Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-02-24 @ 9:44 AM
Study NCT ID:
NCT03755492
Status:
TERMINATED
Last Update Posted:
2022-07-21
First Post:
2018-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initiative to Minimize Disparities in Postoperative Prostate Cancer Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041342', 'term': 'Absorbent Pads'}], 'ancestors': [{'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'COVID related impact on recruitment. Change in treatment (more effective surgical technique ) eliminated the studied side effect, thus making the intervention arm obsolete.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2018-10-03', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Michigan Incontinence Symptom Index (M-ISI)', 'timeFrame': '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)', 'timeFrame': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Prostatectomy']}, 'referencesModule': {'references': [{'pmid': '23945994', 'type': 'BACKGROUND', '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': '24076307', 'type': 'BACKGROUND', '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': '27475967', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nStress 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Males who reside in the health enterprise zone of north Philadelphia and are undergoing radical prostatectomy', 'genderDescription': 'Patients undergoing radical prostatectomy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. History of prostate cancer\n2. Scheduled for radical prostatectomy during a designated academic year\n3. Reside within Health Enterprise Zone (HEZ) of North Broad Street\n4. Median annual household income \\< $50,000\n5. Patient feels that they would struggle to afford absorbent pads and Tadalafil based on their annual income\n6. Patient must have no history of stress urinary incontinence prior to surgery\n\nExclusion Criteria\n\n1. Patient's who do not meet the inclusion criteria above\n2. Patients who meet all inclusion criteria above, but do not want to use absorbent pads secondary to history of hypersensitivity/allergy to absorbent pads\n3. Patients with cognitive impairment will be excluded from the study"}, 'identificationModule': {'nctId': 'NCT03755492', 'briefTitle': 'Initiative to Minimize Disparities in Postoperative Prostate Cancer Care', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein Healthcare Network'}, 'officialTitle': 'Initiative to Minimize Disparities in Postoperative Prostate Cancer Care', 'orgStudyIdInfo': {'id': '5108'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1 (Provided absorbent pads)', 'description': 'Patients will receive a 6 month supply (as needed) of absorbent pads for urinary incontinence.', 'interventionNames': ['Other: Absorbent pad for urinary incontinence']}, {'label': 'Group 2 (not provided absorbent pads)', 'description': 'Patients enrolled in the control arm will not receive absorbent pads.'}], 'interventions': [{'name': 'Absorbent pad for urinary incontinence', 'type': 'OTHER', 'description': '6 month supply provided to patients as needed for urinary incontinence after radical prostatectomy', 'armGroupLabels': ['Group 1 (Provided absorbent pads)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Albert Einstein Healthcare Network', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Serge Ginzburg, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Einstein Healthcare Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein Healthcare Network', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Urologic Oncologist', 'investigatorFullName': 'Serge Ginzburg, MD', 'investigatorAffiliation': 'Albert Einstein Healthcare Network'}}}}