<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/NCT01721343</url>
  </required_header>
  <id_info>
    <org_study_id>MC1193</org_study_id>
    <secondary_id>NCI-2012-01603</secondary_id>
    <secondary_id>P30CA015083</secondary_id>
    <nct_id>NCT01721343</nct_id>
  </id_info>
  <brief_title>Collaborative Targeted Case Management in Improving Functional Status in Patients With Stage III-IV Cancer</brief_title>
  <official_title>MC1193: Collaborative Care to Preserve Performance in Cancer (COPE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies collaborative targeted case management in improving&#xD;
      functional status in patients with stage III-IV cancer. Collaborative targeted case&#xD;
      management may improve functional mobility, improve quality of life, and reduce pain and&#xD;
      health care utilization in patients with advanced cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Establish the comparative effectiveness of the Collaborative Care to Preserve Performance&#xD;
      in Cancer (COPE) trial arms in preserving functional mobility.&#xD;
&#xD;
      II. To assess the comparative cost-effectiveness and cost-utility of the COPE interventions.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 3 arms.&#xD;
&#xD;
      ARM I: Patients undergo enhanced usual care comprising telephonic monitoring with monthly&#xD;
      status reports provided to their oncology care teams for 6 months.&#xD;
&#xD;
      ARM II: Patients undergo enhanced usual care as in Arm I and participate in an individualized&#xD;
      conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted,&#xD;
      as required, by a local physical therapist for 6 months.&#xD;
&#xD;
      ARM III: Patients undergo enhanced usual care as in Arm I, participate in an individualized&#xD;
      conditioning program coordinated by the FCM as in Arm II, and receive optimized pain&#xD;
      management through a nurse Pain Care Manager (PCM) for 6 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 7, 2012</start_date>
  <completion_date type="Anticipated">December 15, 2023</completion_date>
  <primary_completion_date type="Actual">November 14, 2017</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>Functional mobility, as measured by the change in the Activity Measure for Post Acute Care (AM PAC) Computer Adaptive Test (CAT) from baseline [6 months]</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>The mean change in the Ambulatory Post-Acute Care Basic Mobility Computer Adaptive Test (AM PAC CAT) score (month 6 minus baseline) and the [95% confidence interval] for patients assigned to each arm regardless of compliance are reported below. The AM PAC CAT is an item response theory-modeled scale that ranges from 0 to infinity. However, the score range of interest for the trial that corresponds to the ability to ambulate and transfer safely and independently (+/- gait aid) is 55 - 66 with higher scores corresponding to better mobility and the MID for improvement being 1.0. For the primary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain as measured using the Brief Pain Inventory average and total pain interference subscales from baseline [6 months].</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>The change in the Brief Pain Inventory (BPI) average score and total interference score (Month 6 minus baseline) and the and the [95% confidence interval] for patients assigned to each arm regardless of compliance. The BPI average is a single numerical rating scale (NRS) anchored at 0 and 11. The total inference score is a composite of 6 NRS scales. Higher scores indicate more pain or a worse health state. For both measures the minimally important difference (MID) is population dependent and ranges between 0.5 and 2.0. For the secondary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Utility, as measured by the change in EuroQol 5-D (5Q-5D) scale score from baseline</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>The change in health utility, as measured by the change in EuroQol 5-D (5Q-5D) score from baseline score (Month 6 minus baseline) and the and the [95% confidence interval] for patients assigned to each arm regardless of compliance. The EuroQol 5-D utility ranges from 0 to 1.0 with high values indicating better health states. The minimally important difference (MID) is population dependent and range between 0.5 and 1.0. For the secondary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization frequency</measure>
    <time_frame>From registration to 6 months</time_frame>
    <description>The count of hospital admission lasting &gt;24 hours. To assess the impact on number of hospitalizations we will use a negative binomial model, with an offset for number of days of follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>From registration to 6 months</time_frame>
    <description>The count of days spent in the hospital for admissions lasting &gt;24 hours. For patients who had at least one hospitalization, the impact of the interventions on the total number of days in hospital will be assessed using mixed effect Poisson analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge location from hospital</measure>
    <time_frame>From registration to 6 months</time_frame>
