<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/NCT03028961</url>
  </required_header>
  <id_info>
    <org_study_id>BMT313</org_study_id>
    <nct_id>NCT03028961</nct_id>
  </id_info>
  <brief_title>Stanford Letter or Traditional Advance Directive in Advance Care Planning in Patients Undergoing Bone Marrow Transplant</brief_title>
  <acronym>BMTSLPRCT</acronym>
  <official_title>Randomized Clinical Study Comparing the Effectiveness of the Stanford Letter to the Traditional Advance Directive in Bone Marrow Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the proposed research study is to evaluate whether bone marrow transplant&#xD;
      patients prefer the Stanford letter advance care planning tool to the standard Advance&#xD;
      directive.&#xD;
&#xD;
      Completion of advance care planning prior to BMT is very important, but not often done. The&#xD;
      investigators believe that the Stanford Letter will be preferred by patients and will allow&#xD;
      them to feel more comfortable and share more of their wishes with family members and the&#xD;
      medical team.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES I. To compare advance care planning (ACP) completion rate amongst bone&#xD;
      marrow transplant (BMT) recipients receiving the Stanford Letter versus the traditional&#xD;
      advance directive (AD) through a prospective, pilot randomized controlled trial (RCT).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate differences in patient preference for choice to prolong life following&#xD;
      completion of the ACP tool in each group.&#xD;
&#xD;
      II. To assess uncertainty with decision making regarding end of life care following&#xD;
      completion of the ACP tool in each group.&#xD;
&#xD;
      III. To explore patient understanding of and satisfaction with the ACP tool in each group.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 groups.&#xD;
&#xD;
      GROUP I (INTERVENTION): Patients listen to a dialogue on the purpose of ACP. Patients receive&#xD;
      a paper copy and online web link to the Stanford Letter and complete and return the form by&#xD;
      the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured,&#xD;
      research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life&#xD;
      decisions, understanding of the ACP form received, and satisfaction with the ACP form.&#xD;
&#xD;
      GROUP II (CONTROL): Patients listen to a dialogue on the purpose of ACP. Patients receive a&#xD;
      paper copy and online web link to the California (CA) Advance Health Care Directive Form and&#xD;
      complete and return the form by the day of BMT. After completion of the CA Advance Health&#xD;
      Care Directive Form, patients undergo interview as in Group I.&#xD;
&#xD;
      After completion of study, patients are followed up periodically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 3, 2017</start_date>
  <completion_date type="Actual">July 27, 2021</completion_date>
  <primary_completion_date type="Actual">September 14, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record</measure>
    <time_frame>Up to BMT day 0</time_frame>
    <description>The chi-square (X^2) test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation</measure>
    <time_frame>Up to BMT day 0</time_frame>
    <description>The X^2 test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results</measure>
    <time_frame>Up to BMT day 0</time_frame>
    <description>Will be measured using the DCS uncertainty sub-scale (score 0-15; higher score indicates greater uncertainty). Scores from each group will be compared by t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS</measure>
    <time_frame>within 28 days of ACP completion</time_frame>
    <description>Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making). Likert scores of understanding of the ACP from each group will be summarized and compared by t-tests.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS</measure>
    <time_frame>within 28 days of ACP completion</time_frame>
    <description>Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making). Scores from each group will be compared by t-tests. Likert scores of satisfaction with the ACP will be summarized and compared by group using t-tests.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Advance Directives</condition>
  <condition>Bone Marrow Transplant</condition>
  <arm_group>
    <arm_group_label>Group I (Stanford Letter, interview)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (traditional advance directive, interview)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stanford Letter</intervention_name>
    <description>Receive and complete the Stanford Letter</description>
    <arm_group_label>Group I (Stanford Letter, interview)</arm_group_label>
    <other_name>Communication Intervention</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Undergo semi-structured, research staff-led interview</description>
    <arm_group_label>Group I (Stanford Letter, interview)</arm_group_label>
    <arm_group_label>Group II (traditional advance directive, interview)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Group I (Stanford Letter, interview)</arm_group_label>
    <arm_group_label>Group II (traditional advance directive, interview)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CA Advance Health Care Directive Form</intervention_name>
    <description>Receive and complete the CA Advance Health Care Directive Form</description>
    <arm_group_label>Group II (traditional advance directive, interview)</arm_group_label>
    <other_name>Communication Intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All BMT patients at Stanford who are adults and give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori Muffly, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University, School of Medicine</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>June 10, 2022</last_update_submitted>
  <last_update_submitted_qc>June 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03028961
org study id: BMT313
nct id: NCT03028961
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the proposed research study is to evaluate whether bone marrow transplant
      patients prefer the Stanford letter advance care planning tool to the standard Advance
      directive.

      Completion of advance care planning prior to BMT is very important, but not often done. The
      investigators believe that the Stanford Letter will be preferred by patients and will allow
      them to feel more comfortable and share more of their wishes with family members and the
      medical team.
PRIMARY OBJECTIVES I. To compare advance care planning (ACP) completion rate amongst bone
      marrow transplant (BMT) recipients receiving the Stanford Letter versus the traditional
      advance directive (AD) through a prospective, pilot randomized controlled trial (RCT).

      SECONDARY OBJECTIVES:

      I. To evaluate differences in patient preference for choice to prolong life following
      completion of the ACP tool in each group.

      II. To assess uncertainty with decision making regarding end of life care following
      completion of the ACP tool in each group.

      III. To explore patient understanding of and satisfaction with the ACP tool in each group.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I (INTERVENTION): Patients listen to a dialogue on the purpose of ACP. Patients receive
      a paper copy and online web link to the Stanford Letter and complete and return the form by
      the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured,
      research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life
      decisions, understanding of the ACP form received, and satisfaction with the ACP form.

      GROUP II (CONTROL): Patients listen to a dialogue on the purpose of ACP. Patients receive a
      paper copy and online web link to the California (CA) Advance Health Care Directive Form and
      complete and return the form by the day of BMT. After completion of the CA Advance Health
      Care Directive Form, patients undergo interview as in Group I.

      After completion of study, patients are followed up periodically.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: ACP completion rate defined as a completed Advance Directive tool (either Stanford Letter or standard CA AD) brought to Stanford University for upload into the medical record
time frame: Up to BMT day 0
description: The chi-square (X^2) test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.
measure: Patient preferences for life sustaining measures measured via answers to the ACP questions related to use of cardiopulmonary resuscitation and use of mechanical intubation
time frame: Up to BMT day 0
description: The X^2 test will be used to determine a significant difference in proportion of ACP tool completion and preferences for choice to prolong life between the two groups.
measure: Uncertainty with decision making regarding end of life care measured related to the Decisional Conflict Scale (DCS) results
time frame: Up to BMT day 0
description: Will be measured using the DCS uncertainty sub-scale (score 0-15; higher score indicates greater uncertainty). Scores from each group will be compared by t-tests.
measure: Understanding of the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS
time frame: within 28 days of ACP completion
description: Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making). Likert scores of understanding of the ACP from each group will be summarized and compared by t-tests.
measure: Satisfaction with the ACP tool measured using qualitative and quantitative data obtained through the semi-structured interview and DCS
time frame: within 28 days of ACP completion
description: Will be measured using the DCS effective decision-making sub-scale (score 0-15; higher scores indicate 6 less effective decision-making). Scores from each group will be compared by t-tests. Likert scores of satisfaction with the ACP will be summarized and compared by group using t-tests.
arm group label: Group I (Stanford Letter, interview)
arm group type: Experimental
description: Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the Stanford Letter and complete and return the form by the day of BMT. After completion of the Stanford Letter, patients undergo a semi-structured, research staff-led interview to evaluate personal perceptions of uncertainty with end-of-life decisions, understanding of the ACP form received, and satisfaction with the ACP form.
arm group label: Group II (traditional advance directive, interview)
arm group type: Active Comparator
description: Patients listen to a dialogue on the purpose of ACP. Patients receive a paper copy and online web link to the CA Advance Health Care Directive Form and complete and return the form by the day of BMT. After completion of the CA Advance Health Care Directive Form, patients undergo interview as in Group I.
intervention type: Other
intervention name: Stanford Letter
description: Receive and complete the Stanford Letter
arm group label: Group I (Stanford Letter, interview)
other name: Communication Intervention
intervention type: Other
intervention name: Interview
description: Undergo semi-structured, research staff-led interview
arm group label: Group I (Stanford Letter, interview)
arm group label: Group II (traditional advance directive, interview)
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Group I (Stanford Letter, interview)
arm group label: Group II (traditional advance directive, interview)
intervention type: Other
intervention name: CA Advance Health Care Directive Form
description: Receive and complete the CA Advance Health Care Directive Form
arm group label: Group II (traditional advance directive, interview)
other name: Communication Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Lori Muffly, MD
role: Principal Investigator
affiliation: Stanford Cancer Institute
facility: 
country: United States
responsible party type: Sponsor