xml: <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/NCT06037954</url>
    </required_header>
    <id_info>
      <org_study_id>23-218</org_study_id>
      <nct_id>NCT06037954</nct_id>
    </id_info>
    <brief_title>A Study of Mental Health Care in People With Cancer</brief_title>
    <official_title>Mental Health Care Initiation Intervention for Older Adults With Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Memorial Sloan Kettering Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Weill Medical College of Cornell University</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>
        The purpose of this study is to look at mental health services for adults with depressed mood&#xD;
        who were diagnosed with cancer at the age of 65 or older. This study will compare the usual&#xD;
        approach for connecting older adults with depressed mood to mental health services with the&#xD;
        Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and&#xD;
        useful for cancer patients who participate in the intervention and for providers who see or&#xD;
        treat cancer patients.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2026</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>This protocol aims to refine and pilot test a brief telehealth intervention, Open Door for Cancer (OD-C), that addresses individual barriers to mental health service initiation in depressed older adults with cancer (OACs) without requiring in-person appointments.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Refusal rates</measure>
      <time_frame>2 years</time_frame>
      <description>≥75% of eligible patients enroll in the study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Attrition rates</measure>
      <time_frame>2 years</time_frame>
      <description>≥80% of patients who enroll complete all study procedures</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Treatment satisfaction</measure>
      <time_frame>2 years</time_frame>
      <description>Client Satisfaction Questionnaire-8 mean score of ≥3</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">130</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Colorectal Cancer</condition>
    <condition>Lung Cancer</condition>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>Open Door for Cancer (OD-C)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>OD-C includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants assigned to Usual Care (n=50) will receive standard care. MSK's current usual care for distress screening is that all patients are screened for distress when they initiate care at MSK. Additional distress screening is conducted based on the determination of the oncology team. In addition, patients are referred to social work, psychology, and/or psychiatry based on the judgment of the oncology team.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaires</intervention_name>
      <description>Patient demographic characteristics, Clinical variables, Cornell Service Index-Short Form (CSI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder scale-7 (GAD-7), Client Satisfaction Questionnaire (CSQ-8), Intention to Seek Help Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Severity Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Benefits Scale, Barriers to Mental Health Services Scale-Revised, Cues to action, Self-Efficacy to Seek Mental Health Care (SE-SMHC)</description>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Interviews</intervention_name>
      <description>Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.</description>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>30-minute telephone or videoconference sessions</intervention_name>
      <description>Includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded. The five components are:&#xD;
  Provide education about depression and treatment options&#xD;
  Identify treatment preferences and a personal goal achievable with mental health care&#xD;
  Assess barriers to treatment initiation&#xD;
  Recommend a referral using standardized referral options&#xD;
  Address barriers to accessing care</description>
      <arm_group_label>Open Door for Cancer (OD-C)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients&#xD;
  &#xD;
            -  Per medical record, diagnosed with breast, colorectal, lung, or prostate cancer at age&#xD;
               65 years or older&#xD;
  &#xD;
            -  Per medical record, undergoing active cancer treatment (e.g., radiation, chemotherapy,&#xD;
               immunotherapy, surgery) or within six months of completing treatment&#xD;
  &#xD;
            -  Score of ≥3 on the Patient Health Questionnaire-2 (PHQ-2)&#xD;
  &#xD;
            -  Per self-report, fluent in English** ** Language verification: Prior to enrollment,&#xD;
               patients will be asked the following two questions by a Clinical Research Coordinator&#xD;
               (CRC) to verify English fluency necessary for participation in the study:&#xD;
  &#xD;
                 1. How well do you speak English? (must respond &quot;very well&quot; or &quot;well&quot; when given the&#xD;
                    choices of Very well, Well, Not well, Not at all, Don't know, or Refused)&#xD;
  &#xD;
                 2. What is your preferred language for healthcare? (must respond English)&#xD;
  &#xD;
          Providers&#xD;
  &#xD;
            -  Per self-report, works in oncology, nursing, social work, psychology, or psychiatry&#xD;
  &#xD;
            -  Per self-report, currently works in oncology at least 50% of the time&#xD;
  &#xD;
            -  Per self-report, provided cancer care for at least three years at time of consent&#xD;
