<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/NCT03823313</url>
  </required_header>
  <id_info>
    <org_study_id>IUSCC-0665</org_study_id>
    <nct_id>NCT03823313</nct_id>
  </id_info>
  <brief_title>Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention</brief_title>
  <official_title>Feasibility, Acceptability and Preliminary Effects of the Spiritual Care Assessment and Intervention (SCAI) Framework for Adults With Advanced Cancer and Their Caregivers (FCGs): A Clinical Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indiana University Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Indiana University</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>
      The purpose of this study is to test a spiritual care intervention for adults with advanced&#xD;
      cancer and their caregivers. This intervention will assess 4 areas of spiritual experience:&#xD;
      meaning and purpose, relationships, transcendence and peace, self-worth and identity.&#xD;
      Participants will be asked to complete questionnaires and participate in 4 sessions with&#xD;
      research chaplains.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies have shown that cancer affects multiple dimensions of a patient's life as&#xD;
      well as the lives of caregivers and others close to the patient who, when faced with life&#xD;
      crises, may use religion and spirituality (R/S) to cope. This study is the first of its kind&#xD;
      to incorporate a semi-structured spiritual care and intervention (SCAI) framework into the&#xD;
      spiritual care of advanced cancer patients while maintaining proper controls in order to&#xD;
      investigate its feasibility, acceptability and potential effects on the emotional and&#xD;
      spiritual outcomes of advanced cancer patients and their caregivers. This framework will&#xD;
      assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and&#xD;
      peace, self-worth and identity. Additionally, not only will this study assess acceptability&#xD;
      and feasibility of the intervention, it will also track and document coping, satisfaction,&#xD;
      anxiety, depression, quality of life outcomes and follow-up with both patient and caregivers&#xD;
      following Spiritual Care Assessment and Intervention (SCAI).&#xD;
&#xD;
      Specific Aim 1: To evaluate the feasibility and acceptability of the SCAI intervention for&#xD;
      adults with advanced cancer and their caregivers.&#xD;
&#xD;
      Specific Aim 2: To establish our ability to collect outcome data to support a future efficacy&#xD;
      trial for patients and their caregivers in the outpatient clinic and home setting.&#xD;
&#xD;
      Specific Aim 3: To test the preliminary impact of the SCAI intervention on patient and&#xD;
      caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping,&#xD;
      depression, and anxiety (secondary outcomes)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2018</start_date>
  <completion_date type="Actual">August 28, 2019</completion_date>
  <primary_completion_date type="Actual">August 28, 2019</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>Rate of enrollment</measure>
    <time_frame>from recruitment to enrollment (i.e. up to 30 days)</time_frame>
    <description>number of eligible patients that are consented and enrolled in the trial</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attendance Rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>proportion of participants who attend all four intervention sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Satisfaction Score</measure>
    <time_frame>4 weeks</time_frame>
    <description>satisfaction score among participants on the satisfaction survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional assessment of chronic illness therapy-Spiritual Well-being Scale Scores</measure>
    <time_frame>baseline, 1-2 weeks after session 4, 6 weeks, 3 months</time_frame>
    <description>Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of completed baseline surveys</measure>
    <time_frame>baseline</time_frame>
    <description>percentage of completed baseline surveys in enrolled patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of completed follow up surveys</measure>
    <time_frame>baseline, 1-2 weeks after session 4, 6 weeks, 3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>McGrill Quality of Life Questionnaire score</measure>
    <time_frame>baseline, 1-2 weeks after session 4, 6 weeks, 3 months</time_frame>
    <description>Measure of patient quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Quality of Life Index-Cancer Questionnaire score</measure>
    <time_frame>baseline, 1 week, 6 weeks, 3 months</time_frame>
    <description>Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Quality of Life Index-Cancer Questionnaire score</measure>
    <time_frame>baseline, 1-2 weeks after session 4, 6 weeks, 3 months</time_frame>
    <description>Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder Scale Scores</measure>
    <time_frame>baseline, 1-2 weeks after session 4, 6 weeks, 3 months</time_frame>
    <description>Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire Depression Scale (PHQ-8)</measure>
    <time_frame>baseline, 1 week, 6 weeks, 3 months</time_frame>
    <description>Measure of depression through total score at baseline compared to score at 1 week, 6 weeks, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief RCOPE score</measure>
    <time_frame>baseline, 1-2 weeks after session 4, 6 weeks, 3 months</time_frame>
    <description>Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention Satisfaction Questionnaire score</measure>
    <time_frame>baseline, 1-2 weeks after session 4, 6 weeks, 3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Advanced Cancer</condition>
  <condition>Metastatic Cancer</condition>
  <arm_group>
    <arm_group_label>Spiritual Care Assessment and Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SCAI (Spiritual Care Assessment and Intervention)</intervention_name>
    <description>4 sessions completed with an IU Health chaplain using a framework of questions called the Spiritual Care Assessment And Intervention tool. The weekly sessions will focus on one of the 4 areas of spiritual experience (meaning and purpose, relationships, transcendence and peace, self-worth and identity)</description>
    <arm_group_label>Spiritual Care Assessment and Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is at least 18 years of age.&#xD;
&#xD;
          -  Patient is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV)&#xD;
             lung, colorectal, GI neuroendocrine and Hepatobiliary, testicular and esophageal solid&#xD;
             malignancy and receiving cancer care at IU Simon Cancer Center.&#xD;
&#xD;
          -  Patient is willing and able to consent, has a reliable phone and willing to&#xD;
             participate in 4 sessions of 30 (+/- 5) minutes per session.&#xD;
&#xD;
          -  Patient has a family member or eligible friend considered to be a caregiver and&#xD;
             interested in participating in the study.&#xD;
&#xD;
          -  Patient has adequate English fluency for completion of data collection.&#xD;
&#xD;
          -  Family Caregiver (FCG) is at least 18 years of age.&#xD;
&#xD;
          -  Family Caregiver (FCG) has been invited to participate in the trial with a patient who&#xD;
             meets eligibility criteria above.&#xD;
&#xD;
          -  Family Caregiver (FCG) is willing and able to consent and to participate in 4 sessions&#xD;
             of 30 (+/- 5) minutes per session&#xD;
&#xD;
          -  Family Caregiver (FCG) has adequate English fluency for completion of data collection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient makes 3 or more errors on a validated 6-item cognitive screener (Appendix A)&#xD;
             or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium,&#xD;
             retardation, active psychosis) that in the judgment of the investigators would&#xD;
             preclude providing informed consent and study participation.&#xD;
&#xD;
          -  Currently receiving hospice care (patients who enroll in hospice during the trial will&#xD;
             have the option of continuing trial participation).&#xD;
&#xD;
          -  Family Caregiver (FCG) exhibits significant psychiatric or cognitive impairment (e.g.,&#xD;
             dementia/delirium, retardation, active psychosis) that in the judgment of the&#xD;
             investigators would preclude providing informed consent and study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexia Torke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Indiana University Melvin &amp; Bren Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 11, 2020</last_update_submitted>
  <last_update_submitted_qc>February 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Alexia M. Torke</investigator_full_name>
    <investigator_title>Associate Professor of Medicine and Associate Division Chief of General Internal Medicine and Geriatrics</investigator_title>
  </responsible_party>
  <keyword>Spiritual Care</keyword>
  <keyword>Religion</keyword>
  <keyword>Spirituality</keyword>
  <keyword>Caregiver</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasm Metastasis</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/NCT03823313
org study id: IUSCC-0665
nct id: NCT03823313
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test a spiritual care intervention for adults with advanced
      cancer and their caregivers. This intervention will assess 4 areas of spiritual experience:
      meaning and purpose, relationships, transcendence and peace, self-worth and identity.
      Participants will be asked to complete questionnaires and participate in 4 sessions with
      research chaplains.
Several studies have shown that cancer affects multiple dimensions of a patient's life as
      well as the lives of caregivers and others close to the patient who, when faced with life
      crises, may use religion and spirituality (R/S) to cope. This study is the first of its kind
      to incorporate a semi-structured spiritual care and intervention (SCAI) framework into the
      spiritual care of advanced cancer patients while maintaining proper controls in order to
      investigate its feasibility, acceptability and potential effects on the emotional and
      spiritual outcomes of advanced cancer patients and their caregivers. This framework will
      assess 4 areas of spiritual experience: meaning and purpose, relationships, transcendence and
      peace, self-worth and identity. Additionally, not only will this study assess acceptability
      and feasibility of the intervention, it will also track and document coping, satisfaction,
      anxiety, depression, quality of life outcomes and follow-up with both patient and caregivers
      following Spiritual Care Assessment and Intervention (SCAI).

