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Search / Trial NCT06574009

Better Options for Chronic Cancer Pain

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Aug 23, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Survivorship Chronic Pain Analgesics

ClinConnect Summary

This clinical trial, titled "Better Options for Chronic Cancer Pain," is designed to find safer alternatives for cancer survivors who are still using opioids to manage their chronic pain after completing cancer treatment. Many veterans who have survived cancer continue to rely on opioid medications, which can lead to addiction and other health risks. The study will test four different methods to help reduce opioid use and improve pain management for these individuals, aiming to provide better support and treatment options.

To participate in the trial, veterans must have had certain types of cancer (like breast, lung, or prostate) and have been cancer-free for at least six months. They should also be experiencing moderate to severe pain and have been using opioids regularly. Participants can expect to receive care focused on managing their pain without increasing their risk for addiction. It's important to note that this study is not yet recruiting participants, but it aims to make a significant impact on how pain is managed among cancer survivors in the Veterans Health Administration.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

Indianapolis, Indiana, United States

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported