<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/NCT03835052</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0568</org_study_id>
    <nct_id>NCT03835052</nct_id>
  </id_info>
  <brief_title>QOL Assessment in Cancer Survivors Integrated Into Routine Clinical Care</brief_title>
  <official_title>Quality of Life Assessment in Cancer Survivors Integrated Into Routine Clinical Care Implementation in an Integrated Health System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Geisinger Clinic</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 observational cohort study of patients who received cancer treatment (of any modality)&#xD;
      in the last 18 months are evaluated by the use of a validated QOL tool (FACT-GP) and are&#xD;
      evaluated via telephone or in person or both. Patients with high-risk for unmet needs or&#xD;
      distress as determined by the FACT-GP are referred to an in-person Multidisciplinary Cancer&#xD;
      Survivorship Clinic. This is considered standard of care at the investigator's institution&#xD;
      and is part of the continuous clinical quality improvement program within the Geisinger&#xD;
      Cancer Institute.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">March 25, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Survivorship Care Plan (SCP) is completed and given to the patient</measure>
    <time_frame>Within 12 months of date of diagnosis</time_frame>
    <description>A completed Survivorship Care Plan (SCP) as defined by the American College of Surgeons, Committee on Cancer (ACS-CoC) is completed by a member of the clinical care team and is provided personally to the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oncology Behavioral Health Referral Follow-up</measure>
    <time_frame>Within 30 days of administration of FACT-GP</time_frame>
    <description>FACT-GP v.4, Emotional Well-Being Sub-score (EWB) are referred to the Oncology Behavioral Health Service for an evaluation by a PhD behavioral health practitioner.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency Department utilization, 30 days after completion of SCP</measure>
    <time_frame>Within 30 days of receipt of Supportive Care Plan</time_frame>
    <description>Percentage of patients who present to an Emergency Department as captured in central clinical data architecture</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Multidisciplinary Cancer Survivorship Clinic Utilization</measure>
    <time_frame>Within 30 days of administration of FACT-GP</time_frame>
    <description>Patients who have a total score less than 60 on FACT-GP are referred to the Multidisciplinary Cancer Survivorship Clinic for in-person evaluation.</description>
  </other_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients meeting criteria identified through the use of analytics querying the central data&#xD;
        architecture of health system&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of malignancy in the last 18 months, treated with curative intent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients treated with palliative intent, metastatic disease at the time of diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian S Adonizio, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Geisinger Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>March 31, 2021</last_update_submitted>
  <last_update_submitted_qc>March 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Geisinger Clinic</investigator_affiliation>
    <investigator_full_name>Christian S. Adonizio, MD</investigator_full_name>
    <investigator_title>Medical Director: Center for Oncology Research and Innovation</investigator_title>
  </responsible_party>
  <keyword>Survivorship</keyword>
  <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/NCT03835052
org study id: 2018-0568
nct id: NCT03835052
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational cohort study of patients who received cancer treatment (of any modality)
      in the last 18 months are evaluated by the use of a validated QOL tool (FACT-GP) and are
      evaluated via telephone or in person or both. Patients with high-risk for unmet needs or
      distress as determined by the FACT-GP are referred to an in-person Multidisciplinary Cancer
      Survivorship Clinic. This is considered standard of care at the investigator's institution
      and is part of the continuous clinical quality improvement program within the Geisinger
      Cancer Institute.
observational model: Cohort
time perspective: Prospective
measure: Survivorship Care Plan (SCP) is completed and given to the patient
time frame: Within 12 months of date of diagnosis
description: A completed Survivorship Care Plan (SCP) as defined by the American College of Surgeons, Committee on Cancer (ACS-CoC) is completed by a member of the clinical care team and is provided personally to the patient.
measure: Oncology Behavioral Health Referral Follow-up
time frame: Within 30 days of administration of FACT-GP
description: FACT-GP v.4, Emotional Well-Being Sub-score (EWB) are referred to the Oncology Behavioral Health Service for an evaluation by a PhD behavioral health practitioner.
measure: Emergency Department utilization, 30 days after completion of SCP
time frame: Within 30 days of receipt of Supportive Care Plan
description: Percentage of patients who present to an Emergency Department as captured in central clinical data architecture
measure: Multidisciplinary Cancer Survivorship Clinic Utilization
time frame: Within 30 days of administration of FACT-GP
description: Patients who have a total score less than 60 on FACT-GP are referred to the Multidisciplinary Cancer Survivorship Clinic for in-person evaluation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Christian S Adonizio, MD
role: Study Chair
affiliation: Geisinger Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Geisinger Clinic
investigator full name: Christian S. Adonizio, MD
investigator title: Medical Director: Center for Oncology Research and Innovation
sharing ipd: No