<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/NCT04428905</url>
  </required_header>
  <id_info>
    <org_study_id>19556</org_study_id>
    <secondary_id>NCI-2020-03375</secondary_id>
    <secondary_id>19556</secondary_id>
    <secondary_id>R01CA249501</secondary_id>
    <nct_id>NCT04428905</nct_id>
  </id_info>
  <brief_title>Self-Management Survivorship Care in Stage I-III Non-small Cell Lung Cancer or Colorectal Cancer</brief_title>
  <official_title>Self-Management to Optimize Survivorship Care and Outcomes in Lung and Colorectal Cancers</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase III trial studies how well a telehealth self-management program works in improving&#xD;
      survivorship care and outcomes in stage I-III non-small cell lung cancer or colorectal cancer&#xD;
      survivors. Survivor self-management program focuses on coaching patients on follow-up care&#xD;
      after cancer treatments. Participating in the program may improve knowledge and confidence&#xD;
      about follow-up care, communication with cancer care and primary care doctors, and quality of&#xD;
      life after cancer treatment in non-small cell lung cancer or colorectal cancer survivors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine the efficacy of the intervention on care coordination, communication, and&#xD;
      primary care provider (PCP) knowledge, comparing the intervention and attention control arms&#xD;
      at 4 and 8 months post-accrual.&#xD;
&#xD;
      II. Determine the efficacy of the intervention on survivor outcomes, comparing the&#xD;
      intervention and attention control arms at 4 and 8 months post-accrual.&#xD;
&#xD;
      EXPLORATORY OBJECTIVE:&#xD;
&#xD;
      I. Assess the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the&#xD;
      intervention.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I (SURVIVOR SELF-MANAGEMENT): Patients receive a personalized care plan/resource manual.&#xD;
      Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4&#xD;
      months (months 1-4) about self-management skills building, then 3 maintenance telehealth&#xD;
      sessions with a nurse over 60 minutes each for 3 months (months 5-7) for additional&#xD;
      self-management skills building support. A copy of patient's care plan is also sent to their&#xD;
      PCP.&#xD;
&#xD;
      ARM II (ATTENTION CONTROL): Patients receive an American Society of Clinical Oncology (ASCO)&#xD;
      care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes&#xD;
      each for 4 months (months 1-4) to review a handbook about life after cancer treatment, then 3&#xD;
      monthly telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) to&#xD;
      answer questions about the handbook. A copy of the ASCO care plan is also sent to their PCP.&#xD;
&#xD;
      After study initiation, patients are followed up at 4 and 8 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 11, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</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>Care coordination</measure>
    <time_frame>At Baseline</time_frame>
    <description>To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at baseline. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.&#xD;
Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Care coordination</measure>
    <time_frame>At 4 months</time_frame>
    <description>To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at 4 months. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.&#xD;
Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Care coordination</measure>
    <time_frame>At 8 months</time_frame>
    <description>To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at 8 months. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.&#xD;
Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oncologist/primary care providers (PCP) communication</measure>
    <time_frame>At Baseline</time_frame>
    <description>To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at baseline (within group).&#xD;
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oncologist/primary care providers (PCP) communication</measure>
    <time_frame>At 4 months</time_frame>
    <description>To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at 4 months (within group).&#xD;
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oncologist/primary care providers (PCP) communication</measure>
    <time_frame>At 8 months</time_frame>
    <description>To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at 8 months (within group).&#xD;
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCP knowledge in survivorship care</measure>
    <time_frame>At Baseline</time_frame>
    <description>To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.&#xD;
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCP knowledge in survivorship care</measure>
    <time_frame>At 4 months</time_frame>
    <description>To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.&#xD;
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PCP knowledge in survivorship care</measure>
    <time_frame>At 8 months</time_frame>
    <description>To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.&#xD;
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survivor outcomes</measure>
    <time_frame>At Baseline</time_frame>
    <description>Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at baseline into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.&#xD;
Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survivor outcomes</measure>
    <time_frame>At 4 months</time_frame>
    <description>Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at 4 months post enrollment into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.&#xD;
Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Survivor outcomes</measure>
    <time_frame>At 8 months</time_frame>
    <description>Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at 8 months post enrollment into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.&#xD;
Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-centered communication</measure>
    <time_frame>At Baseline</time_frame>
    <description>To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at baseline , controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.&#xD;
Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-centered communication</measure>
    <time_frame>At 4 months</time_frame>
    <description>To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at 4 months (short-term, primary effect), controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.&#xD;
Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-centered communication</measure>
    <time_frame>At 8 months</time_frame>
    <description>To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at 8 months (long-term, secondary effect) and over time (within groups), controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.&#xD;
Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life: survey</measure>
    <time_frame>At Baseline</time_frame>
    <description>A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at baseline, controlling for the baseline measure of patients' quality of life.&#xD;
Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life: survey</measure>
    <time_frame>At 4 months</time_frame>
    <description>A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at 4 months (short-term, primary effect) and over time (within groups), controlling for the baseline measure of patients' quality of life.&#xD;
Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life: survey</measure>
    <time_frame>At 8 months</time_frame>
    <description>A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at 8 months (long-term, secondary effect) and over time (within groups), controlling for the baseline measure of patients' quality of life.&#xD;
Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better</description>
  </primary_outcome>
  <other_outcome>
    <measure>Overall reach (participation rate) with primary care providers (Arm I)</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>Data analysis will be primarily descriptive. Records from the tracking database will be examined and used to understand the extent to which patients' primary care providers assigned to the intervention arm participated in all aspects of the intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of primary care providers who received a clinical care plan (Arm I)</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>Data analysis will be primarily descriptive. Data from the tracking database will also be used to understand the percentage of primary care providers who received a clinician care plan.</description>
  </other_outcome>
  <other_outcome>
    <measure>Primary care providers' use of care plan information for survivorship care (Arm I)</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>Data analysis will be primarily descriptive. Primary care provider survivor clinical visit notes will also be used to qualitatively assess primary care providers' use of the clinician care plan information to provide quality survivorship care to also understand the level of adoption of the intervention.</description>
  </other_outcome>
  <other_outcome>
    <measure>Potential barriers and facilitators for intervention implementation and maintenance</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>Data analysis will be primarily descriptive. Meeting minutes from the quarterly Stakeholder Advisory Council will be qualitatively analyzed to extrapolate data on barriers and facilitators from a clinical, institutional, and implementation (on a systems-level) standpoint.</description>
  </other_outcome>
  <other_outcome>
    <measure>Outcome Measure for facilitators</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>Data analysis will be primarily descriptive. Meeting minutes from the quarterly Stakeholder Advisory Council will be qualitatively analyzed to extrapolate data on barriers and facilitators from a clinical, institutional, and implementation (on a systems-level) standpoint.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">414</enrollment>
  <condition>Lung Non-Small Cell Carcinoma</condition>
  <condition>Stage I Colorectal Cancer AJCC v8</condition>
  <condition>Stage I Lung Cancer AJCC v8</condition>
  <condition>Stage IA1 Lung Cancer AJCC v8</condition>
  <condition>Stage IA2 Lung Cancer AJCC v8</condition>
  <condition>Stage IA3 Lung Cancer AJCC v8</condition>
  <condition>Stage IB Lung Cancer AJCC v8</condition>
  <condition>Stage II Colorectal Cancer AJCC v8</condition>
  <condition>Stage II Lung Cancer AJCC v8</condition>
  <condition>Stage IIA Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIA Lung Cancer AJCC v8</condition>
  <condition>Stage IIB Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIB Lung Cancer AJCC v8</condition>
  <condition>Stage IIC Colorectal Cancer AJCC v8</condition>
  <condition>Stage III Colorectal Cancer AJCC v8</condition>
