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/NCT06022965</url>
    </required_header>
    <id_info>
      <org_study_id>22343</org_study_id>
      <secondary_id>NCI-2023-05945</secondary_id>
      <secondary_id>22343</secondary_id>
      <secondary_id>P30CA033572</secondary_id>
      <nct_id>NCT06022965</nct_id>
    </id_info>
    <brief_title>Telemedicine for Improvement of Care for Older Adults With Cancer in the Underserved Community, The GAIN-S Trial</brief_title>
    <official_title>Geriatric Assessment (GA)-Driven Interventions With Supportive Care (The GAIN-S Trial): Telemedicine to Increase Goal Concordant Care for Older Adults With Cancer in the Community</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>City of Hope Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>City of Hope Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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 clinical trial evaluates whether geriatric assessment-driven interventions with&#xD;
        supportive care (GAIN-S) using telemedicine can be used to identify areas of vulnerability&#xD;
        (weakness) in older adults with cancer and guide interventions to assist the patient and the&#xD;
        healthcare team in the underserved community. The majority of patients diagnosed with cancer&#xD;
        are over age 65 years, yet most cancer treatments are developed and tested in a younger&#xD;
        population. Therefore, older patients with cancer are less likely to be offered standard&#xD;
        treatments because of the concern regarding side effects. Geriatric assessment (GA) is a&#xD;
        multi-dimensional health assessment tool combining patient reported and objective (unbiased)&#xD;
        results. There is no standard tool that can identify which older adults will be more likely&#xD;
        to have side effects from cancer treatment. Telemedicine is a way to provide healthcare&#xD;
        services (including consultations, education, care management and treatment) in which the&#xD;
        health care provider is at a distant site. The goal of this project is to use telemedicine to&#xD;
        identify areas of vulnerability/weakness in older adults with cancer using a patient&#xD;
        assessment, and to identify the potential referrals to a multi-specialty team based on&#xD;
        patient assessment results. Information gathered from this study may help researchers learn&#xD;
        whether GAIN-S can be performed using telemedicine and lead to improvement in care for older&#xD;
        adults compared to standard of care (SOC) in the underserved community.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVES:&#xD;
  &#xD;
        I. To implement Geriatric Assessment-driven interventions with supportive care (GAIN-S)&#xD;
        through telemedicine to:&#xD;
  &#xD;
        Ia. To improve communication between the primary care team (oncologist, nurses) and patients&#xD;
        and caregivers in a remote community setting to increase prognostic discussions and goal&#xD;
        concordant care; Ib. To improve cost-saving in older patients with cancer.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. Determine whether GAIN-S implemented in a community setting will lead to a decrease in&#xD;
        treatment toxicity.&#xD;
  &#xD;
        II. To examine whether GAIN-S intervention will lead to improvement in hospitalizations, dose&#xD;
        delays, dose reduction and discontinuation.&#xD;
  &#xD;
        III. To compare patient satisfaction using the &quot;Was It Worth It&quot; (WIWI) between the 2 arms at&#xD;
        the 3 and/or 6-month timepoint.&#xD;
  &#xD;
        IV. To compare patient preferences at baseline, using the validated patient-defined treatment&#xD;
        preference and goals measures between the 2 arms and longitudinal change, at 3 and/or 6-month&#xD;
        timepoint.&#xD;
  &#xD;
        OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
  &#xD;
        ARM I (GAIN-S): Patients complete the Cancer and Aging Research Group-Geriatric Assessment&#xD;
        (CARG-GA) at baseline and 3 months and receive GA-based interventions using telemedicine over&#xD;
        6 months.&#xD;
  &#xD;
        ARM II (SOC): Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6&#xD;
        months.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 24, 2023</start_date>
    <completion_date type="Anticipated">January 24, 2027</completion_date>
    <primary_completion_date type="Anticipated">January 24, 2027</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Advanced directive (AD) completion</measure>
      <time_frame>At start of treatment and 3 months after treatment initiation</time_frame>
      <description>Will be assessed using medical chart review. Chi-square test will be used to compare the proportions of AD completion between the two arms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of documented conversations.</measure>
