<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/NCT03755492</url>
  </required_header>
  <id_info>
    <org_study_id>5108</org_study_id>
    <nct_id>NCT03755492</nct_id>
  </id_info>
  <brief_title>Initiative to Minimize Disparities in Postoperative Prostate Cancer Care</brief_title>
  <official_title>Initiative to Minimize Disparities in Postoperative Prostate Cancer Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albert Einstein Healthcare Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Albert Einstein Healthcare Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Einstein Healthcare Network in North Philadelphia serves a predominantly underserved medical&#xD;
      community. The investigators routinely see patients who cannot afford absorbent pads after&#xD;
      prostate surgery, which helps with quality of life secondary to urinary incontinence. The&#xD;
      investigators will provide absorbent pads to participants who would be unable to afford them.&#xD;
      The investigators hypothesize that providing absorbent pads for 6 months will result in&#xD;
      improved quality of life in regards to management of urinary incontinence after radical&#xD;
      prostatectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When detected early and managed with appropriate surgical treatment, such as radical&#xD;
      prostatectomy, Prostate cancer prognosis is excellent, but recovery may be associated with&#xD;
      significant transient impact on quality of life. This impact most often manifests in urinary&#xD;
      domains, specifically, development of stress urinary incontinence. Several simple, low-cost&#xD;
      but high-yield interventions may dramatically improve patient's postoperative quality of&#xD;
      life. However, such interventions may be out of reach for patients from Health Enterprise&#xD;
      Zones (HEZ) with limited funds. To make resources readily available for this patient&#xD;
      population, the inclusion criteria will be prostatectomy patients of any age who reside&#xD;
      within the designated North Broad street HEZ.&#xD;
&#xD;
      Stress urinary incontinence after prostatectomy is a source of major distress. Incontinence&#xD;
      tends to improve over time with most patients regaining their urinary function. Symptomatic&#xD;
      support with disposable absorbent pads/diapers for several months helps men effectively&#xD;
      manage this side effect. While for most men the cost of the diapers is manageable, for men in&#xD;
      HEZ this represents a significant financial burden on the patient and on caregivers. As a&#xD;
      result, these patients often choose to remain home bound until they recover urinary control,&#xD;
      preventing them from early return to employment and resulting in social isolation. The&#xD;
      Healthcare Disparity SEED Grant will provide up to a 6-month supply of disposable absorbent&#xD;
      pads/diapers to those patients meeting our inclusion criteria. Michigan Incontinence Symptom&#xD;
      Index (M-ISI) questionnaires will be distributed to patients pre-operatively and during&#xD;
      interval post-operative office visits to assess patient satisfaction with voiding function.&#xD;
&#xD;
      In addition to distributing M-ISI questionnaires, we will also distribute the Extended&#xD;
      Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) to evaluate overall quality&#xD;
      of life. This is a validated questionnaire capable of accurately assessing multiple domains&#xD;
      of quality of life after prostate cancer treatment. Results of M-ISI and EPIC-CP scores will&#xD;
      be compiled and analyzed to determine if intervention has resulted in measurable improvement&#xD;
      between the treatment and control groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID related impact on recruitment. Change in treatment (more effective surgical technique )&#xD;
    eliminated the studied side effect, thus making the intervention arm obsolete.&#xD;
  </why_stopped>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">July 20, 2022</completion_date>
  <primary_completion_date type="Actual">July 20, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Michigan Incontinence Symptom Index (M-ISI)</measure>
    <time_frame>6 months after radical prostatectomy</time_frame>
    <description>Questionnaire to assess severity of urinary incontinence and how it influences a patient's quality of life. The questionnaire asks a total of 10 questions scaled 0 to 4. The 10 questions that make up the questionnaire cover bothersome lower urinary tract symptoms specific to stress urinary incontinence, urge urinary incontinence, how many pads patients are using to manage their incontinence, and how it is influencing their daily activities. Patients with higher scores have more severe and bothersome urinary incontinence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)</measure>
    <time_frame>6 months after radical prostatectomy</time_frame>
    <description>Questionnaire to help assess overall quality of life in patients with prostate cancer. This questionnaire is a 1-page, 16-item questionnaire that is designed to assess urinary incontinence, urinary irritation, bowel irritation, sexual health and hormonal health after prostate cancer surgery. Each domain is scored separately from a scale of 0 to 12. The minimum symptom score in each domain is a 0 and the maximum symptom score in each domain is a 12.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">24</enrollment>
  <condition>Post Prostatectomy</condition>
  <arm_group>
    <arm_group_label>Group 1 (Provided absorbent pads)</arm_group_label>
    <description>Patients will receive a 6 month supply (as needed) of absorbent pads for urinary incontinence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (not provided absorbent pads)</arm_group_label>
    <description>Patients enrolled in the control arm will not receive absorbent pads.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Absorbent pad for urinary incontinence</intervention_name>
    <description>6 month supply provided to patients as needed for urinary incontinence after radical prostatectomy</description>
    <arm_group_label>Group 1 (Provided absorbent pads)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Males who reside in the health enterprise zone of north Philadelphia and are undergoing&#xD;
        radical prostatectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. History of prostate cancer&#xD;
&#xD;
          2. Scheduled for radical prostatectomy during a designated academic year&#xD;
&#xD;
          3. Reside within Health Enterprise Zone (HEZ) of North Broad Street&#xD;
&#xD;
          4. Median annual household income &lt; $50,000&#xD;
&#xD;
          5. Patient feels that they would struggle to afford absorbent pads and Tadalafil based on&#xD;
             their annual income&#xD;
&#xD;
          6. Patient must have no history of stress urinary incontinence prior to surgery&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Patient's who do not meet the inclusion criteria above&#xD;
&#xD;
          2. Patients who meet all inclusion criteria above, but do not want to use absorbent pads&#xD;
             secondary to history of hypersensitivity/allergy to absorbent pads&#xD;
&#xD;
          3. Patients with cognitive impairment will be excluded from the study&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Patients undergoing radical prostatectomy</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Serge Ginzburg, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Einstein Healthcare Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Albert Einstein Healthcare Network</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Suskind AM, Dunn RL, Morgan DM, DeLancey JO, McGuire EJ, Wei JT. The Michigan Incontinence Symptom Index (M-ISI): a clinical measure for type, severity, and bother related to urinary incontinence. Neurourol Urodyn. 2014 Sep;33(7):1128-34. doi: 10.1002/nau.22468. Epub 2013 Aug 14.</citation>
    <PMID>23945994</PMID>
  </reference>
  <reference>
    <citation>Chipman JJ, Sanda MG, Dunn RL, Wei JT, Litwin MS, Crociani CM, Regan MM, Chang P; PROST-QA Consortium. Measuring and predicting prostate cancer related quality of life changes using EPIC for clinical practice. J Urol. 2014 Mar;191(3):638-45. doi: 10.1016/j.juro.2013.09.040. Epub 2013 Sep 25.</citation>
    <PMID>24076307</PMID>
  </reference>
  <reference>
    <citation>Wagner AA, Cheng PJ, Carneiro A, Dovirak O, Khosla A, Taylor KN, Crociani CM, McAnally KC, Percy A, Dewey LE, Sanda MG, Chang P. Clinical Use of Expanded Prostate Cancer Index Composite for Clinical Practice to Assess Patient Reported Prostate Cancer Quality of Life Following Robot-Assisted Radical Prostatectomy. J Urol. 2017 Jan;197(1):109-114. doi: 10.1016/j.juro.2016.07.080. Epub 2016 Jul 27.</citation>
    <PMID>27475967</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>October 3, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>July 19, 2022</last_update_submitted>
  <last_update_submitted_qc>July 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Albert Einstein Healthcare Network</investigator_affiliation>
    <investigator_full_name>Serge Ginzburg, MD</investigator_full_name>
    <investigator_title>Urologic Oncologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The only time that individual participant data will be shared with other researchers is if it is requested and required by a reviewer of our research to aide with publication of our results</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/NCT03755492
org study id: 5108
nct id: NCT03755492
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Einstein Healthcare Network in North Philadelphia serves a predominantly underserved medical
      community. The investigators routinely see patients who cannot afford absorbent pads after
      prostate surgery, which helps with quality of life secondary to urinary incontinence. The
      investigators will provide absorbent pads to participants who would be unable to afford them.
      The investigators hypothesize that providing absorbent pads for 6 months will result in
      improved quality of life in regards to management of urinary incontinence after radical
      prostatectomy.
When detected early and managed with appropriate surgical treatment, such as radical
      prostatectomy, Prostate cancer prognosis is excellent, but recovery may be associated with
      significant transient impact on quality of life. This impact most often manifests in urinary
      domains, specifically, development of stress urinary incontinence. Several simple, low-cost
      but high-yield interventions may dramatically improve patient's postoperative quality of
      life. However, such interventions may be out of reach for patients from Health Enterprise
      Zones (HEZ) with limited funds. To make resources readily available for this patient
      population, the inclusion criteria will be prostatectomy patients of any age who reside
      within the designated North Broad street HEZ.

      Stress urinary incontinence after prostatectomy is a source of major distress. Incontinence
      tends to improve over time with most patients regaining their urinary function. Symptomatic
      support with disposable absorbent pads/diapers for several months helps men effectively
      manage this side effect. While for most men the cost of the diapers is manageable, for men in
      HEZ this represents a significant financial burden on the patient and on caregivers. As a
      result, these patients often choose to remain home bound until they recover urinary control,
      preventing them from early return to employment and resulting in social isolation. The
      Healthcare Disparity SEED Grant will provide up to a 6-month supply of disposable absorbent
      pads/diapers to those patients meeting our inclusion criteria. Michigan Incontinence Symptom
      Index (M-ISI) questionnaires will be distributed to patients pre-operatively and during
      interval post-operative office visits to assess patient satisfaction with voiding function.

      In addition to distributing M-ISI questionnaires, we will also distribute the Extended
      Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) to evaluate overall quality
      of life. This is a validated questionnaire capable of accurately assessing multiple domains
      of quality of life after prostate cancer treatment. Results of M-ISI and EPIC-CP scores will
      be compiled and analyzed to determine if intervention has resulted in measurable improvement
      between the treatment and control groups.
observational model: Case-Control
time perspective: Prospective
measure: Michigan Incontinence Symptom Index (M-ISI)
time frame: 6 months after radical prostatectomy
description: Questionnaire to assess severity of urinary incontinence and how it influences a patient's quality of life. The questionnaire asks a total of 10 questions scaled 0 to 4. The 10 questions that make up the questionnaire cover bothersome lower urinary tract symptoms specific to stress urinary incontinence, urge urinary incontinence, how many pads patients are using to manage their incontinence, and how it is influencing their daily activities. Patients with higher scores have more severe and bothersome urinary incontinence.
measure: Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
time frame: 6 months after radical prostatectomy
description: Questionnaire to help assess overall quality of life in patients with prostate cancer. This questionnaire is a 1-page, 16-item questionnaire that is designed to assess urinary incontinence, urinary irritation, bowel irritation, sexual health and hormonal health after prostate cancer surgery. Each domain is scored separately from a scale of 0 to 12. The minimum symptom score in each domain is a 0 and the maximum symptom score in each domain is a 12.
arm group label: Group 1 (Provided absorbent pads)
description: Patients will receive a 6 month supply (as needed) of absorbent pads for urinary incontinence.
arm group label: Group 2 (not provided absorbent pads)
description: Patients enrolled in the control arm will not receive absorbent pads.
intervention type: Other
intervention name: Absorbent pad for urinary incontinence
description: 6 month supply provided to patients as needed for urinary incontinence after radical prostatectomy
arm group label: Group 1 (Provided absorbent pads)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Patients undergoing radical prostatectomy
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Serge Ginzburg, M.D.
role: Study Director
affiliation: Einstein Healthcare Network
facility: 
country: United States
citation: Suskind AM, Dunn RL, Morgan DM, DeLancey JO, McGuire EJ, Wei JT. The Michigan Incontinence Symptom Index (M-ISI): a clinical measure for type, severity, and bother related to urinary incontinence. Neurourol Urodyn. 2014 Sep;33(7):1128-34. doi: 10.1002/nau.22468. Epub 2013 Aug 14.
PMID: 23945994
citation: Chipman JJ, Sanda MG, Dunn RL, Wei JT, Litwin MS, Crociani CM, Regan MM, Chang P; PROST-QA Consortium. Measuring and predicting prostate cancer related quality of life changes using EPIC for clinical practice. J Urol. 2014 Mar;191(3):638-45. doi: 10.1016/j.juro.2013.09.040. Epub 2013 Sep 25.
PMID: 24076307
citation: Wagner AA, Cheng PJ, Carneiro A, Dovirak O, Khosla A, Taylor KN, Crociani CM, McAnally KC, Percy A, Dewey LE, Sanda MG, Chang P. Clinical Use of Expanded Prostate Cancer Index Composite for Clinical Practice to Assess Patient Reported Prostate Cancer Quality of Life Following Robot-Assisted Radical Prostatectomy. J Urol. 2017 Jan;197(1):109-114. doi: 10.1016/j.juro.2016.07.080. Epub 2016 Jul 27.
PMID: 27475967
responsible party type: Principal Investigator
investigator affiliation: Albert Einstein Healthcare Network
investigator full name: Serge Ginzburg, MD
investigator title: Urologic Oncologist
mesh term: Prostatic Neoplasms
sharing ipd: No
ipd description: The only time that individual participant data will be shared with other researchers is if it is requested and required by a reviewer of our research to aide with publication of our results