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

NCT ID: NCT06893276

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-11-27

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ePSMI Group

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

Group Type: EXPERIMENTAL

ePSMI

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Frank Penedo

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Penedo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Central Contacts

Sara Fleszar-Pavlovic, PhD

Role: CONTACT

sarafleszarpavlovic@med.miami.edu

305-243-8498

Facility Contacts

Lizelh Rodriguez, BA

Role: primary

Lna6@miami.edu

305-243-8498

Other Identifiers

HT94252411001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

20240686

Identifier Type: -

Identifier Source: org_study_id