Clinical trial NCT06893276: e-Health Psychosocial Stress and Symptom Management (ePSMI) for Pancreatic Cancer Patients
Official title: Development of an eHealth Psychosocial Stress and Symptom Management Intervention for Patients With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2025-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Recruited
timeFrame: Up to 1 year.
measure: Percentage of Participants Retained
timeFrame: Up to 1 year.
measure: Percentage of Study Participation
timeFrame: Up to 1 year.
measure: Number of Calls
timeFrame: Up to 10 weeks.
measure: Theoretical Framework on Acceptability Questionnaire
timeFrame: Up to 10 weeks.
measure: Functional Assessment of Cancer Therapy (FACT) - Functional Hepatobiliary-Pancreatic Symptom Index (FHSI)-18
timeFrame: Up to 10 weeks.
measure: Patient-Reported Outcomes Measurement Information System - Pain Short Form
timeFrame: Up to 10 weeks.
measure: Patient-Reported Outcomes Measurement Information System - Fatigue Short Form
timeFrame: Up to 10 weeks.
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Up to 10 weeks.
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Up to 10 weeks.
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Up to 365 days.
measure: Number of Participant's Readmissions
timeFrame: Up to 1 year.
measure: Number of Reoccurrence of Disease in Participants
timeFrame: Up to 1 year.
measure: Progression of Disease
timeFrame: Up to 1 year.
measure: Perceived Stress Scale
timeFrame: Up to 10 weeks.
measure: University of California, Los Angeles (UCLA) Loneliness Scale
timeFrame: Up tp 10 weeks.
measure: Interpersonal Support Evaluation List
timeFrame: Up tp 10 weeks.
measure: Patient-Reported Outcomes Measurement Information System - Depression Short Form
timeFrame: Up to 10 weeks.
measure: Patient-Reported Outcomes Measurement Information System - Anxiety Short Form
timeFrame: Up to 10 weeks.
measure: Patient-Reported Outcomes Measurement Information System - Physical Functioning Short Form
timeFrame: Up to 10 weeks.
measure: Patient-Reported Outcomes Measurement Information System - Self- Efficacy for Managing Symptoms-Short Form 8a
timeFrame: Up to 10 weeks.
measure: Emotional distress measured by Measure of Current State Scale
timeFrame: Up to 10 weeks.
measure: Difficulties in Emotional Regulation Scale
timeFrame: Up to 10 weeks.
measure: Intolerance of Uncertainty Scale
timeFrame: Up to 10 weeks.
measure: Cancer Behavior Inventory
timeFrame: Up to 10 weeks.
measure: Emotional Bond subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)
timeFrame: Up to 10 weeks.
measure: Agreement of Collaboration Subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)
timeFrame: Up to 10 weeks.
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Frank Penedo, PhD
role: PRINCIPAL_INVESTIGATOR
References: