PainNCT07783672
Prospective Randomized Study of TPS + CBT VS TPS Alone: Readmission, Opioid Use, and Chronic Pain
A study testing Transitional Pain Service in people with Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Transitional Pain Service
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 1 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not seen by transitional pain service
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson Cancer Center
Houston, Texas, 77030
Lakshmi Koyyalagunta, MD, 713-745-4939, dkoyyala@mdanderson.org
Lakshmi Koyyalagunta, MD
About this study
Official title: 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
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.
Read the detailed description
Primary Objective:
To compare the 30-day hospital readmission rate in patients seen by to the Transitional Pain Service.
Secondary Objectives:
- To evaluate reduction in opioid use (MME) at 30, 60, 90, 180, and 365 days.
- 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.
- To evaluate the incidence of CPSP
- To assess demographic and clinical predictors of readmission and opioid reduction.
- 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
- Conditions
- Pain
- Being tested
- Transitional Pain Service
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional Pain ServiceBehavioural
Participants will receive a brief, skills-based mini-CBT group intervention
| Study group | Role | What they receive |
|---|---|---|
| CBT: TPS Patients Receiving Mini-CBT | Experimental | Participants consulted to TPS will be prospectively enrolled. Receives: Behavioral: Transitional Pain Service |
| No-CBT: TPS Patients Not Receiving Mini-CBT | Experimental | Participants consulted to TPS will be prospectively enrolled. Receives: Behavioral: Transitional Pain Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lakshmi Koyyalagunta, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783672
- Sponsor's protocol ID
- 2026-0228
- Other IDs
- NCI-2026-06214
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07783672
- Acronym / sponsor ID
- 2026-0228
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate reduction in opioid use (MME) at 30, 60, 90, 180, and 365 days.
- 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.
- To evaluate the incidence of CPSP
- To assess demographic and clinical predictors of readmission and opioid reduction.
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT: TPS Patients Receiving Mini-CBT | Experimental | Behavioral: Transitional Pain ServiceParticipants consulted to TPS will be prospectively enrolled. |
| No-CBT: TPS Patients Not Receiving Mini-CBT | Experimental | Behavioral: Transitional Pain ServiceParticipants consulted to TPS will be prospectively enrolled. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Not seen by transitional pain service
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitional Pain ServiceParticipants will receive a brief, skills-based mini-CBT group intervention | Behavioural | CBT: TPS Patients Receiving Mini-CBT, No-CBT: TPS Patients Not Receiving Mini-CBT |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- MD Anderson WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lakshmi Koyyalagunta, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional Pain Service in people with Pain, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lakshmi Koyyalagunta, MD ((713) 745-4939, dkoyyala@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.