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/NCT05969860</url>
    </required_header>
    <id_info>
      <org_study_id>MC220709</org_study_id>
      <secondary_id>NCI-2023-05420</secondary_id>
      <secondary_id>23-001719</secondary_id>
      <secondary_id>MC220709</secondary_id>
      <nct_id>NCT05969860</nct_id>
    </id_info>
    <brief_title>At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer</brief_title>
    <official_title>Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mayo Clinic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mayo 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 clinical trial studies the effect of cancer directed therapy given at-home versus in the&#xD;
        clinic for patients with cancer that may have spread from where it first started to nearby&#xD;
        tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related&#xD;
        cancer care is conducted in infusion centers or specialty hospitals, where patients spend&#xD;
        many hours a day isolated from family, friends, and familiar surroundings. This separation&#xD;
        adds to the physical, emotional, social, and financial burden for patients and their&#xD;
        families. The logistics and costs of navigating cancer treatments have become a principal&#xD;
        contributor to patients' reduced quality of life. It is therefore important to reduce the&#xD;
        burden of cancer in the lives of patients and their caregivers, and a vital aspect of this&#xD;
        involves moving beyond traditional hospital and clinic-based care and evaluate innovative&#xD;
        care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in&#xD;
        the clinic, may help reduce psychological and financial distress and increase treatment&#xD;
        compliance, especially for marginalized patients and communities.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To compare mean patient-reported rating of Cancer Connected Access and Remote Expertise&#xD;
        (CARE) using a modified question from the Consumer Assessment of Healthcare Providers and&#xD;
        Systems (CAHPS) Cancer Care Survey after 8 weeks between patients randomized to receive care&#xD;
        at home and care in the clinic.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To evaluate patient preference for location of cancer treatment administration, at the&#xD;
        infusion center or in the home.&#xD;
  &#xD;
        II. To evaluate level of comfort with receiving infusions at home based on the following&#xD;
        measures after 24 weeks of treatment (or at end of study):&#xD;
  &#xD;
        IIa. The proportion of patients who indicate a preference for home infusion or no preference&#xD;
        versus outpatient infusion unit administration of cancer treatment as assessed via the&#xD;
        Patient Preference Questionnaire; IIb. The proportion of patients who indicate comfort (quite&#xD;
        a bit or very much) with receiving infusions at home as assessed by the Patient Preference&#xD;
        Questionnaire.&#xD;
  &#xD;
        III. To describe other patient experience questions within the Patient Preference&#xD;
        Questionnaire after 24 weeks of treatment (or at end of study).&#xD;
  &#xD;
        IV. To describe whether patients felt that infusions at home was worthwhile, would do it&#xD;
        again, and recommend it to others after 24 weeks of treatment (or at end of study) using the&#xD;
        Was It Worth It questionnaire.&#xD;
  &#xD;
        V. To test whether home-based virtual delivery of cancer directed therapy is superior to&#xD;
        standard administration (in clinic) in patient-reported function and global health/quality of&#xD;
        life as measured by the European Organization for Research and Treatment of Cancer Quality of&#xD;
        Life Questionnaire Core Function 17-Item (EORTC QLQ-F17) after 8 weeks of home versus&#xD;
        outpatient infusion unit administration of cancer treatment.&#xD;
  &#xD;
        VI. To test whether home-based virtual delivery of cancer directed therapy is superior to&#xD;
        standard administration (in clinic) in patient-reported symptoms as measured by the&#xD;
        Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) after 8&#xD;
        weeks of home versus outpatient infusion unit administration of cancer treatment.&#xD;
  &#xD;
        VII. To assess the safety of cancer directed therapy when administered at home by a home&#xD;
        health provider with remote patient monitoring and Command Center support, based on the&#xD;
        incidence, nature, and severity of the following:&#xD;
  &#xD;
        VIIa. Grade 3+ adverse event (AE) clinically graded using the National Cancer Institute&#xD;
        Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).&#xD;
  &#xD;
        VIII. To test whether home-based virtual delivery of cancer directed therapy is superior to&#xD;
        standard in clinic administration in the proportion of patients with an emergency room visit&#xD;
        or hospitalization at the end of 6 months of study treatment.&#xD;
  &#xD;
        IX. Overall survival.&#xD;
  &#xD;
        EXPLORATORY OBJECTIVES:&#xD;
  &#xD;
        I. To assess the cost of care in first 6 months (data collected out to 1 year). II. To&#xD;
        evaluate administration of treatment based on clinical practice data.&#xD;
  &#xD;
        OUTLINE:&#xD;
  &#xD;
        Patients receive the first 2 cycles of their standard of care (SOC) chemotherapy regimen in&#xD;
        the clinic in the absence of disease progression or unacceptable toxicity. Patients are then&#xD;
        randomized to 1 of 2 arms.&#xD;
  &#xD;
        ARM A: Patients continue receiving their SOC chemotherapy regimen at home for 24 weeks in the&#xD;
        absence of disease progression or unacceptable toxicity. This includes drug administrations,&#xD;
        injections/infusions and routine clinical laboratory tests in the home from the Home Health&#xD;
        Nurse Provider (HHNP), overseen by Mayo Clinic's home health program Cancer CARE Beyond Walls&#xD;
        (CCBW) Command Center. Patients are also provided biometric devices for health monitoring&#xD;
        vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.&#xD;
  &#xD;
        ARM B: Patients continue receiving their SOC chemotherapy regimen in the clinic for 8 weeks&#xD;
        in the absence of disease progression or unacceptable toxicity. Patients then begin receiving&#xD;
        their SOC chemotherapy regimen at home as in Arm I for an additional 16 weeks in the absence&#xD;
        of disease progression or unacceptable toxicity.&#xD;
  &#xD;
        After completion of study intervention, patients are followed for 1 year.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 23, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</primary_completion_date>
    <phase>Phase 2</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>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean patient-reported rating of Cancer Connected Access and Remote Expertise</measure>
      <time_frame>At 8 weeks</time_frame>
      <description>This hypothesis test will use patient ratings from a single 0-10 item from the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey assessing &quot;your overall cancer care experience&quot;. Will be compared between arms using a two-sample t-test.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient-preferred treatment location</measure>
      <time_frame>At 24 weeks</time_frame>
      <description>The proportion of patients who preferred care at home or expressed no preference will be computed and compared to 50% using a one-group test of proportions. Additional Likert patient feedback questions and &quot;Was It Worth It&quot; questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient level of comfort with receiving infusions at home</measure>
      <time_frame>At 24 weeks</time_frame>
      <description>Patient responses to comfort level with receiving infusions at home will be described using frequencies and relative frequencies. The proportion of patients who express comfort (quite a bit or very much) will also be tabulated and a proportion greater than 70% will signify acceptance. Additional Likert patient feedback questions and &quot;Was It Worth It&quot; questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported worthwhileness</measure>
      <time_frame>At 24 weeks</time_frame>
      <description>Measured by the Was it Worth It questionnaire. The Was It Worth It questionnaire asks patients whether they thought that receiving chemo/infusions at home was worthwhile, whether they would do it again, and whether they would recommend it to others.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported function</measure>
      <time_frame>At 8 weeks</time_frame>
      <description>Measured by the European Organization for Research and Treatment of Cancer. Mean and standard deviation of each scale will be computed by arm. Means and standard deviations of each scale will also be computed at all other assessment time points. Mean changes from baseline in each scale at 8 weeks (and other assessment time points) will be compared between arms using a linear combination of parameters from a general linear mixed model. Each model will include all available data from all time points. Fixed effects will include arm, time point, and arm-by-time point interaction. Repeated observations by patient will be modeled using compound symmetric correlation structure over time. Such values as the mean change from baseline at 8 weeks by arm, and difference in mean change from baseline at 8 weeks between arms will be estimated with confidence intervals based on the mixed model. Comparisons at other time points will also be carried out and graphically displayed using mean plots.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported symptoms</measure>
      <time_frame>At 8 weeks</time_frame>
      <description>Will be measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (CTCAE) and summarized using composite grades. The baseline adjustment approach will be applied and resulting maximum baseline-adjusted grade will be reported by symptomatic adverse events (AE) as the proportion of patients with at least one grade &gt;=1 AE during the first 8 weeks. The proportion of patients with at least one grade &gt;= 3 AE per symptomatic AE will also be tabulated during the first 8 weeks. Comparisons between arms will employ Fisher's exact tests. Additional summaries over the 24 weeks by tables and graphics will also be generated.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported side effect impact</measure>
      <time_frame>At 8 weeks</time_frame>
      <description>Will be measured by the General Physical-5 (GP5). The frequency and relative frequency of patient responses to the GP5 at 8 weeks will be computed by arm and compared between arms using a chi-squared test. The categorical analysis will also be computed at other assessment time points. Mean GP5 scores over time will also be explored using a general linear mixed model and mean plots.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>Up to 24 weeks</time_frame>
      <description>The maximum grade for each type of adverse event will be summarized using CTCAE version 5.0. The frequency and percentage of grade 3+ adverse events (by individual AEs and overall) will be reported by arm and compared between arms using a Fisher's exact test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergency room visits and hospitalizations</measure>
      <time_frame>At 8 weeks</time_frame>
      <description>The proportion of patients with an emergency room visit or hospitalization will be computed per arm and compared between arms using a Fisher's exact test. In subsequent analyses, emergency room visits and hospitalizations will be explored separately. Proportion of patients with emergency room visits or hospitalizations will also be summarized over the entire study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>The time from study entry to death from any cause, assessed up to 1 year after completion of study intervention</time_frame>
      <description>Will be estimated using the Kaplan-Meier method and compared between arms using a log-rank test.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Advanced Malignant Solid Neoplasm</condition>
    <condition>Anal Carcinoma</condition>
    <condition>Biliary Tract Carcinoma</condition>
    <condition>Bladder Carcinoma</condition>
    <condition>Breast Carcinoma</condition>
    <condition>Carcinoid Tumor</condition>
    <condition>Cervical Carcinoma</condition>
    <condition>Colorectal Carcinoma</condition>
    <condition>Gastric Carcinoma</condition>
    <condition>Glioblastoma</condition>
    <condition>Head and Neck Carcinoma</condition>
    <condition>HER2-Positive Breast Carcinoma</condition>
    <condition>Lung Carcinoma</condition>
    <condition>Lung Small Cell Carcinoma</condition>
    <condition>Malignant Germ Cell Tumor</condition>
    <condition>Neuroendocrine Carcinoma</condition>
    <condition>Ovarian Carcinoma</condition>
    <condition>Pancreatic Carcinoma</condition>
    <condition>Prostate Small Cell Neuroendocrine Carcinoma</condition>
    <arm_group>
      <arm_group_label>Arm A (at-home treatment)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients continue receiving their SOC chemotherapy regimen at home for 24 weeks in the absence of disease progression or unacceptable toxicity. This includes drug administrations, injections/infusions and routine clinical laboratory tests in the home from the HHNP, overseen by Mayo Clinic's home health program CCBW Command Center. Patients are also provided biometric devices for health monitoring vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm B (clinic &amp; at-home treatment)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients continue receiving their SOC chemotherapy regimen in the clinic for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC chemotherapy regimen at home as in Arm I for an additional 16 weeks in the absence of disease progression or unacceptable toxicity.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Clinical Encounter</intervention_name>
      <description>Receive treatment in clinic</description>
      <arm_group_label>Arm B (clinic &amp; at-home treatment)</arm_group_label>
      <other_name>Patient Encounter</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Home Health Encounter</intervention_name>
      <description>Receive at-home treatment</description>
      <arm_group_label>Arm A (at-home treatment)</arm_group_label>
      <arm_group_label>Arm B (clinic &amp; at-home treatment)</arm_group_label>
      <other_name>HH</other_name>
      <other_name>Home</other_name>
      <other_name>Home Care Visit</other_name>
      <other_name>Home Health</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Quality-of-Life Assessment</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm A (at-home treatment)</arm_group_label>
      <arm_group_label>Arm B (clinic &amp; at-home treatment)</arm_group_label>
      <other_name>Quality of Life Assessment</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm A (at-home treatment)</arm_group_label>
      <arm_group_label>Arm B (clinic &amp; at-home treatment)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female or male patients with histologically confirmed malignancy who are currently&#xD;
               receiving treatment with one of the following eligible chemotherapy treatment&#xD;
               regimens:&#xD;
  &#xD;
                 -  Cisplatin/gemcitabine for bladder, lung, biliary, or breast cancer&#xD;
  &#xD;
                 -  Gemcitabine for pancreatic or ovarian cancer&#xD;
  &#xD;
                 -  Cisplatin/etoposide for small cell lung cancer, germ cell carcinoma, small cell&#xD;
                    prostate cancer, and neuroendocrine/carcinoid cancer&#xD;
  &#xD;
                 -  Cisplatin for lung, bladder, head and neck, cervical, and breast cancer, and&#xD;
                    glioblastoma&#xD;
  &#xD;
                 -  Avastin for glioblastoma, breast, colorectal, and cervical cancer&#xD;
  &#xD;
                 -  Cisplatin/fluorouracil (5-FU) +/- Avastin for anal cancer&#xD;
  &#xD;
                 -  5-FU/leucovorin +/- Avastin for colorectal or gastric cancer&#xD;
  &#xD;
                 -  Fluorouracil + leucovorin + oxaliplatin (FOLFOX 6) +/- Avastin for colorectal&#xD;
                    cancer&#xD;
  &#xD;
                 -  FOLFIRI +/- Avastin (5-FU/leucovorin/irinotecan) for colorectal cancer&#xD;
  &#xD;
                 -  Paclitaxel for breast or bladder cancer&#xD;
  &#xD;
                 -  Trastuzumab maintenance for Her-2 positive breast cancer&#xD;
  &#xD;
                 -  Trastuzumab + paclitaxel for Her-2 positive breast cancer&#xD;
  &#xD;
                 -  Leuprolide for prostate and breast cancer&#xD;
  &#xD;
                 -  Goserelin acetate for breast cancer&#xD;
  &#xD;
            -  Patients have completed the first two treatment cycles in the infusion unit with good&#xD;
               tolerance and have not experienced an infusion reaction&#xD;
  &#xD;
            -  Patients are clinically and/or radiologically free of disease progression at the end&#xD;
