<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/NCT04436835</url>
  </required_header>
  <id_info>
    <org_study_id>19-006093</org_study_id>
    <secondary_id>NCI-2020-04130</secondary_id>
    <secondary_id>19-006093</secondary_id>
    <nct_id>NCT04436835</nct_id>
  </id_info>
  <brief_title>Psychotherapy (Accelerated Resolution Therapy) for Cancer Related Trauma and Distress</brief_title>
  <official_title>Accelerated Resolution Therapy for Cancer Related Trauma and Distress: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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 trial studies whether a form of psychotherapy called accelerated resolution therapy can&#xD;
      help with cancer distress and psychological trauma. Accelerated resolution therapy is an&#xD;
      evidence-based therapy for the treatment of depressive symptoms, trauma, and stress-related&#xD;
      disorders. This study may provide evidence to support integration of accelerated resolution&#xD;
      therapy into psychological treatment of cancer patients, which may decrease cancer related&#xD;
      trauma and distress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Calculate changes, and estimate mean changes, in primary outcomes of psychological trauma&#xD;
      and cancer distress over a six week time period while receiving weekly accelerated resolution&#xD;
      therapy (ART).&#xD;
&#xD;
      II. Calculate changes, and estimate mean changes, in secondary outcomes of anxiety and&#xD;
      depression over a six week period while receiving weekly ART.&#xD;
&#xD;
      III. Will use a qualitative, descriptive design to explore contextual elements of the cancer&#xD;
      experience that are consistently distressing and/or psychologically traumatic to more fully&#xD;
      inform a future RCT testing in ART in cancer distress and psychological trauma.&#xD;
&#xD;
      IV. Calculate changes, and estimate mean changes, in secondary outcomes of resilience and&#xD;
      symptom distress over a six week period while receiving weekly ART.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.&#xD;
&#xD;
      After completion of study intervention, patients are followed up at 1 week and again at 1&#xD;
      month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 27, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">August 19, 2021</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>Psychological trauma</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Symptoms of psychological trauma will be measured with both the Primary Care-Post Traumatic Stress Disorder Screening (PC-PTSD-5) and the Post Traumatic Stress Disorder Checklist (PCL-5). The PCL-5 (PTSD Patient Checklist) is a 20-item self-report instrument that will be used to assess the DSM-5 symptoms of PTSD (psychological trauma). The total symptom severity score ranges from 0 to 80.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cancer distress</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>Cancer distress will be measured with the Cancer Treatment Distress Scale (CTxD). The CTxD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>The General Anxiety Disorder (GAD-7) is a measure of anxiety scored from 0 (not at all)-3 (nearly every day) scale for each item with total scores ranging from 0-21. A score of 10 or more indicates high anxiety, although a cut-score of 7 or higher has been suggested for cancer populations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>The Patient Health Questionnaire (PHQ-8) is an 8 item measure of depression scoring DSM -IV criteria for depression on a 0 (not at all) to 3 (nearly every day) scale for each item with total scores ranging from 0-24 (25). A score of 10 or more indicates depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>The Connor-Davidson Resilience Scale (CD-RISC) is a 10 item scale in which participants rate statements on a scale of 0 (not at all true) to 4 (true nearly all the time). Higher scores indicate higher levels of resilience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom distress</measure>
    <time_frame>Up to 6 weeks</time_frame>
    <description>The Edmonton Symptom Assessment Scale (ESAS) consists of 11-point numerical rating scales for self-report of ten common symptoms of cancer. A summary score is calculated with higher scores representing greater symptom distress.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Hematopoietic and Lymphoid System Neoplasm</condition>
  <condition>Malignant Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>Supportive care (ART)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychotherapy</intervention_name>
    <description>Undergo ART</description>
    <arm_group_label>Supportive care (ART)</arm_group_label>
    <other_name>talk therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (ART)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to read, write and understand English&#xD;
&#xD;
          -  Undergone chemotherapy, radiation therapy, chimeric antigen receptor T cells (CAR-T),&#xD;
             or bone marrow transplant for a cancer diagnosis within the previous 3 years or have&#xD;
             metastatic cancer&#xD;
&#xD;
          -  A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least&#xD;
             one item rated at a 3 (often true) or 4 (nearly all the time)&#xD;
&#xD;
          -  A minimum score of 3 on the Primary Care-Post Traumatic Stress Disorder Screen&#xD;
             (PC-PTSD-5)&#xD;
&#xD;
          -  Denial of suicidal ideation or intent, with no evidence of psychotic behavior&#xD;
&#xD;
          -  Participants must be willing and able to utilize secure web conferencing software,&#xD;
             phone calls, or to travel to Mayo Clinic outside of normally scheduled visits to&#xD;
             participate in the study&#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>Cindy Tofthagen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Cindy Tofthagen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT04436835
org study id: 19-006093
secondary id: NCI-2020-04130
secondary id: 19-006093
nct id: NCT04436835
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies whether a form of psychotherapy called accelerated resolution therapy can
      help with cancer distress and psychological trauma. Accelerated resolution therapy is an
      evidence-based therapy for the treatment of depressive symptoms, trauma, and stress-related
      disorders. This study may provide evidence to support integration of accelerated resolution
      therapy into psychological treatment of cancer patients, which may decrease cancer related
      trauma and distress.
PRIMARY OBJECTIVES:

      I. Calculate changes, and estimate mean changes, in primary outcomes of psychological trauma
      and cancer distress over a six week time period while receiving weekly accelerated resolution
      therapy (ART).

      II. Calculate changes, and estimate mean changes, in secondary outcomes of anxiety and
      depression over a six week period while receiving weekly ART.

      III. Will use a qualitative, descriptive design to explore contextual elements of the cancer
      experience that are consistently distressing and/or psychologically traumatic to more fully
      inform a future RCT testing in ART in cancer distress and psychological trauma.

      IV. Calculate changes, and estimate mean changes, in secondary outcomes of resilience and
      symptom distress over a six week period while receiving weekly ART.

      OUTLINE:

      Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.

      After completion of study intervention, patients are followed up at 1 week and again at 1
      month.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Psychological trauma
time frame: Up to 6 weeks
description: Symptoms of psychological trauma will be measured with both the Primary Care-Post Traumatic Stress Disorder Screening (PC-PTSD-5) and the Post Traumatic Stress Disorder Checklist (PCL-5). The PCL-5 (PTSD Patient Checklist) is a 20-item self-report instrument that will be used to assess the DSM-5 symptoms of PTSD (psychological trauma). The total symptom severity score ranges from 0 to 80.
measure: Cancer distress
time frame: Up to 6 weeks
description: Cancer distress will be measured with the Cancer Treatment Distress Scale (CTxD). The CTxD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience.
measure: Anxiety
time frame: Up to 6 weeks
description: The General Anxiety Disorder (GAD-7) is a measure of anxiety scored from 0 (not at all)-3 (nearly every day) scale for each item with total scores ranging from 0-21. A score of 10 or more indicates high anxiety, although a cut-score of 7 or higher has been suggested for cancer populations.
measure: Depression
time frame: Up to 6 weeks
description: The Patient Health Questionnaire (PHQ-8) is an 8 item measure of depression scoring DSM -IV criteria for depression on a 0 (not at all) to 3 (nearly every day) scale for each item with total scores ranging from 0-24 (25). A score of 10 or more indicates depression.
measure: Resilience
time frame: Up to 6 weeks
description: The Connor-Davidson Resilience Scale (CD-RISC) is a 10 item scale in which participants rate statements on a scale of 0 (not at all true) to 4 (true nearly all the time). Higher scores indicate higher levels of resilience.
measure: Symptom distress
time frame: Up to 6 weeks
description: The Edmonton Symptom Assessment Scale (ESAS) consists of 11-point numerical rating scales for self-report of ten common symptoms of cancer. A summary score is calculated with higher scores representing greater symptom distress.
arm group label: Supportive care (ART)
arm group type: Experimental
description: Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.
intervention type: Behavioral
intervention name: Psychotherapy
description: Undergo ART
arm group label: Supportive care (ART)
other name: talk therapy
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive care (ART)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cindy Tofthagen
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Cindy Tofthagen
investigator title: Principal Investigator
mesh term: Neoplasms