<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/NCT02261051</url>
  </required_header>
  <id_info>
    <org_study_id>2014-48</org_study_id>
    <nct_id>NCT02261051</nct_id>
  </id_info>
  <brief_title>Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm</brief_title>
  <acronym>LCCM-Control</acronym>
  <official_title>Symptom Management, Quality of Life and Satisfaction With Care for Advanced Stage Cancers - Control Arm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lancaster General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lancaster General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is&#xD;
      the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent&#xD;
      Control Study). The primary aim of the study is to compare the proportion of advanced cancer&#xD;
      patients who have a hospitalization or emergency department visit in the last 6 months of&#xD;
      life before and after implementation of a new care model that provides more comprehensive&#xD;
      symptom management and supportive care, including earlier referral to palliative care. The&#xD;
      secondary comparative aim is to assess measures of quality of life and satisfaction in both&#xD;
      groups. This current study is to collect data on the control group only. After system&#xD;
      redesign, we will open an intervention arm study to collect data after implementation of the&#xD;
      new care model (about 18-24 months from start of control phase).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is&#xD;
      the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent&#xD;
      Control Study) that was submitted to the National Cancer Institute (NCI) for funding. A&#xD;
      decision on funding the full study should be forthcoming in the early part of 2015. The&#xD;
      primary aim of the study is to compare the proportion of advanced cancer patients who have a&#xD;
      hospitalization or emergency department visit in the last 6 months of life before and after&#xD;
      implementation of a new care model that provides more comprehensive symptom management and&#xD;
      supportive care, including earlier referral to palliative care. The secondary comparative aim&#xD;
      is to assess measures of quality of life and satisfaction in both groups. To accomplish the&#xD;
      aims of the study by the end of the funding period, we propose to begin data collection in&#xD;
      advance of a funding decision. Should the study not receive funding, the data collected will&#xD;
      be used to inform decisions regarding other funding applications and/or implementation of&#xD;
      program changes at the Ann B. Barshinger Cancer Institute. Data collection does not represent&#xD;
      more than minimal risk for the patients enrolled.&#xD;
&#xD;
      This protocol is for the first phase of the study, which is the enrollment and collection of&#xD;
      data on the control group, to serve as the baseline for comparison regarding&#xD;
      hospitalizations, ED visits, quality of life, and patient and family satisfaction. To achieve&#xD;
      sufficient number of subjects and observed deaths in the control group, we are targeting the&#xD;
      start of enrollment and data collection in this group during the third quarter of 2014. If&#xD;
      the project is funded, the intervention and enrollment in the intervention group are targeted&#xD;
      to start in the second quarter of 2016. Background and study aims are presented for the&#xD;
      entire project to provide context, but the intent of this application is only for approval of&#xD;
      the enrollment and data collection on the control subjects (which contributes to aims 2 and 3&#xD;
      of the larger project). A second protocol would be presented for review and approval at the&#xD;
      start of the intervention if the project funding is granted.&#xD;
&#xD;
      In phase one of the project, subjects would be approached and consented at the point of a&#xD;
      determination/diagnosis of advanced cancer and followed until the end of life or the start of&#xD;
      the intervention period in the 2nd quarter of 2016 (whichever comes first) per protocol.&#xD;
&#xD;
      This current study is to collect data on the control group only. After system redesign, we&#xD;
      will open an intervention arm study to collect data after implementation of the new care&#xD;
      model (about 18-24 months from start of control phase).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Difficulty in recruitment and change in study site protocols.&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of patients' ED visits and hospitalizations</measure>
    <time_frame>Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months</time_frame>
    <description>All cause: ED admission treat and release, ED admission to inpatient visit and direct inpatient admission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient quality of life</measure>
    <time_frame>Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months</time_frame>
    <description>Assessed with FACT-G (Functional Assessment of Cancer-General measure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months</time_frame>
    <description>Assessed with FAMCARE-2 (patient and family satisfaction with care)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver burden</measure>
    <time_frame>Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months</time_frame>
    <description>Assessed with BASC (Brief Assessment Scale for Caregivers) Caregiver Burden</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver satisfaction</measure>
    <time_frame>Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months</time_frame>
    <description>Assessed with FAMCARE-2 (patient and family satisfaction with care)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient symptoms</measure>