               of first two treatment cycles AND are deemed eligible to continue current chemotherapy&#xD;
               treatment per their treating physician&#xD;
  &#xD;
            -  Residing within 35 miles of clinic (hub) or within the area serviced by supplier and&#xD;
               paramedic network&#xD;
  &#xD;
            -  Residence either has wireless fidelity (wifi) or is within the cellular data network&#xD;
               accessible by the study provided devices to enable a reliable connection with the&#xD;
               remote Command Center&#xD;
  &#xD;
            -  Age &gt;= 18 years at time of registration&#xD;
  &#xD;
            -  Signed informed consent form by patient&#xD;
  &#xD;
            -  Willing and able to comply with the study protocol in the investigator's judgment&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2&#xD;
  &#xD;
            -  Ability to complete questionnaire(s)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Receiving any other investigational or standard of care agent which would be&#xD;
               considered as a treatment for the primary neoplasm and is not part of the eligible&#xD;
               treatment regimens (except hormone therapy for breast or prostate cancer)&#xD;
  &#xD;
            -  Requiring 24/7 assistance with activities of daily living (ADLs)&#xD;
  &#xD;
            -  Current inpatient hospitalization (excluding admission to the Advanced Care at Home&#xD;
               program)&#xD;
  &#xD;
            -  Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment&#xD;
               of the investigator, would make the patient inappropriate for entry into this study or&#xD;
               interfere significantly with the proper assessment of safety and toxicity of the&#xD;
               prescribed regimens&#xD;
  &#xD;
            -  Uncontrolled intercurrent illness including, but not limited to:&#xD;
  &#xD;
                 -  Ongoing or active infection&#xD;
  &#xD;
                 -  Symptomatic congestive heart failure&#xD;
  &#xD;
                 -  Unstable angina pectoris&#xD;
  &#xD;
                 -  Cardiac arrhythmia&#xD;
  &#xD;
                 -  Myocardial infarction =&lt; 6 months&#xD;
  &#xD;
                 -  Wound healing disorder&#xD;
  &#xD;
                 -  Or psychiatric illness/social situations that would limit compliance with study&#xD;
                    requirements&#xD;
  &#xD;
            -  Patients with any severe infection within 4 weeks prior to registration including, but&#xD;
               not limited to, hospitalization for complications of infections should not be enrolled&#xD;
               in the trial (in the current situation, this also applies to patients with suspected&#xD;
               or confirmed coronavirus disease 2019 [COVID-19] infection)&#xD;
  &#xD;
            -  Anticipation of the need for major surgery during the course of study treatment&#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>Roxana S Dronca, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mayo Clinic</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trials Referral Office</last_name>
      <phone>855-77 6-0015</phone>
      <email>mayocliniccancerstudies@mayo.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Mayo Clinic in Florida</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32224-9980</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Clinical Trials Referral Office</last_name>
        <phone>855-776-0015</phone>
        <email>mayocliniccancerstudies@mayo.edu</email>
      </contact>
      <investigator>
        <last_name>Roxana S. Dronca, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.mayo.edu/research/clinical-trials</url>
      <description>Mayo Clinic Clinical Trials</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 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>Carcinoma</mesh_term>
      <mesh_term>Glioblastoma</mesh_term>
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Colorectal Neoplasms</mesh_term>
      <mesh_term>Carcinoid Tumor</mesh_term>
      <mesh_term>Carcinoma, Neuroendocrine</mesh_term>
      <mesh_term>Pancreatic Neoplasms</mesh_term>
      <mesh_term>Stomach Neoplasms</mesh_term>
      <mesh_term>Urinary Bladder Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Small Cell</mesh_term>
      <mesh_term>Small Cell Lung Carcinoma</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/NCT05969860
  org study id: MC220709
  secondary id: NCI-2023-05420
  secondary id: 23-001719
  secondary id: MC220709
  nct id: NCT05969860
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial studies the effect of cancer directed therapy given at-home versus in the
        clinic for patients with cancer that may have spread from where it first started to nearby
        tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related
        cancer care is conducted in infusion centers or specialty hospitals, where patients spend
        many hours a day isolated from family, friends, and familiar surroundings. This separation
        adds to the physical, emotional, social, and financial burden for patients and their
        families. The logistics and costs of navigating cancer treatments have become a principal
        contributor to patients' reduced quality of life. It is therefore important to reduce the
        burden of cancer in the lives of patients and their caregivers, and a vital aspect of this
        involves moving beyond traditional hospital and clinic-based care and evaluate innovative
        care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in
        the clinic, may help reduce psychological and financial distress and increase treatment
        compliance, especially for marginalized patients and communities.
  PRIMARY OBJECTIVE:
  