  <condition>Stage III Lung Cancer AJCC v8</condition>
  <condition>Stage IIIA Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIIA Lung Cancer AJCC v8</condition>
  <condition>Stage IIIB Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIIB Lung Cancer AJCC v8</condition>
  <condition>Stage IIIC Colorectal Cancer AJCC v8</condition>
  <condition>Stage IIIC Lung Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Arm I (personalized care plan, telehealth sessions)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive a personalized care plan/resource manual. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) about self-management skills building, then 3 maintenance telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) for additional self-management skills building support. A copy of patient's care plan is also sent to their PCP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (ASCO care plan, telehealth sessions)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive an ASCO care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) to answer questions on a handbook about life after cancer treatment, then 3 monthly telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) to answer questions about the handbook. A copy of the ASCO care plan is also sent to their PCP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (personalized care plan, telehealth sessions)</arm_group_label>
    <arm_group_label>Arm II (ASCO care plan, telehealth sessions)</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 I (personalized care plan, telehealth sessions)</arm_group_label>
    <arm_group_label>Arm II (ASCO care plan, telehealth sessions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survivorship Care Plan</intervention_name>
    <description>Receive personalized care plan/resource manual</description>
    <arm_group_label>Arm I (personalized care plan, telehealth sessions)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Telemedicine</intervention_name>
    <description>Participate in telehealth sessions</description>
    <arm_group_label>Arm I (personalized care plan, telehealth sessions)</arm_group_label>
    <arm_group_label>Arm II (ASCO care plan, telehealth sessions)</arm_group_label>
    <other_name>Telehealth</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-small cell lung cancer (NSCLC) and colorectal cancer survivors who are 4 months&#xD;
             post-treatment completion&#xD;
&#xD;
          -  History of stage I-III disease&#xD;
&#xD;
          -  Ability to read or understand English&#xD;
&#xD;
          -  All subjects must have the ability to understand and the willingness to sign a written&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects, who in the opinion of the principal investigator (PI), may not be able to&#xD;
             comply with the requirements of the study&#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>Virginia Sun</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>Virginia Sun</last_name>
      <phone>626-256-4673</phone>
      <email>VSun@coh.org</email>
    </contact>
    <investigator>
      <last_name>Virginia Sun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 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>Lung Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT04428905
org study id: 19556
secondary id: NCI-2020-03375
secondary id: 19556
secondary id: R01CA249501
nct id: NCT04428905
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This phase III trial studies how well a telehealth self-management program works in improving
      survivorship care and outcomes in stage I-III non-small cell lung cancer or colorectal cancer
      survivors. Survivor self-management program focuses on coaching patients on follow-up care
      after cancer treatments. Participating in the program may improve knowledge and confidence
      about follow-up care, communication with cancer care and primary care doctors, and quality of
      life after cancer treatment in non-small cell lung cancer or colorectal cancer survivors.
PRIMARY OBJECTIVES:

      I. Determine the efficacy of the intervention on care coordination, communication, and
      primary care provider (PCP) knowledge, comparing the intervention and attention control arms
      at 4 and 8 months post-accrual.

      II. Determine the efficacy of the intervention on survivor outcomes, comparing the
      intervention and attention control arms at 4 and 8 months post-accrual.

      EXPLORATORY OBJECTIVE:

      I. Assess the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the
      intervention.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I (SURVIVOR SELF-MANAGEMENT): Patients receive a personalized care plan/resource manual.
      Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4
      months (months 1-4) about self-management skills building, then 3 maintenance telehealth
      sessions with a nurse over 60 minutes each for 3 months (months 5-7) for additional
      self-management skills building support. A copy of patient's care plan is also sent to their
      PCP.

      ARM II (ATTENTION CONTROL): Patients receive an American Society of Clinical Oncology (ASCO)
      care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes
      each for 4 months (months 1-4) to review a handbook about life after cancer treatment, then 3
      monthly telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) to
      answer questions about the handbook. A copy of the ASCO care plan is also sent to their PCP.

      After study initiation, patients are followed up at 4 and 8 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Care coordination
time frame: At Baseline
description: To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at baseline. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.
Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.
measure: Care coordination
time frame: At 4 months
description: To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at 4 months. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.
Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.
measure: Care coordination
time frame: At 8 months
description: To test the short and long term effects of the intervention on care coordination (timely appointments and care, use of information to coordinate care, support in managing treatment effects, provides timely information, involvement of family and friends), a 2x2x2 repeated measures analysis of covariance in which the within groups variables are care coordination scores as measured by the Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey at 8 months. The between groups measures are the comparisons between 1) study arms, attention control versus intervention, and 2) cancer type, non-small cell lung cancer versus colorectal cancer, with at minimum the baseline care coordination score serving as a covariate. Other covariates may be added to the model pending results of the preliminary analysis.
Consumer Assessment of Healthcare Providers and Systems Cancer Care Survey, Minimum value = 1 Never ; maximum value = 4 Always, higher is better.
measure: Oncologist/primary care providers (PCP) communication
time frame: At Baseline
description: To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at baseline (within group).
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better
measure: Oncologist/primary care providers (PCP) communication
time frame: At 4 months
description: To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at 4 months (within group).
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better
measure: Oncologist/primary care providers (PCP) communication
time frame: At 8 months
description: To test the effect of the intervention on improved communication among oncologists and PCP, a 2x2x2 repeated measures analysis of covariance (AofC) will be used to test for differences on the perceived quality of care coordination and communication by the oncologists and primary care providers (PCPs) treating patients in the attention control arm and intervention arm (between groups), by diagnosis (between groups) at 8 months (within group).
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better
measure: PCP knowledge in survivorship care
time frame: At Baseline
description: To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better
measure: PCP knowledge in survivorship care
time frame: At 4 months
description: To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better
measure: PCP knowledge in survivorship care
time frame: At 8 months
description: To test the short and long term effects of the intervention on improved knowledge in survivorship care among primary care providers, a 2x2x2 repeated measures analysis of covariance will be conducted to compare the outcome for the attention control arm and intervention arm (between groups), by diagnosis (between groups) and over time (within groups) with baseline knowledge scores serving as the primary covariate.
Survey of Physician Attitudes Regarding the Care of Cancer Survivors; minimum value=never; maximum value=always/almost always; higher is better
measure: Survivor outcomes
time frame: At Baseline
description: Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at baseline into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.
Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better
measure: Survivor outcomes
time frame: At 4 months
description: Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at 4 months post enrollment into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.
Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better
measure: Survivor outcomes
time frame: At 8 months
description: Will compare the two arms to determine the efficacy of the intervention on survivor outcomes and analyze using a 2x2x2 repeated measures analysis of covariance. By diagnosis, differences between the attention control and intervention arm participants on responses to the Confidence in Survivorship Information survey measuring patients' knowledge of and self-efficacy in survivorship care will be examined at 8 months post enrollment into the study, controlling for baseline scores on the Confidence in Survivorship Information survey.
Confidence in cancer Survivorship: minimum value=strongly disagree; maximum value=strongly agree; higher is better
measure: Patient-centered communication
time frame: At Baseline
description: To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at baseline , controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.
Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better
measure: Patient-centered communication
time frame: At 4 months
description: To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at 4 months (short-term, primary effect), controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.
Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better
measure: Patient-centered communication
time frame: At 8 months
description: To test the short and long term effect of patient-centered communication, a 2x2x2 repeated measure analysis of covariance will be used to test for differences between the attention control arm and intervention arm (between groups), by diagnosis (between groups) using the results from the Patient-Centered Communication survey at 8 months (long-term, secondary effect) and over time (within groups), controlling for the baseline measure of patients' perceptions of whether care is centered around their needs.
Patient-Centered Communication survey; minimum value=never; maximum value=always; higher is better
measure: Quality of life: survey
time frame: At Baseline
description: A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at baseline, controlling for the baseline measure of patients' quality of life.
Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better
measure: Quality of life: survey
time frame: At 4 months
description: A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at 4 months (short-term, primary effect) and over time (within groups), controlling for the baseline measure of patients' quality of life.
Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better
measure: Quality of life: survey
time frame: At 8 months
description: A 2x2x2 repeated measure analysis of covariance will be used to test for differences by diagnosis between the attention control arm and intervention arm (between groups) using the results from the Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey at 8 months (long-term, secondary effect) and over time (within groups), controlling for the baseline measure of patients' quality of life.
Functional Assessment of Cancer Therapy - Lung or Functional Assessment of Cancer Therapy - Colorectal Cancer survey Minimum value=0; maximum value=4; higher is better
measure: Overall reach (participation rate) with primary care providers (Arm I)
time frame: Up to 8 months
description: Data analysis will be primarily descriptive. Records from the tracking database will be examined and used to understand the extent to which patients' primary care providers assigned to the intervention arm participated in all aspects of the intervention.
measure: Percentage of primary care providers who received a clinical care plan (Arm I)
time frame: Up to 8 months
description: Data analysis will be primarily descriptive. Data from the tracking database will also be used to understand the percentage of primary care providers who received a clinician care plan.
measure: Primary care providers' use of care plan information for survivorship care (Arm I)
time frame: Up to 8 months
description: Data analysis will be primarily descriptive. Primary care provider survivor clinical visit notes will also be used to qualitatively assess primary care providers' use of the clinician care plan information to provide quality survivorship care to also understand the level of adoption of the intervention.
measure: Potential barriers and facilitators for intervention implementation and maintenance
time frame: Up to 8 months
description: Data analysis will be primarily descriptive. Meeting minutes from the quarterly Stakeholder Advisory Council will be qualitatively analyzed to extrapolate data on barriers and facilitators from a clinical, institutional, and implementation (on a systems-level) standpoint.
measure: Outcome Measure for facilitators
time frame: Up to 8 months
description: Data analysis will be primarily descriptive. Meeting minutes from the quarterly Stakeholder Advisory Council will be qualitatively analyzed to extrapolate data on barriers and facilitators from a clinical, institutional, and implementation (on a systems-level) standpoint.
arm group label: Arm I (personalized care plan, telehealth sessions)
arm group type: Experimental
description: Patients receive a personalized care plan/resource manual. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) about self-management skills building, then 3 maintenance telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) for additional self-management skills building support. A copy of patient's care plan is also sent to their PCP.
arm group label: Arm II (ASCO care plan, telehealth sessions)
arm group type: Active Comparator
description: Patients receive an ASCO care plan. Patients also participate in 5 telehealth sessions with a nurse over 60 minutes each for 4 months (months 1-4) to answer questions on a handbook about life after cancer treatment, then 3 monthly telehealth sessions with a nurse over 60 minutes each for 3 months (months 5-7) to answer questions about the handbook. A copy of the ASCO care plan is also sent to their PCP.
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (personalized care plan, telehealth sessions)
arm group label: Arm II (ASCO care plan, telehealth sessions)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (personalized care plan, telehealth sessions)
arm group label: Arm II (ASCO care plan, telehealth sessions)
intervention type: Other
intervention name: Survivorship Care Plan
description: Receive personalized care plan/resource manual
arm group label: Arm I (personalized care plan, telehealth sessions)
intervention type: Other
intervention name: Telemedicine
description: Participate in telehealth sessions
arm group label: Arm I (personalized care plan, telehealth sessions)
arm group label: Arm II (ASCO care plan, telehealth sessions)
other name: Telehealth
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Virginia Sun
role: Principal Investigator
affiliation: City of Hope Medical Center
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Colorectal Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung