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临床试验/NCT03755492
NCT03755492终止不适用

Initiative to Minimize Disparities in Postoperative Prostate Cancer Care

Albert Einstein Healthcare Network1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
24
试验地点
1
主要终点
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
Male
接受健康志愿者

入选标准

  • History of prostate cancer
  • Scheduled for radical prostatectomy during a designated academic year
  • Reside within Health Enterprise Zone (HEZ) of North Broad Street
  • Median annual household income < $50,000
  • Patient feels that they would struggle to afford absorbent pads and Tadalafil based on their annual income
  • Patient must have no history of stress urinary incontinence prior to surgery
  • Exclusion Criteria
  • Patient's who do not meet the inclusion criteria above
  • Patients who meet all inclusion criteria above, but do not want to use absorbent pads secondary to history of hypersensitivity/allergy to absorbent pads
  • Patients with cognitive impairment will be excluded from the study

排除标准

  • 未提供

结局指标

主要结局

Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

时间窗: 6 months after radical prostatectomy

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.

Michigan Incontinence Symptom Index (M-ISI)

时间窗: 6 months after radical prostatectomy

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Serge Ginzburg, MD

Urologic Oncologist

Albert Einstein Healthcare Network

研究点 (1)

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