Better Options for Chronic Cancer Pain: a SMART Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral, Drug, Other, Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• 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

Locations
United States
Indiana
Richard L. Roudebush VA Medical Center, Indianapolis, IN
NOT_YET_RECRUITING
Indianapolis
Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
RECRUITING
Ann Arbor
Contact Information
Primary
Maria J Silveira, MD MA MPH
Maria.Silveira2@va.gov
(734) 845-3502
Backup
Karleen F Giannitrapani, PhD MA MPH
karleen.giannitrapani@va.gov
(650) 493-5000
Time Frame
Start Date: 2025-10-07
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 294
Treatments
Experimental: Multimodal pain care 9 months
Findings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration
Experimental: Medication optimization
Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan.
Experimental: Multimodal pain care 6 months / Opioid tapering 3 months
Findings from the comprehensive pain assessment will be used to inform an individualized, multimodal plan crafted by the team physician with the subject's collaboration. After 6 mo, subjects will attempt to taper opioids
Experimental: Medication optimization 9 months
Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain.
Experimental: Medication optimization 6 months/ Buprenorphine rotation 3 months
Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. After 6mo, subjects will receive buprenorphine and attempt to taper opioids for following 3 mo.
Experimental: Medication optimization 6 months/ Opioid tapering 3 months
Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan. Medications will be optimized following an algorithm the investigators created based upon NCCN's Survivorship Guidelines and AHRQ's comprehensive review of non-opioid treatments for chronic pain. After 6mo, subjects will attempt to taper opioids for following 3 mo.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov