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

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05083338

Collaborator

(none)

145

Enrollment

Location

29.7

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Appendix Carcinoma Carcinomatosis Colorectal Carcinoma Gastric Carcinoma Malignant Peritoneal Neoplasm Malignant Solid Neoplasm	Procedure: Biospecimen Collection Procedure: Pain Assessment Other: Questionnaire Administration

Detailed Description

PRIMARY OBJECTIVE:

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:

To evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of persistent postsurgical pain after CRS-HIPEC.
To evaluate the association between preoperative abnormal sensory disturbances and chronic postsurgical pain after CRS-HIPEC.
To assess the association of blood micro ribonucleic acids (RNAs) signatures with the development of chronic postsurgical pain after CRS-HIPEC.
To determine the rate of and factors associated with persistent and chronic opioid use after CRS-HIPEC.
To determine the rate of persistent and chronic postsurgical anxiety and depression.
To investigate changes in psychological risk factors (depression, anxiety or catastrophizing) and sensory disturbances after CRS-HIPEC overtime.

EXPLORATORY OBJECTIVE:

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

145 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 10, 2021

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Observational (questionnaire, pain assessment, biospecimen) 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 Undergo blood sample collection Other Names: Biological Sample Collection Procedure: Pain Assessment Undergo pain assessment Other Names: Pain Measurement Other: Questionnaire Administration Complete questionnaires

Arm

Intervention/Treatment

Observational (questionnaire, pain assessment, biospecimen)

Procedure: Biospecimen Collection

Undergo blood sample collection

Other Names:

Biological Sample Collection

Procedure: Pain Assessment

Undergo pain assessment

Other Names:

Pain Measurement

Other: Questionnaire Administration

Complete questionnaires

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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