SUFICS-PACT for Cancer Survivors

Overseen By Nnenaya Mmonu, MD, MS

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Under 18, Not treated, Vulnerable

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist prostate cancer survivors experiencing sexual and urinary function issues. The study will test a new care model called SUFICS-PACT, which provides a team of healthcare professionals, including mental health and symptom management experts, to offer personalized support and treatment. Participants will either receive this specialized collaborative care or continue with their usual care. Men treated for prostate cancer who face these challenges might find this trial beneficial. As an unphased trial, this study offers a unique opportunity for participants to access innovative care models that could enhance their quality of life.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this collaborative care model is safe for prostate cancer survivors?

In a previous study, patients with prostate cancer experienced significant improvements in urinary and sexual function through comprehensive care programs. These programs often included mental health support and symptom management. Research has shown that a team approach, like the one used in SUFICS-PACT, can be effective and well-received by patients.

While specific safety details for SUFICS-PACT aren't provided, the program's team-based care focuses on coordinated support and symptom management, which generally carries low risk. As this isn't a drug trial, the main risks involve the effectiveness of the care team's collaboration in meeting patients' needs. Overall, the approach is designed to safely address the unmet needs of cancer survivors, enhancing their quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SUFICS-PACT intervention for cancer survivors because it offers a fresh approach to managing sexual and urinary dysfunction, common issues faced by those who have undergone cancer treatment. Unlike standard care, which often involves separate and fragmented care pathways, SUFICS-PACT integrates a collaborative care model directly within primary care settings. This means problems can be identified early, treated comprehensively, and followed up closely, all in one place. This holistic and streamlined approach has the potential to significantly improve quality of life for cancer survivors by addressing these sensitive issues more effectively and efficiently.

What evidence suggests that SUFICS-PACT is effective for treating sexual and urinary dysfunction in prostate cancer survivors?

Research has shown that SUFICS-PACT, which participants in this trial may receive, aims to assist prostate cancer survivors with sexual and urinary problems through a team-based care model. Although specific data on SUFICS-PACT remains limited, this model involves a team of specialists, including mental health and psychosexual counselors, to manage symptoms. This approach addresses both the physical and emotional aspects of these issues. Previous studies suggest that team-based care can enhance symptom management in complex conditions by providing comprehensive support. By bringing together different health experts, this method may lead to better management of sexual and urinary problems in cancer survivors. ^{1 6 7 8 9}

Who Is on the Research Team?

Nnenaya A. Mmonu, MD, MS

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for prostate cancer survivors experiencing sexual or urinary dysfunction. Participants will be treated at NYC Health+Hospitals/Bellevue and must be willing to undergo a collaborative care model treatment. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.

Inclusion Criteria

I have been diagnosed with prostate cancer.

I have sought treatment for prostate cancer.

Exclusion Criteria

I am under 18 years old.

Patients who are categorized as 'vulnerable subjects' such as minors or incarcerated individuals.

I have not sought treatment for prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive collaborative treatment for sexual and urinary dysfunction, including mental health and psychosexual counseling, symptom management, and supervision by primary care physicians

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SUFICS-PACT

Trial Overview The study tests the SUFICS-PACT program's effectiveness in treating sexual and urinary dysfunctions in prostate cancer survivors using a team approach. This includes specialty-trained care managers, nurse practitioners, physicians, and consult liaisons working together.

How Is the Trial Designed?

Group I: SUFICS-PACT Experimental Treatment 1 Intervention

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.

Group II: Usual care Active Control 1 Intervention

Participants assigned to this group will continue with usual care.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Adverse events (AEs) related to regorafenib are significantly more common in patients under 65 years old and are strongly correlated with the higher starting dose of 160 mg, suggesting that younger patients may be at greater risk.

Lowering the regorafenib dose to 120 mg may reduce the incidence of AEs while maintaining efficacy, as 57% of patients recovered from AEs after dose adjustments, indicating the importance of monitoring and managing side effects for continued treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-Analysis of Regorafenib-Associated Adverse Events and Their Management in Colorectal and Gastrointestinal Stromal Cancers. Xie, G., Gong, Y., Wu, S., et al.[2020]

In a meta-analysis of 51 studies with 12,600 participants, the development of immune-related adverse events (irAEs) was linked to improved overall survival (OS) and objective response rate (ORR) in advanced non-small cell lung cancer (NSCLC).

Checkpoint inhibitor pneumonitis (CIP) did not significantly affect overall survival but was associated with a better treatment response, indicating that while CIP may not be detrimental to survival, it can enhance the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Immune-Related Adverse Events and Pneumonitis on Prognosis in Advanced Non-Small Cell Lung Cancer: A Comprehensive Systematic Review and Meta-analysis. Li, Y., Zhang, Y., Jia, X., et al.[2022]

In a meta-analysis of 4413 patients from 8 randomized controlled trials, PD-1/PD-L1 inhibitors showed a significantly lower risk of all-grade adverse events (66.20% vs. 86.08%) and high-grade adverse events (14.26% vs. 43.53%) compared to chemotherapy, indicating a better safety profile.

While PD-1/PD-L1 inhibitors are generally safer, they are associated with a unique set of immune-related adverse events (irAEs) that can be severe, such as pneumonitis and thyroid dysfunction, which clinicians need to monitor closely to manage patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer: a meta-analysis of randomized controlled trials. Luo, W., Wang, Z., Tian, P., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06637852?cond=%22sexual%20dysfunction%22&aggFilters=sex:m,status:not%20rec&rank=4

Sexual and Urinary Function Improvement for Cancer ... The purpose of this study is to test the efficacy of SUFICS-PACT to identify and treat sexual and urinary dysfunction in prostate cancer ...

2. withpower.com withpower.com/clinical-trials/for-erectile-dysfunction?page=2

Top Erectile Dysfunction Clinical Trials | Power 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/ ...

3. safpj.co.za safpj.co.za/index.php/safpj/article/view/5621/7781

https://safpj.co.za/index.php/safpj/article/view/5621/7781 ... sexual and urinary dysfunction. In as much as diagnosing aggressive cancers can be lifesaving, diagnosing harmless cancers does more harm than good.<sup> ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10247235/

Changes in male sexuality after urologic cancer Erectile function was preserved in 78% of patients after 12 months of HIFU half-gland treatment. A recent study compared the impact of focal (N = 195) and whole ...

5. mypcnow.org mypcnow.org/fast-fact/sexual-dysfunction-in-cancer-patients-and-survivors/?print=print

Sexual Dysfunction in Cancer Patients and Survivors Most patients prefer physiological over psychological solutions; however, clinical research outcomes for many of the physiological therapies are mixed (8).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11634280/

Sexuality, sexual function important aspects of survivorship ... An important aspect of survivorship care was omitted; sexuality and sexual function have been identified as unmet needs for cancer survivors.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27226515/

Sexual Function in Cancer Survivors: Updates to the ... By the year 2024, predictions estimate that there will be approximately 19 million cancer survivors in the United States, many of whom will experience the ...

8. urotoday.com urotoday.com/recent-abstracts/urologic-oncology/prostate-cancer/61268-early-post-operative-urinary-and-sexual-function-predicts-functional-recovery-at-one-year-following-prostatectomy-abstract.html

Early post-operative urinary and sexual function predicts ... Patients with complete EPIC-UIN questionnaires (N = 437) had worsened (2.7%), improved (47.8%), and stable (49.4%) urinary function and those ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40173399/

Enhancing Sexual Health for Cancer Survivors A comprehensive, patient-centered approach to sexual health can help improve outcomes and overall well-being for cancer survivors.