    <time_frame>Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months</time_frame>
    <description>Assessed with the ESAS-R (Edmonton Symptom Assessment System Revised) and ECOG (Eastern Cooperative Oncology Group) performance status</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cancer</condition>
  <condition>Advanced Cancer</condition>
  <arm_group>
    <arm_group_label>Non-concurrent control group</arm_group_label>
    <description>A group of advanced cancer patients who received care at our Center before implementation of the LCCM model. They will receive current standard of care.&#xD;
This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Patients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care.</description>
    <arm_group_label>Non-concurrent control group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Our study population includes patients newly diagnosed with a solid tumor-type cancer that&#xD;
        is considered either advanced and unresectable or metastatic. Patients also will be at&#xD;
        least 18 years of age and English-speaking.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Newly diagnosed with a solid tumor-type cancer that is considered either advanced and&#xD;
             unresectable or metastatic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Age &lt; 18&#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>Shanthi Sivendran, MD, MSCR</last_name>
    <role>Study Director</role>
    <affiliation>Lancaster General Ann B. Barshinger Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Randy Oyer, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lancaster General Ann B. Barshinger Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nik Buescher</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lancaster General Ann B. Barshinger Cancer Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joan Harrold, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Palliative Medicine Consultants</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Barbara Martin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lancaster General Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kristina Newport, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Palliative Medicine Consultants</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Horst, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lancaster General Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lancaster General Ann B. Barshinger Cancer Institute</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.dartmouth.org/keyissues/issues.aspx?con=294</url>
    <description>The Dartmouth Atlas of Health Care. (2010). Retrieved May 21, 2014, from www.darthmouth.org/keyissues/issues.aspx?con=294</description>
  </link>
  <link>
    <url>http://ncccp.cancer.gov/Media/FactSheet.htm</url>
    <description>National Community Cancer Centers Program Pilot Fact Sheet, 2007-2010. (n.d.) Retrieved June 16, 2014 from http://ncccp.cancer.gov/Media/FactSheet.htm</description>
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  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>April 21, 2016</last_update_submitted>
  <last_update_submitted_qc>April 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Palliative Care</keyword>
  <keyword>Hospice</keyword>
  <keyword>End of Life</keyword>
  <keyword>Health Service Utilization</keyword>
  <keyword>Quality of Life</keyword>
  <!-- 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/NCT02261051
org study id: 2014-48
nct id: NCT02261051
lead sponsor: 
has dmc: No
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is
      the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent
      Control Study). The primary aim of the study is to compare the proportion of advanced cancer
      patients who have a hospitalization or emergency department visit in the last 6 months of
      life before and after implementation of a new care model that provides more comprehensive
      symptom management and supportive care, including earlier referral to palliative care. The
      secondary comparative aim is to assess measures of quality of life and satisfaction in both
      groups. This current study is to collect data on the control group only. After system
      redesign, we will open an intervention arm study to collect data after implementation of the
      new care model (about 18-24 months from start of control phase).
Symptom Management, Quality of Life and Satisfaction with Care for Advanced Stage Cancers is
      the first part of a two part study (The Lancaster Cancer Care Model (LCCM) - Non-Concurrent
      Control Study) that was submitted to the National Cancer Institute (NCI) for funding. A
      decision on funding the full study should be forthcoming in the early part of 2015. The
      primary aim of the study is to compare the proportion of advanced cancer patients who have a
      hospitalization or emergency department visit in the last 6 months of life before and after
      implementation of a new care model that provides more comprehensive symptom management and
      supportive care, including earlier referral to palliative care. The secondary comparative aim
      is to assess measures of quality of life and satisfaction in both groups. To accomplish the
      aims of the study by the end of the funding period, we propose to begin data collection in
      advance of a funding decision. Should the study not receive funding, the data collected will
      be used to inform decisions regarding other funding applications and/or implementation of
      program changes at the Ann B. Barshinger Cancer Institute. Data collection does not represent
      more than minimal risk for the patients enrolled.

