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Better Options for Chronic Cancer Pain in Veterans

This study is for cancer survivors who are Veterans and continue to use opioid pain medications long after their cancer treatment. It aims to find better ways to manage chronic pain and reduce opioid use. Researchers are testing four different approaches: multimodal pain care (which includes behavioral therapy, physical therapy, and other treatments), optimizing current pain medications, switching from current opioids to buprenorphine, or gradually reducing opioid use. The study will look at how much opioid use is reduced and if pain improves after 9 months. You may be able to join if you are a Veteran aged 18-99, had a solid tumor, and finished most of your cancer treatment at least 6 months ago. The current status of this study is unclear.

Study design
This interventional study plans to enroll 294 participants. It will compare different strategies for managing chronic pain and reducing opioid use.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main results will be measured at 9 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06574009

Better Options for Chronic Cancer Pain

Recruiting
PHASE4Ages 18–99InterventionalSupportive care
VA Office of Research and Development
~294 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:Multimodal pain careMedication optimizationBuprenorphine rotationOpioid tapering

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Opioid dose reduction + Pain response (binary: yes/no)
Measured over 9 months

Conditions

Chronic Pain
Cancer Survivor
Opioid Dependence

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Where it's being run

2 sites across 2 states
Indiana1
Michigan1

Study leadership

  • Karleen F Giannitrapani, PhD MA MPH · PRINCIPAL_INVESTIGATOR · VA Palo Alto Health Care System, Palo Alto, CA
  • Maria J Silveira, MD MA MPH · PRINCIPAL_INVESTIGATOR · VA Ann Arbor Healthcare System, Ann Arbor, MI

Who to contact

Maria J Silveira, MD MA MPH
[email protected]
(734) 845-3502
Email the study team

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Eligibility criteria

Inclusion

Veterans must have had a qualifying solid tumor (bladder, breast, colorectal, head and neck, liver, lung, pancreas, prostate, or urinary tract) without evidence of active disease for at least 6 months
Participants must be 6 months away from their last receipt of cytotoxic, radiation, or surgical cancer treatments but can be on hormonal or biologic therapies needed to sustain remission or cancer control.
Participants must report pain \>=4 (on 0-10 NRS) on their last 3 recordings in the electronic medical record. Veterans should be on Long Term Opioid Therapy (LTOT) defined as:
a qualifying opioid analgesic dispensed within the prior 30 days
plus 150 days' supply of a qualifying opioid (fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone) in the 180 days before the most recent dispensing date with no between-fill gaps \>40 days
There must be advance agreement from their existing opioid prescriber to resume opioid prescribing after study

Exclusion

Veterans with total daily opioid doses \>= 300 Morphine Milligram Equivalents (MME) will be excluded (higher doses require tapering prior to rotation to buprenorphine, which is something the investigators do not want to examine in this study)
Veterans with referrals or visits to a substance abuse clinic within the prior 2 years will be excluded to avoid including individuals requiring addiction expertise that is not available one the multidisciplinary pain teams
The investigators will also exclude Veterans with:
current or past use of buprenorphine
active alcohol use disorder or substance use
risk factors for opioid overdose (e.g. active suicidality or history of self-directed violence)
daily use of benzodiazepines
receipt of opioids from non-VA providers in the prior 3 months
or aberrant urine drug screen at baseline (cannabis is not exclusionary)
To ensure the relevance of our work to as many Veteran cancer survivors as possible, the investigators will not exclude subjects meeting DSM criteria for opioid use disorder if their only source of opioids is the VA

What this trial measures

  • Opioid dose reduction + Pain response (binary: yes/no)9 months

    The primary outcome is a composite variable which combines one objective outcome (opioid dose reduction) and one subjective outcome (pain interference) to reflect two outcomes of equal importance to Veterans. Veterans will be considered as achieving this outcome if they experience 20% reduction in opioid daily dose (in MEDD) from baseline and no worsening of pain interference by more than 1 point on the Pain Enjoyment of Life and General Activity (PEG) score.