    <description>Binary variable describing whether patients were discharged to an inpatient facility (skilled nursing facility, inpatient rehabilitation facility, hospice or long term acute care facility) or home with/without services. Logistic models with random effects for patient will be used to analyze inter-group differences.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Planned admission</measure>
    <time_frame>From registration to 6 months</time_frame>
    <description>Binary variable describing whether an admission was planned for anti-cancer treatment or unplanned. Logistic models with random effects for patient will be used to analyze inter-group differences.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">516</enrollment>
  <condition>Cognitive/Functional Effects</condition>
  <condition>Malignant Neoplasm</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Arm I (enhanced usual care)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (enhanced usual care, RCM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm III (enhanced usual, RCM, PCM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>telephone-based intervention</intervention_name>
    <description>Undergo telephonic monitoring</description>
    <arm_group_label>Arm I (enhanced usual care)</arm_group_label>
    <arm_group_label>Arm II (enhanced usual care, RCM)</arm_group_label>
    <arm_group_label>Arm III (enhanced usual, RCM, PCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>case management</intervention_name>
    <description>Participate in an individualized conditioning program with an RCM</description>
    <arm_group_label>Arm II (enhanced usual care, RCM)</arm_group_label>
    <arm_group_label>Arm III (enhanced usual, RCM, PCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>management of therapy complications</intervention_name>
    <description>Undergo enhanced usual care with an RCM and PCM</description>
    <arm_group_label>Arm III (enhanced usual, RCM, PCM)</arm_group_label>
    <other_name>complications of therapy, management of</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>physical therapy</intervention_name>
    <description>Participate in an individualized conditioning program with an RCM</description>
    <arm_group_label>Arm II (enhanced usual care, RCM)</arm_group_label>
    <arm_group_label>Arm III (enhanced usual, RCM, PCM)</arm_group_label>
    <other_name>physiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (enhanced usual care)</arm_group_label>
    <arm_group_label>Arm II (enhanced usual care, RCM)</arm_group_label>
    <arm_group_label>Arm III (enhanced usual, RCM, PCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>quality-of-life assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (enhanced usual care)</arm_group_label>
    <arm_group_label>Arm II (enhanced usual care, RCM)</arm_group_label>
    <arm_group_label>Arm III (enhanced usual, RCM, PCM)</arm_group_label>
    <other_name>quality of life assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>management of therapy complications</intervention_name>
    <description>Undergo enhanced usual care</description>
    <arm_group_label>Arm I (enhanced usual care)</arm_group_label>
    <other_name>complications of therapy, management of</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>assessment of therapy complications</intervention_name>
    <description>Undergo enhanced usual care</description>
    <arm_group_label>Arm I (enhanced usual care)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>educational intervention</intervention_name>
    <description>Participate in an individualized conditioning program with an RCM</description>
    <arm_group_label>Arm II (enhanced usual care, RCM)</arm_group_label>
    <arm_group_label>Arm III (enhanced usual, RCM, PCM)</arm_group_label>
    <other_name>intervention, educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>management of therapy complications</intervention_name>
    <description>Undergo enhanced usual care with an RCM</description>
    <arm_group_label>Arm II (enhanced usual care, RCM)</arm_group_label>
    <other_name>complications of therapy, management of</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>assessment of therapy complications</intervention_name>
    <description>Undergo enhanced usual care with an RCM</description>
    <arm_group_label>Arm II (enhanced usual care, RCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>assessment of therapy complications</intervention_name>
    <description>Undergo enhanced usual care with an RCM and PCM</description>
    <arm_group_label>Arm III (enhanced usual, RCM, PCM)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of stage III or stage IV cancer&#xD;
&#xD;
          -  Life expectancy &gt; 6 months&#xD;
&#xD;
          -  Ambulatory Post Acute Care (APC) score between 53 and 66&#xD;
&#xD;
          -  Ability to complete questionnaire(s) by themselves or with assistance&#xD;
&#xD;
          -  Provide informed written consent&#xD;
&#xD;
          -  Have working phone to communicate with study team&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
          -  Sufficient auditory acuity&#xD;
&#xD;
          -  Intact cognitive status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is within 2 months of a major surgical procedure&#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>Andrea Cheville, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 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>


