Initiative to Minimize Disparities in Postoperative Prostate Cancer Care

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.

Study Overview

• Status: Terminated
• Conditions: Post Prostatectomy
• Intervention / Treatment: Other: Absorbent pad for urinary incontinence

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Healthcare Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Males who reside in the health enterprise zone of north Philadelphia and are undergoing radical prostatectomy

Description

Inclusion Criteria:

1. History of prostate cancer
2. Scheduled for radical prostatectomy during a designated academic year
3. Reside within Health Enterprise Zone (HEZ) of North Broad Street
4. Median annual household income < $50,000
5. Patient feels that they would struggle to afford absorbent pads and Tadalafil based on their annual income
6. Patient must have no history of stress urinary incontinence prior to surgery

Exclusion Criteria

1. Patient's who do not meet the inclusion criteria above
2. Patients who meet all inclusion criteria above, but do not want to use absorbent pads secondary to history of hypersensitivity/allergy to absorbent pads
3. Patients with cognitive impairment will be excluded from the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 (Provided absorbent pads); Patients will receive a 6 month supply (as needed) of absorbent pads for urinary incontinence.	Other: Absorbent pad for urinary incontinence; 6 month supply provided to patients as needed for urinary incontinence after radical prostatectomy
Group 2 (not provided absorbent pads); Patients enrolled in the control arm will not receive absorbent pads.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Incontinence Symptom Index (M-ISI)	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.	6 months after radical prostatectomy
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)	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.	6 months after radical prostatectomy

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Investigators: Study Director: Serge Ginzburg, M.D., Einstein Healthcare Network

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): July 20, 2022
• Study Completion (Actual): July 20, 2022

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 5108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes