Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy

Study Overview
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Brief Summary
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This study learns if depression, anxiety, and catastrophizing (thought patterns that prompt people to expect the worst) are associated with chronic pain after surgery among patients who are scheduled to have cytoreductive surgery with intraoperative hyperthermic chemotherapy. Information from this study may improve the understanding of persistent and chronic postsurgical pain integrating multiple layers of biological and behavioral sciences.

Detailed Description
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PRIMARY OBJECTIVE: I. To evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of chronic postsurgical pain after cytoreductive surgery with intraoperative hyperthermic chemotherapy (CRS-HIPEC). SECONDARY OBJECTIVES: I. To evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of persistent postsurgical pain after CRS-HIPEC. II. To evaluate the association between preoperative abnormal sensory disturbances and chronic postsurgical pain after CRS-HIPEC. III. To assess the association of blood micro ribonucleic acids (RNAs) signatures with the development of chronic postsurgical pain after CRS-HIPEC. IV. To determine the rate of and factors associated with persistent and chronic opioid use after CRS-HIPEC. V. To determine the rate of persistent and chronic postsurgical anxiety and depression. VI. To investigate changes in psychological risk factors (depression, anxiety or catastrophizing) and sensory disturbances after CRS-HIPEC overtime. EXPLORATORY OBJECTIVE: I. To explore the impact of perioperative (in-patient) opioid use, non-opioid analgesic use and anesthetics on the development of persistent and chronic opioid use after CRS-HIPEC. OUTLINE: Patients complete questionnaires over 15 minutes and undergo pain assessments prior to surgery and at 3, 6 and 12 months after surgery. Patients also undergo blood sample collection before surgery and optionally at 3, 6 and 12 months after surgery.

Official Title
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Prospective Evaluation of Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy in Adult Patients

Conditions
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Appendix Carcinoma, Carcinomatosis, Colorectal Carcinoma, Gastric Carcinoma, Malignant Peritoneal Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Procedure: Pain Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older; with or without history of preoperative abdominal pain American Society of Anesthesiologists physical status (ASA) 1-4 Scheduled surgery: open CRS-HIPEC surgery for primary peritoneal malignancy or secondary carcinomatosis (i.e., appendiceal, colorectal and gastric cancers) Written informed consent Exclusion Criteria: ASA >= 4 or emergency surgeries Patients with extra-abdominal metastatic disease Patients cognitive or neurologically unable to complete questionnaires preoperatively Non-English-speaking patients Pregnant women

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (questionnaire, pain assessment, biospecimen)<br>Patients complete questionnaires over 15 minutes and undergo pain assessments prior to surgery and at 3, 6 and 12 months after surgery. Patients also undergo blood sample collection before surgery and optionally at 3, 6 and 12 months after surgery. | Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Biological Sample Collection;Procedure: Pain Assessment<br>* Undergo pain assessment<br>* Other names: Pain Measurement;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic postsurgical pain | Defined as pain that develops or increases in intensity compared to preoperative after cyotreductive surgery with intraoperative hyperthermic chemotherapy (CRS-HIPEC), lasts for more than 6 months. | through study completion, an average of 1 year |