Cancer Associated Pain, Cancer Pain, Chronic Pain, Neuropathic Pain
Conditions
Keywords
targeted drug delivery, cancer pain, conservative pain management, neuromodulation, opioid, healthcare-utilization, quality of life
Brief summary
This Registry study will prospectively evaluate the differences in treatment outcomes in terms of pain intensity, pain interference, concomitant medication use, health-related quality of life, opioid adverse effects, and healthcare utilization between targeted drug delivery and conservative medication management only groups.
Detailed description
This is a prospective, open-label, short term patient registry where up to 169 subjects with cancer associated pain will be enrolled. Subjects with cancer associated pain who are receiving conservative medical management (CMM) only and cancer patients receiving Intrathecal Drug Delivery system (IDDs) along with CMM will be followed for up to 3 months. Subjects will be evaluated monthly up to 3 months from the medical care initiation which is the implant day for the IDDs group and start of the new treatment plan for the CMM group. Subjects that decide to cross-over to the IDDs group in a future date, will still be followed for their progress. Based on routine care, subjects will be seen at day of implant, 1 month post-implant, 2 months post-implant, and 3- and 6- months post-implant.
Interventions
DEVICEIntrathecal Targeted Drug Delivery
Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.
COMBINATION_PRODUCTConservative medical management
Including physical therapy, oral or transdermal medications and injections
Sponsors
Wake Forest University Health Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 21 and older * Uncontrolled cancer-associated pain (pain score of \>5 on NRS) despite oral use of 60 mg/d morphine equivalent a week prior to screening * Adverse side effects from long term opioid use defined as limiting or severely affecting patient's day to day function * Life expectancy of \> 3 months
Exclusion criteria
* Active infections * Controlled pain without adverse side effects that are limiting day to day function * Mechanical barriers * Obstruction of Cerebrospinal Fluid (CSF)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity from Screening through 3-Months | 3-Months | Change from baseline to Month 3 post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome) |
| Change in Pain Interference from Screening through 3-Months | 3-Months | Change from baseline to Month 3 post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Drug Adverse Levels | 3-Months | Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria |
| Change in Oral Opioid Intake | 3-Months | Average change from baseline to 3-Months in oral opioid intake |
| Change in Healthcare Utilization | 3-Months | Average change from baseline to 3-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain |
| Change in Patient Well-Being | 3-Months | Average change from baseline to 3-Months in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome) |
| Change in Patient Global Impression Change | 3-Months | Average change from baseline to 3-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLauren Littlefield, MD
Wake Forest University Health Sciences
Outcome results
None listed