Recruiting

Psychosocial Program

Sponsor:

University of Miami

Code:

NCT06893276

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ePSMI

Study Details

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.

Conditions

Pancreatic Cancer

Study ID

NCT06893276

Start date

Aug 13, 2026

Status verified date

Aug, 2026

Completion date

Nov 27, 2027

Anticipated

Primary completion date

Nov 27, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: ePSMI Group

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

Interventions

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 measure

  • Percentage of Participants Recruited [ Time Frame: Up to 1 year. ]
  • Percentage of Participants Retained [ Time Frame: Up to 1 year. ]
  • Percentage of Study Participation [ Time Frame: Up to 1 year. ]
  • Number of Calls [ Time Frame: Up to 10 weeks. ]
  • Theoretical Framework on Acceptability Questionnaire [ Time Frame: Up to 10 weeks. ]
  • Functional Assessment of Cancer Therapy (FACT) - Functional Hepatobiliary-Pancreatic Symptom Index (FHSI)-18 [ Time Frame: Up to 10 weeks. ]
  • Patient-Reported Outcomes Measurement Information System - Pain Short Form [ Time Frame: Up to 10 weeks. ]
  • Patient-Reported Outcomes Measurement Information System - Fatigue Short Form [ Time Frame: Up to 10 weeks. ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Up to 10 weeks. ]
  • Gastrointestinal Symptom Rating Scale (GSRS) [ Time Frame: Up to 10 weeks. ]

Central Contacts and Locations

Central contacts

Sara Fleszar-Pavlovic, PhD

305-243-8498sarafleszarpavlovic@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Lizelh Rodriguez, BA

305-243-8498Lna6@miami.edu

Principal Investigator:

Frank Penedo, PhD

More Information

Sponsor

University of Miami

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-26.