      <time_frame>At start of treatment and 3 months after treatment initiation</time_frame>
      <description>Will be assessed using medical chart review. T-test will be used to compare the mean number of documented conversations between the two arms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Direct inpatient cost</measure>
      <time_frame>At 3 and 6-months after treatment initiation</time_frame>
      <description>Will log transformed and Z-score test will be used to compare the mean costs of the two arms. Chi-square test will be used to compare number of patients with short verse (vs.) long stay and Intensive Care Unit (ICU) admission between the two arms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Decrease in treatment toxicity</measure>
      <time_frame>At 3 months after randomization</time_frame>
      <description>Will be described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and will examine toxicities by grade and type. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicity, dose modifications including dose change, dose delay, discontinuation as well as hospitalization, consider treatment worthwhile between two arms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with dose modifications</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Defined as delays and dose reductions experienced by patients for each cohort at each cycle. The reason for dose modifications will be noted and attributed as possibly, probably, or definitely related to treatment. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicity, dose modifications including dose change, dose delay, discontinuation as well as hospitalization, consider treatment worthwhile between two arms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction using the &quot;Was It Worth It&quot; (WIWI)</measure>
      <time_frame>At 3 and/or 6-months after treatment initiation</time_frame>
      <description>Patient satisfaction assessed as whether patients found treatment worthwhile using the &quot;Was it Worth it&quot; (WIWI) questionnaire.&#xD;
  T-test will be used to compare satisfaction rating between the two arms. Chi-square test will be used to compare proportion of patients consider treatment worthwhile between the two groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient preferences and goals</measure>
      <time_frame>At baseline, 3 and/or 6 months after treatment initiation</time_frame>
      <description>Patient-Defined Treatment Preferences and Goals will be measured utilizing the Health Outcomes Questionnaire, Now vs Later Tool and Attitude Scale. Will use the validated patient-defined treatment preference and goals measures between the 2 arms and longitudinal change. Descriptive statistics and plots will be used to describe and compare of longitudinal changes in patient preferences and goals will be plotted.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Association of Community Cancer Centers (ACCC) Geriatric Oncology Gap Assessment Tool</measure>
      <time_frame>Baseline and at the end of study (36 months)</time_frame>
      <description>The tool's name is: Association of Community Cancer Centers: Geriatric Oncology Gap Assessment Tool Scoring for the tool is based on a 1-4 scale with Level 4 representing the optimal practice.&#xD;
  Prior to study initiation, each site will be quantitatively evaluated utilizing the evidence-based ACCC Geriatric Oncology Gap Assessment tool; each site would be reassessed at the end of the study. This tool will provide an evidence-based assessment to evaluate the current geriatric oncology efforts at each site and guide future steps for improvement to these services.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Hematopoietic and Lymphoid System Neoplasm</condition>
    <condition>Malignant Solid Neoplasm</condition>
    <arm_group>
      <arm_group_label>ARM I (GAIN-S)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients complete the CARG-GA at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>ARM II (SOC)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Receive SOC over the first 3 months, then switch to receive GA-based interventions using telemedicine for the following 3 months.&#xD;
  Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Best Practice</intervention_name>
      <description>Receive SOC</description>
      <arm_group_label>ARM I (GAIN-S)</arm_group_label>
      <arm_group_label>ARM II (SOC)</arm_group_label>
      <other_name>standard of care</other_name>
      <other_name>standard therapy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Comprehensive Geriatric Assessment</intervention_name>
      <description>Complete CARG-GA</description>
      <arm_group_label>ARM I (GAIN-S)</arm_group_label>
      <arm_group_label>ARM II (SOC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Electronic Health Record Review</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>ARM I (GAIN-S)</arm_group_label>
