<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/NCT03035773</url>
  </required_header>
  <id_info>
    <org_study_id>J16117</org_study_id>
    <secondary_id>IRB00110605</secondary_id>
    <secondary_id>R-1410-24904</secondary_id>
    <nct_id>NCT03035773</nct_id>
  </id_info>
  <brief_title>Simplifying Survivorship Care Planning</brief_title>
  <acronym>SSCP</acronym>
  <official_title>Simplifying Survivorship Care Planning; Comparing the Efficacy and Patient-Centeredness of Three Care Delivery Models</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      OBJECTIVE: The purpose of this study is to identify an SCP process that is patient-centered,&#xD;
      effective in promoting appropriate survivorship care and can be successfully implemented for&#xD;
      patients with different types of cancer who are being treated in a broad range of clinical&#xD;
      settings. There is a need for research related to SCP that prioritizes outcomes that are most&#xD;
      highly valued by patients, caregivers and clinical stakeholders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Each year, approximately 1.6 million people are diagnosed with cancer and the&#xD;
      relative 5-year survival rate across all cancer types approaches 70%. As of 2014, there were&#xD;
      almost 15 million Americans living with a history of cancer. Cancer survivors face a variety&#xD;
      of health care needs, including surveillance for recurrence, treatment for long-term and late&#xD;
      effects of cancer and its treatment, general primary and preventive care, management of any&#xD;
      comorbidities, encouragement of healthy lifestyle behaviors, and attention to psychosocial&#xD;
      issues. In 2005, the Institute of Medicine (IOM) report 'From Cancer Patient to Cancer&#xD;
      Survivor: Lost in Transition' highlighted the challenges that cancer survivors face as they&#xD;
      transition from acute treatment. The completion of acute cancer treatment is a critical&#xD;
      juncture at which patients are in need of better support and communication to ensure optimal&#xD;
      health and quality of life outcomes as they transition to long-term survivorship. Cancer&#xD;
      survivors face substantial deficiencies in the quality of care that they receive, including&#xD;
      both underuse of recommended care and overuse of services that are not recommended for&#xD;
      routine follow-up. The 2005 IOM report called for all patients completing acute treatment to&#xD;
      be provided with a survivorship care plan (SCP) that summarizes treatments received and&#xD;
      outlines future healthcare priorities in order to facilitate effective management of health&#xD;
      care between survivors and their oncology and primary care providers.&#xD;
&#xD;
      STUDY PROCEDURES: The primary aim of this trial is to assess whether there is a difference&#xD;
      among three SCP models of varying levels of resource intensity and patients' receipt of&#xD;
      recommended health services in the months following completion of acute treatment. The&#xD;
      investigators will conduct a randomized controlled trial (RCT) to measure whether the&#xD;
      provision of the SCP to the survivor and primary care provider (PCP) is associated with&#xD;
      survivors' receipt of cancer follow-up care as outlined on their SCP (primary outcome).&#xD;
      Avoidance of non-recommended care, receipt of recommended primary and preventive care, and&#xD;
      patient-reported outcome measures will serve as secondary endpoints.&#xD;
&#xD;
      Participants in the RCT will have been treated for breast, prostate, or colorectal cancer.&#xD;
      This RCT will be conducted in four oncology clinics in two medical systems. The investigators&#xD;
      will enroll survivors of Stage I-III breast, prostate, or colorectal cancer who are&#xD;
      completing treatment and transitioning to long-term survivorship, and use a stratified&#xD;
      randomization to assign participants to one of three study conditions (Arms A, B or C). This&#xD;
      study will focus specifically on the period following completion of acute treatment (e.g.,&#xD;
      surgery, radiation, and chemotherapy); patients receiving long-term adjuvant&#xD;
      endocrine/antibody therapies will also be eligible.&#xD;
&#xD;
      The proposed trial will be conducted at Johns Hopkins Medical Institution (JHMI) and&#xD;
      Peninsula Regional Medical Center (PRMC). JHMI is a large, academic medical center in an&#xD;
      urban setting with distinct treatment programs based on disease site. At JHMI, the&#xD;
      investigators will recruit from the Breast Cancer Program, the Genitourinary Cancer Program&#xD;
      (prostate cancer), and Gastrointestinal Cancer Program (colorectal cancer). These programs&#xD;