  &#xD;
            -  Per self-report, fluent in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients&#xD;
  &#xD;
            -  Severely cognitively impaired as demonstrated by Blessed Orientation Memory&#xD;
               Concentration scores of ≥ 11&#xD;
  &#xD;
            -  Per research staff judgment and/or self-report, too ill or weak to complete study&#xD;
               procedures&#xD;
  &#xD;
            -  Per medical record and/or self-report, receiving hospice care at the time of&#xD;
               enrollment&#xD;
  &#xD;
            -  Per medical record and/or self-report, currently enrolled in mental health treatment&#xD;
  &#xD;
          Providers&#xD;
  &#xD;
            -  N/A&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kelly McConnell, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kelly McConnell, PhD</last_name>
      <phone>646-888-0026</phone>
      <email>mcconnek@mskcc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Christian Nelson, PhD</last_name>
      <phone>646-888-0030</phone>
    </overall_contact_backup>
    <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>
      <status>Recruiting</status>
      <contact>
        <last_name>Kelly McDonnell, PhD</last_name>
        <phone>646-888-0026</phone>
      </contact>
      <contact_backup>
        <last_name>Christian Nelson, PhD</last_name>
        <phone>646-888-0030</phone>
      </contact_backup>
    </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>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>65 years and older</keyword>
    <keyword>Mental health care</keyword>
    <keyword>23-218</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colorectal 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>
  
  
text: 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/NCT06037954
  org study id: 23-218
  nct id: NCT06037954
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to look at mental health services for adults with depressed mood
        who were diagnosed with cancer at the age of 65 or older. This study will compare the usual
        approach for connecting older adults with depressed mood to mental health services with the
        Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and
        useful for cancer patients who participate in the intervention and for providers who see or
        treat cancer patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This protocol aims to refine and pilot test a brief telehealth intervention, Open Door for Cancer (OD-C), that addresses individual barriers to mental health service initiation in depressed older adults with cancer (OACs) without requiring in-person appointments.
  primary purpose: Other
  masking: None (Open Label)
  measure: Refusal rates
  time frame: 2 years
  description: ≥75% of eligible patients enroll in the study
  measure: Attrition rates
  time frame: 2 years
  description: ≥80% of patients who enroll complete all study procedures
  measure: Treatment satisfaction
  time frame: 2 years
  description: Client Satisfaction Questionnaire-8 mean score of ≥3
  arm group label: Open Door for Cancer (OD-C)
  arm group type: Experimental
  description: OD-C includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded.
  arm group label: Usual Care
  arm group type: Active Comparator
  description: Participants assigned to Usual Care (n=50) will receive standard care. MSK's current usual care for distress screening is that all patients are screened for distress when they initiate care at MSK. Additional distress screening is conducted based on the determination of the oncology team. In addition, patients are referred to social work, psychology, and/or psychiatry based on the judgment of the oncology team.
  intervention type: Other
  intervention name: Questionnaires
  description: Patient demographic characteristics, Clinical variables, Cornell Service Index-Short Form (CSI), Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder scale-7 (GAD-7), Client Satisfaction Questionnaire (CSQ-8), Intention to Seek Help Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Severity Scale, Health Beliefs about Mental Illness Instrument (HBMII) - Emotional/Nervous Benefits Scale, Barriers to Mental Health Services Scale-Revised, Cues to action, Self-Efficacy to Seek Mental Health Care (SE-SMHC)
  arm group label: Usual Care
  intervention type: Other
  intervention name: Interviews
  description: Interviews will be conducted by the qualitative methods specialist and trained study staff and will last 30-45 minutes.
  arm group label: Usual Care
  intervention type: Other
  intervention name: 30-minute telephone or videoconference sessions
  description: Includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded. The five components are:
  Provide education about depression and treatment options
  Identify treatment preferences and a personal goal achievable with mental health care
  Assess barriers to treatment initiation
  Recommend a referral using standardized referral options
  Address barriers to accessing care
  arm group label: Open Door for Cancer (OD-C)
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kelly McConnell, PhD
  role: Principal Investigator
  affiliation: Memorial Sloan Kettering Cancer Center
  last name: Kelly McConnell, PhD
  phone: 646-888-0026
  email: mcconnek@mskcc.org
  last name: Christian Nelson, PhD
  phone: 646-888-0030
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  url: http://www.mskcc.org/mskcc/html/44.cfm
  description: Memorial Sloan Kettering Cancer Center
  responsible party type: Sponsor
  mesh term: Colorectal 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.