Initiative to Minimize Disparities in Postoperative Prostate Cancer Care

NCT03755492 | Terminated

• 1 other identifier: 5108
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Prostatectomy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Group 2 (not provided absorbent pads)

Patients enrolled in the control arm will not receive absorbent pads.

Interventions

Absorbent pad for urinary incontinence OTHER

6 month supply provided to patients as needed for urinary incontinence after radical prostatectomy

Group 1 (Provided absorbent pads)

Eligibility Criteria

• Gender Eligibility Details: Patients undergoing radical prostatectomy
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patients with cognitive impairment will be excluded from the study

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Absorbent Pads

Intervention Hierarchy (Ancestors)

Equipment and Supplies, Hospital; Equipment and Supplies

Study Officials

• Serge Ginzburg, M.D.

  Einstein Healthcare Network

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologic Oncologist

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: November 28, 2018
• Study Start: April 1, 2019
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)