<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/NCT03248258</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-170518009</org_study_id>
    <nct_id>NCT03248258</nct_id>
  </id_info>
  <brief_title>Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)</brief_title>
  <official_title>Enhancing Shared Decision-Making in Metastatic Breast Cancer (Qualitative Study)</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>
  </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>
      Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP).&#xD;
&#xD;
      Phase 1:&#xD;
&#xD;
      Aim 1a: Patient interviews along with navigator, nurse, and physician focus group discussions&#xD;
      will be used to identify factors that influence decision-making in treatment selection and&#xD;
      the optimal approach for sharing information about prognosis and guideline-based care.&#xD;
      Identify decisional needs for Shared Decision Making (SDM) in MBC. Investigators will conduct&#xD;
      semi-structured interviews/discussion groups with patients, navigators, nurses, and&#xD;
      physicians to elements important to decision-making.&#xD;
&#xD;
      Phase 2:&#xD;
&#xD;
      Aim 1b: Develop MBC-specific TP. Investigators will build upon Aim1a to systematically&#xD;
      develop the TP intervention using the Ottawa Decision Support Framework. Investigators will&#xD;
      test the TPs with 5 patients and conduct qualitative investigations to refine the TP using an&#xD;
      iterative process.&#xD;
&#xD;
      Phase 3:Further explore decision-making related to reducing amount of chemotherapy for&#xD;
      patients with good prognosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 1:&#xD;
&#xD;
      Investigators will use patient interviews and navigator, nurse, and physician focus group&#xD;
      discussions to identify factors that influence decision-making in treatment selection and the&#xD;
      optimal approach for sharing information about prognosis and guideline-based care. Patients&#xD;
      will be recruited from the medical oncology clinic. Patients will be identified by their&#xD;
      primary oncologist. All eligible patient will be provided with a study information flyer. All&#xD;
      patient participants will be asked to provide written informed consent prior to participation&#xD;
      in interviews; provider participants will be provided with Information sheets prior to focus&#xD;
      groups by a research coordinator. Participants in Group 1 will be asked to complete a&#xD;
      demographic form. The demographic forms for patients, navigators, nurses, and medical&#xD;
      oncologists are included in Appendix B. Demographic form will include questions about your&#xD;
      age, sex, race and education. The demographic form will take 5 minutes to complete. At study&#xD;
      entry, descriptive data including patient demographics (age, sex, race), breast cancer&#xD;
      characteristics (subtype, line of therapy, specific treatment offered, prior treatments&#xD;
      received), physician will be collected to provide clinical context for the analysis. The&#xD;
      patients will be interviewed at the patient's next appointment (either with the physician or&#xD;
      in the infusion center) or the patients can schedule to come on an off clinic day of their&#xD;
      preference. The study coordinators will offer each patient the option to complete the consent&#xD;
      form at home. If they decide to complete the consent form at home investigators will follow&#xD;
      up with by contacting them on the telephone to ensure that the consent form was completed and&#xD;
      to confirm their interview at their next clinic visit or an off day of their preference. This&#xD;
      30 minute to an hour interview will take place in a private meeting room within the UAB&#xD;
      Comprehensive cancer center. The patient interviews will be audio-recorded by using a digital&#xD;
      audio recorder.&#xD;
&#xD;
      Phase 2:&#xD;
&#xD;
      Patients will be recruited from the medical oncology clinic. Patients will be identified by&#xD;
      their primary oncologist. A trained research coordinator will consent the patient during a&#xD;
      routine clinic visit. This group will consist of 5 new patients who did not participate in&#xD;
      Group 1 patient interviews. Descriptive data including patient name and medical record number&#xD;
      will be collected on a tracking sheet. No other personal identifiable information will be&#xD;
      collected. This 30-minute interview will take place in the clinic room or a private room&#xD;
      within the UAB Comprehensive cancer center (based on patient preference). The researcher will&#xD;
      provide the patient with the iPad for completion of baseline patient-reported outcome&#xD;
      questionnaires using the Carevive® platform for a test patient in a test environment which&#xD;
      will not be linked to the patient's medical record. The intervention questionnaire will&#xD;
      include standard questions used to routine treatment planning at UAB/MCI as well as any&#xD;
      study-specific questions generated from Phase I above. This will allow feedback on the&#xD;
      questionnaire itself. The research coordinator will then provide the patient with an example&#xD;
      TP that includes responses to the questionnaire. The study PI will review the electronic or a&#xD;
      printed version with the patient to get feedback on the acceptability of the TP, content of&#xD;
      the TP, and the best approach to utilizing the TP. This process may be modified based on&#xD;
      results of our qualitative analysis.&#xD;
&#xD;
      Investigators will conduct separate focus groups with each provider group. This will include&#xD;
      7 breast medical oncologists, 10 patient navigators, and 10 nurses (5 clinic nurses who work&#xD;
      directly with the breast oncologists and 5 infusion nurses).&#xD;
&#xD;
      Phase 3:&#xD;
&#xD;
      The purpose of this phase is to (1) further understand patient perspective on the concept of&#xD;
      de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and&#xD;
      (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as&#xD;
      standard or care or within a clinical trial). This study will include both patients and&#xD;
      patient advocates, who bring a broad perspective to how the patient experience should be&#xD;
      considered in research. Interviews with patients, patient advocates, and physicians will be&#xD;
      conducted either in person or by phone/zoom based on patient preference. In person patient&#xD;
      interviews will be conducted (1) in the UAB Medical Oncology outpatient clinic rooms or in&#xD;
      private room in the UAB Comprehensive Cancer Center (based on patient preference for&#xD;
      location). In person patient advocate or physician interviews will be conducted at in-person&#xD;
      meetings of the Eastern Cooperative Group, which are routinely attended by the patient&#xD;
      advocates and physicians in the private room or location of the advocate's choice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2017</start_date>
  <completion_date type="Actual">December 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 20, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Shared Decision Making</measure>
    <time_frame>3 years</time_frame>
    <description>Shared decision making occurs when patients are informed of risks and benefits associated with treatment options and partner with their oncologist to incorporate their personal preferences and values into decision-making. Shared decision making in medicine can improve quality of care and reduce costs. This will be accessed using qualitative interviews and focus groups discussions. This is not a survey based study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concept of de-escalation</measure>
    <time_frame>2 years</time_frame>
    <description>Patients reduce the amount of chemotherapy to avoid side effects</description>
  </primary_outcome>
  <number_of_groups>8</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Decision Making ,Shared</condition>
  <condition>De-escalation</condition>
  <arm_group>
    <arm_group_label>Metastatic Breast Interview Participants - Shared Decision Making</arm_group_label>
    <description>Metastatic Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Stage Breast Interview Participants - Shared Decision Making</arm_group_label>
    <description>Early Stage Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Provider Focus Group -Shared Decision Making</arm_group_label>
    <description>Clinic Provider Participants will participate in a focus group on the topic of Shared Decision Making. This will be a one time, focus group interview with a trained moderator.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-UAB Provider Shared Decision Making</arm_group_label>
    <description>Non-UAB Provider Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Stage de-escalation Interview Participants</arm_group_label>
    <description>Early Stage Breast Patient Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Advocate de-escalation Interview Participants</arm_group_label>
    <description>Patient Advocate Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physician de-escalation Interview Participants</arm_group_label>
    <description>Physician Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Stage Feedback Interview Participants</arm_group_label>
    <description>Early Stage Breast Patient Participants will be interviewed to provide feedback on a decision making tool (video). This will be a one time, one-on-one interview with a trained interviewer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Qualitative Interview or Focus group discussions</intervention_name>
    <description>The purpose of this study is to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care.&#xD;
Secondly, to further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial).</description>
    <arm_group_label>Early Stage Breast Interview Participants - Shared Decision Making</arm_group_label>
    <arm_group_label>Early Stage Feedback Interview Participants</arm_group_label>
    <arm_group_label>Early Stage de-escalation Interview Participants</arm_group_label>
    <arm_group_label>Metastatic Breast Interview Participants - Shared Decision Making</arm_group_label>
    <arm_group_label>Non-UAB Provider Shared Decision Making</arm_group_label>
    <arm_group_label>Patient Advocate de-escalation Interview Participants</arm_group_label>
    <arm_group_label>Physician de-escalation Interview Participants</arm_group_label>
    <arm_group_label>Provider Focus Group -Shared Decision Making</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Metastatic and Early stage Breast Cancer patients receiving care at UAB Hematology/Oncology&#xD;
        Kirklin Clinic. Breast Cancer Patient advocates, oncology nurses, navigators, and Oncology&#xD;
        Physicians&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Patient Criteria (Phase I,II,III):&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Women with age ≥ 18&#xD;
&#xD;
          -  2. Presence of Metastatic Breast Cancer or Early Stage Breast Cancer&#xD;
&#xD;
          -  3. Patients may be receiving any line and type of therapy including both standard of&#xD;
             care and clinical trials.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Patient who are not able to read and/or speak English&#xD;
&#xD;
          -  2. Patients with a life expectancy less than 3 months&#xD;
&#xD;
          -  3. Patients unable to provide informed consent&#xD;
&#xD;
          -  4. Men&#xD;
&#xD;
        Patient Advocates (Phase III)&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
        1. Providers who are self-identified patient advocates working with breast cancer&#xD;
        researchers&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. None&#xD;
&#xD;
             Sampling: We will conduct interviews with 10-20 patient advocates for phase 3 of this&#xD;
             project.&#xD;
&#xD;
             Provider (navigator, nurse, physician) (Pjhase I, III)&#xD;
&#xD;
             Inclusion criteria:&#xD;
&#xD;
          2. Providers who have direct contact with breast cancer patients&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        2. None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patient Participant Groups are women only</gender_description>
    <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>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35249</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>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</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>
  <keyword>Early Stage Breast Cancer</keyword>
  <keyword>De-escalation</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/NCT03248258
org study id: IRB-170518009
nct id: NCT03248258
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Develop a Metastatic Breast Cancer (MBC)-specific electronic Treatment Plans (TP).

      Phase 1:

      Aim 1a: Patient interviews along with navigator, nurse, and physician focus group discussions
      will be used to identify factors that influence decision-making in treatment selection and
      the optimal approach for sharing information about prognosis and guideline-based care.
      Identify decisional needs for Shared Decision Making (SDM) in MBC. Investigators will conduct
      semi-structured interviews/discussion groups with patients, navigators, nurses, and
      physicians to elements important to decision-making.

      Phase 2:

      Aim 1b: Develop MBC-specific TP. Investigators will build upon Aim1a to systematically
      develop the TP intervention using the Ottawa Decision Support Framework. Investigators will
      test the TPs with 5 patients and conduct qualitative investigations to refine the TP using an
      iterative process.

      Phase 3:Further explore decision-making related to reducing amount of chemotherapy for
      patients with good prognosis.
Phase 1:

      Investigators will use patient interviews and navigator, nurse, and physician focus group
      discussions to identify factors that influence decision-making in treatment selection and the
      optimal approach for sharing information about prognosis and guideline-based care. Patients
      will be recruited from the medical oncology clinic. Patients will be identified by their
      primary oncologist. All eligible patient will be provided with a study information flyer. All
      patient participants will be asked to provide written informed consent prior to participation
      in interviews; provider participants will be provided with Information sheets prior to focus
      groups by a research coordinator. Participants in Group 1 will be asked to complete a
      demographic form. The demographic forms for patients, navigators, nurses, and medical
      oncologists are included in Appendix B. Demographic form will include questions about your
      age, sex, race and education. The demographic form will take 5 minutes to complete. At study
      entry, descriptive data including patient demographics (age, sex, race), breast cancer
      characteristics (subtype, line of therapy, specific treatment offered, prior treatments
      received), physician will be collected to provide clinical context for the analysis. The
      patients will be interviewed at the patient's next appointment (either with the physician or
      in the infusion center) or the patients can schedule to come on an off clinic day of their
      preference. The study coordinators will offer each patient the option to complete the consent
      form at home. If they decide to complete the consent form at home investigators will follow
      up with by contacting them on the telephone to ensure that the consent form was completed and
      to confirm their interview at their next clinic visit or an off day of their preference. This
      30 minute to an hour interview will take place in a private meeting room within the UAB
      Comprehensive cancer center. The patient interviews will be audio-recorded by using a digital
      audio recorder.

      Phase 2:

      Patients will be recruited from the medical oncology clinic. Patients will be identified by
      their primary oncologist. A trained research coordinator will consent the patient during a
      routine clinic visit. This group will consist of 5 new patients who did not participate in
      Group 1 patient interviews. Descriptive data including patient name and medical record number
      will be collected on a tracking sheet. No other personal identifiable information will be
      collected. This 30-minute interview will take place in the clinic room or a private room
      within the UAB Comprehensive cancer center (based on patient preference). The researcher will
      provide the patient with the iPad for completion of baseline patient-reported outcome
      questionnaires using the Carevive® platform for a test patient in a test environment which
      will not be linked to the patient's medical record. The intervention questionnaire will
      include standard questions used to routine treatment planning at UAB/MCI as well as any
      study-specific questions generated from Phase I above. This will allow feedback on the
      questionnaire itself. The research coordinator will then provide the patient with an example
      TP that includes responses to the questionnaire. The study PI will review the electronic or a
      printed version with the patient to get feedback on the acceptability of the TP, content of
      the TP, and the best approach to utilizing the TP. This process may be modified based on
      results of our qualitative analysis.

      Investigators will conduct separate focus groups with each provider group. This will include
      7 breast medical oncologists, 10 patient navigators, and 10 nurses (5 clinic nurses who work
      directly with the breast oncologists and 5 infusion nurses).

      Phase 3:

      The purpose of this phase is to (1) further understand patient perspective on the concept of
      de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and
      (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as
      standard or care or within a clinical trial). This study will include both patients and
      patient advocates, who bring a broad perspective to how the patient experience should be
      considered in research. Interviews with patients, patient advocates, and physicians will be
      conducted either in person or by phone/zoom based on patient preference. In person patient
      interviews will be conducted (1) in the UAB Medical Oncology outpatient clinic rooms or in
      private room in the UAB Comprehensive Cancer Center (based on patient preference for
      location). In person patient advocate or physician interviews will be conducted at in-person
      meetings of the Eastern Cooperative Group, which are routinely attended by the patient
      advocates and physicians in the private room or location of the advocate's choice.
observational model: Other
time perspective: Prospective
measure: Shared Decision Making
time frame: 3 years
description: Shared decision making occurs when patients are informed of risks and benefits associated with treatment options and partner with their oncologist to incorporate their personal preferences and values into decision-making. Shared decision making in medicine can improve quality of care and reduce costs. This will be accessed using qualitative interviews and focus groups discussions. This is not a survey based study.
measure: Concept of de-escalation
time frame: 2 years
description: Patients reduce the amount of chemotherapy to avoid side effects
arm group label: Metastatic Breast Interview Participants - Shared Decision Making
description: Metastatic Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.
arm group label: Early Stage Breast Interview Participants - Shared Decision Making
description: Early Stage Breast Patient Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.
arm group label: Provider Focus Group -Shared Decision Making
description: Clinic Provider Participants will participate in a focus group on the topic of Shared Decision Making. This will be a one time, focus group interview with a trained moderator.
arm group label: Non-UAB Provider Shared Decision Making
description: Non-UAB Provider Participants will be interviewed on the topic of Shared Decision Making. This will be a one time, one-on-one interview with a trained interviewer.
arm group label: Early Stage de-escalation Interview Participants
description: Early Stage Breast Patient Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.
arm group label: Patient Advocate de-escalation Interview Participants
description: Patient Advocate Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.
arm group label: Physician de-escalation Interview Participants
description: Physician Participants will be interviewed on the topic of de-escalation of cancer treatment. This will be a one time, one-on-one interview with a trained interviewer.
arm group label: Early Stage Feedback Interview Participants
description: Early Stage Breast Patient Participants will be interviewed to provide feedback on a decision making tool (video). This will be a one time, one-on-one interview with a trained interviewer.
intervention type: Other
intervention name: Qualitative Interview or Focus group discussions
description: The purpose of this study is to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care.
Secondly, to further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial).
arm group label: Early Stage Breast Interview Participants - Shared Decision Making
arm group label: Early Stage Feedback Interview Participants
arm group label: Early Stage de-escalation Interview Participants
arm group label: Metastatic Breast Interview Participants - Shared Decision Making
arm group label: Non-UAB Provider Shared Decision Making
arm group label: Patient Advocate de-escalation Interview Participants
arm group label: Physician de-escalation Interview Participants
arm group label: Provider Focus Group -Shared Decision Making
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Patient Participant Groups are women only
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gabrielle B Rocque, MD
role: Principal Investigator
affiliation: Assistant Professor
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