<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/NCT03824132</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2018-05-ASHER-IMPROV2</org_study_id>
    <nct_id>NCT03824132</nct_id>
  </id_info>
  <brief_title>LOL: It's All Improv After Cancer!™</brief_title>
  <acronym>IMPROV2</acronym>
  <official_title>IIT2018-05-ASHER-IMPROV2 - LOL: It's All Improv After Cancer!™ - A Randomized Clinical Trial Examining the Impact of an Improvisational Comedy Intervention on Well-Being Among Patients With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arash Asher, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tower Cancer Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical 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 is a 2-arm randomized waitlist controlled trial. A total of 46 of subjects are planned.&#xD;
      Subjects will be assigned to the intervention vs. waitlist control group in a randomized&#xD;
      fashion. All subjects will complete baseline assessments prior to randomization. Baseline&#xD;
      assessments will be completed within two weeks before the start of the improv series.&#xD;
      Subjects in the intervention group will complete 6 consecutive improv classes. Patients in&#xD;
      the control group will be permitted to complete the improv course (within 10-12 weeks) and&#xD;
      follow-up after their 10 week control timeline is complete. Evaluations for the intervention&#xD;
      group will be taken at baseline (T0), the last day of class (T1), one month after the last&#xD;
      day of class (T2), and 6 months after the last day of class (T3). Evaluations for the&#xD;
      waitlist control group will be taken at baseline #1 (T0), 6 weeks after T0 (T1), one month&#xD;
      after T1 (T2), first day of class (Baseline 2, T0b), last day of class (T1b), one month after&#xD;
      the last day of class (T2b), and 6 months after the last day of class (T3b). Screening data&#xD;
      will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria&#xD;
      and none of the exclusion criteria will be entered into the study.&#xD;
&#xD;
      Total duration of the study is expected to be 2 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 2, 2019</start_date>
  <completion_date type="Anticipated">July 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall well-being</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change of the Functional Assessment of Cancer Therapy - General (FACT-G) score between the intervention and control groups. Total scores range from 0-108, with higher scores representing better outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress - Anxiety - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with lower scores representing better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress - Depression - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with lower scores representing better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Isolation</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Social Isolation score between the intervention and control groups. Total scores range from 14-70, with lower scores representing better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General self-efficacy</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) General Self-Efficacy score between the intervention and control groups. Total scores range from 10-50, with higher scores representing better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy for managing emotions</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Self-Efficacy for Managing Emotions - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with higher scores representing better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive psychosocial outcomes of illness</measure>
    <time_frame>6 weeks</time_frame>
    <description>Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Psychosocial Illness Impact - Positive - Short Form 8a score between the intervention and control groups. Total scores range from 32-80, with higher scores representing better outcomes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Psychological Distress</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Improvisational comedy classes</intervention_name>
    <description>6 consecutive improvisational comedy classes</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Waitlist control</intervention_name>
    <description>After 10 week waitlist control, subjects will complete 6 consecutive improvisational comedy classes.</description>
    <arm_group_label>Waitlist Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with breast cancer stage 1-3 (no distant metastases)&#xD;
&#xD;
          -  Completed cancer treatment (including chemotherapy, radiation therapy, biologic&#xD;
             treatment, and/or any combination). At time of consent, patient must be at least 2&#xD;
             months (60 days) from their last treatment and no more than 18 months (547 days)&#xD;
             post-treatment. Long term hormonal/biologic treatments are ok.&#xD;
&#xD;
          -  Adult female age ≥18&#xD;
&#xD;
          -  Scores ≤82 on the FACT-G (Patients do not need to maintain score ≤82 after initial&#xD;
             screening FACT-G to remain on study)&#xD;
&#xD;
          -  Agrees to complete study surveys&#xD;
&#xD;
          -  Agrees to attend at least 4 of 6 Improv classes&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Reasonable medical stability (per physician clearance).&#xD;
&#xD;
          -  Emotionally stable (per physician clearance) to participate in this series.&#xD;
&#xD;
          -  Written informed consent obtained from subject and ability for subject to comply with&#xD;
             the requirements of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have significant personality disorders or unstable psychiatric disorders&#xD;
             that are severe enough to detract from the group process, as determined by their&#xD;
             treating physician.&#xD;
&#xD;
          -  Patients with severe cognitive impairments, as determined by their treating physician.&#xD;
&#xD;
          -  Non-English speakers.&#xD;
&#xD;
          -  Patients who have previously participated in an improvisational comedy program in the&#xD;
             past year.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arash Asher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arash Asher, MD</last_name>
    <phone>310-423-1218</phone>
    <email>Arash.Asher@cshs.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cancer Clinical Trials Office</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cancer Clinical Trials Office</last_name>
      <phone>310-423-2133</phone>
      <email>Cancer.Trials.Info@cshs.org</email>
    </contact>
    <investigator>
      <last_name>Arash Asher, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Arash Asher, MD</investigator_full_name>
    <investigator_title>Director, Cancer Rehabilitation &amp; Survivorship</investigator_title>
  </responsible_party>
  <!-- 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/NCT03824132
org study id: IIT2018-05-ASHER-IMPROV2
nct id: NCT03824132
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a 2-arm randomized waitlist controlled trial. A total of 46 of subjects are planned.
      Subjects will be assigned to the intervention vs. waitlist control group in a randomized
      fashion. All subjects will complete baseline assessments prior to randomization. Baseline
      assessments will be completed within two weeks before the start of the improv series.
      Subjects in the intervention group will complete 6 consecutive improv classes. Patients in
      the control group will be permitted to complete the improv course (within 10-12 weeks) and
      follow-up after their 10 week control timeline is complete. Evaluations for the intervention
      group will be taken at baseline (T0), the last day of class (T1), one month after the last
      day of class (T2), and 6 months after the last day of class (T3). Evaluations for the
      waitlist control group will be taken at baseline #1 (T0), 6 weeks after T0 (T1), one month
      after T1 (T2), first day of class (Baseline 2, T0b), last day of class (T1b), one month after
      the last day of class (T2b), and 6 months after the last day of class (T3b). Screening data
      will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria
      and none of the exclusion criteria will be entered into the study.

      Total duration of the study is expected to be 2 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Overall well-being
time frame: 6 weeks
description: Change of the Functional Assessment of Cancer Therapy - General (FACT-G) score between the intervention and control groups. Total scores range from 0-108, with higher scores representing better outcomes.
measure: Anxiety
time frame: 6 weeks
description: Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress - Anxiety - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with lower scores representing better outcomes.
measure: Depression
time frame: 6 weeks
description: Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Emotional Distress - Depression - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with lower scores representing better outcomes.
measure: Social Isolation
time frame: 6 weeks
description: Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Social Isolation score between the intervention and control groups. Total scores range from 14-70, with lower scores representing better outcomes.
measure: General self-efficacy
time frame: 6 weeks
description: Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) General Self-Efficacy score between the intervention and control groups. Total scores range from 10-50, with higher scores representing better outcomes.
measure: Self-efficacy for managing emotions
time frame: 6 weeks
description: Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Self-Efficacy for Managing Emotions - Short Form 8a score between the intervention and control groups. Total scores range from 8-40, with higher scores representing better outcomes.
measure: Positive psychosocial outcomes of illness
time frame: 6 weeks
description: Change of the PROMIS (Patient-Reported Outcomes Measurement Information System) Psychosocial Illness Impact - Positive - Short Form 8a score between the intervention and control groups. Total scores range from 32-80, with higher scores representing better outcomes.
arm group label: Intervention Group
arm group type: Experimental
arm group label: Waitlist Control Group
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Improvisational comedy classes
description: 6 consecutive improvisational comedy classes
arm group label: Intervention Group
intervention type: Behavioral
intervention name: Waitlist control
description: After 10 week waitlist control, subjects will complete 6 consecutive improvisational comedy classes.
arm group label: Waitlist Control Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arash Asher, MD
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Arash Asher, MD
phone: 310-423-1218
email: Arash.Asher@cshs.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Arash Asher, MD
investigator title: Director, Cancer Rehabilitation & Survivorship