<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/NCT03227744</url>
  </required_header>
  <id_info>
    <org_study_id>17314</org_study_id>
    <nct_id>NCT03227744</nct_id>
  </id_info>
  <brief_title>A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance</brief_title>
  <official_title>A Pilot Study of Prostate Cancer-specific Anxiety in Active Surveillance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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 study is a clinical trial to determine whether a 12-week group therapy intervention for&#xD;
      patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related&#xD;
      anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal&#xD;
      of the study is to further our understanding of anxiety in men who have been diagnosed with&#xD;
      prostate cancer and are undergoing Active Surveillance. Men who have elected Active&#xD;
      Surveillance for their management of prostate cancer are eligible to participate in this&#xD;
      study. After signing informed consent, all participants will complete two brief&#xD;
      questionnaires (The Memorial Anxiety Scale for Prostate Cancer [MAX-PC] and the General&#xD;
      Anxiety and Depression Scale 7 [GAD-7] to measure their anxiety levels. If the participant&#xD;
      scores above a certain number, they will be asked to participate in the study. Patients will&#xD;
      be randomly assigned to either a control group, who will receive no treatment, but continue&#xD;
      to follow up with their urologist to manage their prostate cancer as usual, or the treatment&#xD;
      group. The treatment group will receive 12 one-hour group therapy sessions that will take&#xD;
      place once a week for 12 weeks with a licensed psychologist free of charge. They will be&#xD;
      instructed to follow up with their urologist as previously determined for their prostate&#xD;
      cancer management. Patients in both groups will be monitored for anxiety completing three&#xD;
      questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional&#xD;
      Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If&#xD;
      patients require further therapy beyond the group treatment sessions, the investigators may&#xD;
      refer them to a psychologist or psychiatrist for further treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study has been terminated&#xD;
  </why_stopped>
  <start_date type="Actual">April 19, 2017</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 28, 2018</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>Assessment of MAX-PC Scores</measure>
    <time_frame>Change from baseline to 4 weeks to 12 weeks</time_frame>
    <description>Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their MAX-PC questionnaire scores. Eighteen questions about anxiety related to prostate cancer and prostate specific antigen (PSA) tests are graded from 0-3 (0 = not at all; 3 = often), yielding a total between 0 and 54.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of FACT-P Scores</measure>
    <time_frame>Change from baseline to 4 weeks to 12 weeks</time_frame>
    <description>Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their FACT-P questionnaire scores. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of anxiety scores as a function of time</measure>
    <time_frame>Change from baseline to 4 weeks to 12 weeks</time_frame>
    <description>In secondary analysis, a mixed effects model will be used when the outcome vector consists of all three measurements (baseline, 4 and 12 weeks) and via statistical contrasts will examine whether the relationship between PSA anxiety scores and time is linear or if the effect of intervention on anxiety scores is fully observed by week 4. Two-sided p-values ≤ 0.05 will be considered statistically significant.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Enrolled in group therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the group therapy arm will be enrolled in group therapy and be issued surveys.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Not enrolled in group therapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in control arm will be issued surveys</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group therapy</intervention_name>
    <description>Twelve 1-hour group therapy sessions with a licensed psychologist for prostate-cancer related anxiety.</description>
    <arm_group_label>Enrolled in group therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surveys</intervention_name>
    <description>MAX-PC, GAD and FACT-P</description>
    <arm_group_label>Enrolled in group therapy</arm_group_label>
    <arm_group_label>Not enrolled in group therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of 40&#xD;
&#xD;
          -  Primary diagnosis of Prostate Cancer&#xD;
&#xD;
          -  Initial MAX-PC score of ≥16.&#xD;
&#xD;
          -  Sign a consent form allowing related information to be included in this research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prostate cancer is not their primary diagnosis.&#xD;
&#xD;
          -  Have pre-existing diagnosed psychiatric conditions, are currently taking psychotropic&#xD;