      operate across disciplines (e.g., medical, radiation, and surgical oncology) but separately&#xD;
      from each other, enabling evaluation of 3 separate clinical settings within JHMI. In&#xD;
      addition, the trial will include the PRMC Richard A. Henson Cancer Institute, a community&#xD;
      cancer program located in the rural area of Maryland's eastern shore. At PRMC there is a&#xD;
      single general oncology practice. The four programs differ in the extent to which&#xD;
      survivorship care planning is already a part of routine care. As yet, none of the clinics in&#xD;
      this study has a consistent format for the delivery of SCP universally at the completion of&#xD;
      acute treatment. The study design (cancer types, clinical systems and SCP models) is intended&#xD;
      to enable the development of real-world best practices for the implementation of SCPs and&#xD;
      assess whether these are consistent or vary across a wide range of clinical contexts and&#xD;
      survivor characteristics.&#xD;
&#xD;
      Each participant will be followed for 18 months, with the number of visits dependent on the&#xD;
      randomization arm (described below). The investigators will abstract 18 months of follow-up&#xD;
      data for enrolled patients from medical records, as well as from patient reports of health&#xD;
      service use; data will be collected at months 6, 12, and 18. The investigators will obtain&#xD;
      and abstract medical records guided by the information in the summary document (see Health&#xD;
      Services Use Summary included as a supplemental study document) and from the patient using&#xD;
      provided tracking tools of providers they have seen, tests they have undergone, etc. (see Tip&#xD;
      Sheet in supplemental study documents). Patient-reported outcomes will be collected at&#xD;
      baseline, 6, 12, and 18 months primarily via a REDCap form, with telephone or in-person data&#xD;
      collection as a back-up when needed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Receipt of appropriate cancer-related follow-up care</measure>
    <time_frame>18 Months</time_frame>
    <description>The primary endpoint of this study will be the proportion of patients who receive appropriate cancer-related follow-up care (based on the individual's SCP). The outcome will be operationalized as a dichotomous variable (received recommended care: yes/no). This endpoint will be used to determine the preferable delivery modality (study arm).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Receipt of appropriate primary care</measure>
    <time_frame>18 Months</time_frame>
    <description>This outcome will be operationalized as a dichotomous variable (received recommended primary care: yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of appropriate preventive care</measure>
    <time_frame>18 Months</time_frame>
    <description>This outcome will be operationalized as a dichotomous variable (received recommended preventive care: yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Not receiving tests that are not recommended</measure>
    <time_frame>18 Months</time_frame>
    <description>This outcome will be operationalized as a dichotomous variable (did not receive inappropriate care: yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of individual care services.</measure>
    <time_frame>18 Months</time_frame>
    <description>For example, the primary dichotomous outcome for colorectal cancer patients may include receipt of colonoscopy and CEA testing; we will examine receipt of each of those services separately. Each of these outcomes will be operationalized as a dichotomous variable (received colonoscopy: yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported Outcomes: Preparing for Life as a (New) Survivor (PLANS)</measure>
    <time_frame>18 Months</time_frame>
    <description>Scores will be compared at different timepoints for the assessment:&#xD;
Preparing for Life as a (New) Survivor (PLANS): 11 knowledge items rated on a 4-point Likert scale that was developed at the University of Michigan and was used by our team in a previous survivorship care planning evaluation (Dunn, R., Crowley, S., &amp; Janz, N., 2011; Smith et al., 2016).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported Outcomes: Assessment of Survivor Concerns (ASC)</measure>
    <time_frame>18 Months</time_frame>
    <description>Scores will be compared at different timepoints for the assessment:&#xD;
Assessment of Survivor Concerns (ASC): a 5-item questionnaire that assesses two subscales: cancer worry and general health worry (Gotay, C. C., &amp; Pagano, I. S., 2007; Hershman, D. L., et al., 2013).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported Outcomes: Follow-up Care Use among Survivors (FOCUS)-Information Needs Module</measure>
    <time_frame>18 Months</time_frame>
    <description>Scores will be compared at different timepoints for the assessment:&#xD;
Follow-up Care Use among Survivors (FOCUS)-Information Needs Module (Kent, E. E., et al., 2012): an information needs questionnaire that asks about the need for information regarding 12 topics; developed by the National Cancer Institute based on previously published information needs questionnaires (Beckjord, E. B., et al., 2008; Mallinger, et al., 2005; Nelson, et al., 2004).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">405</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>ARM A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCP document delivered to the patient &amp; Primary Care Provider</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ARM C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care Plan Only</intervention_name>
    <description>Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.</description>
    <arm_group_label>ARM A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care Plan During a Visit</intervention_name>
    <description>Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.</description>
    <arm_group_label>ARM B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Care Plan During a Visit with an Additional Visit</intervention_name>
    <description>Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.</description>
    <arm_group_label>ARM C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 21 years or older;&#xD;
&#xD;
          -  Diagnosed with breast, colorectal, or prostate cancer (stages I-III);&#xD;
&#xD;
          -  Treated with intent to cure&#xD;
&#xD;
          -  People who are on long-term (&gt;1 year) chronic treatment are eligible;&#xD;
&#xD;
          -  No evidence of disease;&#xD;
&#xD;
          -  Able to complete the study data collection in English;&#xD;
&#xD;
          -  Had their cancer care primarily managed by either JHMI or PRMC, with JHMI or PRMC&#xD;
             primarily responsible for the patients' survivorship care; and&#xD;
&#xD;
          -  Has private insurance, or covered by Medicare or Medicaid.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 21 years of age;&#xD;
&#xD;
          -  Diagnosed with in situ or metastatic breast, prostate or colorectal cancer (i.e. Stage&#xD;
             0 or IV);&#xD;
&#xD;
          -  Not treated with intent to cure;&#xD;
&#xD;
          -  Did not have cancer care primarily managed within one of the 4 participating clinics,&#xD;
             or JHMI or PRMC is not primarily responsible for the patients' survivorship care; and&#xD;
&#xD;
          -  Does not have health insurance at screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine C Smith, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins Bloomberg School of Public Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Regional Medical Center</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Beckjord EB, Arora NK, McLaughlin W, Oakley-Girvan I, Hamilton AS, Hesse BW. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008 Sep;2(3):179-89. doi: 10.1007/s11764-008-0055-0. Epub 2008 Jun 3.</citation>
    <PMID>18792791</PMID>
  </reference>
  <reference>
    <citation>Dunn, R., Crowley, S., &amp; Janz, N. (2011). Impact of a transition visit on addressing quality of life and readiness to assume greater self-management among breast cancer survivors. Psycho-Oncology, 20(S1), S91.</citation>
  </reference>
  <reference>
    <citation>Gotay CC, Pagano IS. Assessment of Survivor Concerns (ASC): a newly proposed brief questionnaire. Health Qual Life Outcomes. 2007 Mar 13;5:15. doi: 10.1186/1477-7525-5-15.</citation>
    <PMID>17352831</PMID>
  </reference>
  <reference>
    <citation>Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, Brafman L, Jayasena R, Tsai WY, Neugut AI, Crew KD. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013 Apr;138(3):795-806. doi: 10.1007/s10549-013-2486-1. Epub 2013 Mar 31.</citation>
    <PMID>23542954</PMID>
  </reference>
  <reference>
    <citation>Hewitt, M., Greenfield, S., &amp; Stovall, E. (Eds.). (2005). From cancer patient to cancer survivor: lost in transition. National Academies Press.</citation>
  </reference>
  <reference>
    <citation>Kent EE, Arora NK, Rowland JH, Bellizzi KM, Forsythe LP, Hamilton AS, Oakley-Girvan I, Beckjord EB, Aziz NM. Health information needs and health-related quality of life in a diverse population of long-term cancer survivors. Patient Educ Couns. 2012 Nov;89(2):345-52. doi: 10.1016/j.pec.2012.08.014. Epub 2012 Sep 28.</citation>
    <PMID>23021856</PMID>
  </reference>
  <reference>
    <citation>Mallinger JB, Griggs JJ, Shields CG. Patient-centered care and breast cancer survivors' satisfaction with information. Patient Educ Couns. 2005 Jun;57(3):342-9. doi: 10.1016/j.pec.2004.09.009.</citation>
    <PMID>15893218</PMID>
  </reference>
  <reference>
    <citation>Nelson DE, Kreps GL, Hesse BW, Croyle RT, Willis G, Arora NK, Rimer BK, Viswanath KV, Weinstein N, Alden S. The Health Information National Trends Survey (HINTS): development, design, and dissemination. J Health Commun. 2004 Sep-Oct;9(5):443-60; discussion 81-4. doi: 10.1080/10810730490504233.</citation>
    <PMID>15513791</PMID>
  </reference>
  <reference>
    <citation>Smith KC, Tolbert E, Hannum SM, Radhakrishnan A, Zorn K, Blackford A, Greco S, Smith K, Snyder CF. Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. JMIR Cancer. 2016 Aug 30;2(2):e12. doi: 10.2196/cancer.5947.</citation>
    <PMID>28410187</PMID>
  </reference>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oncology</keyword>
  <keyword>Survivorship</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>February 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03035773
org study id: J16117
secondary id: IRB00110605
secondary id: R-1410-24904
nct id: NCT03035773
lead sponsor: 
collaborator: 
has dmc: No
OBJECTIVE: The purpose of this study is to identify an SCP process that is patient-centered,
      effective in promoting appropriate survivorship care and can be successfully implemented for
      patients with different types of cancer who are being treated in a broad range of clinical
      settings. There is a need for research related to SCP that prioritizes outcomes that are most
      highly valued by patients, caregivers and clinical stakeholders.
BACKGROUND: Each year, approximately 1.6 million people are diagnosed with cancer and the
      relative 5-year survival rate across all cancer types approaches 70%. As of 2014, there were
      almost 15 million Americans living with a history of cancer. Cancer survivors face a variety
      of health care needs, including surveillance for recurrence, treatment for long-term and late
      effects of cancer and its treatment, general primary and preventive care, management of any
      comorbidities, encouragement of healthy lifestyle behaviors, and attention to psychosocial
      issues. In 2005, the Institute of Medicine (IOM) report 'From Cancer Patient to Cancer
      Survivor: Lost in Transition' highlighted the challenges that cancer survivors face as they
      transition from acute treatment. The completion of acute cancer treatment is a critical
      juncture at which patients are in need of better support and communication to ensure optimal
      health and quality of life outcomes as they transition to long-term survivorship. Cancer
      survivors face substantial deficiencies in the quality of care that they receive, including
      both underuse of recommended care and overuse of services that are not recommended for
      routine follow-up. The 2005 IOM report called for all patients completing acute treatment to
      be provided with a survivorship care plan (SCP) that summarizes treatments received and
      outlines future healthcare priorities in order to facilitate effective management of health
      care between survivors and their oncology and primary care providers.

      STUDY PROCEDURES: The primary aim of this trial is to assess whether there is a difference
      among three SCP models of varying levels of resource intensity and patients' receipt of
      recommended health services in the months following completion of acute treatment. The
      investigators will conduct a randomized controlled trial (RCT) to measure whether the
      provision of the SCP to the survivor and primary care provider (PCP) is associated with
      survivors' receipt of cancer follow-up care as outlined on their SCP (primary outcome).
      Avoidance of non-recommended care, receipt of recommended primary and preventive care, and
      patient-reported outcome measures will serve as secondary endpoints.

      Participants in the RCT will have been treated for breast, prostate, or colorectal cancer.
      This RCT will be conducted in four oncology clinics in two medical systems. The investigators
      will enroll survivors of Stage I-III breast, prostate, or colorectal cancer who are
      completing treatment and transitioning to long-term survivorship, and use a stratified
      randomization to assign participants to one of three study conditions (Arms A, B or C). This
      study will focus specifically on the period following completion of acute treatment (e.g.,
      surgery, radiation, and chemotherapy); patients receiving long-term adjuvant
      endocrine/antibody therapies will also be eligible.

      The proposed trial will be conducted at Johns Hopkins Medical Institution (JHMI) and
      Peninsula Regional Medical Center (PRMC). JHMI is a large, academic medical center in an
      urban setting with distinct treatment programs based on disease site. At JHMI, the
      investigators will recruit from the Breast Cancer Program, the Genitourinary Cancer Program
      (prostate cancer), and Gastrointestinal Cancer Program (colorectal cancer). These programs
      operate across disciplines (e.g., medical, radiation, and surgical oncology) but separately
      from each other, enabling evaluation of 3 separate clinical settings within JHMI. In
      addition, the trial will include the PRMC Richard A. Henson Cancer Institute, a community
      cancer program located in the rural area of Maryland's eastern shore. At PRMC there is a
      single general oncology practice. The four programs differ in the extent to which
      survivorship care planning is already a part of routine care. As yet, none of the clinics in
      this study has a consistent format for the delivery of SCP universally at the completion of
      acute treatment. The study design (cancer types, clinical systems and SCP models) is intended
      to enable the development of real-world best practices for the implementation of SCPs and
      assess whether these are consistent or vary across a wide range of clinical contexts and
      survivor characteristics.

      Each participant will be followed for 18 months, with the number of visits dependent on the
      randomization arm (described below). The investigators will abstract 18 months of follow-up
      data for enrolled patients from medical records, as well as from patient reports of health
      service use; data will be collected at months 6, 12, and 18. The investigators will obtain
      and abstract medical records guided by the information in the summary document (see Health
      Services Use Summary included as a supplemental study document) and from the patient using
      provided tracking tools of providers they have seen, tests they have undergone, etc. (see Tip
      Sheet in supplemental study documents). Patient-reported outcomes will be collected at
      baseline, 6, 12, and 18 months primarily via a REDCap form, with telephone or in-person data
      collection as a back-up when needed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Receipt of appropriate cancer-related follow-up care
time frame: 18 Months
description: The primary endpoint of this study will be the proportion of patients who receive appropriate cancer-related follow-up care (based on the individual's SCP). The outcome will be operationalized as a dichotomous variable (received recommended care: yes/no). This endpoint will be used to determine the preferable delivery modality (study arm).
measure: Receipt of appropriate primary care
time frame: 18 Months
description: This outcome will be operationalized as a dichotomous variable (received recommended primary care: yes/no).
measure: Receipt of appropriate preventive care
time frame: 18 Months
description: This outcome will be operationalized as a dichotomous variable (received recommended preventive care: yes/no).
measure: Not receiving tests that are not recommended
time frame: 18 Months
description: This outcome will be operationalized as a dichotomous variable (did not receive inappropriate care: yes/no).
measure: Receipt of individual care services.
time frame: 18 Months
description: For example, the primary dichotomous outcome for colorectal cancer patients may include receipt of colonoscopy and CEA testing; we will examine receipt of each of those services separately. Each of these outcomes will be operationalized as a dichotomous variable (received colonoscopy: yes/no).
measure: Patient-reported Outcomes: Preparing for Life as a (New) Survivor (PLANS)
time frame: 18 Months
description: Scores will be compared at different timepoints for the assessment:
Preparing for Life as a (New) Survivor (PLANS): 11 knowledge items rated on a 4-point Likert scale that was developed at the University of Michigan and was used by our team in a previous survivorship care planning evaluation (Dunn, R., Crowley, S., & Janz, N., 2011; Smith et al., 2016).
measure: Patient-reported Outcomes: Assessment of Survivor Concerns (ASC)
time frame: 18 Months
description: Scores will be compared at different timepoints for the assessment:
Assessment of Survivor Concerns (ASC): a 5-item questionnaire that assesses two subscales: cancer worry and general health worry (Gotay, C. C., & Pagano, I. S., 2007; Hershman, D. L., et al., 2013).
measure: Patient-reported Outcomes: Follow-up Care Use among Survivors (FOCUS)-Information Needs Module
time frame: 18 Months
description: Scores will be compared at different timepoints for the assessment:
Follow-up Care Use among Survivors (FOCUS)-Information Needs Module (Kent, E. E., et al., 2012): an information needs questionnaire that asks about the need for information regarding 12 topics; developed by the National Cancer Institute based on previously published information needs questionnaires (Beckjord, E. B., et al., 2008; Mallinger, et al., 2005; Nelson, et al., 2004).
arm group label: ARM A
arm group type: Experimental
description: SCP document delivered to the patient & Primary Care Provider
arm group label: ARM B
arm group type: Experimental
description: SCP document provided to the patient in an in-person survivorship visit and copy sent to PCP
arm group label: ARM C
arm group type: Experimental
description: SCP document provided to the patient in an in-person survivorship visit with an additional follow-up visit and copy of the document sent to PCP
intervention type: Behavioral
intervention name: Care Plan Only
description: Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.
arm group label: ARM A
intervention type: Behavioral
intervention name: Care Plan During a Visit
description: Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.
arm group label: ARM B
intervention type: Behavioral
intervention name: Care Plan During a Visit with an Additional Visit
description: Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
arm group label: ARM C
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Katherine C Smith, PhD
role: Principal Investigator
affiliation: Johns Hopkins Bloomberg School of Public Health
facility: 
facility: 
country: United States
citation: Beckjord EB, Arora NK, McLaughlin W, Oakley-Girvan I, Hamilton AS, Hesse BW. Health-related information needs in a large and diverse sample of adult cancer survivors: implications for cancer care. J Cancer Surviv. 2008 Sep;2(3):179-89. doi: 10.1007/s11764-008-0055-0. Epub 2008 Jun 3.
PMID: 18792791
citation: Dunn, R., Crowley, S., & Janz, N. (2011). Impact of a transition visit on addressing quality of life and readiness to assume greater self-management among breast cancer survivors. Psycho-Oncology, 20(S1), S91.
citation: Gotay CC, Pagano IS. Assessment of Survivor Concerns (ASC): a newly proposed brief questionnaire. Health Qual Life Outcomes. 2007 Mar 13;5:15. doi: 10.1186/1477-7525-5-15.
PMID: 17352831
citation: Hershman DL, Greenlee H, Awad D, Kalinsky K, Maurer M, Kranwinkel G, Brafman L, Jayasena R, Tsai WY, Neugut AI, Crew KD. Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Breast Cancer Res Treat. 2013 Apr;138(3):795-806. doi: 10.1007/s10549-013-2486-1. Epub 2013 Mar 31.
PMID: 23542954
citation: Hewitt, M., Greenfield, S., & Stovall, E. (Eds.). (2005). From cancer patient to cancer survivor: lost in transition. National Academies Press.
citation: Kent EE, Arora NK, Rowland JH, Bellizzi KM, Forsythe LP, Hamilton AS, Oakley-Girvan I, Beckjord EB, Aziz NM. Health information needs and health-related quality of life in a diverse population of long-term cancer survivors. Patient Educ Couns. 2012 Nov;89(2):345-52. doi: 10.1016/j.pec.2012.08.014. Epub 2012 Sep 28.
PMID: 23021856
citation: Mallinger JB, Griggs JJ, Shields CG. Patient-centered care and breast cancer survivors' satisfaction with information. Patient Educ Couns. 2005 Jun;57(3):342-9. doi: 10.1016/j.pec.2004.09.009.
PMID: 15893218
citation: Nelson DE, Kreps GL, Hesse BW, Croyle RT, Willis G, Arora NK, Rimer BK, Viswanath KV, Weinstein N, Alden S. The Health Information National Trends Survey (HINTS): development, design, and dissemination. J Health Commun. 2004 Sep-Oct;9(5):443-60; discussion 81-4. doi: 10.1080/10810730490504233.
PMID: 15513791
citation: Smith KC, Tolbert E, Hannum SM, Radhakrishnan A, Zorn K, Blackford A, Greco S, Smith K, Snyder CF. Comparing Web-Based Provider-Initiated and Patient-Initiated Survivorship Care Planning for Cancer Patients: A Randomized Controlled Trial. JMIR Cancer. 2016 Aug 30;2(2):e12. doi: 10.2196/cancer.5947.
PMID: 28410187
responsible party type: Sponsor
sharing ipd: No
submitted: February 9, 2023