Sexual and Urinary Function Improvement for Cancer Survivors

NCT06637852 — Not applicable, Not yet recruiting, 200 participants, NYU Langone Health

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

Registry	NCT06637852
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	200 (Estimated)
Sponsor	NYU Langone Health (Other)
Conditions	Urinary Dysfunction, Sexual Dysfunction
Interventions	SUFICS-PACT (Behavioral)
Dates	start 2026-10-01 (estimated), primary completion 2029-10-01 (estimated), completion 2030-03-31 (estimated), first posted 2024-10-15, last updated 2026-07-30
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
SUFICS-PACT	Experimental	Behavioral: 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.
Usual care	No intervention		Participants assigned to this group will continue with usual care.

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.

+Outcome measures

Primary outcomes

Number of patients identified and treated for sexual dysfunction [Year 5]
Number of patients identified and treated for urinary dysfunction [Year 5]

+Eligibility

Sex: Male, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
NYU Langone Health	New York, New York	United States

+Investigators

Nnenaya A. Mmonu, MD, MS, Principal investigator, NYU Langone Health