<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/NCT03285048</url>
  </required_header>
  <id_info>
    <org_study_id>MIRB 02072 MB0018</org_study_id>
    <nct_id>NCT03285048</nct_id>
  </id_info>
  <brief_title>Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer</brief_title>
  <acronym>CaCRT</acronym>
  <official_title>Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer: A Single-arm Proof of Concept Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to determine the safety, feasibility and acceptability of an 8-week cognitive&#xD;
      remediation training (CRT) in patients treated for cancer. The secondary objective of the&#xD;
      study is to estimate the effect size of CRT in improving neurocognitive functioning and&#xD;
      quality of life. This is a single-arm proof of concept study. Patients treated for cancer&#xD;
      with persistent cognitive complaints will be recruited from the outpatient clinic of the VA&#xD;
      Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven&#xD;
      community.The active treatment phase will be followed by an assessment at the conclusion of&#xD;
      treatment to evaluate changes in cognitive function and quality of life. Participants will be&#xD;
      invited back to participate in a final follow-up assessment 2 months later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objectives:&#xD;
&#xD;
      The primary objective of this study is to determine the safety, feasibility and acceptability&#xD;
      of an 8-week cognitive training intervention in patients treated for cancer. The secondary&#xD;
      objective of the study is to estimate the effect size of CRT in improving neurocognitive&#xD;
      functioning and quality of life for three different populations of cancer patients.&#xD;
&#xD;
      Research Design:&#xD;
&#xD;
      This is a single-arm proof of concept study with three cancer groups. Patients treated for&#xD;
      cancer with persistent cognitive complaints will be recruited from the outpatient clinic of&#xD;
      the VA Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven&#xD;
      community. We intend to enroll approximately 30 participants, with approximately 10 from each&#xD;
      of the following cancer treatment types (1) participants who are at least six months from&#xD;
      completion of adjuvant chemotherapy or chemoradiation and are in remission; (2) participants&#xD;
      who are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV&#xD;
      cancer and with stable medical condition; (3) participants who are receiving long-term (6&#xD;
      months or longer) hormone therapy (androgen deprivation therapy or anti-estrogen therapy).&#xD;
      Patients in this group who received chemotherapy will be eligible if they completed&#xD;
      chemotherapy at least 6 months prior to enrolling. There will be an eight-week intervention&#xD;
      period and a two-month follow-up assessment.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      Participants will participate in a pre-assessment to establish eligibility, baseline&#xD;
      cognitive function, and quality of life. This will be followed by participation in a&#xD;
      cognitive remediation program (Brain HQ) for eight weeks during which all participants&#xD;
      receive up to 16 hours of computerized cognitive training and 16 45-minute Bridging groups&#xD;
      where they learn cognitive skills for daily living. The active treatment phase will be&#xD;
      followed by an assessment at the conclusion of treatment to evaluate changes in cognitive&#xD;
      function and quality of life. Participants will be invited back to participate in a final&#xD;
      follow-up assessment 2 months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-report of daily cognitive function</measure>
    <time_frame>8 weeks</time_frame>
    <description>Self-reported cognitive function includes symptoms of perceived cognitive impairments, perceived cognitive abilities, and overall quality of life. These are aggregated into a classification of overall degree of impairment and disability</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive function</measure>
    <time_frame>8 weeks</time_frame>
    <description>Neurocognitive assessments using neurocognitive tests of attention, processing speed, executive function and memory changes from baseline. Results are aggregated into an overall score reflecting neurocognitive change from baseline.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Cancer of the Prostate</condition>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Cognitive Remediation Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Remediation Training is comprised of 8 weeks of active cognitive training using Brain HQ auditory and visual training tasks. Training is twice per week for up to 2 hours. Also included is a Bridging Group at each training session. The Bridging group provides information about cognitive training and compensatory strategies to generalize the benefits of training to daily life.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Remediation Therapy</intervention_name>
    <description>Brain HQ is a computer based cognitive training that uses hierarchical adaptive technology to provide challenging and demanding training that is not too frustrating or discouraging. Training includes auditory and visual sensory training, memory and executive function exercises. The Bridging group is based on similar training programs that focus on self-regulation training, problem focused cognitive behavior therapy and compensatory cognitive strategies.</description>
    <arm_group_label>Cognitive Remediation Therapy</arm_group_label>
    <other_name>Cognitive Remediation Training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.Participants who:&#xD;
&#xD;
          1. are at least six months from completion of adjuvant chemotherapy or chemoradiation and&#xD;
             are in remission or;&#xD;
&#xD;
          2. are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV&#xD;
             cancer and with stable medical conditions or;&#xD;
&#xD;
          3. are receiving long-term (6 months or longer) hormone therapy (androgen deprivation&#xD;
             therapy or anti-estrogen therapy). Patients in this group who received chemotherapy&#xD;
             will be eligible if they completed chemotherapy at least 6 months prior to enrolling.&#xD;
&#xD;
        2. Subjective reports of cognitive decline. 3. Report that they are interested in seeking&#xD;
        treatment to address their cognitive concerns.&#xD;
&#xD;
        4. Age 18 or older. 5. Fluency in English and a 6th grade or higher reading level.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Does not meet one of the three participant categories&#xD;
&#xD;
          2. Unstable medical condition.&#xD;
&#xD;
          3. History of, or current symptoms of, serious psychiatric disorder requiring&#xD;
             antipsychotic medications or hospitalization.&#xD;
&#xD;
          4. Current substance abuse disorder.&#xD;
&#xD;
          5. History of, or current central nervous system (CNS) malignancies, CNS radiation,&#xD;
             intrathecal chemotherapy, or CNS-involved surgery.&#xD;
&#xD;
          6. Current IQ estimate less than 80.&#xD;
&#xD;
          7. Unable to give written informed consent.&#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>Morris D Bell, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Connecticut Healthcare System</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>October 18, 2018</last_update_submitted>
  <last_update_submitted_qc>October 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>cognitive impairment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic 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/NCT03285048
org study id: MIRB 02072 MB0018
nct id: NCT03285048
lead sponsor: 
has dmc: No
This study is to determine the safety, feasibility and acceptability of an 8-week cognitive
      remediation training (CRT) in patients treated for cancer. The secondary objective of the
      study is to estimate the effect size of CRT in improving neurocognitive functioning and
      quality of life. This is a single-arm proof of concept study. Patients treated for cancer
      with persistent cognitive complaints will be recruited from the outpatient clinic of the VA
      Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven
      community.The active treatment phase will be followed by an assessment at the conclusion of
      treatment to evaluate changes in cognitive function and quality of life. Participants will be
      invited back to participate in a final follow-up assessment 2 months later.
Objectives:

      The primary objective of this study is to determine the safety, feasibility and acceptability
      of an 8-week cognitive training intervention in patients treated for cancer. The secondary
      objective of the study is to estimate the effect size of CRT in improving neurocognitive
      functioning and quality of life for three different populations of cancer patients.

      Research Design:

      This is a single-arm proof of concept study with three cancer groups. Patients treated for
      cancer with persistent cognitive complaints will be recruited from the outpatient clinic of
      the VA Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven
      community. We intend to enroll approximately 30 participants, with approximately 10 from each
      of the following cancer treatment types (1) participants who are at least six months from
      completion of adjuvant chemotherapy or chemoradiation and are in remission; (2) participants
      who are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV
      cancer and with stable medical condition; (3) participants who are receiving long-term (6
      months or longer) hormone therapy (androgen deprivation therapy or anti-estrogen therapy).
      Patients in this group who received chemotherapy will be eligible if they completed
      chemotherapy at least 6 months prior to enrolling. There will be an eight-week intervention
      period and a two-month follow-up assessment.

      Methodology:

      Participants will participate in a pre-assessment to establish eligibility, baseline
      cognitive function, and quality of life. This will be followed by participation in a
      cognitive remediation program (Brain HQ) for eight weeks during which all participants
      receive up to 16 hours of computerized cognitive training and 16 45-minute Bridging groups
      where they learn cognitive skills for daily living. The active treatment phase will be
      followed by an assessment at the conclusion of treatment to evaluate changes in cognitive
      function and quality of life. Participants will be invited back to participate in a final
      follow-up assessment 2 months later.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Self-report of daily cognitive function
time frame: 8 weeks
description: Self-reported cognitive function includes symptoms of perceived cognitive impairments, perceived cognitive abilities, and overall quality of life. These are aggregated into a classification of overall degree of impairment and disability
measure: Neurocognitive function
time frame: 8 weeks
description: Neurocognitive assessments using neurocognitive tests of attention, processing speed, executive function and memory changes from baseline. Results are aggregated into an overall score reflecting neurocognitive change from baseline.
arm group label: Cognitive Remediation Therapy
arm group type: Experimental
description: Cognitive Remediation Training is comprised of 8 weeks of active cognitive training using Brain HQ auditory and visual training tasks. Training is twice per week for up to 2 hours. Also included is a Bridging Group at each training session. The Bridging group provides information about cognitive training and compensatory strategies to generalize the benefits of training to daily life.
intervention type: Behavioral
intervention name: Cognitive Remediation Therapy
description: Brain HQ is a computer based cognitive training that uses hierarchical adaptive technology to provide challenging and demanding training that is not too frustrating or discouraging. Training includes auditory and visual sensory training, memory and executive function exercises. The Bridging group is based on similar training programs that focus on self-regulation training, problem focused cognitive behavior therapy and compensatory cognitive strategies.
arm group label: Cognitive Remediation Therapy
other name: Cognitive Remediation Training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Morris D Bell, Ph.D.
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No