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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care | No Intervention | Participants assigned to this group will continue with usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients identified and treated for sexual dysfunction | Year 5 | |
| Number of patients identified and treated for urinary dysfunction | Year 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nnenaya Mmonu, MD, MS | Contact | 646-825-6300 | Nnenaya.Mmonu@nyulangone.org | |
| Favour Nnah | Contact | 917-854-5895 | Favour.Nnah@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Nnenaya A. Mmonu, MD, MS | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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