      Specific Aim 1: To evaluate the feasibility and acceptability of the SCAI intervention for
      adults with advanced cancer and their caregivers.

      Specific Aim 2: To establish our ability to collect outcome data to support a future efficacy
      trial for patients and their caregivers in the outpatient clinic and home setting.

      Specific Aim 3: To test the preliminary impact of the SCAI intervention on patient and
      caregiver spiritual wellbeing (primary outcome) and quality of life, religious coping,
      depression, and anxiety (secondary outcomes)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of enrollment
time frame: from recruitment to enrollment (i.e. up to 30 days)
description: number of eligible patients that are consented and enrolled in the trial
measure: Attendance Rate
time frame: 4 weeks
description: proportion of participants who attend all four intervention sessions
measure: Mean Satisfaction Score
time frame: 4 weeks
description: satisfaction score among participants on the satisfaction survey
measure: Functional assessment of chronic illness therapy-Spiritual Well-being Scale Scores
time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
description: Total score at baseline will be compared to score at to the score at 1 week, 6 weeks, and 3 months
measure: Percentage of completed baseline surveys
time frame: baseline
description: percentage of completed baseline surveys in enrolled patients
measure: Percentage of completed follow up surveys
time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
measure: McGrill Quality of Life Questionnaire score
time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
description: Measure of patient quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
measure: Caregiver Quality of Life Index-Cancer Questionnaire score
time frame: baseline, 1 week, 6 weeks, 3 months
description: Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
measure: Caregiver Quality of Life Index-Cancer Questionnaire score
time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
description: Measure of caregiver quality of life through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
measure: Generalized Anxiety Disorder Scale Scores
time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
description: Measure of Anxiety through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
measure: Patient Health Questionnaire Depression Scale (PHQ-8)
time frame: baseline, 1 week, 6 weeks, 3 months
description: Measure of depression through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
measure: Brief RCOPE score
time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
description: Measure of coping through total score at baseline compared to score at 1 week, 6 weeks, and 3 months
measure: Intervention Satisfaction Questionnaire score
time frame: baseline, 1-2 weeks after session 4, 6 weeks, 3 months
arm group label: Spiritual Care Assessment and Intervention
arm group type: Experimental
intervention type: Behavioral
intervention name: SCAI (Spiritual Care Assessment and Intervention)
description: 4 sessions completed with an IU Health chaplain using a framework of questions called the Spiritual Care Assessment And Intervention tool. The weekly sessions will focus on one of the 4 areas of spiritual experience (meaning and purpose, relationships, transcendence and peace, self-worth and identity)
arm group label: Spiritual Care Assessment and Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexia Torke, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Alexia M. Torke
investigator title: Associate Professor of Medicine and Associate Division Chief of General Internal Medicine and Geriatrics
mesh term: Neoplasm Metastasis
sharing ipd: No