QOL and GI Outcomes in Malignancies

Psychosocial Determinants of Health-Related Quality of Life (QOL) and Gastrointestinal (GI) Functional Outcomes During Treatment for Malignancies

The purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress, Emotional; Psychological Adjustment; Psychological Adaptation
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy (CBT)-based skills; Behavioral: Standard Education

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Fleszar-Pavlovic, PhD; Phone Number: 8504456978; Email: sarafleszarpavlovic@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
      • Principal Investigator: Frank Penedo
      • Contact: Sara Fleszar-Pavlovic, PhD; Phone Number: 305-243-4009; Email: sarafleszarpavlovic@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. Willingness to be assessed at diagnosis, during neoadjuvant chemotherapy (if applicable), preoperatively (if applicable - unless time of diagnosis is preoperative visit), and postoperatively for up to two years following surgery.

Exclusion Criteria:

1. Patients unable to read Spanish or English, as they will be unable to complete surveys.
2. History of previous invasive cancer or treatment with chemotherapy, as they may have a different baseline functional status, quality of life, and gastrointestinal function compared to the normal healthy population, per principal investigator discretion, based on a case-by-case review.
3. Prior inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis) within the past six months as these conditions can interfere with adequate participation in assessments, per principal investigator discretion, based on a case-by-case review.
4. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm; Participants in this group will receive the Cognitive Behavioral Therapy (CBT)-based skills over a 10-week period.	Behavioral: Cognitive Behavioral Therapy (CBT)-based skills; The 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.
Active Comparator: Usual Clinical Care Control Arm; Participants in this group will receive standard education.	Behavioral: Standard Education; Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life as Measured by Perceived Stress Scale	Perceived Stress Scale (Scale of 1-40 with higher scores indicating higher stress)	Up to 10 weeks.
Health Related Quality of Life as Measured by University of California, Los Angeles (UCLA) Loneliness Scale	UCLA Loneliness Scale (Scale of 20-80 with higher scores indicating higher loneliness)	Up to 10 weeks.
Health Related Quality of Life as Measured by Interpersonal Support Evaluation List	Interpersonal Support Evaluation List (12 item questionnaire evaluated on a 4-point Likert scale with a higher score indicating higher support).	Up to 10 weeks.
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy General - 7 Item Version (FACT-G7)	FACT-G7 (Scale of 0-28 with higher scores indicating better quality of life)	Up to 10 weeks.
Health Related Quality of Life as Measured by Functional Assessment of Cancer Therapy (FACT) Hepatobiliary-Pancreatic Symptom Index (FHSI)-18	FACT FHSI-18 (Scale of 0-72 with lower scores indicating better quality of life)	Up to 10 weeks.
The Gastrointestinal Symptom Rating Scale (GSRS)	GSRS (Scale of 0-78 with higher scores indicating worse gastrointestinal symptoms)	Up to 10 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical Stress Response as measured by pro-inflammatory cytokine genes	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/Cyclooxygenase (COX)-2 from serum blood samples.	Up to 10 weeks.
Biochemical Stress Response as measured by pro-inflammatory chemokine genes/receptors	Pro-inflammatory chemokine genes/receptors including: Chemokine ligand (CCL)-3, CCL7, CCL20, CCL3L1, CCL4L2, and CXC Chemokine Receptor (CXCR)-7 from serum blood samples.	Up to 10 weeks.
Biochemical Stress Response as measured by tumor promoting factor genes	Tumor promoting factor genes including: Matrix Metallopeptidase (MMP)-9 & Lamin A/C (LMNA) from serum blood samples.	Up to 10 weeks.
Biochemical Stress Response as measured by circulating peripheral blood mononuclear cells (PBMCs)	Circulating peripheral blood mononuclear cells (PBMCs) from serum blood samples.	Up to 10 weeks.

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Frank Penedo, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: eHealth Intervention; Psychosocial Symptom Management
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 20190846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No