<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/NCT03233555</url>
  </required_header>
  <id_info>
    <org_study_id>131318</org_study_id>
    <secondary_id>NCI-2017-01185</secondary_id>
    <secondary_id>Pro2013003309</secondary_id>
    <secondary_id>131318</secondary_id>
    <secondary_id>R01CA176838</secondary_id>
    <nct_id>NCT03233555</nct_id>
  </id_info>
  <brief_title>Extended Cancer Education for Longer-Term Survivors in Primary Care for Patients With Stage I-II Breast or Prostate Cancer or Stage I-III Colorectal Cancer</brief_title>
  <official_title>Extended Cancer Education for Longer-Term Survivors (EXCELS) In Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study tests four different methods of educating patients about follow-up care (NCI&#xD;
      facing forward, brochure, EXCELS website alone, EXCELS health coaching alone and EXCELS&#xD;
      website &amp; health coaching combination) after cancer treatment ends. While it is known that&#xD;
      patients need information to guide follow-up it remains unknown how to best provide this in&#xD;
      primary care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Develop the EXCELS intervention to facilitate engaged self-management of cancer follow-up&#xD;
      for cancer survivors.&#xD;
&#xD;
      II. Evaluate the efficacy of EXCELS intervention in a small randomized controlled trial.&#xD;
&#xD;
      III. Assess/refine intervention usability and acceptability for primary care patients.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      PHASE I: EXCELS intervention is developed and assessed.&#xD;
&#xD;
      PHASE II: Participants are randomized into 1 of 4 arms.&#xD;
&#xD;
      ARM I: Participants receive National Cancer Institute's Facing Forward brochure.&#xD;
&#xD;
      ARM II: Participants have untimed access to the EXCELS mobile web application.&#xD;
&#xD;
      ARM III: Participants also receive 4 calls of 15-20 minutes each over 3 months focusing on&#xD;
      assisting survivors with addressing challenges to receiving preventive service and health&#xD;
      care.&#xD;
&#xD;
      ARM IV: Participants have access to EXCELS website as in Arm II. Participants also receive 4&#xD;
      health coaching calls as in Arm III.&#xD;
&#xD;
      Patients are followed up at 6 months, 12 months and 18 months post randomization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2013</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">January 15, 2020</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>Use of preventive services</measure>
    <time_frame>Up to 18 months</time_frame>
    <description>Preventative services will be measured using adherence to evidence based guideline care which will be computed as a percentage of the eligible guideline related services provided to each patient.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">535</enrollment>
  <condition>Stage I Breast Cancer</condition>
  <condition>Stage I Colorectal Cancer AJCC v6 and v7</condition>
  <condition>Stage I Prostate Cancer</condition>
  <condition>Stage IA Breast Cancer</condition>
  <condition>Stage IB Breast Cancer</condition>
  <condition>Stage II Breast Cancer</condition>
  <condition>Stage II Colorectal Cancer AJCC v7</condition>
  <condition>Stage II Prostate Cancer</condition>
  <condition>Stage IIA Breast Cancer</condition>
  <condition>Stage IIA Colorectal Cancer AJCC v7</condition>
  <condition>Stage IIA Prostate Cancer</condition>
  <condition>Stage IIB Breast Cancer</condition>
  <condition>Stage IIB Colorectal Cancer AJCC v7</condition>
  <condition>Stage IIB Prostate Cancer</condition>
  <condition>Stage IIC Colorectal Cancer AJCC v7</condition>
  <condition>Stage III Colorectal Cancer AJCC v7</condition>
  <condition>Stage IIIA Colorectal Cancer AJCC v7</condition>
  <condition>Stage IIIB Colorectal Cancer AJCC v7</condition>
  <condition>Stage IIIC Colorectal Cancer AJCC v7</condition>
  <arm_group>
    <arm_group_label>Arm I (brochure)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants receive National Cancer Institute's Facing Forward brochure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (EXCELS website)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants have untimed access to the EXCELS mobile web application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm III (Healthcare coaching call)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants also receive 4 quarterly calls of 15-20 minutes each over 3 months. These calls focus on checking if patients have received preventive and cancer related follow-up care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm IV (EXCELS website, health coaching calls)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Informational Intervention</intervention_name>
    <description>Receive brochure</description>
    <arm_group_label>Arm I (brochure)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Based Intervention</intervention_name>
    <description>Have access to EXCELS</description>
    <arm_group_label>Arm II (EXCELS website)</arm_group_label>
    <arm_group_label>Arm IV (EXCELS website, health coaching calls)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (brochure)</arm_group_label>
    <arm_group_label>Arm II (EXCELS website)</arm_group_label>
    <arm_group_label>Arm III (Healthcare coaching call)</arm_group_label>
    <arm_group_label>Arm IV (EXCELS website, health coaching calls)</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 (brochure)</arm_group_label>
    <arm_group_label>Arm II (EXCELS website)</arm_group_label>
    <arm_group_label>Arm III (Healthcare coaching call)</arm_group_label>
    <arm_group_label>Arm IV (EXCELS website, health coaching calls)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Telephone-Based Intervention</intervention_name>
    <description>Receive quarterly calls</description>
    <arm_group_label>Arm III (Healthcare coaching call)</arm_group_label>
    <arm_group_label>Arm IV (EXCELS website, health coaching calls)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have been diagnosed with localized breast or prostate (stages 1-2) or colorectal&#xD;
             cancer (stage 1-3)&#xD;
&#xD;
          -  Have completed active treatment for their cancer diagnosis (excluding hormonal&#xD;
             therapy)&#xD;
&#xD;
          -  Have access to a phone for contact with health coach&#xD;
&#xD;
          -  Be able to communicate in English; and be competent to consent&#xD;
&#xD;
          -  Usability Testing and the randomized control trial (RCT): have access to a computer, a&#xD;
             smartphone or an i-Pad/tablet equivalent with internet access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are required because of their disease to see primarily oncologists for&#xD;
             follow-up will be excluded (i.e., those diagnosed with lymph node or distant&#xD;
             metastasis, those with a new primary cancer)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shawna Hudson</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers Cancer Institute of New Jersey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2022</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>Breast Neoplasms</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03233555/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03233555
org study id: 131318
secondary id: NCI-2017-01185
secondary id: Pro2013003309
secondary id: 131318
secondary id: R01CA176838
nct id: NCT03233555
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study tests four different methods of educating patients about follow-up care (NCI
      facing forward, brochure, EXCELS website alone, EXCELS health coaching alone and EXCELS
      website & health coaching combination) after cancer treatment ends. While it is known that
      patients need information to guide follow-up it remains unknown how to best provide this in
      primary care.
PRIMARY OBJECTIVES:

      I. Develop the EXCELS intervention to facilitate engaged self-management of cancer follow-up
      for cancer survivors.

      II. Evaluate the efficacy of EXCELS intervention in a small randomized controlled trial.

      III. Assess/refine intervention usability and acceptability for primary care patients.

      OUTLINE:

      PHASE I: EXCELS intervention is developed and assessed.

      PHASE II: Participants are randomized into 1 of 4 arms.

      ARM I: Participants receive National Cancer Institute's Facing Forward brochure.

      ARM II: Participants have untimed access to the EXCELS mobile web application.

      ARM III: Participants also receive 4 calls of 15-20 minutes each over 3 months focusing on
      assisting survivors with addressing challenges to receiving preventive service and health
      care.

      ARM IV: Participants have access to EXCELS website as in Arm II. Participants also receive 4
      health coaching calls as in Arm III.

      Patients are followed up at 6 months, 12 months and 18 months post randomization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Use of preventive services
time frame: Up to 18 months
description: Preventative services will be measured using adherence to evidence based guideline care which will be computed as a percentage of the eligible guideline related services provided to each patient.
arm group label: Arm I (brochure)
arm group type: Active Comparator
description: Participants receive National Cancer Institute's Facing Forward brochure.
arm group label: Arm II (EXCELS website)
arm group type: Experimental
description: Participants have untimed access to the EXCELS mobile web application.
arm group label: Arm III (Healthcare coaching call)
arm group type: Experimental
description: Participants also receive 4 quarterly calls of 15-20 minutes each over 3 months. These calls focus on checking if patients have received preventive and cancer related follow-up care.
arm group label: Arm IV (EXCELS website, health coaching calls)
arm group type: Experimental
description: Participants have access to EXCELS as in Arm II. Participants also receive 4 calls as in Arm III.
intervention type: Other
intervention name: Informational Intervention
description: Receive brochure
arm group label: Arm I (brochure)
intervention type: Other
intervention name: Internet-Based Intervention
description: Have access to EXCELS
arm group label: Arm II (EXCELS website)
arm group label: Arm IV (EXCELS website, health coaching calls)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm I (brochure)
arm group label: Arm II (EXCELS website)
arm group label: Arm III (Healthcare coaching call)
arm group label: Arm IV (EXCELS website, health coaching calls)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (brochure)
arm group label: Arm II (EXCELS website)
arm group label: Arm III (Healthcare coaching call)
arm group label: Arm IV (EXCELS website, health coaching calls)
intervention type: Behavioral
intervention name: Telephone-Based Intervention
description: Receive quarterly calls
arm group label: Arm III (Healthcare coaching call)
arm group label: Arm IV (EXCELS website, health coaching calls)
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Shawna Hudson
role: Principal Investigator
affiliation: Rutgers Cancer Institute of New Jersey
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Prostatic Neoplasms
mesh term: Colorectal Neoplasms
sharing ipd: No
provided document: 