Pancreatic CancerNCT06893276
e-Health Psychosocial Stress and Symptom Management (ePSMI) for Pancreatic Cancer Patients
A study testing ePSMI in people with Pancreatic Cancer, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- ePSMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2026to 27 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Lizelh Rodriguez, BA, 305-243-8498, Lna6@miami.edu
Frank Penedo, PhD
About this study
Official title: Development of an eHealth Psychosocial Stress and Symptom Management Intervention for Patients With Pancreatic Cancer
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
- Being tested
- ePSMI
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePSMIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ePSMI Group | Experimental | Participants in this group will receive the ePSMI intervention for up to ten weeks. Receives: Behavioral: ePSMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Recruited
Will be measured in percentages (%). The study will be considered feasible passed 60%.
Measured: Up to 1 year.
Percentage of Participants Retained
Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.
Measured: Up to 1 year.
Percentage of Study Participation
Will be measured in percentages (%). The study will be considered feasible passed ≥ 80%.
Measured: Up to 1 year.
Number of Calls
It will be measured by number of biweekly calls.
Measured: Up to 10 weeks.
Theoretical Framework on Acceptability Questionnaire
Scores will range from 10-50. Higher scores indicate higher acceptability.
Measured: Up to 10 weeks.
Functional Assessment of Cancer Therapy (FACT) - Functional Hepatobiliary-Pancreatic Symptom Index (FHSI)-18
Scores will range 0-72 with lower scores indicating better quality of life.
Measured: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Pain Short Form
Scores will range 0-80 with higher scores indicating higher pain symptoms
Measured: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Fatigue Short Form
Scores will range 0-80 with higher scores indicating higher fatigue symptoms
Measured: Up to 10 weeks.
Pittsburgh Sleep Quality Index (PSQI)
Scores will range from 0-21 with higher scores indicating worse sleep quality.
Measured: Up to 10 weeks.
Gastrointestinal Symptom Rating Scale (GSRS)
Scores will range from 0-78 with higher scores indicating worse gastrointestinal symptoms.
Measured: Up to 10 weeks.
Secondary outcomes (17)
Length of Hospital Stay
Measured in number of days.
Measured: Up to 365 days.
Number of Participant's Readmissions
Measured in number of readmissions.
Measured: Up to 1 year.
Number of Reoccurrence of Disease in Participants
Responses will be binary (yes or no). Will be measured in numbers.
Measured: Up to 1 year.
Progression of Disease
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
Measured: Up to 1 year.
Perceived Stress Scale
Scores will range from 0 to 40 with higher scores indicating greater perceived stress levels.
Measured: Up to 10 weeks.
University of California, Los Angeles (UCLA) Loneliness Scale
Scale of 20-80 with higher scores indicating higher loneliness
Measured: Up tp 10 weeks.
Interpersonal Support Evaluation List
12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support
Measured: Up tp 10 weeks.
Patient-Reported Outcomes Measurement Information System - Depression Short Form
Scores will range 0-80 with higher scores indicating higher pain symptoms
Measured: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Anxiety Short Form
Scores will range 0-80 with higher scores indicating higher pain symptoms
Measured: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Physical Functioning Short Form
Scores will range 0-80 with higher scores indicating higher pain symptoms
Measured: Up to 10 weeks.
Patient-Reported Outcomes Measurement Information System - Self- Efficacy for Managing Symptoms-Short Form 8a
Scores will range 8-40 with greater scores indicating greater self- efficacy for managing symptoms.
Measured: Up to 10 weeks.
Emotional distress measured by Measure of Current State Scale
Scores will range from 0-80 with higher scores indicating more intense emotional distress.
Measured: Up to 10 weeks.
Difficulties in Emotional Regulation Scale
Scores will range from 18-90 with higher scores indicating less emotional regulation.
Measured: Up to 10 weeks.
Intolerance of Uncertainty Scale
Scores will range from 27-135 with higher scores indicated greater intolerance of uncertainties.
Measured: Up to 10 weeks.
Cancer Behavior Inventory
Scores will range from 33-297 with higher scores indicating greater self-efficacy in coping with cancer.
Measured: Up to 10 weeks.
Emotional Bond subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)
Scores will range from, 5-25; higher scores indicate greater emotional connection between the therapist and patient.
Measured: Up to 10 weeks.
Agreement of Collaboration Subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)
Scores will range from, 5-25; higher scores indicate greater agreement on collaboration between the therapist and patient.
Measured: Up to 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start13 Aug 2026
- Primary completion27 Nov 2027 (estimated)
- Study completion27 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Frank Penedo, University of Miami
- Investigators
- Frank Penedo, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893276
- Sponsor's protocol ID
- 20240686
- Other IDs
- HT94252411001
- Status last verified
- Aug 2026
- First submitted
- 18 Mar 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an eHealth Psychosocial Stress and Symptom Management Intervention for Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06893276
- Acronym / sponsor ID
- 20240686
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 27 Nov 2027 (estimated)
- Study completion
- 27 Nov 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ePSMI Group | Experimental | Behavioral: ePSMIParticipants in this group will receive the ePSMI intervention for up to ten weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePSMIParticipants 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. | Behavioural | ePSMI Group |
Primary outcome
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.
17 secondary outcomes
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.
Difficulties in Emotional Regulation Scale
Time frame: Up to 10 weeks.
Intolerance of Uncertainty Scale
Time frame: Up to 10 weeks.
Cancer Behavior Inventory
Time frame: Up to 10 weeks.
Emotional Bond subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)
Time frame: Up to 10 weeks.
Agreement of Collaboration Subscale of the Multiperspective Assessment of General Change Mechanisms in Psychotherapy (MPACM-P)
Time frame: Up to 10 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Penedo, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePSMI in people with Pancreatic Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Fleszar-Pavlovic, PhD (305-243-8498, sarafleszarpavlovic@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Recruited (time frame: Up to 1 year.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.