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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-09684 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2021-0027 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with or without history of preoperative abdominal pain
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| Name | Affiliation | Role |
|---|---|---|
| Juan P Cata | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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Blood
| Pain Assessment | Procedure | Undergo pain assessment |
|
|
| Questionnaire Administration | Other | Complete questionnaires |
|
| ID | Term |
|---|---|
| D001063 | Appendiceal Neoplasms |
| D002277 | Carcinoma |
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D002430 | Cecal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D003108 | Colonic Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
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