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Trial Title:
Sexual and Urinary Function Improvement for Cancer Survivors
NCT ID:
NCT06637852
Condition:
Urinary Dysfunction
Sexual Dysfunction
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
SUFICS-PACT
Description:
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.
Arm group label:
SUFICS-PACT
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Start date:
October 1, 2026
Completion date:
March 31, 2030
Lead sponsor:
Agency:
NYU Langone Health
Agency class:
Other
Source:
NYU Langone Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06637852
