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NCT Number: NCT06893276

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Frank Penedo, PhD

PRINCIPAL_INVESTIGATOR

Lizelh Rodriguez, BA

CONTACT

[email protected]

305-243-8498

Nipun Merchant, MD

PRINCIPAL_INVESTIGATOR

Sara Fleszar-Pavlovic, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Participants Recruited

    Time frame: Up to 1 year.

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

  2. Percentage of Participants Retained

    Time frame: Up to 1 year.

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

  3. Percentage of Study Participation

    Time frame: Up to 1 year.

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

  4. Number of Calls

    Time frame: Up to 10 weeks.

    It will be measured by number of biweekly calls.

  5. Theoretical Framework on Acceptability Questionnaire

    Time frame: Up to 10 weeks.

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

  6. 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.

  7. 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

  8. 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

  9. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Up to 10 weeks.

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

  10. Gastrointestinal Symptom Rating Scale (GSRS)

    Time frame: Up to 10 weeks.

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

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: Up to 365 days.

    Measured in number of days.

  2. Number of Participant's Readmissions

    Time frame: Up to 1 year.

    Measured in number of readmissions.

  3. Number of Reoccurrence of Disease in Participants

    Time frame: Up to 1 year.

    Responses will be binary (yes or no). Will be measured in numbers.

  4. Progression of Disease

    Time frame: 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

  5. Perceived Stress Scale

    Time frame: Up to 10 weeks.

    Scores will range from 0 to 40 with higher scores indicating greater perceived stress levels.

  6. University of California, Los Angeles (UCLA) Loneliness Scale

    Time frame: Up tp 10 weeks.

    Scale of 20-80 with higher scores indicating higher loneliness

  7. Interpersonal Support Evaluation List

    Time frame: Up tp 10 weeks.

    12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support

  8. Patient-Reported Outcomes Measurement Information System - Depression Short Form

    Time frame: Up to 10 weeks.

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

  9. Patient-Reported Outcomes Measurement Information System - Anxiety Short Form

    Time frame: Up to 10 weeks.

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

  10. Patient-Reported Outcomes Measurement Information System - Physical Functioning Short Form

    Time frame: Up to 10 weeks.

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

  11. Patient-Reported Outcomes Measurement Information System - Self- Efficacy for Managing Symptoms-Short Form 8a

    Time frame: Up to 10 weeks.

    Scores will range 8-40 with greater scores indicating greater self- efficacy for managing symptoms.

  12. Emotional distress measured by Measure of Current State Scale

    Time frame: Up to 10 weeks.

    Scores will range from 0-80 with higher scores indicating more intense emotional distress.

  13. Difficulties in Emotional Regulation Scale

    Time frame: Up to 10 weeks.

    Scores will range from 18-90 with higher scores indicating less emotional regulation.

  14. Intolerance of Uncertainty Scale

    Time frame: Up to 10 weeks.

    Scores will range from 27-135 with higher scores indicated greater intolerance of uncertainties.

  15. Cancer Behavior Inventory

    Time frame: Up to 10 weeks.

    Scores will range from 33-297 with higher scores indicating greater self-efficacy in coping with cancer.

  16. Emotional Bond subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)

    Time frame: Up to 10 weeks.

    Scores will range from, 5-25; higher scores indicate greater emotional connection between the therapist and patient.

  17. Agreement of Collaboration Subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)

    Time frame: Up to 10 weeks.

    Scores will range from, 5-25; higher scores indicate greater agreement on collaboration between the therapist and patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Fleszar-Pavlovic, PhD

CONTACT

[email protected]

305-243-8498

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Official study title

Development of an eHealth Psychosocial Stress and Symptom Management Intervention for Patients With Pancreatic Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2025
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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