Skip to content

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07783672
Enrollment
400
Registered
2026-08-25
Start date
2027-02-01
Completion date
2031-05-01
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Detailed description

Primary Objective: To compare the 30-day hospital readmission rate in patients seen by to the Transitional Pain Service. Secondary Objectives: 1. To evaluate reduction in opioid use (MME) at 30, 60, 90, 180, and 365 days. 2. To evaluate patient reported outcomes using BPI, CAGE-AID, SOAPP-14, ESAS, PROMIS-29 at 30, 60, 90, 180, and 365 days to assess patient-reported quality of life and pain outcomes longitudinally. 3. To evaluate the incidence of CPSP 4. To assess demographic and clinical predictors of readmission and opioid reduction. 5. Compare outcomes between TPS patients who receive a brief, skills-based mini-CBT group intervention vs. TPS patients who do not receive mini-CBT, including: * Time trends across 30, 60, 90 days, and 6 and 12 months. * Opioid use (daily MME), and proportion achieving ≥30% MME reduction from baseline; * Pain intensity (NRS/10), BPI severity & interference, PROMIS-29 domains; * beyond 30-day hospital readmission rate

Interventions

Participants will receive a brief, skills-based mini-CBT group intervention

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Not seen by transitional pain service

Design outcomes

Primary

MeasureTime frameDescription
Safety and Adverse Events (AEs)Through study completion; an average of 1 year.Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Countries

United States

Contacts

CONTACTLakshmi Koyyalagunta, MD
dkoyyala@mdanderson.org(713) 745-4939
PRINCIPAL_INVESTIGATORLakshmi Koyyalagunta, MD

UT MD Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026