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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment SUFICS-PACT for cancer survivors?

The research highlights the benefits of survivorship care plans (SCPs), which are part of SUFICS-PACT, in improving patient satisfaction and health literacy among cancer survivors. These plans help patients understand their care better and may lead to improved health outcomes. ^{1 2 3 4 5}

What safety data exists for SUFICS-PACT or similar treatments?

The safety of treatments similar to SUFICS-PACT, like immune checkpoint inhibitors, has been studied in conditions such as lung cancer. These treatments can cause immune-related side effects like diarrhea, colitis (inflammation of the colon), and pneumonitis (lung inflammation), which require careful management. ^{6 7 8 9 10}

Research Team

Nnenaya A. Mmonu, MD, MS

Principal Investigator

NYU Langone Health

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Enhancing survivorship care planning for patients with localized prostate cancer using a couple-focused web-based, mHealth program: the results of a pilot feasibility study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of an Automatically Generated Cancer Survivorship Care Plan on Patient-Reported Outcomes in Routine Clinical Practice: Longitudinal Outcomes of a Pragmatic, Cluster Randomized Trial. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Provision of a personalized survivorship care plan and its impact on cancer-related health literacy among childhood cancer survivors in Hong Kong. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes and satisfaction after delivery of a breast cancer survivorship care plan: results of a multicenter trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Health information technology to support cancer survivorship care planning: A systematic review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Immune-Related Diarrhea and Colitis in Non-small Cell Lung Cancers: Impact of Multidisciplinary Management in a Real-World Setting. [2023]

7. Germany 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. [2021]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Meta-Analysis of Regorafenib-Associated Adverse Events and Their Management in Colorectal and Gastrointestinal Stromal Cancers. [2020]

10. France pubmed.ncbi.nlm.nih.gov

[Management of immune-related toxicities associated with immune checkpoints inhibitors: Data from the multidisciplinary meeting « ToxImmun » in Eastern Occitania]. [2022]