Trials / Completed
CompletedNCT05083338
Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy
Prospective Evaluation of Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy in Adult Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 24 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Appendix Carcinoma
- Carcinomatosis
- Colorectal Carcinoma
- Gastric Carcinoma
- Malignant Peritoneal Neoplasm
- Malignant Solid Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biospecimen Collection | Undergo blood sample collection |
| PROCEDURE | Pain Assessment | Undergo pain assessment |
| OTHER | Questionnaire Administration | Complete questionnaires |
Timeline
- Start date
- 2021-08-10
- Primary completion
- 2024-02-09
- Completion
- 2024-02-09
- First posted
- 2021-10-19
- Last updated
- 2024-02-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05083338. Inclusion in this directory is not an endorsement.