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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer associated pain treated with conservative medical management (CMM) only | 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 |
| |
| Cancer associated pain treated with Intrathecal Drug Delivery system (IDDs) along with CMM | Patients in this group are those that opted for targeted drug delivery along with conservative medical management of their cancer-associated pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Targeted Drug Delivery | Device | Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 3-Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Drug Adverse Levels | Average change from baseline to 3-Months in drug adverse levels as assessed through the Common Toxicity Criteria | 3-Months |
| Change in Oral Opioid Intake | Average change from baseline to 3-Months in oral opioid intake |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2-Months |
| Change in Pain Interference |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Littlefield, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Aurora Health | Oshkosh | Wisconsin | 54904 | United States |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Conservative medical management | Combination Product | Including physical therapy, oral or transdermal medications and injections |
|
| 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 | 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) | 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) | 3-Months |
Change from baseline to 2-Months post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)
| 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 | 2-Months |
| Change in Oral Opioid Intake | Average change from baseline to 2-Months in oral opioid intake | 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) | 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) | 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) | 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) | 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 | 1-Month |
| Change in Oral Opioid Intake | Average change from baseline to 1-Month in oral opioid intake | 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) | 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) | 1-Month |
| Average change from baseline to 6-Months in drug adverse levels as assessed through the Common Toxicity Criteria (NCI) | 6-Months |
| Average change from baseline to 6-Months in oral opioid intake | 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 | 6-Months |
| Average change from baseline to 6-Months in patient well being as measured through FACT-G questionnaire | 6-Months |
| Overall patient satisfaction in 6-Months as assessed through PGIC questionnaire | 6-Months |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |