NCT06893276 · University of Miami
e-Health Psychosocial Stress and Symptom Management (ePSMI) for Pancreatic Cancer Patients
What this study is about
The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
View original scientific description
The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
Interventions
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., 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.
Primary outcome measures
Percentage of Participants Recruited
Time frame: Up to 1 year.
Will be measured in percentages (%). The study will be considered feasible passed 60%.
Percentage of Participants Retained
Time frame: Up to 1 year.
Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.
Percentage of Study Participation
Time frame: Up to 1 year.
Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.
Number of Calls
Time frame: Up to 10 weeks.
It will be measured by number of biweekly calls.
Theoretical Framework on Acceptability Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 10 weeks.
Scores will range 0-80 with higher scores indicating higher fatigue symptoms
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Up to 10 weeks.
Scores will range from 0-21 with higher scores indicating worse sleep quality.
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Up to 10 weeks.
Scores will range from 0-78 with higher scores indicating worse gastrointestinal symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Where
- Miami, Florida
Collaborators
U.S. Army Medical Research and Development Command
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2026 · Source of record for eligibility and locations