Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy
NCT ID: NCT05083338
Last Updated: 2024-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2021-08-10
2024-02-09
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Biospecimen Collection
Undergo blood sample collection
Pain Assessment
Undergo pain assessment
Questionnaire Administration
Complete questionnaires
Interventions
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Biospecimen Collection
Undergo blood sample collection
Pain Assessment
Undergo pain assessment
Questionnaire Administration
Complete questionnaires
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with extra-abdominal metastatic disease
* Patients cognitive or neurologically unable to complete questionnaires preoperatively
* Non-English-speaking patients
* Pregnant women
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Juan P Cata
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-09684
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-0027
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0027
Identifier Type: -
Identifier Source: org_study_id
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