Sexual and Urinary Function Improvement for Cancer Survivors

NCT06637852 | Not Yet Recruiting

• 1 other identifier: 23-00945
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Dysfunction; Sexual Dysfunction

Outcome Measures

Primary Outcomes (2)

• Number of patients identified and treated for sexual dysfunction

  Year 5

• Number of patients identified and treated for urinary dysfunction

  Year 5

Study Arms (2)

SUFICS-PACT

EXPERIMENTAL

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

Usual care

NO INTERVENTION

Participants assigned to this group will continue with usual care.

Interventions

SUFICS-PACT BEHAVIORAL

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.

SUFICS-PACT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Nnenaya A. Mmonu, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nnenaya Mmonu, MD, MS

CONTACT

646-825-6300; Nnenaya.Mmonu@nyulangone.org

Favour Nnah

CONTACT

917-854-5895; Favour.Nnah@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): March 31, 2030
• Last Updated: September 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)