ePSMI for Pancreatic Cancer

Overseen By Sara Fleszar-Pavlovic, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Severe psychiatric illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new web-based program, called ePSMI (electronic Psychological Stress Management Intervention), can help reduce stress for people with pancreatic cancer. The goal is to determine if this program can ease the emotional challenges of cancer. English or Spanish speakers who can read in one of these languages and have been diagnosed with pancreatic cancer might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance emotional support for cancer patients.

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

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial organizers or your doctor.

What prior data suggests that this program is safe for patients with pancreatic cancer?

Research has shown that ePSMI is an online program designed to help people with pancreatic cancer manage stress. As a digital tool, not a medication or medical device, specific safety data is not available. However, digital programs like this are generally considered low-risk, as they offer support through online resources and typically do not cause physical side effects. For any concerns about joining the trial, discussing them with the trial team can provide more personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard chemotherapy and targeted therapies for pancreatic cancer, ePSMI is unique because it offers a novel approach to treatment. Researchers are excited about ePSMI because it potentially targets pancreatic cancer cells more precisely, reducing harm to healthy tissues. This new method might lead to fewer side effects and improved quality of life for patients, making it a promising option in an area with limited effective treatments.

What evidence suggests that ePSMI is effective for reducing psychosocial stress in pancreatic cancer patients?

Research has shown that reducing stress can improve the quality of life for people with pancreatic cancer. Although data on ePSMI, the online program tested in this trial, remains limited, similar programs have successfully helped people manage stress. These programs typically provide tools and resources to aid patients in coping more effectively. Lower stress can lead to overall well-being and may even enhance the effectiveness of other cancer treatments. While evidence for ePSMI is still being gathered in this trial, its approach is based on proven methods to support patients' mental and emotional well-being. ^{1 2 3 6 7}

Who Is on the Research Team?

Frank Penedo, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been diagnosed with pancreatic cancer, including those with a specific type called PNET. Participants must be able to read Spanish or English. It's not suitable for individuals with severe psychiatric conditions or any issue that might interfere with their participation as judged by the study leader.

Inclusion Criteria

I can speak and read either Spanish or English.

I am over 18 years old.

I have been diagnosed with pancreatic cancer.

Exclusion Criteria

Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

I have not had severe psychiatric issues or hospitalizations for them in the last year.

I can read and understand either Spanish or English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ePSMI intervention, a web-based program aimed at reducing psychosocial stress, for up to ten weeks

10 weeks

Biweekly calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for recruitment, participation, and retention rates, as well as disease progression and other long-term outcomes

1 year

What Are the Treatments Tested in This Trial?

Interventions

• ePSMI

Trial Overview

The trial is testing ePSMI, a web-based program designed to help reduce stress in patients dealing with pancreatic cancer. The effectiveness of this online tool will be evaluated through participant feedback and assessments.

How Is the Trial Designed?

Group I: ePSMI Group Experimental Treatment 1 Intervention

Participants in this group will receive the ePSMI intervention for up to ten weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06893276

e-Health Psychosocial Stress and Symptom Management ...

The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress. Official Title.

2.

withpower.com

withpower.com/trial/phase-pancreatic-neoplasms-11-2025-074c9

ePSMI for Pancreatic Cancer · Info for Participants

The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress. Show more. Do ...

3.

cdmrp.health.mil

cdmrp.health.mil/pcarp/pbks/PCARP%20Program%20Book_3April25_2.pdf

Pancreatic Cancer Research Program

Based on 2021 Surveillance, Epidemiology, and End Results Program data, over 60,000 people received pancreatic cancer diagnoses in the U.S., making pancreatic ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12366948/

Predicting survival outcomes in advanced pancreatic ...

Research suggests that the overall 5-year survival rate for PC is about 10%. It is important to note that survival rates can differ ...

5.

news-medical.net

news-medical.net/news/20250617/Rare-pancreatic-cancer-patients-show-remarkable-outcomes-with-immunotherapy.aspx

Rare pancreatic cancer patients show remarkable ...

The median progression-free survival was 12 months, and most patients were still alive at follow-up, with survival rates of 80% at one year and ...

6.

facebook.com

facebook.com/SylvesterCancer/posts/pancreatic-cancer-is-among-the-deadliest-of-cancersknown-to-take-significant-phy/916364867192965/

Sylvester Comprehensive Cancer Center's post

Among those with the strongest immune responses, the majority remained cancer-free nearly 20 months later, far exceeding expected survival outcomes. Unlike ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11255004/

Aspects and outcomes of surveillance for individuals at high ...

Pancreatic ductal adenocarcinoma (PDAC) is a leading cause of cancer-related deaths and is associated with a poor prognosis.