        I. To compare mean patient-reported rating of Cancer Connected Access and Remote Expertise
        (CARE) using a modified question from the Consumer Assessment of Healthcare Providers and
        Systems (CAHPS) Cancer Care Survey after 8 weeks between patients randomized to receive care
        at home and care in the clinic.
  
        SECONDARY OBJECTIVES:
  
        I. To evaluate patient preference for location of cancer treatment administration, at the
        infusion center or in the home.
  
        II. To evaluate level of comfort with receiving infusions at home based on the following
        measures after 24 weeks of treatment (or at end of study):
  
        IIa. The proportion of patients who indicate a preference for home infusion or no preference
        versus outpatient infusion unit administration of cancer treatment as assessed via the
        Patient Preference Questionnaire; IIb. The proportion of patients who indicate comfort (quite
        a bit or very much) with receiving infusions at home as assessed by the Patient Preference
        Questionnaire.
  
        III. To describe other patient experience questions within the Patient Preference
        Questionnaire after 24 weeks of treatment (or at end of study).
  
        IV. To describe whether patients felt that infusions at home was worthwhile, would do it
        again, and recommend it to others after 24 weeks of treatment (or at end of study) using the
        Was It Worth It questionnaire.
  
        V. To test whether home-based virtual delivery of cancer directed therapy is superior to
        standard administration (in clinic) in patient-reported function and global health/quality of
        life as measured by the European Organization for Research and Treatment of Cancer Quality of
        Life Questionnaire Core Function 17-Item (EORTC QLQ-F17) after 8 weeks of home versus
        outpatient infusion unit administration of cancer treatment.
  