      <arm_group_label>ARM II (SOC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>ARM I (GAIN-S)</arm_group_label>
      <arm_group_label>ARM II (SOC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Supportive Care</intervention_name>
      <description>Receive GA-based interventions</description>
      <arm_group_label>ARM I (GAIN-S)</arm_group_label>
      <other_name>Supportive Therapy</other_name>
      <other_name>Symptom Management</other_name>
      <other_name>Therapy, Supportive</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Telemedicine</intervention_name>
      <description>Receive GA-based interventions via telemedicine</description>
      <arm_group_label>ARM I (GAIN-S)</arm_group_label>
      <other_name>Telehealth</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Documented informed consent of the participant.&#xD;
  &#xD;
            -  Patient's physician must agree for patient participation.&#xD;
  &#xD;
            -  Ability to read English, Spanish, or Chinese. Other languages will be acceptable with&#xD;
               site principal investigator (PI) agreement if surveys are available, and language does&#xD;
               not preclude completing study procedures.&#xD;
  &#xD;
            -  Age: &gt;=65 years at the time of enrollment.&#xD;
  &#xD;
            -  Diagnosis of stage I-IV cancer.&#xD;
  &#xD;
            -  Scheduled to start a new therapy (chemotherapy, immunotherapy, or targeted therapy).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prospective participants who, in the opinion of the investigator, may not be able to&#xD;
               comply with all study procedures (including compliance issues related to&#xD;
               feasibility/logistics).&#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>William Dale</last_name>
      <role>Principal Investigator</role>
      <affiliation>City of Hope Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>City of Hope Medical Center</name>
        <address>
          <city>Duarte</city>
          <state>California</state>
          <zip>91010</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>William Dale</last_name>
        <phone>626-256-4673</phone>
        <email>wdale@coh.org</email>
      </contact>
      <investigator>
        <last_name>William Dale</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>City of Hope Antelope Valley</name>
        <address>
          <city>Lancaster</city>
          <state>California</state>
          <zip>93534</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>William Dale</last_name>
        <phone>626-256-4673</phone>
        <email>wdale@coh.org</email>
      </contact>
      <investigator>
        <last_name>William Dale</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>City of Hope Upland</name>
        <address>
          <city>Upland</city>
          <state>California</state>
          <zip>91786</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>William Dale</last_name>
        <phone>626-256-4673</phone>
        <email>wdale@coh.org</email>
      </contact>
      <investigator>
        <last_name>William Dale</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06022965
  org study id: 22343
  secondary id: NCI-2023-05945
  secondary id: 22343
  secondary id: P30CA033572
  nct id: NCT06022965
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial evaluates whether geriatric assessment-driven interventions with
        supportive care (GAIN-S) using telemedicine can be used to identify areas of vulnerability
        (weakness) in older adults with cancer and guide interventions to assist the patient and the
        healthcare team in the underserved community. The majority of patients diagnosed with cancer
        are over age 65 years, yet most cancer treatments are developed and tested in a younger
        population. Therefore, older patients with cancer are less likely to be offered standard
        treatments because of the concern regarding side effects. Geriatric assessment (GA) is a
        multi-dimensional health assessment tool combining patient reported and objective (unbiased)
        results. There is no standard tool that can identify which older adults will be more likely
        to have side effects from cancer treatment. Telemedicine is a way to provide healthcare
        services (including consultations, education, care management and treatment) in which the
        health care provider is at a distant site. The goal of this project is to use telemedicine to
        identify areas of vulnerability/weakness in older adults with cancer using a patient
        assessment, and to identify the potential referrals to a multi-specialty team based on
        patient assessment results. Information gathered from this study may help researchers learn
        whether GAIN-S can be performed using telemedicine and lead to improvement in care for older
        adults compared to standard of care (SOC) in the underserved community.
  PRIMARY OBJECTIVES:
  
