Prospective Randomized Study of TPS + CBT VS TPS Alone: Readmission, Opioid Use, and Chronic Pain
Prospective Randomized Study Of Transitional Pain Service (TPS) With Mini-Cognitive Behavioral Therapy (CBT) Versus TPS Alone For Evaluating Hospital Readmission, Opioid Outcomes, And Chronic Post-Surgical Pain
2 other identifiers
interventional
400
1 country
1
Brief Summary
This study aims to evaluate the impact of a Transitional Pain Service (TPS) on hospital readmission rates, opioid consumption, and chronic post-surgical pain(CPSP), Despite increasing recognition of the benefits of integrated transitional pain care, there are limited prospective data evaluating its impact on 30-day readmissions, longitudinal opioid use, and CPSP. This protocol will systematically collect prospective patient data to assess these outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started Feb 2027
Longer than P75 for not_applicable pain
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
First Submitted
Initial submission to the registry
August 21, 2026
CompletedFirst Posted
Study publicly available on registry
August 25, 2026
CompletedStudy Start
First participant enrolled
February 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
Study Completion
Last participant's last visit for all outcomes
May 1, 2031
August 25, 2026
August 1, 2026
2.2 years
August 21, 2026
August 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year.
Study Arms (2)
CBT: TPS Patients Receiving Mini-CBT
EXPERIMENTALParticipants consulted to TPS will be prospectively enrolled.
No-CBT: TPS Patients Not Receiving Mini-CBT
EXPERIMENTALParticipants consulted to TPS will be prospectively enrolled.
Interventions
Participants will receive a brief, skills-based mini-CBT group intervention
Eligibility Criteria
You may qualify if:
- Chronic pain syndrome Patients with a h/o or current substance use Patients on a daily opioid dose (morphine equivalency) of ≥90 Consulted for transitional pain service
You may not qualify if:
- Not seen by transitional pain service
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lakshmi Koyyalagunta, MD
UT MD Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2026
First Posted
August 25, 2026
Study Start (Estimated)
February 1, 2027
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2031
Last Updated
August 25, 2026
Record last verified: 2026-08