<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/NCT03806738</url>
  </required_header>
  <id_info>
    <org_study_id>427 BC SDM</org_study_id>
    <nct_id>NCT03806738</nct_id>
  </id_info>
  <brief_title>Enhancing Shared Decision-Making in Breast Cancer</brief_title>
  <official_title>Enhancing Shared Decision-Making in Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Cancer Society, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carevive Systems, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM&#xD;
      Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology&#xD;
      care (delayed delivery of standard-of-care TPs) to determine impact on SDM. The intervention&#xD;
      will be piloted in a RCT with 140 early stage breast cancer (EBC) and 140 metastatic breast&#xD;
      cancer (MBC) patients to assess impact. Subjects will be enrolled across two sites. Our&#xD;
      primary outcome will be the increase in percentage of patients reporting a perception of&#xD;
      shared decision-making.&#xD;
&#xD;
      Aim.1: The primary outcome will be to evaluate the impact of the SDM intervention on the&#xD;
      percentage of patients perceiving shared or greater role in decision-making.&#xD;
&#xD;
      Aim 2: To evaluate the impact of the SDM intervention on provider outcomes including the&#xD;
      percentage of providers perceiving SDM with the patient, number of treatment options offered&#xD;
      to patients, the proportion of times that clinical trials are offered to patients, the use of&#xD;
      NCCN guideline-based treatment, and self-report of treatment plan use.&#xD;
&#xD;
      Aim 3: Secondary fidelity and provider outcomes from audio recording will include whether&#xD;
      providers elicit: any patient preferences during treatment planning, preferences related to&#xD;
      physical side effects or efficacy, or preferences related to other aspects of the patient&#xD;
      experience. We will also assess whether providers use the TP in the decision-making&#xD;
      discussion and whether providers discuss or offer clinical trials to the patient.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two sites (UAB and MCI) will conduct the RCT of 140 patients with MBC and 140 patients with&#xD;
      EBC comparing use of SDM TPs delivered during decision-making visits compared to TPs&#xD;
      delivered post-decision-making. The Carevive Care Planning System (CPS) treatment planning&#xD;
      software will be used at all clinical sites to provide treatment care plans to patients with&#xD;
      breast cancer. This software platform, which is currently utilized after decision-making,&#xD;
      will be modified within this project to facilitate SDM through the creation of a SDM TP&#xD;
      utilized during decision-making. Together, the patients and physician will be able to review&#xD;
      the patient's decision-making style, patient's desire for prognostic information treatments,&#xD;
      and patient preferences about decision-making.&#xD;
&#xD;
      Participants will be compensated in the form of a $20 gift card at the time of consent. After&#xD;
      the patient provides consent, the research coordinator will evaluate the electronic medical&#xD;
      record (EMR) for completion of standard of care elements necessary for the generation of TPs.&#xD;
      At UAB, an embedded form with the necessary information for TP generation is completed in the&#xD;
      EMR as part of standard of care by clinical providers. If this form has not been completed,&#xD;
      the research coordinator may either notify the provider to initiate form completion or&#xD;
      complete this form within the EMR to ensure availability at the time of the treatment&#xD;
      decision. If the research coordinator completes this form, it will be reviewed by a clinical&#xD;
      provider. The completion of the form prior to consent for patients approached by telephone&#xD;
      will be necessary to allow new patients to receive TPs if a decision is made at their initial&#xD;
      visit. For other sites who do not use EMR forms, the clinical information will be entered&#xD;
      directly into the Carevive platform by either the research coordinators or clinical staff.&#xD;
&#xD;
      We will survey patients as described above on an iPad using the Carevive platform at baseline&#xD;
      and every 6 months until a treatment decision is made (intervention or standard-of-care).&#xD;
      Post-treatment surveys will be administered using a REDCap survey. To minimize participant&#xD;
      burden, we will allow patients to complete surveys in-person during routine clinic visits, by&#xD;
      telephone, or at home using an e-mailed link to the survey based on patient preference. To&#xD;
      accommodate patients who would like to complete surveys in-person, we will allow for a&#xD;
      1-month window around the initial 6-month survey (for those without a treatment decision&#xD;
      within 6 months) and a 2-week window around post-treatment survey. We will record if surveys&#xD;
      are completed by email, telephone, or in-person.After each decision-making encounter, the&#xD;
      physician will be asked to complete a patient-specific survey in REDCap. For standard of care&#xD;
      patients, this will include the Control Preferences Scale. For intervention patients, the&#xD;
      survey will include both the Control Preferences Scale and three study-specific questions&#xD;
      about use of TP during decision-making.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2018</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2022</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>
    <intervention_model_description>Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP.&#xD;
Patients randomized to standard of care will receive their standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months until a treatment decision is made.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact of Shared Decision Making</measure>
    <time_frame>3 years</time_frame>
    <description>Impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Shared Decision Making</condition>
  <arm_group>
    <arm_group_label>Shared Decision Making Questionnaire</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP.&#xD;
One month or at the next visit following the decision, the patient will be asked to complete a research survey using REDCap.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Questionnaire</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients randomized to standard of care will receive the standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months for patients with MBC who have not made a treatment decision until a treatment decision is made.&#xD;
One month or at the next visit following the decision, the patient will be asked to complete a post-treatment survey using REDCap.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Intervention-specific Carevive questionnaire</intervention_name>
    <description>includes standard of care questions with additional decision-making questions</description>
    <arm_group_label>Shared Decision Making Questionnaire</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care questionnaire</intervention_name>
    <description>includes the standard of care questions that are already in place for Carevive questionnaires</description>
    <arm_group_label>Standard of Care Questionnaire</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women age ≥ 18&#xD;
&#xD;
          -  Presence of breast cancer&#xD;
&#xD;
          -  Receiving any line and type of therapy (including both standard of care and clinical&#xD;
             trials)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not able to read and/or speak English&#xD;
&#xD;
          -  Patients who are not being offered any medical therapy (hormone therapy, chemotherapy,&#xD;
             targeted therapy) for their breast cancer&#xD;
&#xD;
          -  Patients with a life-expectancy of less than 3 months&#xD;
&#xD;
          -  Patients unable to provide informed consent&#xD;
&#xD;
          -  Men&#xD;
&#xD;
          -  Patients who do not plan to receive treatment at UAB or MCI&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabrielle B Rocque, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 4, 2023</last_update_submitted>
  <last_update_submitted_qc>January 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Gabrielle Rocque</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Metastatic Breast Cancer</keyword>
  <keyword>Treatment Decision Making</keyword>
  <keyword>Shared Decision Making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03806738
org study id: 427 BC SDM
nct id: NCT03806738
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The objective of this trial is to conduct a two-arm, randomized controlled trial (RCT) of SDM
      Treatment Plans (TPs) delivered at the time of decision-making compared to standard oncology
      care (delayed delivery of standard-of-care TPs) to determine impact on SDM. The intervention
      will be piloted in a RCT with 140 early stage breast cancer (EBC) and 140 metastatic breast
      cancer (MBC) patients to assess impact. Subjects will be enrolled across two sites. Our
      primary outcome will be the increase in percentage of patients reporting a perception of
      shared decision-making.

      Aim.1: The primary outcome will be to evaluate the impact of the SDM intervention on the
      percentage of patients perceiving shared or greater role in decision-making.

      Aim 2: To evaluate the impact of the SDM intervention on provider outcomes including the
      percentage of providers perceiving SDM with the patient, number of treatment options offered
      to patients, the proportion of times that clinical trials are offered to patients, the use of
      NCCN guideline-based treatment, and self-report of treatment plan use.

      Aim 3: Secondary fidelity and provider outcomes from audio recording will include whether
      providers elicit: any patient preferences during treatment planning, preferences related to
      physical side effects or efficacy, or preferences related to other aspects of the patient
      experience. We will also assess whether providers use the TP in the decision-making
      discussion and whether providers discuss or offer clinical trials to the patient.
Two sites (UAB and MCI) will conduct the RCT of 140 patients with MBC and 140 patients with
      EBC comparing use of SDM TPs delivered during decision-making visits compared to TPs
      delivered post-decision-making. The Carevive Care Planning System (CPS) treatment planning
      software will be used at all clinical sites to provide treatment care plans to patients with
      breast cancer. This software platform, which is currently utilized after decision-making,
      will be modified within this project to facilitate SDM through the creation of a SDM TP
      utilized during decision-making. Together, the patients and physician will be able to review
      the patient's decision-making style, patient's desire for prognostic information treatments,
      and patient preferences about decision-making.

      Participants will be compensated in the form of a $20 gift card at the time of consent. After
      the patient provides consent, the research coordinator will evaluate the electronic medical
      record (EMR) for completion of standard of care elements necessary for the generation of TPs.
      At UAB, an embedded form with the necessary information for TP generation is completed in the
      EMR as part of standard of care by clinical providers. If this form has not been completed,
      the research coordinator may either notify the provider to initiate form completion or
      complete this form within the EMR to ensure availability at the time of the treatment
      decision. If the research coordinator completes this form, it will be reviewed by a clinical
      provider. The completion of the form prior to consent for patients approached by telephone
      will be necessary to allow new patients to receive TPs if a decision is made at their initial
      visit. For other sites who do not use EMR forms, the clinical information will be entered
      directly into the Carevive platform by either the research coordinators or clinical staff.

      We will survey patients as described above on an iPad using the Carevive platform at baseline
      and every 6 months until a treatment decision is made (intervention or standard-of-care).
      Post-treatment surveys will be administered using a REDCap survey. To minimize participant
      burden, we will allow patients to complete surveys in-person during routine clinic visits, by
      telephone, or at home using an e-mailed link to the survey based on patient preference. To
      accommodate patients who would like to complete surveys in-person, we will allow for a
      1-month window around the initial 6-month survey (for those without a treatment decision
      within 6 months) and a 2-week window around post-treatment survey. We will record if surveys
      are completed by email, telephone, or in-person.After each decision-making encounter, the
      physician will be asked to complete a patient-specific survey in REDCap. For standard of care
      patients, this will include the Control Preferences Scale. For intervention patients, the
      survey will include both the Control Preferences Scale and three study-specific questions
      about use of TP during decision-making.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP.
Patients randomized to standard of care will receive their standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months until a treatment decision is made.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Impact of Shared Decision Making
time frame: 3 years
description: Impact of the SDM intervention on the percentage of patients perceiving shared or greater role in decision-making
arm group label: Shared Decision Making Questionnaire
arm group type: Experimental
description: Patients randomized to the intervention arm will receive the intervention-specific Carevive questionnaire, which includes standard questions with additional decision-making questions. These surveys will be repeated every 6 months until the patient has received a TP.
One month or at the next visit following the decision, the patient will be asked to complete a research survey using REDCap.
arm group label: Standard of Care Questionnaire
arm group type: Other
description: Patients randomized to standard of care will receive the standard-of-care Carevive questionnaire used to generate TPs at time of enrollment and then every 6 months for patients with MBC who have not made a treatment decision until a treatment decision is made.
One month or at the next visit following the decision, the patient will be asked to complete a post-treatment survey using REDCap.
intervention type: Other
intervention name: Intervention-specific Carevive questionnaire
description: includes standard of care questions with additional decision-making questions
arm group label: Shared Decision Making Questionnaire
intervention type: Other
intervention name: Standard of Care questionnaire
description: includes the standard of care questions that are already in place for Carevive questionnaires
arm group label: Standard of Care Questionnaire
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gabrielle B Rocque, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Gabrielle Rocque
investigator title: Assistant Professor
mesh term: Breast Neoplasms
sharing ipd: No