Appendix Carcinoma, Carcinomatosis, Colorectal Carcinoma, Gastric Carcinoma, Malignant Peritoneal Neoplasm, Malignant Solid Neoplasm
Conditions
Brief summary
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
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo blood sample collection
PROCEDUREPain Assessment
Undergo pain assessment
OTHERQuestionnaire Administration
Complete questionnaires
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic postsurgical pain | through study completion, an average of 1 year | 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. |
Countries
United States
Outcome results
None listed