Health TrialsbyHealthPanel

Better Options for Chronic Cancer Pain

ConditionsChronic PainCancer SurvivorOpioid Dependence
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorVA Office of Research and Development

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

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

Disqualifiers

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

current or past use of buprenorphine

active alcohol use disorder or substance use

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

294 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Multimodal pain care 9 monthsExperimental treatment 1 intervention
Group B: Medication optimizationExperimental treatment 2 interventions
Group C: Multimodal pain care 6 months / Opioid tapering 3 monthsExperimental treatment 2 interventions
Group D: Medication optimization 9 monthsExperimental treatment 1 intervention
Group E: Medication optimization 6 months/ Buprenorphine rotation 3 monthsExperimental treatment 2 interventions
Group F: Medication optimization 6 months/ Opioid tapering 3 monthsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Opioid dose reduction + Pain response (binary: yes/no)

The primary outcome is a composite variable which combines one objective outcome (opioid dose reduction) and one subjective outcome (pain interference) to reflect two outcomes of equal importance to Veterans. Veterans will be considered as achieving this outcome if they experience 20% reduction in opioid daily dose (in MEDD) from baseline and no worsening of pain interference by more than 1 point on the Pain Enjoyment of Life and General Activity (PEG) score.

Time frame
9 months

Secondary outcomes

1

Opioid dose

total daily opioid dose will be measured in MEDD and based upon prescription tracking records and adjusted based upon self-report in the patient's diary.

Time frame
9 months
2

Pain interference

Pain interference will be measured using PROMIS Pain Interference 6b measure

Time frame
9 months
3

Pain intensity

Pain intensity will be measured using a 0-10 Numeric Rating Scale

Time frame
9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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