<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/NCT04480008</url>
  </required_header>
  <id_info>
    <org_study_id>19-011510</org_study_id>
    <nct_id>NCT04480008</nct_id>
  </id_info>
  <brief_title>Resilient Living Program for Patients With Advanced Cancer and Their Caregivers</brief_title>
  <official_title>Resilient Living Program for Patients With Advanced Cancer and Their Caregivers</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>
      Researchers are trying to find out if the Resilient Living Program will improve quality of&#xD;
      life, stress, anxiety, sleep, fatigue, and resilience in patients with advanced cancer and&#xD;
      their caregivers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</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>Perceived Stress</measure>
    <time_frame>Baseline</time_frame>
    <description>Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress</measure>
    <time_frame>Week 5 (after 2nd intervention session)</time_frame>
    <description>Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress</measure>
    <time_frame>Week 9 (after 4th intervention session)</time_frame>
    <description>Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived Stress</measure>
    <time_frame>Week 12 (one month after completing all intervention sessions)</time_frame>
    <description>Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Baseline</time_frame>
    <description>Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Week 5 (after 2nd intervention session)</time_frame>
    <description>Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Week 9 (after 4th intervention session)</time_frame>
    <description>Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Week 12 (one month after completing all intervention sessions)</time_frame>
    <description>Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Resilient Living Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be in the Resilient Living Program arm. Study participation involves participating in a 12-week stress management and resilience training program. This will involve four virtual sessions (video or phone) and answering questions about their health, well-being, and quality of life. There will also be online modules to watch and an accompanying journal (with prompts) to keep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Resilient Living Program</intervention_name>
    <description>Participants will be given the journal Resilient Living with Dr. Sood: Building Strength for Difficult Days to use throughout the study. The initial session with one of the investigators will be an introduction and a review of Module 1: Gratitude, and will last 30-60min. Three follow-up sessions will occur approximately every two weeks and the participants should view the videos before those virtual meetings (Session 2 will review Module II: Mindful Presence; Session 3 will review Module III: Kindness; Session 4 will review Module IV: Resilient Mindset). The videos will take approximately 30 minutes each to review and virtual sessions will each take 30-60 minutes.</description>
    <arm_group_label>Resilient Living Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for patients:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
          -  No diagnosed severe cognitive impairment&#xD;
&#xD;
          -  Diagnosis of stage IV solid tumor cancer&#xD;
&#xD;
          -  Expected prognosis &gt;6 &lt;18 months&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
          -  Ability to complete questionnaire(s) by themselves or with assistance&#xD;
&#xD;
          -  Patient baseline distress score ≥4/10 OR identified as having distress that would&#xD;
             benefit from program by care team or provider&#xD;
&#xD;
          -  Ability to do first Resilient Living session in person&#xD;
&#xD;
        Inclusion Criteria for caregivers:&#xD;
&#xD;
          -  Self-identifies as a caregiver of a patient that meets the above cancer diagnosis&#xD;
             criteria, and who also participates in the study&#xD;
&#xD;
          -  Provide written informed consent&#xD;
&#xD;
          -  Ability to complete questionnaire(s) by themselves or with assistance&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
          -  No diagnosed severe cognitive impairment&#xD;
&#xD;
          -  Ability to do first Resilient Living session in person&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  As determined through self-report, those diagnosed with a history of a psychotic&#xD;
             episode will be excluded.&#xD;
&#xD;
          -  Other psychological co-morbidities such as untreated schizophrenia, bipolar disease&#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>Deirdre Pachman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Deirdre R. Pachman</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>
  <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/NCT04480008
org study id: 19-011510
nct id: NCT04480008
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Researchers are trying to find out if the Resilient Living Program will improve quality of
      life, stress, anxiety, sleep, fatigue, and resilience in patients with advanced cancer and
      their caregivers.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Perceived Stress
time frame: Baseline
description: Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.
measure: Perceived Stress
time frame: Week 5 (after 2nd intervention session)
description: Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.
measure: Perceived Stress
time frame: Week 9 (after 4th intervention session)
description: Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.
measure: Perceived Stress
time frame: Week 12 (one month after completing all intervention sessions)
description: Stress, as measured by the Perceived Stress Scale (PSS). The PSS has 14 items, 7 positively stated and 7 negatively stated. Likert-type 5-point scale. Positively stated items reverse coded; scores are summed; scores range 0-56. High score indicates greater stress level.
measure: Anxiety
time frame: Baseline
description: Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
measure: Anxiety
time frame: Week 5 (after 2nd intervention session)
description: Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
measure: Anxiety
time frame: Week 9 (after 4th intervention session)
description: Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
measure: Anxiety
time frame: Week 12 (one month after completing all intervention sessions)
description: Anxiety, as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7). The GAD-7 has 7 items, about which the participant has felt bothered by in the prior two weeks. 0=not at all, 1=several days, 2=more than half the days, 3=nearly every day. Scores are summed; range 0-21. Score 0-4 minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.
arm group label: Resilient Living Program
arm group type: Experimental
description: All participants will be in the Resilient Living Program arm. Study participation involves participating in a 12-week stress management and resilience training program. This will involve four virtual sessions (video or phone) and answering questions about their health, well-being, and quality of life. There will also be online modules to watch and an accompanying journal (with prompts) to keep.
intervention type: Behavioral
intervention name: Resilient Living Program
description: Participants will be given the journal Resilient Living with Dr. Sood: Building Strength for Difficult Days to use throughout the study. The initial session with one of the investigators will be an introduction and a review of Module 1: Gratitude, and will last 30-60min. Three follow-up sessions will occur approximately every two weeks and the participants should view the videos before those virtual meetings (Session 2 will review Module II: Mindful Presence; Session 3 will review Module III: Kindness; Session 4 will review Module IV: Resilient Mindset). The videos will take approximately 30 minutes each to review and virtual sessions will each take 30-60 minutes.
arm group label: Resilient Living Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Deirdre Pachman, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Deirdre R. Pachman
investigator title: Principal Investigator
mesh term: Neoplasms
sharing ipd: No