<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/NCT02200133</url>
  </required_header>
  <id_info>
    <org_study_id>13-SCP</org_study_id>
    <nct_id>NCT02200133</nct_id>
  </id_info>
  <brief_title>Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors</brief_title>
  <official_title>Randomized Study of Individualized Care Plans for Hematopoietic Cell Transplant Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center for International Blood and Marrow Transplant Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Marrow Donor Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Center for International Blood and Marrow Transplant Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized study will compare a personalized Survivorship Care Plan (SCP) template with&#xD;
      usual care (no SCP). The investigators hypothesize that the personalized SCP that&#xD;
      incorporates patient specific treatment exposures and provides a framework for long term&#xD;
      followup based on those exposures and subsequent risks for late complications will enhance&#xD;
      patient survivorship confidence in knowledge, increase adherence to recommended healthcare,&#xD;
      improve health behaviors and reduce HCT-related emotional distress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized study will compare a personalized Survivorship Care Plan (SCP) template with&#xD;
      usual care (no SCP). The investigators hypothesize that the personalized SCP that&#xD;
      incorporates patient specific treatment exposures and provides a framework for long term&#xD;
      followup based on those exposures and subsequent risks for late complications will enhance&#xD;
      patient survivorship confidence in knowledge, increase adherence to recommended healthcare,&#xD;
      improve health behaviors and reduce hematopoietic cell transplant (HCT) - related emotional&#xD;
      distress.&#xD;
&#xD;
      The randomized study design will be able to evaluate the efficacy of individualized SCP in&#xD;
      enhancing transplant survivor knowledge, health behaviors and health care utilization for&#xD;
      recommended preventive care. Most transplant centers do not use a standardized SCP for their&#xD;
      HCT recipients, and hence, the control arm would represent prevalent standard of care (e.g.,&#xD;
      discharge summary, provider-to-provider communication).&#xD;
&#xD;
      Transplant centers that will participate in this study will represent a spectrum of center&#xD;
      types (e.g., geographic location, center volume, resources and infrastructure) and patient&#xD;
      populations (e.g., healthcare disparities, urban/rural population, distance from transplant&#xD;
      center). Usual care for each center will be documented at the time of determining center&#xD;
      eligibility. The study principal investigators, in consultation with the protocol team, will&#xD;
      make the determination about center eligibility after reviewing the centers &quot;usual care&quot;&#xD;
      procedures. In order to avoid contamination of the study intervention, centers will be asked&#xD;
      not to change their follow-up practices for the period they are enrolling patients on the&#xD;
      study.&#xD;
&#xD;
      The primary objective of the investigators study is to evaluate the impact of an&#xD;
      individualized SCP on survivor knowledge about past diagnostic and treatment details,&#xD;
      confidence in knowledge about prevention and treatment of late-effects, access to resources&#xD;
      and familial risk of cancer. For this objective, the investigators will compare the change in&#xD;
      score on the Confidence in Survivorship Information instrument from baseline to 6 months&#xD;
      after the study intervention.&#xD;
&#xD;
      Secondary objectives will investigate the influence of individualized SCP on standardized&#xD;
      measures of HCT related distress, knowledge of recommended care, health behaviors,&#xD;
      self-efficacy, and health care utilization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Confidence in Survivorship Information instrument score</measure>
    <time_frame>baseline to 6 months after the study intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HCT treatment distress instrument score</measure>
    <time_frame>baseline to 6 months after the study intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Health behaviors instrument score</measure>
    <time_frame>baseline to 6 months after the study intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Healthcare utilization instrument score</measure>
    <time_frame>baseline to 6 months after the study intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knowledge about transplant exposures instrument score</measure>
    <time_frame>baseline to 6 months after the study intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life instrument score</measure>
    <time_frame>baseline to 6 months after the study intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-efficacy instrument score</measure>
    <time_frame>baseline to 6 months after the study intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">495</enrollment>
  <condition>Adult Hematopoietic Cell Transplant (HCT) Survivors 1-2 Yrs Post Most Recent HCT</condition>
  <arm_group>
    <arm_group_label>Individualized Survivorship Care Plan (SCP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participant information sheet and instructions on how to use the SCP&#xD;
Patient version of individualized SCP that includes but is not limited to: (1) a treatment summary that consists of disease characteristics and treatment details (including HCT), and (2) recommendations for preventive care and screening for late complications based on patient treatment exposures (age, type of transplant, use of TBI, corticosteroid exposure as part of HCT, and history of GVHD)&#xD;
Newest Vital Sign nutrition label to measure health literacy and its instructions&#xD;
Participants may receive other materials their transplant center routinely provides to patients for follow-up care (e.g., discharge summary or clinic note)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care (no SCP)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Materials that their transplant center routinely provides to patients for follow-up care&#xD;
Newest Vital Sign nutrition label to measure health literacy and its instructions&#xD;
Participants randomized to the usual care arm who complete the 6 month study assessments will receive their individualized SCP upon completion of the patient's participation. Participants who withdraw from the study or who do not complete the 6 month assessment will not receive the individualized SCP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Individualized Survivorship Care Plan (SCP)</intervention_name>
    <description>The individualized SCP incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications.</description>
    <arm_group_label>Individualized Survivorship Care Plan (SCP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (≥ 18 years at time of allogeneic HCT recipient at participating transplant&#xD;
             centers)&#xD;
&#xD;
          -  Survival 1-2 years after most recent HCT with no evidence of relapse, disease&#xD;
             progression, or secondary cancer on last follow-up&#xD;
&#xD;
          -  All diagnoses will be eligible&#xD;
&#xD;
          -  All transplant types will be eligible (autologous or allogeneic related or unrelated)&#xD;
&#xD;
          -  All graft sources will be eligible (bone marrow, peripheral blood or umbilical cord&#xD;
             blood)&#xD;
&#xD;
          -  All conditioning regimens will be eligible (in case of allogeneic HCT, patient could&#xD;
             have received myeloablative or non-myeloablative/reduced-intensity conditioning)&#xD;
&#xD;
          -  Patient may have received more than one HCT&#xD;
&#xD;
          -  Patient must be proficient in English (written and spoken) to complete study&#xD;
             assessments&#xD;
&#xD;
          -  Patient must have a valid mailing address within the United States to receive study&#xD;
             materials&#xD;
&#xD;
          -  Signed informed consent form from patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients who have received their transplant at a different transplant center will not be&#xD;
        eligible for 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>Elizabeth Murphy, EdD, RN</last_name>
    <role>Study Chair</role>
    <affiliation>National Marrow Donor Program</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Navneet Majhail, MD, MS</last_name>
    <role>Study Chair</role>
    <affiliation>Cleveland Clinic Foundation; National Marrow Donor Program</affiliation>
  </overall_official>
  <overall_official>
    <last_name>K Scott Baker, MD, MS</last_name>
    <role>Study Chair</role>
    <affiliation>Fred Hutchinson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259-5499</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida, Shands Hospital</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt-Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hematopoietic cell transplant (HCT) survivors</keyword>
  <keyword>Survivorship Care Plan</keyword>
  <pending_results>
    <submitted>February 28, 2018</submitted>
    <returned>October 8, 2018</returned>
  </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/NCT02200133
org study id: 13-SCP
nct id: NCT02200133
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This randomized study will compare a personalized Survivorship Care Plan (SCP) template with
      usual care (no SCP). The investigators hypothesize that the personalized SCP that
      incorporates patient specific treatment exposures and provides a framework for long term
      followup based on those exposures and subsequent risks for late complications will enhance
      patient survivorship confidence in knowledge, increase adherence to recommended healthcare,
      improve health behaviors and reduce HCT-related emotional distress.
This randomized study will compare a personalized Survivorship Care Plan (SCP) template with
      usual care (no SCP). The investigators hypothesize that the personalized SCP that
      incorporates patient specific treatment exposures and provides a framework for long term
      followup based on those exposures and subsequent risks for late complications will enhance
      patient survivorship confidence in knowledge, increase adherence to recommended healthcare,
      improve health behaviors and reduce hematopoietic cell transplant (HCT) - related emotional
      distress.

      The randomized study design will be able to evaluate the efficacy of individualized SCP in
      enhancing transplant survivor knowledge, health behaviors and health care utilization for
      recommended preventive care. Most transplant centers do not use a standardized SCP for their
      HCT recipients, and hence, the control arm would represent prevalent standard of care (e.g.,
      discharge summary, provider-to-provider communication).

      Transplant centers that will participate in this study will represent a spectrum of center
      types (e.g., geographic location, center volume, resources and infrastructure) and patient
      populations (e.g., healthcare disparities, urban/rural population, distance from transplant
      center). Usual care for each center will be documented at the time of determining center
      eligibility. The study principal investigators, in consultation with the protocol team, will
      make the determination about center eligibility after reviewing the centers "usual care"
      procedures. In order to avoid contamination of the study intervention, centers will be asked
      not to change their follow-up practices for the period they are enrolling patients on the
      study.

      The primary objective of the investigators study is to evaluate the impact of an
      individualized SCP on survivor knowledge about past diagnostic and treatment details,
      confidence in knowledge about prevention and treatment of late-effects, access to resources
      and familial risk of cancer. For this objective, the investigators will compare the change in
      score on the Confidence in Survivorship Information instrument from baseline to 6 months
      after the study intervention.

      Secondary objectives will investigate the influence of individualized SCP on standardized
      measures of HCT related distress, knowledge of recommended care, health behaviors,
      self-efficacy, and health care utilization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Confidence in Survivorship Information instrument score
time frame: baseline to 6 months after the study intervention
measure: Change in HCT treatment distress instrument score
time frame: baseline to 6 months after the study intervention
measure: Change in Health behaviors instrument score
time frame: baseline to 6 months after the study intervention
measure: Changes in Healthcare utilization instrument score
time frame: baseline to 6 months after the study intervention
measure: Change in Knowledge about transplant exposures instrument score
time frame: baseline to 6 months after the study intervention
measure: Change in Quality of life instrument score
time frame: baseline to 6 months after the study intervention
measure: Change in Self-efficacy instrument score
time frame: baseline to 6 months after the study intervention
arm group label: Individualized Survivorship Care Plan (SCP)
arm group type: Experimental
description: Participant information sheet and instructions on how to use the SCP
Patient version of individualized SCP that includes but is not limited to: (1) a treatment summary that consists of disease characteristics and treatment details (including HCT), and (2) recommendations for preventive care and screening for late complications based on patient treatment exposures (age, type of transplant, use of TBI, corticosteroid exposure as part of HCT, and history of GVHD)
Newest Vital Sign nutrition label to measure health literacy and its instructions
Participants may receive other materials their transplant center routinely provides to patients for follow-up care (e.g., discharge summary or clinic note)
arm group label: Usual care (no SCP)
arm group type: No Intervention
description: Materials that their transplant center routinely provides to patients for follow-up care
Newest Vital Sign nutrition label to measure health literacy and its instructions
Participants randomized to the usual care arm who complete the 6 month study assessments will receive their individualized SCP upon completion of the patient's participation. Participants who withdraw from the study or who do not complete the 6 month assessment will not receive the individualized SCP.
intervention type: Other
intervention name: Individualized Survivorship Care Plan (SCP)
description: The individualized SCP incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications.
arm group label: Individualized Survivorship Care Plan (SCP)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth Murphy, EdD, RN
role: Study Chair
affiliation: National Marrow Donor Program
last name: Navneet Majhail, MD, MS
role: Study Chair
affiliation: Cleveland Clinic Foundation; National Marrow Donor Program
last name: K Scott Baker, MD, MS
role: Study Chair
affiliation: Fred Hutchinson Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
submitted: February 28, 2018
returned: October 8, 2018