<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/NCT04435444</url>
  </required_header>
  <id_info>
    <org_study_id>20-018</org_study_id>
    <nct_id>NCT04435444</nct_id>
  </id_info>
  <brief_title>Meaning-Centered Intervention for Muslim Patients Who Are Being Treated for Advanced Cancer</brief_title>
  <official_title>Pilot of a Meaning-Centered Intervention for Muslims Undergoing Treatment for Stage III or IV Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UConn Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the effectiveness of the Masterful supportive care intervention with&#xD;
      that of the non-faith-based active control supportive care intervention, which uses the&#xD;
      American Cancer Society's patient education materials, for Muslim patients who have advanced&#xD;
      cancers.&#xD;
&#xD;
      All 3 sessions may occur within one week or over multiple weeks (nonconsecutively), depending&#xD;
      on the participants preference. The participant will have up to 12 weeks from recruitment to&#xD;
      complete all sessions and follow up surveys.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</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>
    <intervention_model_description>2-group randomized controlled trial (RCT). Using a consecutive patient sampling scheme, we will randomize Muslim patients with stage III or IV cancer.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of enrolled participants completing at least one psychotherapy session out of the planned three.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Masterful supportive care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This intervention uses teachings, discussions, and exercises about personal experiences that focus on specific topics related to meaning and cancer. For example, we may discuss what is meaningful in your life, how you identify yourself before and after cancer, and your hopes for the future. The Masterful intervention is available in both English and Arabic, and it will be delivered by a trained bilingual member of the study team. It includes 3 weekly (or at participant's preference) 1-hour sessions with a member of the study team. The sessions for either the treatment or the control arm will take place in-person in a private room at MSKCC or via teleconference, depending on the patients preference. Meeting one-on-one with an interventionist was feasible in our pilot study and will enhance relationship-building between interventionist and patient. Participants will have the option to meet with the interventionist via teleconference in order to reduce in-person contact burden.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention control supportive care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This intervention uses the American Cancer Society's patient education materials. These sessions will include discussions about managing a self-identified current problem in your life. The attention control supportive care intervention is available in both English and Arabic, and it will be delivered by a trained bilingual member of the study team. It includes 3 weekly (or at participant's preference) 1-hour sessions with a member of the study team. The sessions for either the treatment or the control arm will take place in-person in a private room at MSKCC or via teleconference, depending on the patients preference. Meeting one-on-one with an interventionist was feasible in our pilot study and will enhance relationship-building between interventionist and patient. Participants will have the option to meet with the interventionist via teleconference in order to reduce in-person contact burden.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Masterful supportive care</intervention_name>
    <description>Three study questionnaires:&#xD;
Functional Assessment of Cancer Therapy-General* (FACT-G), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being* (FACIT-Sp) Memorial Symptom Assessment Scale Short Form* (MSAS-SF)</description>
    <arm_group_label>Masterful supportive care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Attention control supportive care</intervention_name>
    <description>Three study questionnaires:&#xD;
Functional Assessment of Cancer Therapy-General* (FACT-G), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being* (FACIT-Sp) Memorial Symptom Assessment Scale Short Form* (MSAS-SF)</description>
    <arm_group_label>Attention control supportive care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age&#xD;
&#xD;
          -  identify, either as self-report or on the MSKCC EMR, as Muslim&#xD;
&#xD;
          -  are in treatment including surveillance, for a confirmed diagnosis of stage III or IV&#xD;
             cancer (solid or liquid) as per clinician or pathology report&#xD;
&#xD;
          -  have an estimated life expectancy of at least 6 months, as determined by their primary&#xD;
             oncologist&#xD;
&#xD;
          -  are cognitively intact (oncologist's clinical impression or judgement of study staff)&#xD;
&#xD;
          -  able to speak and read English or Arabic (self-reported preference or on the MSKCC EMR&#xD;
             system).&#xD;
&#xD;
          -  To assess English proficiency, participants will be asked two questions: (1) the&#xD;
             Census limited English proficient item &quot;How well do you speak English?&quot; with response&#xD;
             options &quot;Not at all, Not well, Well, or Very well&quot; and (2) &quot;What is your preferred&#xD;
             language for healthcare?&quot;&#xD;
&#xD;
          -  Participants who are eligible for the study and are fluent in English will be&#xD;
             identified by the response &quot;Very well&quot; to the 1st question and a response indicating&#xD;
             English as the preferred language for healthcare.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Major psychiatric illness or cognitive impairment that in the judgment of the study&#xD;
             investigators or study staff would preclude study participation&#xD;
&#xD;
          -  patients diagnosed with primary brain tumors as per clinician report, as they may have&#xD;
             difficulty completing the intervention and answering the questionnaires&#xD;
&#xD;
          -  undergoing hematopoietic stem cell transplantation (HSCT) as per clinican report or&#xD;
             the EMR&#xD;
&#xD;
          -  currently in psychotherapeutic treatment. Symptoms of anxiety and depression are&#xD;
             common among patients with stage III or IV cancer. Antidepressants, anxiolytics, and&#xD;
             other psychotropic medications do not diminish the effects of psychotherapy; thus we&#xD;
             will not exclude patients who are being treated with these medications, as long as&#xD;
             they are not in psychotherapy.&#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>Francesca Gany, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Meaning-Centered Intervention</keyword>
  <keyword>Masterful intervention</keyword>
  <keyword>20-018</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </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/NCT04435444
org study id: 20-018
nct id: NCT04435444
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study will compare the effectiveness of the Masterful supportive care intervention with
      that of the non-faith-based active control supportive care intervention, which uses the
      American Cancer Society's patient education materials, for Muslim patients who have advanced
      cancers.

      All 3 sessions may occur within one week or over multiple weeks (nonconsecutively), depending
      on the participants preference. The participant will have up to 12 weeks from recruitment to
      complete all sessions and follow up surveys.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2-group randomized controlled trial (RCT). Using a consecutive patient sampling scheme, we will randomize Muslim patients with stage III or IV cancer.
primary purpose: Supportive Care
masking: None (Open Label)
measure: number of enrolled participants completing at least one psychotherapy session out of the planned three.
time frame: 1 year
arm group label: Masterful supportive care
arm group type: Experimental
description: This intervention uses teachings, discussions, and exercises about personal experiences that focus on specific topics related to meaning and cancer. For example, we may discuss what is meaningful in your life, how you identify yourself before and after cancer, and your hopes for the future. The Masterful intervention is available in both English and Arabic, and it will be delivered by a trained bilingual member of the study team. It includes 3 weekly (or at participant's preference) 1-hour sessions with a member of the study team. The sessions for either the treatment or the control arm will take place in-person in a private room at MSKCC or via teleconference, depending on the patients preference. Meeting one-on-one with an interventionist was feasible in our pilot study and will enhance relationship-building between interventionist and patient. Participants will have the option to meet with the interventionist via teleconference in order to reduce in-person contact burden.
arm group label: Attention control supportive care
arm group type: Active Comparator
description: This intervention uses the American Cancer Society's patient education materials. These sessions will include discussions about managing a self-identified current problem in your life. The attention control supportive care intervention is available in both English and Arabic, and it will be delivered by a trained bilingual member of the study team. It includes 3 weekly (or at participant's preference) 1-hour sessions with a member of the study team. The sessions for either the treatment or the control arm will take place in-person in a private room at MSKCC or via teleconference, depending on the patients preference. Meeting one-on-one with an interventionist was feasible in our pilot study and will enhance relationship-building between interventionist and patient. Participants will have the option to meet with the interventionist via teleconference in order to reduce in-person contact burden.
intervention type: Other
intervention name: Masterful supportive care
description: Three study questionnaires:
Functional Assessment of Cancer Therapy-General* (FACT-G), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being* (FACIT-Sp) Memorial Symptom Assessment Scale Short Form* (MSAS-SF)
arm group label: Masterful supportive care
intervention type: Other
intervention name: Attention control supportive care
description: Three study questionnaires:
Functional Assessment of Cancer Therapy-General* (FACT-G), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being* (FACIT-Sp) Memorial Symptom Assessment Scale Short Form* (MSAS-SF)
arm group label: Attention control supportive care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francesca Gany, MD, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.