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Behavioral Intervention
Cognitive Behavioral Therapy for Pancreatic Cancer Stress Management
N/A
Waitlist Available
Led By Frank Penedo, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Greater than 18 years of age
Diagnosis of pancreatic cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 weeks.
Awards & highlights
Study Summary
This trial will test a new program to help reduce stress in pancreatic cancer patients.
Who is the study for?
This trial is for adults over 18 with pancreatic cancer who can read Spanish or English. They must be willing to participate in assessments from diagnosis through up to two years after surgery, if applicable. Those with severe mental illness history, other invasive cancers, or prior chemotherapy are excluded.Check my eligibility
What is being tested?
The study tests a web-based program designed to reduce stress in pancreatic cancer patients using Cognitive Behavioral Therapy (CBT)-based skills versus standard education about the disease and treatment.See study design
What are the potential side effects?
Since this trial involves psychological interventions rather than medications, traditional side effects are not expected. However, participants may experience emotional discomfort when discussing personal issues during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have been diagnosed with pancreatic cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy (FACT) Hepatobiliary-Pancreatic Symptom Index (FHSI)-18
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7)
Health Related Quality of Life as Measured by Interpersonal Support Evaluation List
+3 moreSecondary outcome measures
Biochemical Stress Response as measured by circulating peripheral blood mononuclear cells (PBMCs)
Biochemical Stress Response as measured by pro-inflammatory chemokine genes/receptors
Biochemical Stress Response as measured by pro-inflammatory cytokine genes
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Psychosocial Symptom Management Intervention (PSMI) Experimental Condition ArmExperimental Treatment1 Intervention
Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period.
Group II: Usual Clinical Care Control ArmActive Control1 Intervention
Participants in this group will receive standard education.
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Who is running the clinical trial?
University of MiamiLead Sponsor
898 Previous Clinical Trials
409,591 Total Patients Enrolled
1 Trials studying Psychological Adaptation
64 Patients Enrolled for Psychological Adaptation
Frank Penedo, PhDPrincipal InvestigatorUniversity of Miami
2 Previous Clinical Trials
700 Total Patients Enrolled
Frank PenedoPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can read and understand either Spanish or English.I am older than 18 years.I can speak and read either Spanish or English.I have been diagnosed with pancreatic cancer.I agree to be checked regularly for up to two years after my surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm
- Group 2: Usual Clinical Care Control Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it still possible for participants to enroll in this experiment?
"The particulars of this clinical trial, which was made public on December 15th 2021 and recently revised on April 28th 2022, are available for consultation on clinicaltrials.gov; indicating that recruitment is ongoing."
Answered by AI
What hopes does the research team have for this clinical experiment?
"This clinical trial has a time frame of up to 10 weeks and is aimed at assessing Health Related Quality of Life through the Perceived Stress Scale. Secondary objectives include evaluating Biochemical Stress Response using circulating peripheral blood mononuclear cells (PBMCs) from serum samples, pro-inflammatory cytokine genes including Interleukin (IL)-1A, IL1B, IL6, Tumor Necrosis Factor (TNF)- Super Family (SF)-10, TNF-alpha, TNFRSF21 and Prostaglandin-endoperoxide Synthase (PTGS)-2/Cyclooxy"
Answered by AI
What is the total number of participants being admitted to this trial?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, posted on December 15th 2021 and recently updated April 28th 2022, is actively recruiting participants from a single location with an overall objective of finding 60 patients."
Answered by AI
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