Actively Recruiting
Better Options for Chronic Cancer Pain: a SMART Study
Led by VA Office of Research and Development · Updated on 2026-05-11
294
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating four different approaches to reduce long-term opioid use in cancer survivors who continue to experience chronic pain after completing cancer treatment. The study focuses on Veterans who have used opioids for a long time, aiming to find safer alternatives to manage their pain without worsening their symptoms. This trial addresses an important gap since current programs do not offer evidence-based options for opioid reduction in this group. It is a phase 4, randomized, two-stage trial conducted by the VA Office of Research and Development. Participants will be randomized to receive either multimodal pain care or medication optimization for the first six months. Multimodal pain care includes behavioral therapy, physical therapy, assistive devices like TENS or bracing, specialist referrals, and complementary therapies such as acupuncture or massage. Medication optimization involves adjusting non-opioid pain medications based on established guidelines. After six months, those who do not respond will be assigned to either buprenorphine rotation, where they switch from their current opioid to buprenorphine, or opioid tapering following VA recommendations. The study lasts nine months with different treatment stages. During the study, participants will undergo comprehensive pain assessments and regular monitoring of opioid doses and pain interference at six and nine months. Researchers will measure opioid dose reduction combined with changes in pain interference as the primary outcome. Secondary outcomes include opioid dose alone, pain intensity, and pain interference. The study also aims to understand challenges in implementing each treatment to help integrate successful strategies into VA care for cancer survivors on long-term opioid therapy.
CONDITIONS
Brief Title
Better Options for Chronic Cancer Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans with a qualifying solid tumor (bladder, breast, colorectal, head and neck, liver, lung, pancreas, prostate, or urinary tract) without active disease for at least 6 months
- At least 6 months since last cytotoxic, radiation, or surgical cancer treatment
- On hormonal or biologic therapies needed to sustain remission or control
- Report pain of 4 or higher on a 0-10 scale in last 3 medical record entries
- On long-term opioid therapy with qualifying opioids dispensed within past 30 days and 150 days supply in prior 180 days without gaps over 40 days
- Agreement from current opioid prescriber to resume opioid prescribing after study
You will not qualify if you...
- Total daily opioid doses of 300 Morphine Milligram Equivalents or higher
- Referrals or visits to substance abuse clinics within past 2 years
- Current or past use of buprenorphine
- Active alcohol use disorder or other substance use
- Risk factors for opioid overdose such as active suicidality or history of self-directed violence
- Daily benzodiazepine use
- Receiving opioids from non-VA providers in past 3 months
- Aberrant urine drug screen at baseline (cannabis use allowed)
- Veterans needing addiction expertise beyond the study's multidisciplinary pain teams unless opioid use disorder is only from VA source
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either multimodal pain care including behavioral therapy, physical therapy, assistive devices, and complementary therapies, or medication optimization following a pain medication algorithm.
Regular visits as part of treatment plan
Duration - 3 months
Participants who do not respond to initial treatment are randomized to either buprenorphine rotation using a standardized protocol or opioid tapering based on VA guidelines.
Visits scheduled as part of intervention protocols
Duration - Up to 3 months after end of treatment
Participants are monitored for opioid dose reduction and pain interference outcomes at 9 months after treatment initiation.
Follow-up visits for assessments
Trial Site Locations
Total: 2 locations
1
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States, 46202-2884
Not Yet Recruiting
2
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
Research Team
M
Maria J Silveira, MD MA MPH
M
Matthew D McCaa, MS OTR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here