xml: <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/NCT06042400</url>
    </required_header>
    <id_info>
      <org_study_id>21-0243</org_study_id>
      <nct_id>NCT06042400</nct_id>
    </id_info>
    <brief_title>Trial of Written Exposure for Metastatic Cancer Patients (EASE)</brief_title>
    <official_title>Pilot Trial of Written Exposure Intervention for Metastatic Cancer Patients: The EASE Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Colorado, Boulder</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Colorado, Denver</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Colorado, Boulder</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>
        In the face of imminent loss, many adults with metastatic cancer report a range of mental&#xD;
        health challenges, including cancer-related trauma symptoms, fear of cancer progression and&#xD;
        dying/death, anxiety, depression, and hopelessness, as well as physical symptoms such as&#xD;
        fatigue and pain. Cancer patients may report feeling upset or haunted by imagined scenarios&#xD;
        in a way that causes them distress and lowers their quality of life.&#xD;
  &#xD;
        This study aims to look at the acceptability and feasability of a writing-based intervention&#xD;
        for adults with late-stage or recurrent cancer, or actively treated blood cancer. The EASE&#xD;
        study uses a writing-based approach to address an individual's worst-case scenario about&#xD;
        cancer because previous studies have shown that similar approaches have shown promise in&#xD;
        reducing fear in early-stage cancer survivors and among adults with PTSD (posttraumatic&#xD;
        stress disorder). The EASE study represents a novel adaptation of this foundational work on&#xD;
        written exposure therapy (WET) to address worst-case scenarios among adults with late stage&#xD;
        cancers.&#xD;
  &#xD;
        The EASE study will include 5 weekly one-on-one online video sessions with a trained&#xD;
        therapist where participants will be coached through writing exercises based on a worst-case&#xD;
        scenario related to their cancer experience.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This single-arm pilot trial aims to look at the acceptability and feasibility of a&#xD;
        writing-based intervention for adults with metastatic or recurrent cancer, or actively&#xD;
        treated blood cancer.&#xD;
  &#xD;
        The EASE intervention represents a novel adaptation of foundational work on written exposure&#xD;
        therapy (WET) to address worst-case scenarios among adults with metastatic cancer, including&#xD;
        cancer diagnosed at Stage III or IV, cancer that has recurred, or actively treated&#xD;
        lymphoproliferative cancer. The study will consist of 5 weekly one-on-one online sessions&#xD;
        with a trained graduate student therapist who will explain the approach and coach&#xD;
        participants through writing exercises based on a worst-case scenario related to their fears&#xD;
        about cancer.&#xD;
  &#xD;
        Remote Delivery.&#xD;
  &#xD;
        The intervention will be delivered remotely via videoconferencing software or&#xD;
        videoconferencing plus phone. Phone sessions will be available as a backup if a participant&#xD;
        has significant technical difficulties with Zoom. All sessions will be recorded.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 18, 2022</start_date>
    <completion_date type="Anticipated">October 18, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 18, 2024</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>
      <intervention_model_description>Single-arm pilot trial: all participants will receive intervention</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cancer-related trauma symptoms</measure>
      <time_frame>Assessed seven times: prior to the intervention (Pre), before each intervention session, 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>A primary outcome will be change in cancer-related trauma symptoms, assessed by the 22-item Impact of Events Scale-Revised. Possible scores range 0-88 with higher scores indicating greater distress/bother.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fear of cancer progression</measure>
      <time_frame>Assessed: prior to the intervention (Pre), before each intervention session, 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>A primary outcome will be change in fear of cancer progression, assessed by the 12-item Fear of Progression Questionnaire - Short Form and by the four general scale items from the Concerns about Recurrence Scale, with wording adapted to focus on cancer progression rather than recurrence. Range: 12-60, higher scores are associated with higher fear of cancer progression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention acceptability</measure>
      <time_frame>Assessed in order to compare values at 2 timepoints: 6 weeks after baseline (Post) and separately at 1.5-month follow-up (FU)</time_frame>
      <description>Assessed with the Acceptability of Intervention Scale. Possible scores range from 4-20, with higher scores indicating greater intervention acceptability.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Intervention Feasibility</measure>
      <time_frame>Assessed at each intervention session 1-5, 1 to 5 weeks after baseline.</time_frame>
      <description>For participants who begin the intervention, at least 70% complete all intervention sessions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-8)</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post),, at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Patient-reported depression symptom questionnaire. Range is 0 to 24. Higher scores indicate more depression symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder-7 Questionnaire</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Patient-reported anxiety symptom questionnaire. Possible scores range from 0-21, with higher scores indicating more anxiety symptoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Death Attitude Profile-Revised, Fear of Death and Death Avoidance Scales</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Patient-reported fear of death and dying questionnaire. Possible scores range from 12-84, with higher scores indicating greater fear of death and dying</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hopelessness Assessment in Illness Questionnaire 8-item</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Patient-reported hopelessness specifically intended for use with adults with incurable cancer. Possible scores range 0-16, with higher scores indicating greater hopelessness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form v1.0</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Patient-reported levels of fatigue. Possible scores range 6-30, with higher scores indicating greater fatigue.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference-Short Form v1.0</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Patient-reported dimension of pain interference (e.g., the extent to which pain interferes with daily life and life roles). Possible scores range 6-30, with higher scores indicating greater pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotional Approach Coping Scale (COPE): Avoidance coping (process measure)</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Patient-reported coping through avoidance using three avoidance coping scales (mental disengagement, denial, physical disengagement) with cancer as the anchor. Possible scores range 8-28, with higher scores indicating greater denial, mental and behavioral disengagement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Five Factor Mindfulness Questionnaire, Nonjudge and nonreact scales (process measure)</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Patient-reported coping through acceptance. Possible scores range 15-75, with higher scores reflecting greater nonreactivity and nonjudging of inner experience.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Valuing Questionnaire</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Valued engagement in daily life. Possible scores range 0-30 for each of the two subscales with higher scores indicating greater engagement and sense of purpose in life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-compassion Scale-Short Form</measure>
      <time_frame>Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)</time_frame>
      <description>Self-compassion questionnaire. Possible scores range 12-60 with higher scores indicating higher self-compassion.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Intervention Acceptability: Session Feedback Questionnaire</measure>
      <time_frame>Once weekly during intervention period from Pre to Post (6 weeks after baseline, e.g., at the end of each weekly session during the intervention period)</time_frame>
      <description>Participant value of the session will be assessed through the Session Feedback. Possible scores range 4-20, with higher scores indicating higher value and acceptability of the session.</description>
    </other_outcome>
    <other_outcome>
      <measure>Intervention Acceptability: Client Satisfaction Questionnaire-8</measure>
      <time_frame>Assessed and reported two times: 6 weeks after baseline (Post), 3-month follow-up (FU)</time_frame>
      <description>Participant satisfaction will be measured using the Client Satisfaction Questionnaire-8 (adapted to the current intervention). Possible scores range 8-32, with higher scores indicating more satisfaction.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Metastatic Cancer</condition>
    <condition>Solid Tumor Cancer</condition>
    <condition>Lymphoproliferative Disorders</condition>
    <condition>Anxiety</condition>
    <condition>Post-traumatic Stress Symptoms</condition>
    <condition>Fear of Cancer Progression</condition>
    <arm_group>
      <arm_group_label>EASE Written Exposure Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Assigned Intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Written Exposure Therapy</intervention_name>
      <description>An innovative written exposure therapy intervention that addresses psychosocial needs commonly experienced by patients with late stage cancers.</description>
      <arm_group_label>EASE Written Exposure Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. At least 18 years of age&#xD;
  &#xD;
            2. English-speaking (able to speak, read, and write well in English)&#xD;
  &#xD;
            3. Diagnosed with solid tumor cancer at Stage III (locally metastatic) or Stage IV&#xD;
               (distantly metastatic) or solid tumor cancer that has recurred, or actively treated&#xD;
               lymphoproliferative cancer (e.g., non-solid tumor cancer)&#xD;
  &#xD;
            4. Report elevated cancer-related trauma symptoms or fear of cancer progression on the&#xD;
               screening measures: IES-R, FoP-Q 12-item short version.&#xD;
  &#xD;
            5. No moderate to severe dementia reported by patient or seen during eligibility&#xD;
               confirmation in the medical chart&#xD;
  &#xD;
            6. Are capable at time of consent of understanding and voluntarily consenting themselves&#xD;
               to the study, attending EASE sessions, and completing the online sessions at home,&#xD;
               confirmed by an Eastern Cooperative Group Performance Status Scale of 0 to 2. Given&#xD;
               that the study does not require individuals to leave their home, we will make an&#xD;
               exception for individuals endorsing an Eastern Cooperative Group Performance Status&#xD;
               Scale score of 3 (confined to bed or chair for &lt;50% of waking hours, able to do only&#xD;
               limited selfcare) if they meet all other study criteria, including criteria 7.&#xD;
  &#xD;
            7. Report that they are able and willing to complete all study procedures, including the&#xD;
               online assessments and the intervention itself, including being physically able to&#xD;
               write by hand or type for 30 minutes at a time and do weekly hour-long EASE sessions&#xD;
               by Zoom.&#xD;
  &#xD;
            8. Has access to a computer with internet connection or are willing to use a study-loaned&#xD;
               computer tablet for the study duration, and are willing to conduct sessions via&#xD;
               videoconferencing on a computer&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1. Current moderate or high suicide risk evaluated by the Columbia Suicide Severity Rating&#xD;
          Scale (CSSRS)&#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>Joanna Arch, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Colorado, Boulder</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elizabeth Slivjak, MA</last_name>
      <phone>‪720-340-3273‬</phone>
      <email>elizabeth.slivjak@colorado.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Madeline Nealis, MPH</last_name>
      <phone>720-515-9461</phone>
      <email>valuedliving@colorado.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Colorado Boulder</name>
        <address>
          <city>Boulder</city>
          <state>Colorado</state>
          <zip>80309</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>May 16, 2022</study_first_submitted>
    <study_first_submitted_qc>September 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Colorado, Boulder</investigator_affiliation>
      <investigator_full_name>Joanna Arch</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasm Metastasis</mesh_term>
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Neoplasms, Second Primary</mesh_term>
      <mesh_term>Lymphoproliferative Disorders</mesh_term>
      <mesh_term>Disease Progression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042400
  org study id: 21-0243
  nct id: NCT06042400
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In the face of imminent loss, many adults with metastatic cancer report a range of mental
        health challenges, including cancer-related trauma symptoms, fear of cancer progression and
        dying/death, anxiety, depression, and hopelessness, as well as physical symptoms such as
        fatigue and pain. Cancer patients may report feeling upset or haunted by imagined scenarios
        in a way that causes them distress and lowers their quality of life.
  
        This study aims to look at the acceptability and feasability of a writing-based intervention
        for adults with late-stage or recurrent cancer, or actively treated blood cancer. The EASE
        study uses a writing-based approach to address an individual's worst-case scenario about
        cancer because previous studies have shown that similar approaches have shown promise in
        reducing fear in early-stage cancer survivors and among adults with PTSD (posttraumatic
        stress disorder). The EASE study represents a novel adaptation of this foundational work on
        written exposure therapy (WET) to address worst-case scenarios among adults with late stage
        cancers.
  
        The EASE study will include 5 weekly one-on-one online video sessions with a trained
        therapist where participants will be coached through writing exercises based on a worst-case
        scenario related to their cancer experience.
  This single-arm pilot trial aims to look at the acceptability and feasibility of a
        writing-based intervention for adults with metastatic or recurrent cancer, or actively
        treated blood cancer.
  
        The EASE intervention represents a novel adaptation of foundational work on written exposure
        therapy (WET) to address worst-case scenarios among adults with metastatic cancer, including
        cancer diagnosed at Stage III or IV, cancer that has recurred, or actively treated
        lymphoproliferative cancer. The study will consist of 5 weekly one-on-one online sessions
        with a trained graduate student therapist who will explain the approach and coach
        participants through writing exercises based on a worst-case scenario related to their fears
        about cancer.
  
        Remote Delivery.
  
        The intervention will be delivered remotely via videoconferencing software or
        videoconferencing plus phone. Phone sessions will be available as a backup if a participant
        has significant technical difficulties with Zoom. All sessions will be recorded.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single-arm pilot trial: all participants will receive intervention
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Cancer-related trauma symptoms
  time frame: Assessed seven times: prior to the intervention (Pre), before each intervention session, 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: A primary outcome will be change in cancer-related trauma symptoms, assessed by the 22-item Impact of Events Scale-Revised. Possible scores range 0-88 with higher scores indicating greater distress/bother.
  measure: Fear of cancer progression
  time frame: Assessed: prior to the intervention (Pre), before each intervention session, 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: A primary outcome will be change in fear of cancer progression, assessed by the 12-item Fear of Progression Questionnaire - Short Form and by the four general scale items from the Concerns about Recurrence Scale, with wording adapted to focus on cancer progression rather than recurrence. Range: 12-60, higher scores are associated with higher fear of cancer progression.
  measure: Intervention acceptability
  time frame: Assessed in order to compare values at 2 timepoints: 6 weeks after baseline (Post) and separately at 1.5-month follow-up (FU)
  description: Assessed with the Acceptability of Intervention Scale. Possible scores range from 4-20, with higher scores indicating greater intervention acceptability.
  measure: Intervention Feasibility
  time frame: Assessed at each intervention session 1-5, 1 to 5 weeks after baseline.
  description: For participants who begin the intervention, at least 70% complete all intervention sessions
  measure: Patient Health Questionnaire (PHQ-8)
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post),, at 1.5 and 3-month follow-up (FU)
  description: Patient-reported depression symptom questionnaire. Range is 0 to 24. Higher scores indicate more depression symptoms
  measure: Generalized Anxiety Disorder-7 Questionnaire
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: Patient-reported anxiety symptom questionnaire. Possible scores range from 0-21, with higher scores indicating more anxiety symptoms
  measure: The Death Attitude Profile-Revised, Fear of Death and Death Avoidance Scales
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: Patient-reported fear of death and dying questionnaire. Possible scores range from 12-84, with higher scores indicating greater fear of death and dying
  measure: Hopelessness Assessment in Illness Questionnaire 8-item
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: Patient-reported hopelessness specifically intended for use with adults with incurable cancer. Possible scores range 0-16, with higher scores indicating greater hopelessness.
  measure: The Patient Reported Outcome Measurement Information System (PROMIS) Fatigue-Short Form v1.0
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: Patient-reported levels of fatigue. Possible scores range 6-30, with higher scores indicating greater fatigue.
  measure: The Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference-Short Form v1.0
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: Patient-reported dimension of pain interference (e.g., the extent to which pain interferes with daily life and life roles). Possible scores range 6-30, with higher scores indicating greater pain.
  measure: Emotional Approach Coping Scale (COPE): Avoidance coping (process measure)
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: Patient-reported coping through avoidance using three avoidance coping scales (mental disengagement, denial, physical disengagement) with cancer as the anchor. Possible scores range 8-28, with higher scores indicating greater denial, mental and behavioral disengagement.
  measure: Five Factor Mindfulness Questionnaire, Nonjudge and nonreact scales (process measure)
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: Patient-reported coping through acceptance. Possible scores range 15-75, with higher scores reflecting greater nonreactivity and nonjudging of inner experience.
  measure: Valuing Questionnaire
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: Valued engagement in daily life. Possible scores range 0-30 for each of the two subscales with higher scores indicating greater engagement and sense of purpose in life.
  measure: Self-compassion Scale-Short Form
  time frame: Assessed: prior to the intervention (Pre), 3 weeks after the intervention begins (Mid), 6 weeks after baseline (Post), at 1.5 and 3-month follow-up (FU)
  description: Self-compassion questionnaire. Possible scores range 12-60 with higher scores indicating higher self-compassion.
  measure: Intervention Acceptability: Session Feedback Questionnaire
  time frame: Once weekly during intervention period from Pre to Post (6 weeks after baseline, e.g., at the end of each weekly session during the intervention period)
  description: Participant value of the session will be assessed through the Session Feedback. Possible scores range 4-20, with higher scores indicating higher value and acceptability of the session.
  measure: Intervention Acceptability: Client Satisfaction Questionnaire-8
  time frame: Assessed and reported two times: 6 weeks after baseline (Post), 3-month follow-up (FU)
  description: Participant satisfaction will be measured using the Client Satisfaction Questionnaire-8 (adapted to the current intervention). Possible scores range 8-32, with higher scores indicating more satisfaction.
  arm group label: EASE Written Exposure Intervention
  arm group type: Experimental
  description: Assigned Intervention
  intervention type: Behavioral
  intervention name: Written Exposure Therapy
  description: An innovative written exposure therapy intervention that addresses psychosocial needs commonly experienced by patients with late stage cancers.
  arm group label: EASE Written Exposure Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Joanna Arch, PhD
  role: Principal Investigator
  affiliation: University of Colorado, Boulder
  last name: Elizabeth Slivjak, MA
  phone: ‪720-340-3273‬
  email: elizabeth.slivjak@colorado.edu
  last name: Madeline Nealis, MPH
  phone: 720-515-9461
  email: valuedliving@colorado.edu
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Colorado, Boulder
  investigator full name: Joanna Arch
  investigator title: Associate Professor
  mesh term: Neoplasm Metastasis
  mesh term: Neoplasms
  mesh term: Neoplasms, Second Primary
  mesh term: Lymphoproliferative Disorders
  mesh term: Disease Progression
  sharing ipd: No