Trial Title:
Better Options for Chronic Cancer Pain
NCT ID:
NCT06574009
Condition:
Chronic Pain
Cancer Survivor
Opioid Dependence
Conditions: Official terms:
Chronic Pain
Cancer Pain
Opioid-Related Disorders
Buprenorphine
Conditions: Keywords:
survivorship
chronic pain
analgesics
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Masking description:
Data analyst will be masked.
Intervention:
Intervention type:
Behavioral
Intervention name:
Multimodal pain care
Description:
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
Arm group label:
Medication optimization
Arm group label:
Multimodal pain care 6 months / Opioid tapering 3 months
Arm group label:
Multimodal pain care 9 months
Intervention type:
Drug
Intervention name:
Medication optimization
Description:
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.
Arm group label:
Medication optimization 6 mo/ Opioid tapering 3 months
Arm group label:
Medication optimization 6 months/ Buprenorphine rotation 3 months
Arm group label:
Medication optimization 9 months
Intervention type:
Device
Intervention name:
Buprenorphine rotation
Description:
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
Arm group label:
Medication optimization
Arm group label:
Medication optimization 6 months/ Buprenorphine rotation 3 months
Intervention type:
Other
Intervention name:
Opioid tapering
Description:
Subjects randomized to tapering will receive recommendations based upon the VA PBM's
opioid tapering reference guide
Arm group label:
Medication optimization 6 mo/ Opioid tapering 3 months
Arm group label:
Multimodal pain care 6 months / Opioid tapering 3 months
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.
Detailed description:
Background: Twenty-four percent of Veterans who survive cancer remain on long term opioid
therapy (LTOT) after completing cancer treatment, placing them at significant risk of
opioid addiction, overdose, and other opioid-related health conditions. To reduce opioid
use in this population, the investigators will examine the impacts of multimodal pain
care and buprenorphine rotation - two strategies that have demonstrated efficacy in
Veterans with musculoskeletal pain on LTOT but have not been tested in cancer survivors
on LTOT, revealing a critical knowledge gap. The overall scientific premise of this
project is that these two approaches can effectively reduce LTOT in cancer survivors
without worsening chronic pain, and that they are better than pain medication
optimization and opioid tapering. The primary objective is to examine which treatment
strategy or combination of strategies is most successful at achieving a reduction in LTOT
without worsening chronic pain over 6 and 9 months. The investigators will also identify
the key challenges and strategies in the implementation of each treatment strategy to
facilitate future translation of study findings into VA practice.
Significance: There are currently no care pathways at the VHA to help cancer survivors on
LTOT find alternatives to opioids for managing chronic pain, nor evidence to guide which
interventions to include. By addressing these unmet needs, this work aligns with
POU-AMP's priority to examine clinical interventions for tapering opioid medications.
Innovation: The investigators are among the first to examine multimodal care and
buprenorphine rotation to reduce LTOT in cancer survivors. Also, the investigators are
among the first to apply VHA's evidence-based, stepped care model of multidisciplinary
pain care to cancer survivors on LTOT.
Aim 1: To test if Veterans who receive multimodal pain care will be more likely to
decrease total daily opioid use by at least 20% at 6 and 9 months without experiencing
worsened pain interference compared to those who receive optimization of non-opioid pain
medications.
Aim 2: To test if Veterans who do not respond to 6 months of multimodal care or
medication optimization are more likely to achieve the desired outcome at 9 months when
they are offered buprenorphine rotation as opposed to opioid tapering.
Exploratory Aim 3: To examine which combination of interventions is most likely to
achieve the desired outcome at 9 months.
Aim 4: To understand the key challenges and strategies in the implementation of each
intervention to facilitate future translation of study findings into practice.
Methodology: The investigators plan a two-site, two-stage, response-adaptive, comparative
effectiveness trial following SMART (Sequential, Multiple-Assignment Randomized Trial)
principles. The investigators will enroll 294 Veteran cancer survivors on LTOT who
receive their care at the Indianapolis or Ann Arbor VAMC. Subjects will be randomized to
either multimodal pain care or pain medication optimization at Stage 1. After 6 months,
non-respondents will be randomized to buprenorphine rotation or opioid tapering in Stage
2. The primary outcome is a composite variable combining one objective outcome (opioid
dose reduction) and one subjective outcome (pain interference), assessed at 6 and 9
months. The secondary outcomes are opioid dose reduction and pain interference
individually.
Next Steps/Implementation: Successful execution of this project will provide actionable
information, including an implementation strategy, that VHA's Offices of Pain Management
and Oncology can put in place to support over 240,000 cancer survivors on LTOT for
chronic pain.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Address:
City:
Indianapolis
Zip:
46202-2884
Country:
United States
Contact:
Last name:
David Haggstrom, MD
Email:
dahaggst@iu.edu
Contact backup:
Last name:
Jasma Adams, BA
Email:
jasma.adams2@va.gov
Facility:
Name:
VA Ann Arbor Healthcare System, Ann Arbor, MI
Address:
City:
Ann Arbor
Zip:
48105-2303
Country:
United States
Contact:
Last name:
Elizabeth Koester
Phone:
734-845-5844
Email:
Elizabeth.Koester@va.gov
Investigator:
Last name:
Maria J. Silveira, MD MA MPH
Email:
Principal Investigator
Start date:
April 1, 2025
Completion date:
December 31, 2029
Lead sponsor:
Agency:
VA Office of Research and Development
Agency class:
U.S. Fed
Source:
VA Office of Research and Development
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06574009