      This protocol is for the first phase of the study, which is the enrollment and collection of
      data on the control group, to serve as the baseline for comparison regarding
      hospitalizations, ED visits, quality of life, and patient and family satisfaction. To achieve
      sufficient number of subjects and observed deaths in the control group, we are targeting the
      start of enrollment and data collection in this group during the third quarter of 2014. If
      the project is funded, the intervention and enrollment in the intervention group are targeted
      to start in the second quarter of 2016. Background and study aims are presented for the
      entire project to provide context, but the intent of this application is only for approval of
      the enrollment and data collection on the control subjects (which contributes to aims 2 and 3
      of the larger project). A second protocol would be presented for review and approval at the
      start of the intervention if the project funding is granted.

      In phase one of the project, subjects would be approached and consented at the point of a
      determination/diagnosis of advanced cancer and followed until the end of life or the start of
      the intervention period in the 2nd quarter of 2016 (whichever comes first) per protocol.

      This current study is to collect data on the control group only. After system redesign, we
      will open an intervention arm study to collect data after implementation of the new care
      model (about 18-24 months from start of control phase).
time perspective: Prospective
measure: Frequency of patients' ED visits and hospitalizations
time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
description: All cause: ED admission treat and release, ED admission to inpatient visit and direct inpatient admission
measure: Patient quality of life
time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
description: Assessed with FACT-G (Functional Assessment of Cancer-General measure)
measure: Patient satisfaction
time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
description: Assessed with FAMCARE-2 (patient and family satisfaction with care)
measure: Caregiver burden
time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
description: Assessed with BASC (Brief Assessment Scale for Caregivers) Caregiver Burden
measure: Caregiver satisfaction
time frame: Collected at baseline and every 2 months from enrollment until death from any cause or assessed up to 18 months
description: Assessed with FAMCARE-2 (patient and family satisfaction with care)
measure: Patient symptoms
time frame: Collected at baseline and every outpatient oncology clinic visit from enrollment until death from any cause or assessed up to 18 months
description: Assessed with the ESAS-R (Edmonton Symptom Assessment System Revised) and ECOG (Eastern Cooperative Oncology Group) performance status
arm group label: Non-concurrent control group
description: A group of advanced cancer patients who received care at our Center before implementation of the LCCM model. They will receive current standard of care.
This current study is to collect data on the control group only. After system redesign, we will open an intervention arm study to collect data after implementation of the new care model (about 18-24 months from start of control phase).
intervention type: Other
intervention name: Standard of care
description: Patients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care.
arm group label: Non-concurrent control group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Shanthi Sivendran, MD, MSCR
role: Study Director
affiliation: Lancaster General Ann B. Barshinger Cancer Institute
last name: Randy Oyer, MD
role: Study Director
affiliation: Lancaster General Ann B. Barshinger Cancer Institute
last name: Nik Buescher
role: Principal Investigator
affiliation: Lancaster General Ann B. Barshinger Cancer Institute
last name: Joan Harrold, MD
role: Principal Investigator
affiliation: Palliative Medicine Consultants
last name: Barbara Martin, PhD
role: Principal Investigator
affiliation: Lancaster General Research Institute
last name: Kristina Newport, MD
role: Principal Investigator
affiliation: Palliative Medicine Consultants
last name: Michael Horst, PhD
role: Principal Investigator
affiliation: Lancaster General Research Institute
facility: 
country: United States
url: http://www.dartmouth.org/keyissues/issues.aspx?con=294
description: The Dartmouth Atlas of Health Care. (2010). Retrieved May 21, 2014, from www.darthmouth.org/keyissues/issues.aspx?con=294
url: http://ncccp.cancer.gov/Media/FactSheet.htm
description: National Community Cancer Centers Program Pilot Fact Sheet, 2007-2010. (n.d.) Retrieved June 16, 2014 from http://ncccp.cancer.gov/Media/FactSheet.htm
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