E-Health Psychosocial Stress And Symptom Management (ePSMI) For Pancreatic Cancer Patients

Study Overview

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

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

N/A

Pancreatic Cancer

BEHAVIORAL: ePSMI

20240686
HT94252411001 (OTHER_GRANT Identifier) (OTHER_GRANT: US Army Medical Research Acquisition Activity (USARAA))

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-03-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-18
First Submitted that Met QC Criteria 2025-03-18	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-25
First Posted (ACTUAL) 2025-03-25	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ePSMI Group Participants in this group will receive the ePSMI intervention for up to ten weeks.	BEHAVIORAL: ePSMI 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: ePSMI Group

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

BEHAVIORAL: ePSMI

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.

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Length of Hospital Stay	Measured in number of days.	Up to 365 days.
Number of Participant's Readmissions	Measured in number of readmissions.	Up to 1 year.
Number of Reoccurrence of Disease in Participants	Responses will be binary (yes or no). Will be measured in numbers.	Up to 1 year.
Progression of Disease	Stages range from 0 to 4. Stage 0: carcinoma in situa Stage 1: localized Stage II: locally advanced Stage III: locally advanced with major blood vessel involvement Stage IV: Metastatic	Up to 1 year.
Perceived Stress Scale	Scores will range from 0 to 40 with higher scores indicating greater perceived stress levels.	Up to 10 weeks.
University of California, Los Angeles (UCLA) Loneliness Scale	Scale of 20-80 with higher scores indicating higher loneliness	Up tp 10 weeks.
Interpersonal Support Evaluation List	12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support	Up tp 10 weeks.
Patient-Reported Outcomes Measurement Information System - Depression Short Form	Scores will range 0-80 with higher scores indicating higher pain symptoms	Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Anxiety Short Form	Scores will range 0-80 with higher scores indicating higher pain symptoms	Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Physical Functioning Short Form	Scores will range 0-80 with higher scores indicating higher pain symptoms	Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Self- Efficacy for Managing Symptoms-Short Form 8a	Scores will range 8-40 with greater scores indicating greater self- efficacy for managing symptoms.	Up to 10 weeks.
Emotional distress measured by Measure of Current State Scale	Scores will range from 0-80 with higher scores indicating more intense emotional distress.	Up to 10 weeks.
Difficulties in Emotional Regulation Scale	Scores will range from 18-90 with higher scores indicating less emotional regulation.	Up to 10 weeks.
Intolerance of Uncertainty Scale	Scores will range from 27-135 with higher scores indicated greater intolerance of uncertainties.	Up to 10 weeks.
Cancer Behavior Inventory	Scores will range from 33-297 with higher scores indicating greater self-efficacy in coping with cancer.	Up to 10 weeks.
Emotional Bond subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)	Scores will range from, 5-25; higher scores indicate greater emotional connection between the therapist and patient.	Up to 10 weeks.
Agreement of Collaboration Subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)	Scores will range from, 5-25; higher scores indicate greater agreement on collaboration between the therapist and patient.	Up to 10 weeks.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sara Fleszar-Pavlovic, PhD

Phone Number: 305-243-8498

Email: sarafleszarpavlovic@med.miami.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

U.S. Army Medical Research and Development Command

Investigators

PRINCIPAL_INVESTIGATOR: Frank Penedo, PhD, University of Miami

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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