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/NCT01721343
org study id: MC1193
secondary id: NCI-2012-01603
secondary id: P30CA015083
nct id: NCT01721343
lead sponsor: 
collaborator: 
has dmc: Yes
This randomized clinical trial studies collaborative targeted case management in improving
      functional status in patients with stage III-IV cancer. Collaborative targeted case
      management may improve functional mobility, improve quality of life, and reduce pain and
      health care utilization in patients with advanced cancer
PRIMARY OBJECTIVES:

      I. Establish the comparative effectiveness of the Collaborative Care to Preserve Performance
      in Cancer (COPE) trial arms in preserving functional mobility.

      II. To assess the comparative cost-effectiveness and cost-utility of the COPE interventions.

      OUTLINE: Patients are randomized to 1 of 3 arms.

      ARM I: Patients undergo enhanced usual care comprising telephonic monitoring with monthly
      status reports provided to their oncology care teams for 6 months.

      ARM II: Patients undergo enhanced usual care as in Arm I and participate in an individualized
      conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted,
      as required, by a local physical therapist for 6 months.

      ARM III: Patients undergo enhanced usual care as in Arm I, participate in an individualized
      conditioning program coordinated by the FCM as in Arm II, and receive optimized pain
      management through a nurse Pain Care Manager (PCM) for 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Functional mobility, as measured by the change in the Activity Measure for Post Acute Care (AM PAC) Computer Adaptive Test (CAT) from baseline [6 months]
time frame: From baseline to 6 months
description: The mean change in the Ambulatory Post-Acute Care Basic Mobility Computer Adaptive Test (AM PAC CAT) score (month 6 minus baseline) and the [95% confidence interval] for patients assigned to each arm regardless of compliance are reported below. The AM PAC CAT is an item response theory-modeled scale that ranges from 0 to infinity. However, the score range of interest for the trial that corresponds to the ability to ambulate and transfer safely and independently (+/- gait aid) is 55 - 66 with higher scores corresponding to better mobility and the MID for improvement being 1.0. For the primary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.
measure: Pain as measured using the Brief Pain Inventory average and total pain interference subscales from baseline [6 months].
time frame: From baseline to 6 months
description: The change in the Brief Pain Inventory (BPI) average score and total interference score (Month 6 minus baseline) and the and the [95% confidence interval] for patients assigned to each arm regardless of compliance. The BPI average is a single numerical rating scale (NRS) anchored at 0 and 11. The total inference score is a composite of 6 NRS scales. Higher scores indicate more pain or a worse health state. For both measures the minimally important difference (MID) is population dependent and ranges between 0.5 and 2.0. For the secondary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.
measure: Health Utility, as measured by the change in EuroQol 5-D (5Q-5D) scale score from baseline
time frame: From baseline to 6 months
description: The change in health utility, as measured by the change in EuroQol 5-D (5Q-5D) score from baseline score (Month 6 minus baseline) and the and the [95% confidence interval] for patients assigned to each arm regardless of compliance. The EuroQol 5-D utility ranges from 0 to 1.0 with high values indicating better health states. The minimally important difference (MID) is population dependent and range between 0.5 and 1.0. For the secondary outcome group differences will be assessed over the 6 months of the trial using mixed-effects model repeated measures (MMRM) analysis which will include a random effect for patient, a fixed effect for measurement point (3 months or 6 months), and adjustment for age, gender, baseline value of the outcome variable, cancer type, cancer stage (IV versus other), and time.
measure: Hospitalization frequency
time frame: From registration to 6 months
description: The count of hospital admission lasting >24 hours. To assess the impact on number of hospitalizations we will use a negative binomial model, with an offset for number of days of follow-up.
measure: Hospital length of stay
time frame: From registration to 6 months
