<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/NCT02992405</url>
  </required_header>
  <id_info>
    <org_study_id>IIT2016-02-SALTZMAN-FOCUS</org_study_id>
    <nct_id>NCT02992405</nct_id>
  </id_info>
  <brief_title>FOCUS:Families OverComing Under Stress</brief_title>
  <official_title>Evaluation of Feasibility and Effect Size of a Resilience Enhancement Program for Couples and Families Contending With Cancer (FOCUS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The FOCUS program (study treatment) is an established evidence-based intervention whose&#xD;
      redesign for families and couples dealing with serious and chronic illnesses will provide a&#xD;
      creative and promising supplement to the existing support services at Cedars-Sinai Medical&#xD;
      Center. All participants will receive the 10-weeks of 75-minute weekly study treatment, but&#xD;
      will be split into two groups, the immediate treatment group and the wait list treatment&#xD;
      group, who will receive the study treatment after the immediate 10 weeks of treatment is&#xD;
      completed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite advances in the development of brief evidence-based programs for families and couples&#xD;
      contending with illness, trauma or loss, the support services provided at even top-tier&#xD;
      medical facilities are overwhelmingly focused on the individual patient. In most cases,&#xD;
      combined treatment with spouses and family members is the exception rather than the rule.&#xD;
&#xD;
      FOCUS is one of the very few programs that has a strong evidence base and has been used in&#xD;
      medical settings. It is a preventive, skill-based training program that is customized for&#xD;
      each couple or family and is designed to build upon existing strengths in order to enhance&#xD;
      family and individual resilience.&#xD;
&#xD;
      A cancer diagnosis is a family affair. Research has shown that the family or spousal&#xD;
      relationship can be instrumental in lessening patient distress and supporting treatment&#xD;
      compliance and positive adjustment across the various stages of treatment, survivorship,&#xD;
      recurrence / relapse, and end-of-life. Reductions in patient depression and anxiety through&#xD;
      couple or family interventions may reduce overall healthcare utilization and cost while&#xD;
      improving care quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">May 18, 2018</completion_date>
  <primary_completion_date type="Actual">May 18, 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>Feasibility of program as defined by dropout rate</measure>
    <time_frame>10 weeks</time_frame>
    <description>A randomized controlled trial will be considered feasible if the dropout rate is less than or equal to 20%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in score of depression as measured by the Patient Health Questionnaire 9 (PHQ-9).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of anxiety as measured by the General Anxiety Disorder 7 (GAD-7).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of post traumatic stress as measured by the PTSD Checklist - Civilian (PCL-C).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of stress in Human Functioning as measured by the Sense of Coherency (SOC).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of quality of life as measured by the Functional Assessment of Cancer Therapy - General Version (FACT-G).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of caregiver's quality of life as measured by the Caregiver Quality of Life Index - Cancer (CQOLC).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of family functioning as measured by the McMasters Family Assessment Device (FAD).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of couples relational functioning as measured by the Revised Dyadic Adjustment Scale (RDAS).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parents' score of child functioning as measured by the Strengths and Difficulties Questionnaire (SDQ).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in patient satisfaction score as measured by the FOCUS Impact Rating Scale (FIRS).</measure>
    <time_frame>10 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Cancer</condition>
  <condition>Depression</condition>
  <condition>PostTraumatic Stress Disorder</condition>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>FOCUS Resilience Enhancement Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Those assigned to the immediate treatment group will participate in the 10-week treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After the 10-week immediate treatment period, wait-list control participants will be administered the treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>FOCUS Resilience Enhancement Program</intervention_name>
    <description>Each couple or family will have 10 weekly 75 minute sessions comprising the treatment protocol.Questionnaires will be administered at baseline-before the immediate treatment phase (T1) and after the 10-week treatment is completed (T2).</description>
    <arm_group_label>FOCUS Resilience Enhancement Program</arm_group_label>
    <other_name>Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Waitlist (No Study Treatment)</intervention_name>
    <description>Participants assigned to the Waitlist (No Treatment) group will receive the study intervention only after the 10 weeks of the immediate treatment phase has been completed. Questionnaires will be administered at baseline-before the immediate treatment phase (T1) and after the immediate treatment phase is completed (T2).</description>
    <arm_group_label>Waitlist Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Written informed consent will be obtained from each participating adult subject and written&#xD;
        assent from each minor participating in the program. Specific criteria for inclusion into&#xD;
        the program are as follows:&#xD;
&#xD;
          1. Couples must have at least one partner and families at least one parent who is or has&#xD;
             been diagnosed with cancer at least 30 days prior to study start and not more than one&#xD;
             year from last treatment visit.&#xD;
&#xD;
          2. Couples or parents must be at least 18 years old and must be English speakers.&#xD;
&#xD;
          3. At least one member of the couple must score &gt;60 on the Anxiety or Depression scale on&#xD;
             the Brief Symptom Index 18 administered during the screening visit and/or have notable&#xD;
             difficulties in relationship or family functioning, as resulted in a ≥2 score in FAD&#xD;
