An observational study in Cancer Pain, Chronic Pain and Cancer Associated Pain, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Wake Forest University Health Sciences · Observational
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.
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.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's enrollment of 30 is below the median of 140 across 68 observational studies indexed under Cancer Pain.
Browse Cancer Pain studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Up to 169 subjects with cancer-associated pain who are going to be treated either with conservative medical management (CMM) only or with Intrathecal Drug Delivery along with CMM per treatment plan.
Exclusion Criteria:
Subjects in this group are patients who opted for conservative medical management for their chronic pain that is cancer associated, including physical therapy, oral or transdermal medications and injections
Combination Product: Conservative medical management
Patients in this group are those that opted for targeted drug delivery along with conservative medical management of their cancer-associated pain
Device: Intrathecal Targeted Drug Delivery · Combination Product: Conservative medical management
Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.
Also known as: Medtronic SynchroMed™ II pump
Including physical therapy, oral or transdermal medications and injections
Change in Pain Intensity from Screening through 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)
Time frame: 3-Months
Change in Pain Interference from Screening through 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)
Time frame: 3-Months
Change in Drug Adverse Levels
Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria
Time frame: 3-Months
Change in Oral Opioid Intake
Average change from baseline to 3-Months in oral opioid intake
Time frame: 3-Months
Change in Healthcare Utilization
Average change from baseline to 3-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain
Time frame: 3-Months
Change in Patient Well-Being
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)
Time frame: 3-Months
Change in Patient Global Impression Change
Average change from baseline to 3-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)
Time frame: 3-Months
Change in Pain Intensity
Change from baseline to 2-Months post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)
Time frame: 2-Months
Change in Pain Interference
Change from baseline to 2-Months post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 2-Months
Change in Drug Adverse Levels
Average change from baseline to 2-Months in drug adverse levels as assessed through the Common Toxicity Criteria
Time frame: 2-Months
Change in Oral Opioid Intake
Average change from baseline to 2-Months in oral opioid intake
Time frame: 2-Months
Change in Patient Well-Being
Average change from baseline to 2-Months in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)
Time frame: 2-Months
Change in Patient Global Impression Change
Average change from baseline to 2-Months in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)
Time frame: 2-Months
Change in Pain Intensity
Change from baseline to 1-Month post treatment plan implementation in average pain as measured through Numerical Rating Scale (0-10 where higher scores mean worse outcome)
Time frame: 1-Month
Change in Pain Interference
Change from baseline to 1-Month post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Time frame: 1-Month
Change in Drug Adverse Levels
Average change from baseline to 1-Month in drug adverse levels as assessed through the Common Toxicity Criteria
Time frame: 1-Month
Change in Oral Opioid Intake
Average change from baseline to 1-Month in oral opioid intake
Time frame: 1-Month
Change in Patient Well-Being
Average change from baseline to 1-Month in patient well-being as measured through Functional Assessment of Cancer Therapy: General (FACT-G) (0-4 where higher scores mean worse outcome)
Time frame: 1-Month
Change in Patient Global Impression Change
Average change from baseline to 1-Month in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)
Time frame: 1-Month
Average change from baseline to 6-Months in drug adverse levels as assessed through the Common Toxicity Criteria (NCI)
Time frame: 6-Months
Average change from baseline to 6-Months in oral opioid intake
Time frame: 6-Months
Average change from baseline to 6-Months in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain and length of hospital stays
Time frame: 6-Months
Average change from baseline to 6-Months in patient well being as measured through FACT-G questionnaire
Time frame: 6-Months
Overall patient satisfaction in 6-Months as assessed through PGIC questionnaire
Time frame: 6-Months
Plan to share: Undecided
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences