Sexual and Urinary Function Improvement for Cancer Survivors

Sexual and Urinary Function Improvement for Cancer Survivors- Promoting Access to Collaborative Treatment (SUFICS-PACT)

The purpose of this study is to test the efficacy of SUFICS-PACT to identify and treat sexual and urinary dysfunction in prostate cancer survivors at NYC H+ H/Bellevue, the oldest public hospital in the US. This study will evaluate the implementation of an adapted sexual and urinary function collaborative care model at NYC Health+Hospitals/Bellevue. The study will test the efficacy of this collaborative care model through a randomized controlled trial in the adult primary care clinic; the intervention arm will receive collaborative treatment consisting of a care manager who has specialty training in mental health and psychosexual counseling, a primary care nurse practitioner who leads symptom management, primary care physicians who supervise the team, and a team specialty consult liaison.

Study Overview

• Status: Not yet recruiting
• Conditions: Sexual Dysfunction; Urinary Dysfunction
• Intervention / Treatment: Behavioral: SUFICS-PACT

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nnenaya Mmonu, MD, MS; Phone Number: 646-825-6300; Email: Nnenaya.Mmonu@nyulangone.org
• Study Contact Backup: Name: Favour Nnah; Phone Number: 917-854-5895; Email: Favour.Nnah@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• At least 18 years old
• Have a diagnosis of prostate cancer
• Have sought care/treatment for prostate cancer

Exclusion Criteria:

• Patients under 18 years old
• Patients who have not sought care/treatment for prostate cancer
• Patients who are categorized as "vulnerable subjects," such as minors or incarcerated individuals.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SUFICS-PACT; The Sexual and Urinary Function Improvement for Cancer Survivors- Promoting Access to Collaborative Treatment (SUFICS-PACT) intervention integrates a collaborative care model in primary care to facilitate problem identification, comprehensive treatment, and close follow-up for sexual and urinary dysfunction.	Behavioral: SUFICS-PACT; SUFICS-PACT includes sexual and urinary dysfunction screening, collaborative treatment of sexual and urinary dysfunction, and care managers who are mental health professionals with training in psychosexual counseling. Mental health professionals will facilitate a comprehensive approach to sexual dysfunction, as emphasized by the biopsychosocial model of sexual health. SUFICS-PACT also emphasizes close follow up, which is important for sexual function recovery after prostate cancer treatment.
No Intervention: Usual care; Participants assigned to this group will continue with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients identified and treated for sexual dysfunction	Year 5
Number of patients identified and treated for urinary dysfunction	Year 5

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nnenaya A. Mmonu, MD, MS, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): March 31, 2030

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological
• Other Study ID Numbers: 23-00945

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nnenaya.Mmonu@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No