description: The count of days spent in the hospital for admissions lasting >24 hours. For patients who had at least one hospitalization, the impact of the interventions on the total number of days in hospital will be assessed using mixed effect Poisson analysis.
measure: Discharge location from hospital
time frame: From registration to 6 months
description: Binary variable describing whether patients were discharged to an inpatient facility (skilled nursing facility, inpatient rehabilitation facility, hospice or long term acute care facility) or home with/without services. Logistic models with random effects for patient will be used to analyze inter-group differences.
measure: Planned admission
time frame: From registration to 6 months
description: Binary variable describing whether an admission was planned for anti-cancer treatment or unplanned. Logistic models with random effects for patient will be used to analyze inter-group differences.
arm group label: Arm I (enhanced usual care)
arm group type: Experimental
description: Patients undergo enhanced usual care comprising telephonic monitoring with monthly status reports provided to their oncology care teams for 6 months.
arm group label: Arm II (enhanced usual care, RCM)
arm group type: Experimental
description: Patients undergo enhanced usual care as in Arm I and participate in an individualized conditioning program delivered telephonically by the Fitness Care Manager (FCM) and adapted, as required, by a local physical therapist for 6 months.
arm group label: Arm III (enhanced usual, RCM, PCM)
arm group type: Experimental
description: Patients undergo enhanced usual care as in Arm I, participate in an individualized conditioning program coordinated by the FCM as in Arm II, and receive optimized pain management through a nurse Pain Care Manager (PCM) for 6 months.
intervention type: Behavioral
intervention name: telephone-based intervention
description: Undergo telephonic monitoring
arm group label: Arm I (enhanced usual care)
arm group label: Arm II (enhanced usual care, RCM)
arm group label: Arm III (enhanced usual, RCM, PCM)
intervention type: Other
intervention name: case management
description: Participate in an individualized conditioning program with an RCM
arm group label: Arm II (enhanced usual care, RCM)
arm group label: Arm III (enhanced usual, RCM, PCM)
intervention type: Procedure
intervention name: management of therapy complications
description: Undergo enhanced usual care with an RCM and PCM
arm group label: Arm III (enhanced usual, RCM, PCM)
other name: complications of therapy, management of
intervention type: Procedure
intervention name: physical therapy
description: Participate in an individualized conditioning program with an RCM
arm group label: Arm II (enhanced usual care, RCM)
arm group label: Arm III (enhanced usual, RCM, PCM)
other name: physiotherapy
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Arm I (enhanced usual care)
arm group label: Arm II (enhanced usual care, RCM)
arm group label: Arm III (enhanced usual, RCM, PCM)
intervention type: Procedure
intervention name: quality-of-life assessment
description: Ancillary studies
arm group label: Arm I (enhanced usual care)
arm group label: Arm II (enhanced usual care, RCM)
arm group label: Arm III (enhanced usual, RCM, PCM)
other name: quality of life assessment
intervention type: Procedure
intervention name: management of therapy complications
description: Undergo enhanced usual care
arm group label: Arm I (enhanced usual care)
other name: complications of therapy, management of
intervention type: Procedure
intervention name: assessment of therapy complications
description: Undergo enhanced usual care
arm group label: Arm I (enhanced usual care)
intervention type: Other
intervention name: educational intervention
description: Participate in an individualized conditioning program with an RCM
arm group label: Arm II (enhanced usual care, RCM)
arm group label: Arm III (enhanced usual, RCM, PCM)
other name: intervention, educational
intervention type: Procedure
intervention name: management of therapy complications
description: Undergo enhanced usual care with an RCM
arm group label: Arm II (enhanced usual care, RCM)
other name: complications of therapy, management of
intervention type: Procedure
intervention name: assessment of therapy complications
description: Undergo enhanced usual care with an RCM
arm group label: Arm II (enhanced usual care, RCM)
intervention type: Procedure
intervention name: assessment of therapy complications
description: Undergo enhanced usual care with an RCM and PCM
arm group label: Arm III (enhanced usual, RCM, PCM)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Cheville, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Neoplasms