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Not yet recruiting NCT06893276

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

No phase Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ePSMI.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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 onlin

Primary outcome measures

  • 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.]
Secondary outcome measures (12)
  • Length of Hospital Stay [Time frame: Up to 365 days.]
  • Number of Participant's Readmissions [Time frame: Up to 1 year.]
  • Number of Reoccurrence of Disease in Participants [Time frame: Up to 1 year.]
  • Progression of Disease [Time frame: Up to 1 year.]
  • Perceived Stress Scale [Time frame: Up to 10 weeks.]
  • University of California, Los Angeles (UCLA) Loneliness Scale [Time frame: Up tp 10 weeks.]
  • Interpersonal Support Evaluation List [Time frame: Up tp 10 weeks.]
  • Patient-Reported Outcomes Measurement Information System - Depression Short Form [Time frame: Up to 10 weeks.]
  • Patient-Reported Outcomes Measurement Information System - Anxiety Short Form [Time frame: Up to 10 weeks.]
  • Patient-Reported Outcomes Measurement Information System - Physical Functioning Short Form [Time frame: Up to 10 weeks.]
  • Patient-Reported Outcomes Measurement Information System - Self- Efficacy for Managing Symptoms-Short Form 8a [Time frame: Up to 10 weeks.]
  • Emotional distress measured by Measure of Current State Scale [Time frame: Up to 10 weeks.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06893276 · 20240686 · HT94252411001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