Better Options for Chronic Cancer Pain

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
VA Office of Research and Development
Study ID
NCT06574009
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cancer Survivor
  • Chronic Pain
  • Opioid Dependence

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Multimodal pain care — BEHAVIORAL
    Behavioral therapy (as below), physical therapy, assistive devices (e.g. TENS, bracing), referrals to VA specialists (e.g. interventional pain), and complementary and integrative therapies (e.g. acupuncture or massage
  • Medication optimization — DRUG
    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.
  • Buprenorphine rotation — DEVICE
    Subjects randomized to this arm at 6 months will be offered the chance to rotate from their full mu agonist opioid to buprenorphine using a standardized protocol
  • Opioid tapering — OTHER
    Subjects randomized to tapering will receive recommendations based upon the VA PBM's opioid tapering reference guide

Study Details

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.

Key Dates

Start date
Oct 7, 2025
Status verified
May 2026
Primary completion
Apr 1, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
294 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Opioid dose reduction + Pain response (binary: yes/no) [ Time Frame: 9 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Richard L. Roudebush VA Medical Center, Indianapolis, INIndianapolisIndiana46202-2884
David Haggstrom, MD
[email protected]
Jasma Adams, BA
[email protected]
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105
Maria J Silveira, MD MA MPH
[email protected]
734-845-3502

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