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

Not Applicable

Not yet recruiting

• Conditions: Pancreatic Cancer

• Registration Number: NCT06893276
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-12-01
• Primary Completion: 2026-11-27
• Study Completion: 2026-11-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

1. Patients unable to read Spanish or English, as participants will not be unable to complete surveys.
2. Have a history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months).
3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Recruited	Up to 1 year.	Will be measured in percentages (%). The study will be considered feasible passed 60%.
Percentage of Participants Retained	Up to 1 year.	Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.
Percentage of Study Participation	Up to 1 year.	Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.
Number of Calls	Up to 10 weeks.	It will be measured by number of biweekly calls.
Theoretical Framework on Acceptability Questionnaire	Up to 10 weeks.	Scores will range from 10-50. Higher scores indicate higher acceptability.
Functional Assessment of Cancer Therapy (FACT) - Functional Hepatobiliary-Pancreatic Symptom Index (FHSI)-18	Up to 10 weeks.	Scores will range 0-72 with lower scores indicating better quality of life.
Patient-Reported Outcomes Measurement Information System - Pain Short Form	Up to 10 weeks.	Scores will range 0-80 with higher scores indicating higher pain symptoms
Patient-Reported Outcomes Measurement Information System - Fatigue Short Form	Up to 10 weeks.	Scores will range 0-80 with higher scores indicating higher fatigue symptoms
Pittsburgh Sleep Quality Index (PSQI)	Up to 10 weeks.	Scores will range from 0-21 with higher scores indicating worse sleep quality.
Gastrointestinal Symptom Rating Scale (GSRS)	Up to 10 weeks.	Scores will range from 0-78 with higher scores indicating worse gastrointestinal symptoms.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States