Better Options for Chronic Cancer Pain
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorVA Office of Research and Development
About this trial
This proposal is relevant to the 240,000 cancer survivors who continue to use opioids long after they have successfully completed treatment for cancer at the VHA, placing them at risk of opioid addiction and overdose, and other opioid-related problems. Yet, there are no programs at the VHA to help them find alternatives to opioids, nor evidence to inform the choice of interventions. This study will meet these needs by examining four interventions that are effective at reducing opioid use in patients with chronic musculoskeletal pain but have yet to be tested in cancer survivors on long term opioid therapy. The proposed work is relevant to the VHA Pain Office's mission to provide Veterans better pain management while limiting the risks of long-term opioid therapy and it aligns with VHA Research and Development's priority to examine clinical interventions for tapering opioids. Successful completion this project will keep VHA at the forefront of the battle against the opioid epidemic with a strategy that may be adapted to address the same needs in non-Veterans.
Eligibility criteria
Qualifiers
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.
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
Disqualifiers
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
current or past use of buprenorphine
active alcohol use disorder or substance use
Trial design
Treatments tested in this trial
- Multimodal pain care
- Medication optimization
- Buprenorphine rotation
- Opioid tapering
Treatment groups
294 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov