<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/NCT03776253</url>
  </required_header>
  <id_info>
    <org_study_id>18305</org_study_id>
    <secondary_id>NCI-2018-02405</secondary_id>
    <secondary_id>18305</secondary_id>
    <nct_id>NCT03776253</nct_id>
  </id_info>
  <brief_title>Conquer Fear SUPPORT Intervention in Supporting Patients With Stage III-IV Lung or Gynecologic Cancer</brief_title>
  <official_title>Conquer Fear SUPPORT: A Psychosocial Intervention in Patients With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>City of Hope Medical Center</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will pilot a psychosocial intervention called Conquer Fear Support (CFS) in&#xD;
      patients with stage III-IV lung or gynecologic cancer who are experiencing fear of cancer&#xD;
      progression. The intervention is adapted from a novel program called &quot;Conquer Fear&quot; which was&#xD;
      developed by researchers in Australia. CFS may help in reducing worries, fears, and&#xD;
      uncertainty in patients with advanced lung or gynecological cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Assess the feasibility and acceptability of the CFS intervention in patients with advanced&#xD;
      lung and gynecologic (GYN) cancer (stages III or IV) who have clinically significant levels&#xD;
      of fear of cancer progression (FOP) or cancer-related distress.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Assess preliminary effects of the intervention on FOP, cancer-specific distress, anxiety,&#xD;
      depression, overall symptom distress, metacognitions, and mindfulness.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients attend CFS psychosocial intervention consisting of 7 nurse-led sessions (session 1&#xD;
      in-person and sessions 2-7 via video conferencing) over 45 minutes each for 8 weeks. Patients&#xD;
      also complete home practice assignments comprising attention training technique and&#xD;
      mindfulness practice sessions after each session.&#xD;
&#xD;
      After completion of study intervention, patients are followed up at week 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 15, 2018</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</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>Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking enrollment rate.</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Evaluate the enrollment (recruitment) rate over the study period. Feasibility will be deemed acceptable if at least 25 eligible participants are accrued within 9 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attrition.</measure>
    <time_frame>Up to week 12</time_frame>
    <description>Evaluate attrition (drop-out rate) over time for enrolled participants. Feasibility will be deemed acceptable if the percentage of patients who drop-out does not exceed 20% by week 8 of the intervention and 50% by week 12 of the intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attendance.</measure>
    <time_frame>Up to week 12</time_frame>
    <description>Evaluate the percentage of sessions attended. Feasibility will be deemed acceptable if participants attend an average of 5 of the 7 scheduled sessions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fear of progression (FOP) assessed using Fear of Progression Questionnaire-Short Form (SF)</measure>
    <time_frame>Up to week 12</time_frame>
    <description>Fear of progression will be assessed using Fear of Progression Questionnaire-Short Form (FOP-Q-SF) at baseline (T1), 8 weeks (T2), and 12 weeks (T3).&#xD;
FOP-Q-SF consists of 12 items scored on a 5-point Likert scale (1=never to 5=very often); scores range from 12-60 with higher levels indicating greater FOP. Researchers have used a cut-off of 34 and above to indicate dysfunctional FOP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific distress assessed using the Impact of Event Scale-Revised (IES-R)</measure>
    <time_frame>Up to week 12</time_frame>
    <description>Cancer-specific distress will be assessed using the Impact of Event Scale-Revised (IES-R) at baseline (T1), 8 weeks (T2), and 12 weeks (T3). IES-R is a 22-item scale consisting of 3 subscales a) Intrusion; b) Avoidance; and c) Hyperarousal. Items are scored on a 0-4 response format. Subscale scores are calculated by taking the mean of the subscale responses. Total scores range from 0-88. A score of 24 or greater indicates clinical levels of distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety assessed using the PROMIS-Anxiety 8a</measure>
    <time_frame>Up to week 12</time_frame>
    <description>Anxiety will be assessed using the PROMIS-Anxiety 8a at baseline (T1), 8 weeks (T2), and 12 weeks (T3). PROMIS-Anxiety measures fear, dread, worry, hyperarousal, and related somatic symptoms. The short-form consists of 8 items that are scored on a 0-5 response format. The raw score is calculated by summing the values of the response to each question (range 8-40). Scores are standardized such that the scale produces continuous T scores with a mean of 50 and a SD of 10, higher scores reflect higher distress. PROMIS T score thresholds for anxiety are: ˂ 55 normal; 55-64 mild; 65-74 moderate; ≥75 severe.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression assessed using the Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Up to week 12</time_frame>
    <description>Depression will be assessed using the Patient Health Questionnaire (PHQ-9) at baseline (T1), 8 weeks (T2), and 12 weeks (T3). The PHQ-9 includes the two major symptom domains: affective and somatic symptoms. It is rated from a 0 (not at all) to 3 (nearly every day) scale. Items are summed and a score of 10 or greater is considered clinically significant symptoms of depression. Scores of 0-4, 5-9, 10-14, and ≥15 represent minimal, mild, moderate, and severe levels of symptom burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall symptom distress assessed using the Memorial Symptom Assessment Scale (MSAS)</measure>
    <time_frame>Up to week 12</time_frame>
    <description>Overall symptom distress will be assessed using the Memorial Symptom Assessment Scale (MSAS) at baseline (T1), 8 weeks (T2), and 12 weeks (T3). The MSAS assesses 32 common symptoms experienced by cancer patients. A modified version of the MSAS will be used to evaluate the occurrence, severity, and distress of symptoms. Symptom severity is rated on a 4 point Likert scale (1=slight) to 4=very much). Distress is rated on a 0-4 Likert scale ranging from not at all (0) to very much (4). The physical symptom subscale is the average of the severity and distress associated with 12 physical symptoms. The psychological symptom subscale is the average of the severity and distress associated with 6 psychological symptoms. The total MSAS score (TMSAS) is the average of the symptom scores of all 32 symptoms; higher scores indicate greater symptom severity and distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metacognitions (MCQ-30) assessed using the Metacognitions Questionnaire</measure>
    <time_frame>Up to week 12</time_frame>
    <description>Metacognitions (MCQ-30) will be assessed using the Metacognitions Questionnaire at baseline (T1), 8 weeks (T2), and 12 weeks (T3). The MCQ-30 is a 30-item questionnaire that assesses beliefs about worry. It consists of 5 subscales: Positive beliefs about worry; Negative beliefs about worry, Cognitive confidence; Need to control thoughts; and Cognitive self-consciousness. For each subscale, items are scored 1-4 and subscale scores range from 6-24. Total scores range from 30 to 120; higher scores indicate more dysfunctional metacognitions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness assessed using the Five Facet Mindfulness Questionnaire (FFMQ-15)</measure>
    <time_frame>Up to week 12</time_frame>
    <description>Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ-15) at baseline (T1), 8 weeks (T2), and 12 weeks (T3). The FFMQ-15 assesses five facets of mindfulness: observing, describing, acting with awareness, non-reactivity, and non-judging of inner experience. Items are rated on a 5-point Likert scale ranging from 1 (never or rarely true) to 5 (very often or always true). 3 items comprise each subscale and subscale scores range from 3-15. Higher scores indicate greater engagement with mindfulness skills.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">33</enrollment>
  <condition>Advanced Lung Carcinoma</condition>
  <condition>Malignant Female Reproductive System Neoplasm</condition>
  <condition>Stage III Lung Cancer AJCC v8</condition>
  <condition>Stage IIIA Lung Cancer AJCC v8</condition>
  <condition>Stage IIIB Lung Cancer AJCC v8</condition>
  <condition>Stage IIIC Lung Cancer AJCC v8</condition>
  <condition>Stage IV Lung Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Supportive care (CFS)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients attend CFS psychosocial intervention consisting of 7 nurse-led sessions (session 1 in-person and sessions 2-7 via video conferencing) over 45 minutes each for 8 weeks. Patients also complete home practice assignments comprising attention training technique and mindfulness practice after each session.&#xD;
Patients complete self-report questionnaires at baseline (T1), 8 weeks (T2) and 12 weeks (T3).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components)</intervention_name>
    <description>Attend CFS</description>
    <arm_group_label>Supportive care (CFS)</arm_group_label>
    <other_name>Conquer Fear Support</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive care (CFS)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with gynecologic (GYN) and lung cancer will be recruited&#xD;
&#xD;
          -  Stage III or IV disease&#xD;
&#xD;
          -  At least 3 months from initial diagnosis&#xD;
&#xD;
          -  Receiving disease-focused treatment or active surveillance mode&#xD;
&#xD;
          -  A score of ≥ 34 on the Fear of Progression Questionnaire-Short Form (SF) or ≥ 24 on&#xD;
             the Impact of Event Scale-Revised&#xD;
&#xD;
          -  All subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current severe depression or psychosis; significant cognitive impairment&#xD;
&#xD;
          -  Patients enrolled in hospice care or who opt to receive no further disease-focused&#xD;
             treatment&#xD;
&#xD;
          -  Patients who are currently receiving ongoing psychiatric treatment&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Reb, NP, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>City of Hope Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>September 7, 2023</last_update_submitted>
  <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Genital Neoplasms, Female</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/NCT03776253
org study id: 18305
secondary id: NCI-2018-02405
secondary id: 18305
nct id: NCT03776253
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This trial will pilot a psychosocial intervention called Conquer Fear Support (CFS) in
      patients with stage III-IV lung or gynecologic cancer who are experiencing fear of cancer
      progression. The intervention is adapted from a novel program called "Conquer Fear" which was
      developed by researchers in Australia. CFS may help in reducing worries, fears, and
      uncertainty in patients with advanced lung or gynecological cancer.
PRIMARY OBJECTIVES:

      I. Assess the feasibility and acceptability of the CFS intervention in patients with advanced
      lung and gynecologic (GYN) cancer (stages III or IV) who have clinically significant levels
      of fear of cancer progression (FOP) or cancer-related distress.

      SECONDARY OBJECTIVES:

      I. Assess preliminary effects of the intervention on FOP, cancer-specific distress, anxiety,
      depression, overall symptom distress, metacognitions, and mindfulness.

      OUTLINE:

      Patients attend CFS psychosocial intervention consisting of 7 nurse-led sessions (session 1
      in-person and sessions 2-7 via video conferencing) over 45 minutes each for 8 weeks. Patients
      also complete home practice assignments comprising attention training technique and
      mindfulness practice sessions after each session.

      After completion of study intervention, patients are followed up at week 12.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking enrollment rate.
time frame: Up to 9 months
description: Evaluate the enrollment (recruitment) rate over the study period. Feasibility will be deemed acceptable if at least 25 eligible participants are accrued within 9 months.
measure: Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attrition.
time frame: Up to week 12
description: Evaluate attrition (drop-out rate) over time for enrolled participants. Feasibility will be deemed acceptable if the percentage of patients who drop-out does not exceed 20% by week 8 of the intervention and 50% by week 12 of the intervention.
measure: Feasibility of the Conquer Fear SUPPORT (CFS) intervention is assessed by tracking attendance.
time frame: Up to week 12
description: Evaluate the percentage of sessions attended. Feasibility will be deemed acceptable if participants attend an average of 5 of the 7 scheduled sessions.
measure: Fear of progression (FOP) assessed using Fear of Progression Questionnaire-Short Form (SF)
time frame: Up to week 12
description: Fear of progression will be assessed using Fear of Progression Questionnaire-Short Form (FOP-Q-SF) at baseline (T1), 8 weeks (T2), and 12 weeks (T3).
FOP-Q-SF consists of 12 items scored on a 5-point Likert scale (1=never to 5=very often); scores range from 12-60 with higher levels indicating greater FOP. Researchers have used a cut-off of 34 and above to indicate dysfunctional FOP.
measure: Cancer-specific distress assessed using the Impact of Event Scale-Revised (IES-R)
time frame: Up to week 12
description: Cancer-specific distress will be assessed using the Impact of Event Scale-Revised (IES-R) at baseline (T1), 8 weeks (T2), and 12 weeks (T3). IES-R is a 22-item scale consisting of 3 subscales a) Intrusion; b) Avoidance; and c) Hyperarousal. Items are scored on a 0-4 response format. Subscale scores are calculated by taking the mean of the subscale responses. Total scores range from 0-88. A score of 24 or greater indicates clinical levels of distress.
measure: Anxiety assessed using the PROMIS-Anxiety 8a
time frame: Up to week 12
description: Anxiety will be assessed using the PROMIS-Anxiety 8a at baseline (T1), 8 weeks (T2), and 12 weeks (T3). PROMIS-Anxiety measures fear, dread, worry, hyperarousal, and related somatic symptoms. The short-form consists of 8 items that are scored on a 0-5 response format. The raw score is calculated by summing the values of the response to each question (range 8-40). Scores are standardized such that the scale produces continuous T scores with a mean of 50 and a SD of 10, higher scores reflect higher distress. PROMIS T score thresholds for anxiety are: ˂ 55 normal; 55-64 mild; 65-74 moderate; ≥75 severe.
measure: Depression assessed using the Patient Health Questionnaire (PHQ-9)
time frame: Up to week 12
description: Depression will be assessed using the Patient Health Questionnaire (PHQ-9) at baseline (T1), 8 weeks (T2), and 12 weeks (T3). The PHQ-9 includes the two major symptom domains: affective and somatic symptoms. It is rated from a 0 (not at all) to 3 (nearly every day) scale. Items are summed and a score of 10 or greater is considered clinically significant symptoms of depression. Scores of 0-4, 5-9, 10-14, and ≥15 represent minimal, mild, moderate, and severe levels of symptom burden.
measure: Overall symptom distress assessed using the Memorial Symptom Assessment Scale (MSAS)
time frame: Up to week 12
description: Overall symptom distress will be assessed using the Memorial Symptom Assessment Scale (MSAS) at baseline (T1), 8 weeks (T2), and 12 weeks (T3). The MSAS assesses 32 common symptoms experienced by cancer patients. A modified version of the MSAS will be used to evaluate the occurrence, severity, and distress of symptoms. Symptom severity is rated on a 4 point Likert scale (1=slight) to 4=very much). Distress is rated on a 0-4 Likert scale ranging from not at all (0) to very much (4). The physical symptom subscale is the average of the severity and distress associated with 12 physical symptoms. The psychological symptom subscale is the average of the severity and distress associated with 6 psychological symptoms. The total MSAS score (TMSAS) is the average of the symptom scores of all 32 symptoms; higher scores indicate greater symptom severity and distress.
measure: Metacognitions (MCQ-30) assessed using the Metacognitions Questionnaire
time frame: Up to week 12
description: Metacognitions (MCQ-30) will be assessed using the Metacognitions Questionnaire at baseline (T1), 8 weeks (T2), and 12 weeks (T3). The MCQ-30 is a 30-item questionnaire that assesses beliefs about worry. It consists of 5 subscales: Positive beliefs about worry; Negative beliefs about worry, Cognitive confidence; Need to control thoughts; and Cognitive self-consciousness. For each subscale, items are scored 1-4 and subscale scores range from 6-24. Total scores range from 30 to 120; higher scores indicate more dysfunctional metacognitions.
measure: Mindfulness assessed using the Five Facet Mindfulness Questionnaire (FFMQ-15)
time frame: Up to week 12
description: Mindfulness will be assessed using the Five Facet Mindfulness Questionnaire (FFMQ-15) at baseline (T1), 8 weeks (T2), and 12 weeks (T3). The FFMQ-15 assesses five facets of mindfulness: observing, describing, acting with awareness, non-reactivity, and non-judging of inner experience. Items are rated on a 5-point Likert scale ranging from 1 (never or rarely true) to 5 (very often or always true). 3 items comprise each subscale and subscale scores range from 3-15. Higher scores indicate greater engagement with mindfulness skills.
arm group label: Supportive care (CFS)
arm group type: Experimental
description: Patients attend CFS psychosocial intervention consisting of 7 nurse-led sessions (session 1 in-person and sessions 2-7 via video conferencing) over 45 minutes each for 8 weeks. Patients also complete home practice assignments comprising attention training technique and mindfulness practice after each session.
Patients complete self-report questionnaires at baseline (T1), 8 weeks (T2) and 12 weeks (T3).
intervention type: Behavioral
intervention name: Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components)
description: Attend CFS
arm group label: Supportive care (CFS)
other name: Conquer Fear Support
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive care (CFS)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Anne Reb, NP, PhD
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Genital Neoplasms, Female