Better Options for Chronic Cancer Pain

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byKarleen F Giannitrapani, PhD MA MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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.

Research Team

Maria J. Silveira, MD MA MPH

Principal Investigator

VA Ann Arbor Healthcare System, Ann Arbor, MI

Karleen F Giannitrapani, PhD MA MPH

Principal Investigator

VA Palo Alto Health Care System, Palo Alto, CA

Eligibility Criteria

This trial is for cancer survivors who have finished treatment but are still using opioids, potentially facing addiction or overdose risks. It's designed to help them find non-opioid pain relief alternatives.

Inclusion Criteria

It's been 6 months since my last major cancer treatment, but I may be on ongoing hormone or biologic therapy.

My current doctor agrees to continue prescribing opioids after the study.

I am a veteran with a history of certain cancers but have been cancer-free for 6 months.

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Exclusion Criteria

I take less than 300mg of opioids daily.

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 on the multidisciplinary pain teams

I do not use buprenorphine, have an alcohol or substance use disorder, use benzodiazepines daily, get opioids from non-VA providers, or have a history of self-harm.

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Treatment Details

Interventions

Buprenorphine rotation (Other)
Medication optimization (Other)
Multimodal pain care (Behavioral Intervention)
Opioid tapering (Other)

Trial OverviewThe study tests four strategies: multimodal pain care, reducing opioid doses gradually (tapering), switching from other opioids to buprenorphine (rotation), and optimizing medications to manage chronic cancer-related pain.

Participant Groups

6Treatment groups

Experimental Treatment

Group I: Multimodal pain care 9 monthsExperimental Treatment1 Intervention

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

Group II: Multimodal pain care 6 months / Opioid tapering 3 monthsExperimental Treatment2 Interventions

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

Group III: Medication optimization 9 monthsExperimental Treatment1 Intervention

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.

Group IV: Medication optimization 6 months/ Opioid tapering 3 monthsExperimental Treatment2 Interventions

Group V: Medication optimization 6 months/ Buprenorphine rotation 3 monthsExperimental Treatment2 Interventions

Group VI: Medication optimizationExperimental Treatment2 Interventions

Findings from the comprehensive pain assessment will be used to inform a medication-focused pain plan.