        VI. To test whether home-based virtual delivery of cancer directed therapy is superior to
        standard administration (in clinic) in patient-reported symptoms as measured by the
        Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) after 8
        weeks of home versus outpatient infusion unit administration of cancer treatment.
  
        VII. To assess the safety of cancer directed therapy when administered at home by a home
        health provider with remote patient monitoring and Command Center support, based on the
        incidence, nature, and severity of the following:
  
        VIIa. Grade 3+ adverse event (AE) clinically graded using the National Cancer Institute
        Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
  
        VIII. To test whether home-based virtual delivery of cancer directed therapy is superior to
        standard in clinic administration in the proportion of patients with an emergency room visit
        or hospitalization at the end of 6 months of study treatment.
  
        IX. Overall survival.
  
        EXPLORATORY OBJECTIVES:
  
        I. To assess the cost of care in first 6 months (data collected out to 1 year). II. To
        evaluate administration of treatment based on clinical practice data.
  
        OUTLINE:
  
        Patients receive the first 2 cycles of their standard of care (SOC) chemotherapy regimen in
        the clinic in the absence of disease progression or unacceptable toxicity. Patients are then
        randomized to 1 of 2 arms.
  
        ARM A: Patients continue receiving their SOC chemotherapy regimen at home for 24 weeks in the
        absence of disease progression or unacceptable toxicity. This includes drug administrations,
        injections/infusions and routine clinical laboratory tests in the home from the Home Health
        Nurse Provider (HHNP), overseen by Mayo Clinic's home health program Cancer CARE Beyond Walls
        (CCBW) Command Center. Patients are also provided biometric devices for health monitoring
        vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.
  
        ARM B: Patients continue receiving their SOC chemotherapy regimen in the clinic for 8 weeks
        in the absence of disease progression or unacceptable toxicity. Patients then begin receiving
        their SOC chemotherapy regimen at home as in Arm I for an additional 16 weeks in the absence
        of disease progression or unacceptable toxicity.
  
