used to test the efficacy of this brief
      behavioral treatment compared to attention control on sleep, mood, functional, status and
      quality of life and determine predictors for efficacy of Brief Behavioral Treatment for
      Insomnia (BBTI).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Insomnia Severity Index (ISI)
time frame: One month
description: One month after the intervention, experimental group mean ISI will be compared to control group mean ISI.
arm group label: Behavioral: Brief behavioral treatment for insomnia
arm group type: Experimental
description: Brief behavioral treatment for insomnia includes 45 minute individual intervention with two follow up phone calls.
arm group label: Behavioral: Healthy eating control
arm group type: Active Comparator
description: Healthy eating control involves a 45 minute individual session with two follow up phone calls.
intervention type: Behavioral
intervention name: Brief behavioral treatment for insomnia
description: Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.
arm group label: Behavioral: Brief behavioral treatment for insomnia
arm group label: Behavioral: Healthy eating control
other name: Brief behavioral treatment for insomnia includes content on sleep restriction, stimulus control, and sleep hygiene content with 1 month 3 month 12 month follow-up visits.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Suzanne S. Dickerson, PhD
role: Principal Investigator
affiliation: University at Buffalo, School of Nursing
facility: 
facility: 
country: United States
url: http://www.ncbi.nlm.nih.gov/pubmed/17326546?dopt=Abstract
description: Dose-response effects of cognitive-behavioral insomnia therapy: a randomized clinical trial.
url: http://www.ncbi.nlm.nih.gov/pubmed/12683477?dopt=Abstract
description: A primary care "friendly" cognitive behavioral insomnia therapy.
url: http://www.ncbi.nlm.nih.gov/pubmed/16777060?dopt=Abstract
description: Effects of a brief behavioral treatment for PTSD-related sleep disturbances: a pilot study.
url: http://www.ncbi.nlm.nih.gov/pubmed/18591549?dopt=Abstract
description: Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.
url: http://www.ncbi.nlm.nih.gov/pubmed/17352006?dopt=Abstract
description: How to provide insomnia interventions to people with cancer: insights from patients.
responsible party type: Principal Investigator
investigator affiliation: State University of New York at Buffalo
investigator full name: Suzanne Dickerson
investigator title: Principal Investigator
mesh term: Sleep Initiation and Maintenance Disorders
sharing ipd: No