QOL and GI Outcomes in Malignancies

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

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

Conditions
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Psychological Adaptation, Psychological Adjustment, Stress, Emotional

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy (CBT)-based skills
* Behavioral: Standard Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than 18 years of age Spanish or English speaker with ability to read one of these languages Diagnosis of pancreatic cancer . 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: Patients unable to read Spanish or English, as they will be unable to complete surveys. 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. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychosocial Symptom Management Intervention (PSMI) Experimental Condition Arm<br>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<br>* 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.<br>|
| Active Comparator: Usual Clinical Care Control Arm<br>Participants in this group will receive standard education. | Behavioral: Standard Education<br>* Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychosocial Symptom Management, eHealth Intervention