        I. To implement Geriatric Assessment-driven interventions with supportive care (GAIN-S)
        through telemedicine to:
  
        Ia. To improve communication between the primary care team (oncologist, nurses) and patients
        and caregivers in a remote community setting to increase prognostic discussions and goal
        concordant care; Ib. To improve cost-saving in older patients with cancer.
  
        SECONDARY OBJECTIVES:
  
        I. Determine whether GAIN-S implemented in a community setting will lead to a decrease in
        treatment toxicity.
  
        II. To examine whether GAIN-S intervention will lead to improvement in hospitalizations, dose
        delays, dose reduction and discontinuation.
  
        III. To compare patient satisfaction using the "Was It Worth It" (WIWI) between the 2 arms at
        the 3 and/or 6-month timepoint.
  
        IV. To compare patient preferences at baseline, using the validated patient-defined treatment
        preference and goals measures between the 2 arms and longitudinal change, at 3 and/or 6-month
        timepoint.
  
        OUTLINE: Patients are randomized to 1 of 2 arms.
  
        ARM I (GAIN-S): Patients complete the Cancer and Aging Research Group-Geriatric Assessment
        (CARG-GA) at baseline and 3 months and receive GA-based interventions using telemedicine over
        6 months.
  
        ARM II (SOC): Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6
        months.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Advanced directive (AD) completion
  time frame: At start of treatment and 3 months after treatment initiation
  description: Will be assessed using medical chart review. Chi-square test will be used to compare the proportions of AD completion between the two arms.
  measure: Number of documented conversations.
  time frame: At start of treatment and 3 months after treatment initiation
  description: Will be assessed using medical chart review. T-test will be used to compare the mean number of documented conversations between the two arms.
  measure: Direct inpatient cost
  time frame: At 3 and 6-months after treatment initiation
  description: Will log transformed and Z-score test will be used to compare the mean costs of the two arms. Chi-square test will be used to compare number of patients with short verse (vs.) long stay and Intensive Care Unit (ICU) admission between the two arms.
  measure: Decrease in treatment toxicity
  time frame: At 3 months after randomization
  description: Will be described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and will examine toxicities by grade and type. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicity, dose modifications including dose change, dose delay, discontinuation as well as hospitalization, consider treatment worthwhile between two arms.
  measure: Proportion of patients with dose modifications
  time frame: Up to 6 months
  description: Defined as delays and dose reductions experienced by patients for each cohort at each cycle. The reason for dose modifications will be noted and attributed as possibly, probably, or definitely related to treatment. Chi-square test will be used to compare proportion of patients with grade 3-5 toxicity, dose modifications including dose change, dose delay, discontinuation as well as hospitalization, consider treatment worthwhile between two arms.
  measure: Patient satisfaction using the "Was It Worth It" (WIWI)
  time frame: At 3 and/or 6-months after treatment initiation
  description: Patient satisfaction assessed as whether patients found treatment worthwhile using the "Was it Worth it" (WIWI) questionnaire.
  T-test will be used to compare satisfaction rating between the two arms. Chi-square test will be used to compare proportion of patients consider treatment worthwhile between the two groups.
  measure: Patient preferences and goals
  time frame: At baseline, 3 and/or 6 months after treatment initiation
  description: Patient-Defined Treatment Preferences and Goals will be measured utilizing the Health Outcomes Questionnaire, Now vs Later Tool and Attitude Scale. Will use the validated patient-defined treatment preference and goals measures between the 2 arms and longitudinal change. Descriptive statistics and plots will be used to describe and compare of longitudinal changes in patient preferences and goals will be plotted.
  measure: Association of Community Cancer Centers (ACCC) Geriatric Oncology Gap Assessment Tool
  time frame: Baseline and at the end of study (36 months)
  description: The tool's name is: Association of Community Cancer Centers: Geriatric Oncology Gap Assessment Tool Scoring for the tool is based on a 1-4 scale with Level 4 representing the optimal practice.
  Prior to study initiation, each site will be quantitatively evaluated utilizing the evidence-based ACCC Geriatric Oncology Gap Assessment tool; each site would be reassessed at the end of the study. This tool will provide an evidence-based assessment to evaluate the current geriatric oncology efforts at each site and guide future steps for improvement to these services.
  arm group label: ARM I (GAIN-S)
  arm group type: Experimental
  description: Patients complete the CARG-GA at baseline and 3 months and receive GA-based interventions using telemedicine over 6 months.
  arm group label: ARM II (SOC)
  arm group type: Active Comparator
  description: Receive SOC over the first 3 months, then switch to receive GA-based interventions using telemedicine for the following 3 months.
  Patients complete the CARG-GA at baseline and 3 months and receive SOC over 6 months.
  intervention type: Other
  intervention name: Best Practice
  description: Receive SOC
  arm group label: ARM I (GAIN-S)
  arm group label: ARM II (SOC)
  other name: standard of care
  other name: standard therapy
  intervention type: Other
  intervention name: Comprehensive Geriatric Assessment
  description: Complete CARG-GA
  arm group label: ARM I (GAIN-S)
  arm group label: ARM II (SOC)
  intervention type: Other
  intervention name: Electronic Health Record Review
  description: Ancillary studies
  arm group label: ARM I (GAIN-S)
  arm group label: ARM II (SOC)
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Ancillary studies
  arm group label: ARM I (GAIN-S)
  arm group label: ARM II (SOC)
  intervention type: Other
  intervention name: Supportive Care
  description: Receive GA-based interventions
  arm group label: ARM I (GAIN-S)
  other name: Supportive Therapy
  other name: Symptom Management
  other name: Therapy, Supportive
  intervention type: Other
  intervention name: Telemedicine
  description: Receive GA-based interventions via telemedicine
  arm group label: ARM I (GAIN-S)
  other name: Telehealth
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: William Dale
  role: Principal Investigator
  affiliation: City of Hope Medical Center
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Neoplasms