e-Health Psychosocial Stress and Symptom Management (ePSMI) for Pancreatic Cancer Patients

NCT06893276 | Not Yet Recruiting

• 2 other identifiers: 20240686HT94252411001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (10)

• Percentage of Participants Recruited

  Will be measured in percentages (%). The study will be considered feasible passed 60%.

  Up to 1 year.

• Percentage of Participants Retained

  Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.

  Up to 1 year.

• Percentage of Study Participation

  Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.

  Up to 1 year.

• Number of Calls

  It will be measured by number of biweekly calls.

  Up to 10 weeks.

• Theoretical Framework on Acceptability Questionnaire

  Scores will range from 10-50. Higher scores indicate higher acceptability.

  Up to 10 weeks.

• Functional Assessment of Cancer Therapy (FACT) - Functional Hepatobiliary-Pancreatic Symptom Index (FHSI)-18

  Scores will range 0-72 with lower scores indicating better quality of life.

  Up to 10 weeks.

• Patient-Reported Outcomes Measurement Information System - Pain Short Form

  Scores will range 0-80 with higher scores indicating higher pain symptoms

  Up to 10 weeks.

• Patient-Reported Outcomes Measurement Information System - Fatigue Short Form

  Scores will range 0-80 with higher scores indicating higher fatigue symptoms

  Up to 10 weeks.

• Pittsburgh Sleep Quality Index (PSQI)

  Scores will range from 0-21 with higher scores indicating worse sleep quality.

  Up to 10 weeks.

• Gastrointestinal Symptom Rating Scale (GSRS)

  Scores will range from 0-78 with higher scores indicating worse gastrointestinal symptoms.

  Up to 10 weeks.

Secondary Outcomes (17)

• Length of Hospital Stay

  Up to 365 days.

• Number of Participant's Readmissions

  Up to 1 year.

• Number of Reoccurrence of Disease in Participants

  Up to 1 year.

• Progression of Disease

  Up to 1 year.

• Perceived Stress Scale

  Up to 10 weeks.

Study Arms (1)

ePSMI Group

EXPERIMENTAL

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

Behavioral: ePSMI

Interventions

ePSMI BEHAVIORAL

Participants will complete an hour of cognitive behavioral stress management program in person or remote each week for ten weeks. The cognitive behavioral therapy (CBT) skills target reducing anxiety, (e.g., relaxation), changing negative appraisals (e.g., cognitive restructuring), coping skills training (e.g., enhancing adaptive skills), behavioral activation, interpersonal skills (e.g., communication skills) and building or enhancing social networks. The intervention will be administered online, and each module will last about 1-hour. After module completion, participants will have access to modules covered during session.

ePSMI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years of age.
• Spanish or English speaker with ability to read one of these languages.
• Diagnosis of pancreatic cancer.
• Patients diagnosed with pancreatic neuroendocrine tumor (PNET).

You may not qualify if:

• Patients unable to read Spanish or English, as participants will not be unable to complete surveys.
• Have a history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months).
• Have 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.

Sponsors & Collaborators

• University of Miami: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Frank Penedo, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Fleszar-Pavlovic, PhD

CONTACT

305-243-8498; sarafleszarpavlovic@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): November 27, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)