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
2 other identifiers
observational
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2021
CompletedFirst Submitted
Initial submission to the registry
October 7, 2021
CompletedFirst Posted
Study publicly available on registry
October 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2024
CompletedFebruary 13, 2024
February 1, 2024
2.5 years
October 7, 2021
February 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
Undergo blood sample collection
Undergo pain assessment
Complete questionnaires
Eligibility Criteria
Patients with or without history of preoperative abdominal pain
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan P Cata
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2021
First Posted
October 19, 2021
Study Start
August 10, 2021
Primary Completion
February 9, 2024
Study Completion
February 9, 2024
Last Updated
February 13, 2024
Record last verified: 2024-02