Better Options for Chronic Cancer Pain

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.

Conditions

• Chronic Pain
• Cancer Survivor
• Opioid Dependence

Interventions

BEHAVIORAL

Multimodal pain care

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

DRUG

Medication optimization

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.

DEVICE

Buprenorphine rotation

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

OTHER

Opioid tapering

Subjects randomized to tapering will receive recommendations based upon the VA PBM's opioid tapering reference guide

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Karleen F Giannitrapani, PhD MA MPH · VA Palo Alto Health Care System, Palo Alto, CA

• Maria J Silveira, MD MA MPH · VA Ann Arbor Healthcare System, Ann Arbor, MI

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-07

Primary Completion

2029-04-01

Completion

2029-12-31

FDA Drug

Yes

Countries

• United States

Study Locations