             subscale or at least one RDAS subscale question answered 'more often than not' or more&#xD;
             frequent.&#xD;
&#xD;
          4. The families participating in the study must have at least one child older than the&#xD;
             age of five.&#xD;
&#xD;
          5. Participating families must have at least one parent who can provide legal consent for&#xD;
             the participation of their child(ren) in the program.&#xD;
&#xD;
          6. Participants must be willing and able to complete 10 sessions within 14 weeks.&#xD;
&#xD;
          7. Participants undergoing active management or care plans for abuse or psychopathology&#xD;
             may enroll in study if reports of ongoing management are provided.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. There must not be any participant with urgent and/or immediate health needs (where a&#xD;
             possible 10-week wait time poses more than minimal risks).&#xD;
&#xD;
          2. There must not be active (within the last 30 days and/or during study intervention)&#xD;
             and unmanaged domestic violence or abuse, substance abuse, or extreme forms of&#xD;
             psychopathology such as psychosis that would interfere with the treatment.&#xD;
&#xD;
          3. Primary presenting personal and/or relational issues are largely unrelated to the&#xD;
             cancer diagnosis and treatment, as determined by the screening clinician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Saltzman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinal Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</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>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>William Saltzman</investigator_full_name>
    <investigator_title>Psychologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT02992405
org study id: IIT2016-02-SALTZMAN-FOCUS
nct id: NCT02992405
lead sponsor: 
has dmc: No
The FOCUS program (study treatment) is an established evidence-based intervention whose
      redesign for families and couples dealing with serious and chronic illnesses will provide a
      creative and promising supplement to the existing support services at Cedars-Sinai Medical
      Center. All participants will receive the 10-weeks of 75-minute weekly study treatment, but
      will be split into two groups, the immediate treatment group and the wait list treatment
      group, who will receive the study treatment after the immediate 10 weeks of treatment is
      completed.
Despite advances in the development of brief evidence-based programs for families and couples
      contending with illness, trauma or loss, the support services provided at even top-tier
      medical facilities are overwhelmingly focused on the individual patient. In most cases,
      combined treatment with spouses and family members is the exception rather than the rule.

      FOCUS is one of the very few programs that has a strong evidence base and has been used in
      medical settings. It is a preventive, skill-based training program that is customized for
      each couple or family and is designed to build upon existing strengths in order to enhance
      family and individual resilience.

      A cancer diagnosis is a family affair. Research has shown that the family or spousal
      relationship can be instrumental in lessening patient distress and supporting treatment
      compliance and positive adjustment across the various stages of treatment, survivorship,
      recurrence / relapse, and end-of-life. Reductions in patient depression and anxiety through
      couple or family interventions may reduce overall healthcare utilization and cost while
      improving care quality.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of program as defined by dropout rate
time frame: 10 weeks
description: A randomized controlled trial will be considered feasible if the dropout rate is less than or equal to 20%.
measure: Change in score of depression as measured by the Patient Health Questionnaire 9 (PHQ-9).
time frame: 10 weeks
measure: Change in score of anxiety as measured by the General Anxiety Disorder 7 (GAD-7).
time frame: 10 weeks
measure: Change in score of post traumatic stress as measured by the PTSD Checklist - Civilian (PCL-C).
time frame: 10 weeks
measure: Change in score of stress in Human Functioning as measured by the Sense of Coherency (SOC).
time frame: 10 weeks
measure: Change in score of quality of life as measured by the Functional Assessment of Cancer Therapy - General Version (FACT-G).
time frame: 10 weeks
measure: Change in score of caregiver's quality of life as measured by the Caregiver Quality of Life Index - Cancer (CQOLC).
time frame: 10 weeks
measure: Change in score of family functioning as measured by the McMasters Family Assessment Device (FAD).
time frame: 10 weeks
measure: Change in score of couples relational functioning as measured by the Revised Dyadic Adjustment Scale (RDAS).
time frame: 10 weeks
measure: Change in parents' score of child functioning as measured by the Strengths and Difficulties Questionnaire (SDQ).
time frame: 10 weeks
measure: Change in patient satisfaction score as measured by the FOCUS Impact Rating Scale (FIRS).
time frame: 10 weeks
arm group label: FOCUS Resilience Enhancement Program
arm group type: Experimental
description: Those assigned to the immediate treatment group will participate in the 10-week treatment.
arm group label: Waitlist Treatment
arm group type: Experimental
description: After the 10-week immediate treatment period, wait-list control participants will be administered the treatment.
intervention type: Behavioral
intervention name: FOCUS Resilience Enhancement Program
description: Each couple or family will have 10 weekly 75 minute sessions comprising the treatment protocol.Questionnaires will be administered at baseline-before the immediate treatment phase (T1) and after the 10-week treatment is completed (T2).
arm group label: FOCUS Resilience Enhancement Program
other name: Therapy
intervention type: Behavioral
intervention name: Waitlist (No Study Treatment)
description: Participants assigned to the Waitlist (No Treatment) group will receive the study intervention only after the 10 weeks of the immediate treatment phase has been completed. Questionnaires will be administered at baseline-before the immediate treatment phase (T1) and after the immediate treatment phase is completed (T2).
arm group label: Waitlist Treatment
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: William Saltzman, PhD
role: Principal Investigator
affiliation: Cedars-Sinal Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: William Saltzman
investigator title: Psychologist
mesh term: Stress Disorders, Post-Traumatic