<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/NCT04472117</url>
  </required_header>
  <id_info>
    <org_study_id>20-287</org_study_id>
    <nct_id>NCT04472117</nct_id>
  </id_info>
  <brief_title>PREPARE: Patient Centered Perioperative Experience</brief_title>
  <official_title>PREPARE: Patient Centered Perioperative Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</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 purpose of this study is to determine whether an educational video about patients'&#xD;
      perioperative experience (period that spans from the time of admission to the hospital to the&#xD;
      time of recovery after surgery) will affect the timing of hospital discharge. The researchers&#xD;
      will use information collected during this study to create a questionnaire and an educational&#xD;
      video related to the patient perioperative experience. The educational video will address&#xD;
      patient concerns about the perioperative period and recovery after surgery (post-operative&#xD;
      recovery).&#xD;
&#xD;
      All participants in this study will be undergoing a MIS hysterectomy according to their&#xD;
      routine care in the Gynecology&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 9, 2020</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2024</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>Single Group Assignment</intervention_model>
    <intervention_model_description>There will be three phases in this study. Phase I will comprise 25 evaluable women (15 pre-operatively and a separate 10 post-operatively). The results of the pre-operative interviews will be closely monitored for data saturation and we may stop accrual earlier than the planned 15. Phase II will comprise 100 evaluable women. Phase III will comprise 100 evaluable women. All patients will undergo standard-of-care MIS hysterectomy, with standard follow-up with the addition of the interventions and randomization takes place here.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>2 years</time_frame>
    <description>Data from the discrete-choice experiment will be used to summarize patients' preferences and priorities. The discrete-choice experiment will entail a series of 28 side-by-side comparisons of hypothetical scenarios.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">262</enrollment>
  <condition>Minimally Invasive Surgery (MIS) Hysterectomy</condition>
  <arm_group>
    <arm_group_label>Usual care and usual care plus video</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase I (completed 3/31/2021): A sample of patients in phase I will complete a qualitative interview prior to or after surgery. Twenty-five evaluable patients (15 pre-operatively and a separate 10 post-operatively) will be selected to participate in an in-person/phone interview. Phase II: A separate group of women will compose phase II. All patients (N = 100) in phase II will complete discrete-choice surveys. Patients in phase III of the study will be randomized evenly to usual care plus video or usual care only. Phase III: One hundred participants will be randomized via CRDB to receive standard pre-operative counseling or standard pre-operative counseling with the additional of an educational video. Those randomized to view the video will also complete the post-video survey. All patients will complete the Decision Regret Scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>usual care</intervention_name>
    <description>Interviews will be conducted in person or by telephone by an MD on the research team who does not have an ongoing treatment relationship with the patient, and has been trained by the qualitative methods specialist. Interviews will take place over the phone or in person and are anticipated to last approximately 20-30 minutes.</description>
    <arm_group_label>Usual care and usual care plus video</arm_group_label>
    <other_name>Qualitative Interviews</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational video</intervention_name>
    <description>Watch an educational video created by the research team and.will also complete the post-video survey,</description>
    <arm_group_label>Usual care and usual care plus video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman ≥18 years of age.&#xD;
&#xD;
          -  Scheduled to undergo MIS hysterectomy by a gynecologic oncologist at MSK at either&#xD;
             Josie Robertston Surgery Center or the main hospital OR completed MIS hysterectomy by&#xD;
             a gynecologic oncologist at MSK at either Josie Robertson Surgery Center or the main&#xD;
             hospital within 1 month of consent (post-op patients eligible for Phase 1 only). Phase&#xD;
             1 was completed on 3/31/2021).&#xD;
&#xD;
          -  Determined to be an appropriate candidate for the AXR program or expected to be&#xD;
             discharged within 23 hours after surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not able to speak and read English.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Woman undergoing MIS hysterectomy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth Jewell, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Jewell, MD</last_name>
    <phone>212-639-3366</phone>
    <email>jewelle@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yuelin Li, PhD</last_name>
    <phone>646-888-0047</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth (All Protocol Activities)</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Jewell, MD</last_name>
      <phone>212-639-3366</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen (All protocol activities)</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Jewell, MD</last_name>
      <phone>212-639-3366</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack (All protocol activities)</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Jewell, MD</last_name>
      <phone>212-639-3366</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester (All Protocol Activities)</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Jewell, MD</last_name>
      <phone>212-639-3366</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge (All protocol activitie)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Jewell, MD</last_name>
      <phone>212-639-3366</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Jewell, MD</last_name>
      <phone>212-639-3366</phone>
    </contact>
    <contact_backup>
      <last_name>Yuelin Li, PhD</last_name>
      <phone>646-888-0047</phone>
    </contact_backup>
    <investigator>
      <last_name>Elizabeth Jewell, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau (All protocol activities)</name>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Jewell, MD</last_name>
      <phone>212-639-3366</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patient education</keyword>
  <keyword>Perioperative setting</keyword>
  <keyword>PREPARE</keyword>
  <keyword>Patient centeREd PerioperAtive expeRiencE</keyword>
  <keyword>20-287</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </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/NCT04472117
org study id: 20-287
nct id: NCT04472117
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether an educational video about patients'
      perioperative experience (period that spans from the time of admission to the hospital to the
      time of recovery after surgery) will affect the timing of hospital discharge. The researchers
      will use information collected during this study to create a questionnaire and an educational
      video related to the patient perioperative experience. The educational video will address
      patient concerns about the perioperative period and recovery after surgery (post-operative
      recovery).

      All participants in this study will be undergoing a MIS hysterectomy according to their
      routine care in the Gynecology
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: There will be three phases in this study. Phase I will comprise 25 evaluable women (15 pre-operatively and a separate 10 post-operatively). The results of the pre-operative interviews will be closely monitored for data saturation and we may stop accrual earlier than the planned 15. Phase II will comprise 100 evaluable women. Phase III will comprise 100 evaluable women. All patients will undergo standard-of-care MIS hysterectomy, with standard follow-up with the addition of the interventions and randomization takes place here.
primary purpose: Other
masking: None (Open Label)
measure: Percentages of Ambulatory Extended Recovery (AXR) vs same day discharge
time frame: 2 years
measure: Patient satisfaction
time frame: 2 years
description: Data from the discrete-choice experiment will be used to summarize patients' preferences and priorities. The discrete-choice experiment will entail a series of 28 side-by-side comparisons of hypothetical scenarios.
arm group label: Usual care and usual care plus video
arm group type: Experimental
description: Phase I (completed 3/31/2021): A sample of patients in phase I will complete a qualitative interview prior to or after surgery. Twenty-five evaluable patients (15 pre-operatively and a separate 10 post-operatively) will be selected to participate in an in-person/phone interview. Phase II: A separate group of women will compose phase II. All patients (N = 100) in phase II will complete discrete-choice surveys. Patients in phase III of the study will be randomized evenly to usual care plus video or usual care only. Phase III: One hundred participants will be randomized via CRDB to receive standard pre-operative counseling or standard pre-operative counseling with the additional of an educational video. Those randomized to view the video will also complete the post-video survey. All patients will complete the Decision Regret Scale.
intervention type: Other
intervention name: usual care
description: Interviews will be conducted in person or by telephone by an MD on the research team who does not have an ongoing treatment relationship with the patient, and has been trained by the qualitative methods specialist. Interviews will take place over the phone or in person and are anticipated to last approximately 20-30 minutes.
arm group label: Usual care and usual care plus video
other name: Qualitative Interviews
intervention type: Other
intervention name: Educational video
description: Watch an educational video created by the research team and.will also complete the post-video survey,
arm group label: Usual care and usual care plus video
criteria: 
gender: Female
gender based: Yes
gender description: Woman undergoing MIS hysterectomy
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Elizabeth Jewell, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Elizabeth Jewell, MD
phone: 212-639-3366
email: jewelle@mskcc.org
last name: Yuelin Li, PhD
phone: 646-888-0047
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.