             medications (e.g., antidepressants, anxiolytics, mood stabilizers.)&#xD;
&#xD;
          -  Have been diagnosed with cancer other than prostate cancer (and non-melanoma skin&#xD;
             cancer)&#xD;
&#xD;
          -  Evidence of active substance abuse.&#xD;
&#xD;
          -  Participants in the treatment group who are absent from more than 3 therapy sessions&#xD;
             will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aaron Pinkhasov, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Winthrop Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Winthrop Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>June 30, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer, Anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03227744/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03227744/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03227744
org study id: 17314
nct id: NCT03227744
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is a clinical trial to determine whether a 12-week group therapy intervention for
      patients undergoing Active Surveillance for Prostate Cancer can relieve disease-related
      anxiety and improve quality of life and delay elective treatment of prostate cancer. The goal
      of the study is to further our understanding of anxiety in men who have been diagnosed with
      prostate cancer and are undergoing Active Surveillance. Men who have elected Active
      Surveillance for their management of prostate cancer are eligible to participate in this
      study. After signing informed consent, all participants will complete two brief
      questionnaires (The Memorial Anxiety Scale for Prostate Cancer [MAX-PC] and the General
      Anxiety and Depression Scale 7 [GAD-7] to measure their anxiety levels. If the participant
      scores above a certain number, they will be asked to participate in the study. Patients will
      be randomly assigned to either a control group, who will receive no treatment, but continue
      to follow up with their urologist to manage their prostate cancer as usual, or the treatment
      group. The treatment group will receive 12 one-hour group therapy sessions that will take
      place once a week for 12 weeks with a licensed psychologist free of charge. They will be
      instructed to follow up with their urologist as previously determined for their prostate
      cancer management. Patients in both groups will be monitored for anxiety completing three
      questionnaires, the MAX-PC and GAD-7 which they previously completed, and the Functional
      Assessment of Cancer Therapy - Prostate (FACT-P) during the 4th and 12th weeks of therapy. If
      patients require further therapy beyond the group treatment sessions, the investigators may
      refer them to a psychologist or psychiatrist for further treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Assessment of MAX-PC Scores
time frame: Change from baseline to 4 weeks to 12 weeks
description: Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their MAX-PC questionnaire scores. Eighteen questions about anxiety related to prostate cancer and prostate specific antigen (PSA) tests are graded from 0-3 (0 = not at all; 3 = often), yielding a total between 0 and 54.
measure: Assessment of FACT-P Scores
time frame: Change from baseline to 4 weeks to 12 weeks
description: Two groups, the experimental (recipients of group therapy) and the control (literature only) will be compared for anxiety based on their FACT-P questionnaire scores. Twenty-seven questions about physical, social/family, emotional and functional well-being are graded from 0-4 (0 = not at all; 4 = very much), yielding a total between 0 and 108.
measure: Assessment of anxiety scores as a function of time
time frame: Change from baseline to 4 weeks to 12 weeks
description: In secondary analysis, a mixed effects model will be used when the outcome vector consists of all three measurements (baseline, 4 and 12 weeks) and via statistical contrasts will examine whether the relationship between PSA anxiety scores and time is linear or if the effect of intervention on anxiety scores is fully observed by week 4. Two-sided p-values ≤ 0.05 will be considered statistically significant.
arm group label: Enrolled in group therapy
arm group type: Active Comparator
description: Patients in the group therapy arm will be enrolled in group therapy and be issued surveys.
arm group label: Not enrolled in group therapy
arm group type: Placebo Comparator
description: Patients in control arm will be issued surveys
intervention type: Behavioral
intervention name: Group therapy
description: Twelve 1-hour group therapy sessions with a licensed psychologist for prostate-cancer related anxiety.
arm group label: Enrolled in group therapy
intervention type: Other
intervention name: Surveys
description: MAX-PC, GAD and FACT-P
arm group label: Enrolled in group therapy
arm group label: Not enrolled in group therapy
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Aaron Pinkhasov, MD
role: Principal Investigator
affiliation: NYU Winthrop Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
provided document: 
provided document: 