<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/NCT02992171</url>
  </required_header>
  <id_info>
    <org_study_id>PRO16100199</org_study_id>
    <secondary_id>130225-PEP-16-205-01-PCSM</secondary_id>
    <nct_id>NCT02992171</nct_id>
  </id_info>
  <brief_title>Primary Palliative Care for Patients With Advanced Hematologic Malignancies</brief_title>
  <official_title>SHARE - Supportive Care Management for Patients With Hematologic Cancers by Registered Nurses</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</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>
      This study seeks to develop and pilot-test an oncology nurse-led care management intervention&#xD;
      to meet the primary palliative care needs of patients with advanced hematologic malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study investigators will develop and pilot-test an oncology nurse-led care management&#xD;
      intervention to meet the primary palliative care needs of patients with advanced hematologic&#xD;
      malignancies.&#xD;
&#xD;
      Aim 1 is a case series to develop and refine the intervention. During this time, we will&#xD;
      develop initial interventionist training materials, study protocols, and a web-based outcomes&#xD;
      database; train 2 hematology-oncology nurses; enroll 10 patients with advanced hematologic&#xD;
      malignancies and their informal caregivers to receive intervention visits; conduct debriefing&#xD;
      interviews; iteratively refine the intervention based on nurse, oncologist, patient, and&#xD;
      caregiver feedback; and prepare the protocol for Aim 2. Aim 2 is a pilot study to assess the&#xD;
      feasibility and acceptability of administering the intervention and assessing outcomes. We&#xD;
      will recruit 30 patients and their informal caregivers to receive the intervention developed&#xD;
      in Aim 1 and collect measures of quality of life, symptom burden, anxiety and depressive&#xD;
      symptoms, caregiver burden, and healthcare utilization at baseline and monthly for up to&#xD;
      three months. Trial outcomes will include: rates of enrollment, study completion, and outcome&#xD;
      completion; intervention fidelity; and self-reported measures of study burdensomeness and&#xD;
      effectiveness among patients, caregivers, and clinicians.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2017</start_date>
  <completion_date type="Actual">March 19, 2020</completion_date>
  <primary_completion_date type="Actual">March 19, 2020</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>Successful enrollment of 30 patient-caregiver pairs</measure>
    <time_frame>Baseline to 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Consent-to-approach rate</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Consent to approach rates will be tracked to assess feasibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enrolled-to-consent rate</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Enrolled-to-consent rates will be tracked to assess feasibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention completion rate</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Intervention completion rate among enrolled participants will be tracked to assess feasibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention fidelity</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Percent of intervention components completed according to protocol will be tracked to assess feasibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome assessment rate</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Outcome assessment rates among enrolled participants will be tracked to assess feasibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Missing data</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>Missing data rates will be tracked to assess feasibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability</measure>
    <time_frame>3 months</time_frame>
    <description>We will assess acceptability based on patient, caregiver, and clinician responses to closed-end survey questions. Definitions of adequate acceptability based on these surveys include:&#xD;
&gt; 80% of patient and caregiver participants would recommend the intervention to other patients with advanced hematologic malignancies and their caregivers.&#xD;
&gt; 80% of patient and caregiver participants agree or strongly agree that intervention visits have been helpful for (a) improving pain or other symptoms, (b) helping with illness understanding, (c) helping with coping, and (d) helping with planning for the future.&#xD;
&gt; 80% of oncologist participants disagree or strongly disagree that (a) working with intervention nurses has been burdensome or (b) the intervention has been disruptive to clinic workflow.&#xD;
&gt; 80% of oncologist and nurse participants agree or strongly agree that the intervention (a) has helped me to take better care of my patients and (b) has improved the quality of care.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>care management by oncology nurses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>care management by oncology nurses</intervention_name>
    <description>The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.</description>
    <arm_group_label>care management by oncology nurses</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Participants will be (1) patients with advanced hematologic malignancies receiving care at&#xD;
        a participating clinic; (2) their caregivers; (3) participating clinicians.&#xD;
&#xD;
        Patient:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  adults (≥ 21 years old)&#xD;
&#xD;
          -  Refractory or Recurrent hematologic cancer: lymphoma, leukemia, myeloma, amyloidosis&#xD;
             (secondary manifestation myeloma &amp; AL Amyloidosis), and CML (CML can only be&#xD;
             accelerated or blast phase)&#xD;
&#xD;
          -  planning to receive ongoing care from a participating oncologist and willing to be&#xD;
             seen at least monthly.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  chronic myeloid leukemia (CML) OTHER THAN accelerated or blast phase&#xD;
&#xD;
          -  unable to read and respond to questions in English&#xD;
&#xD;
          -  lacks decision-making capacity, as determined by the patient's oncologist&#xD;
&#xD;
          -  unable to complete baseline interview&#xD;
&#xD;
        Caregiver&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  adults (≥ 21 years old)&#xD;
&#xD;
          -  family member or friend of an eligible patient&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  unable to read and respond to questions in English&#xD;
&#xD;
          -  unable to complete the baseline interview (patients will be asked to select as&#xD;
             caregiver the person who is most likely to accompany them to visits or help with their&#xD;
             care should they need it)&#xD;
&#xD;
        Eligible clinicians will be oncology nurses and oncologists practicing at participating&#xD;
        clinics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yael Schenker, MD, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>April 22, 2020</last_update_submitted>
  <last_update_submitted_qc>April 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Yael Schenker, MD, MAS</investigator_full_name>
    <investigator_title>Assistant Professor Director, Palliative Care Research</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will share study data with investigators at Duke University. They will have access to de-identified research data, specifically audio recordings and debriefing interviews, for purposes of quality assurance and/or data analysis.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT02992171/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02992171
org study id: PRO16100199
secondary id: 130225-PEP-16-205-01-PCSM
nct id: NCT02992171
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to develop and pilot-test an oncology nurse-led care management intervention
      to meet the primary palliative care needs of patients with advanced hematologic malignancies.
Study investigators will develop and pilot-test an oncology nurse-led care management
      intervention to meet the primary palliative care needs of patients with advanced hematologic
      malignancies.

      Aim 1 is a case series to develop and refine the intervention. During this time, we will
      develop initial interventionist training materials, study protocols, and a web-based outcomes
      database; train 2 hematology-oncology nurses; enroll 10 patients with advanced hematologic
      malignancies and their informal caregivers to receive intervention visits; conduct debriefing
      interviews; iteratively refine the intervention based on nurse, oncologist, patient, and
      caregiver feedback; and prepare the protocol for Aim 2. Aim 2 is a pilot study to assess the
      feasibility and acceptability of administering the intervention and assessing outcomes. We
      will recruit 30 patients and their informal caregivers to receive the intervention developed
      in Aim 1 and collect measures of quality of life, symptom burden, anxiety and depressive
      symptoms, caregiver burden, and healthcare utilization at baseline and monthly for up to
      three months. Trial outcomes will include: rates of enrollment, study completion, and outcome
      completion; intervention fidelity; and self-reported measures of study burdensomeness and
      effectiveness among patients, caregivers, and clinicians.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Successful enrollment of 30 patient-caregiver pairs
time frame: Baseline to 3 months
measure: Consent-to-approach rate
time frame: Baseline to 3 months
description: Consent to approach rates will be tracked to assess feasibility
measure: Enrolled-to-consent rate
time frame: Baseline to 3 months
description: Enrolled-to-consent rates will be tracked to assess feasibility
measure: Intervention completion rate
time frame: Baseline to 3 months
description: Intervention completion rate among enrolled participants will be tracked to assess feasibility
measure: Intervention fidelity
time frame: Baseline to 3 months
description: Percent of intervention components completed according to protocol will be tracked to assess feasibility
measure: Outcome assessment rate
time frame: Baseline to 3 months
description: Outcome assessment rates among enrolled participants will be tracked to assess feasibility
measure: Missing data
time frame: Baseline to 3 months
description: Missing data rates will be tracked to assess feasibility
measure: Acceptability
time frame: 3 months
description: We will assess acceptability based on patient, caregiver, and clinician responses to closed-end survey questions. Definitions of adequate acceptability based on these surveys include:
> 80% of patient and caregiver participants would recommend the intervention to other patients with advanced hematologic malignancies and their caregivers.
> 80% of patient and caregiver participants agree or strongly agree that intervention visits have been helpful for (a) improving pain or other symptoms, (b) helping with illness understanding, (c) helping with coping, and (d) helping with planning for the future.
> 80% of oncologist participants disagree or strongly disagree that (a) working with intervention nurses has been burdensome or (b) the intervention has been disruptive to clinic workflow.
> 80% of oncologist and nurse participants agree or strongly agree that the intervention (a) has helped me to take better care of my patients and (b) has improved the quality of care.
arm group label: care management by oncology nurses
arm group type: Experimental
description: The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.
intervention type: Behavioral
intervention name: care management by oncology nurses
description: The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.
arm group label: care management by oncology nurses
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Yael Schenker, MD, MAS
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Yael Schenker, MD, MAS
investigator title: Assistant Professor Director, Palliative Care Research
sharing ipd: Yes
ipd description: We will share study data with investigators at Duke University. They will have access to de-identified research data, specifically audio recordings and debriefing interviews, for purposes of quality assurance and/or data analysis.
provided document: 