        After completion of study intervention, patients are followed for 1 year.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Mean patient-reported rating of Cancer Connected Access and Remote Expertise
  time frame: At 8 weeks
  description: This hypothesis test will use patient ratings from a single 0-10 item from the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey assessing "your overall cancer care experience". Will be compared between arms using a two-sample t-test.
  measure: Patient-preferred treatment location
  time frame: At 24 weeks
  description: The proportion of patients who preferred care at home or expressed no preference will be computed and compared to 50% using a one-group test of proportions. Additional Likert patient feedback questions and "Was It Worth It" questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.
  measure: Patient level of comfort with receiving infusions at home
  time frame: At 24 weeks
  description: Patient responses to comfort level with receiving infusions at home will be described using frequencies and relative frequencies. The proportion of patients who express comfort (quite a bit or very much) will also be tabulated and a proportion greater than 70% will signify acceptance. Additional Likert patient feedback questions and "Was It Worth It" questions at each time point will be described using frequencies and relative frequencies by arm (or overall if applicable) and compared between arms (if applicable) using chi-squared tests. Numeric analog scale questions will be described using means and standard deviations and compared between arms (if applicable) using t-tests.
  measure: Patient-reported worthwhileness
  time frame: At 24 weeks
  description: Measured by the Was it Worth It questionnaire. The Was It Worth It questionnaire asks patients whether they thought that receiving chemo/infusions at home was worthwhile, whether they would do it again, and whether they would recommend it to others.
  measure: Patient-reported function
  time frame: At 8 weeks
  description: Measured by the European Organization for Research and Treatment of Cancer. Mean and standard deviation of each scale will be computed by arm. Means and standard deviations of each scale will also be computed at all other assessment time points. Mean changes from baseline in each scale at 8 weeks (and other assessment time points) will be compared between arms using a linear combination of parameters from a general linear mixed model. Each model will include all available data from all time points. Fixed effects will include arm, time point, and arm-by-time point interaction. Repeated observations by patient will be modeled using compound symmetric correlation structure over time. Such values as the mean change from baseline at 8 weeks by arm, and difference in mean change from baseline at 8 weeks between arms will be estimated with confidence intervals based on the mixed model. Comparisons at other time points will also be carried out and graphically displayed using mean plots.
  measure: Patient-reported symptoms
  time frame: At 8 weeks
  description: Will be measured by the Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (CTCAE) and summarized using composite grades. The baseline adjustment approach will be applied and resulting maximum baseline-adjusted grade will be reported by symptomatic adverse events (AE) as the proportion of patients with at least one grade >=1 AE during the first 8 weeks. The proportion of patients with at least one grade >= 3 AE per symptomatic AE will also be tabulated during the first 8 weeks. Comparisons between arms will employ Fisher's exact tests. Additional summaries over the 24 weeks by tables and graphics will also be generated.
  measure: Patient-reported side effect impact
  time frame: At 8 weeks
  description: Will be measured by the General Physical-5 (GP5). The frequency and relative frequency of patient responses to the GP5 at 8 weeks will be computed by arm and compared between arms using a chi-squared test. The categorical analysis will also be computed at other assessment time points. Mean GP5 scores over time will also be explored using a general linear mixed model and mean plots.
  measure: Incidence of adverse events
  time frame: Up to 24 weeks
  description: The maximum grade for each type of adverse event will be summarized using CTCAE version 5.0. The frequency and percentage of grade 3+ adverse events (by individual AEs and overall) will be reported by arm and compared between arms using a Fisher's exact test.
  measure: Emergency room visits and hospitalizations
  time frame: At 8 weeks
  description: The proportion of patients with an emergency room visit or hospitalization will be computed per arm and compared between arms using a Fisher's exact test. In subsequent analyses, emergency room visits and hospitalizations will be explored separately. Proportion of patients with emergency room visits or hospitalizations will also be summarized over the entire study.
  measure: Overall survival
  time frame: The time from study entry to death from any cause, assessed up to 1 year after completion of study intervention
  description: Will be estimated using the Kaplan-Meier method and compared between arms using a log-rank test.
  arm group label: Arm A (at-home treatment)
  arm group type: Experimental
  description: Patients continue receiving their SOC chemotherapy regimen at home for 24 weeks in the absence of disease progression or unacceptable toxicity. This includes drug administrations, injections/infusions and routine clinical laboratory tests in the home from the HHNP, overseen by Mayo Clinic's home health program CCBW Command Center. Patients are also provided biometric devices for health monitoring vital signs, as well as a computer tablet for video visits with the Mayo Clinic care team.
  arm group label: Arm B (clinic & at-home treatment)
  arm group type: Experimental
  description: Patients continue receiving their SOC chemotherapy regimen in the clinic for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then begin receiving their SOC chemotherapy regimen at home as in Arm I for an additional 16 weeks in the absence of disease progression or unacceptable toxicity.
  intervention type: Procedure
  intervention name: Clinical Encounter
  description: Receive treatment in clinic
  arm group label: Arm B (clinic & at-home treatment)
  other name: Patient Encounter
  intervention type: Other
  intervention name: Home Health Encounter
  description: Receive at-home treatment
  arm group label: Arm A (at-home treatment)
  arm group label: Arm B (clinic & at-home treatment)
  other name: HH
  other name: Home
  other name: Home Care Visit
  other name: Home Health
  intervention type: Other
  intervention name: Quality-of-Life Assessment
  description: Ancillary studies
  arm group label: Arm A (at-home treatment)
  arm group label: Arm B (clinic & at-home treatment)
  other name: Quality of Life Assessment
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Ancillary studies
  arm group label: Arm A (at-home treatment)
  arm group label: Arm B (clinic & at-home treatment)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Roxana S Dronca, M.D.
  role: Principal Investigator
  affiliation: Mayo Clinic
  last name: Clinical Trials Referral Office
  phone: 855-77 6-0015
  email: mayocliniccancerstudies@mayo.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: https://www.mayo.edu/research/clinical-trials
  description: Mayo Clinic Clinical Trials
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Glioblastoma
  mesh term: Breast Neoplasms
  mesh term: Colorectal Neoplasms
  mesh term: Carcinoid Tumor
  mesh term: Carcinoma, Neuroendocrine
  mesh term: Pancreatic Neoplasms
  mesh term: Stomach Neoplasms
  mesh term: Urinary Bladder Neoplasms
  mesh term: Carcinoma, Small Cell
  mesh term: Small Cell Lung Carcinoma