Prospective Evaluation of Intrathecal Targeted Drug Delivery for Cancer Associated Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 months post-implant.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Combination Product: Conservative medical management
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 |
Device: Intrathecal Targeted Drug Delivery
Intrathecal drug delivery systems (IDDs) deliver small doses of analgesics directly to the spinal cord.
Other Names:
Combination Product: Conservative medical management
Including physical therapy, oral or transdermal medications and injections
|
Outcome Measures
Primary Outcome Measures
- Change in Pain Intensity from Screening through 3 Months [Month 3]
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 [Month 3]
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 Outcome Measures
- Change in Drug Adverse Levels [Month 3]
Average change from baseline to Month 3 in drug adverse levels as assessed through the Common Terminology Criteria for Adverse Events (CTCAE)
- Change in Oral Opioid Intake [Month 3]
Average change from baseline to Month 3 in oral opioid intake
- Change in Healthcare Utilization [Month 3]
Average change from baseline to Month 3 in healthcare utilization as assessed by number of emergency, inpatient, and outpatient visits due to pain
- Change in Patient Well-Being [Month 3]
Average change from baseline to Month 3 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 [Month 3]
Average change from baseline to Month 3 in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)
Other Outcome Measures
- Change in Pain Intensity [Month 2]
Change from baseline to Month 2 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 [Month 2]
Change from baseline to Month 2 post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)
- Change in Drug Adverse Levels [Month 2]
Average change from baseline to Month 2 in drug adverse levels as assessed through the CTCAE
- Change in Oral Opioid Intake [Month 2]
Average change from baseline to Month 2 in oral opioid intake
- Change in Patient Well-Being [Month 2]
Average change from baseline to Month 2 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 [Month 2]
Average change from baseline to Month 2 in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)
- Change in Pain Intensity [Month 1]
Change from baseline to Month 1 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 [Month 1]
Change from baseline to Month 1 post treatment plan implementation in pain interference as measured through Patient-Reported Outcomes Measurement Information System (PROMIS-29)
- Change in Drug Adverse Levels [Month 1]
Average change from baseline to Month 1 in drug adverse levels as assessed through the CTCAE
- Change in Oral Opioid Intake [Month 1]
Average change from baseline to Month 1 in oral opioid intake
- Change in Patient Well-Being [Month 1]
Average change from baseline to Month 1 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 [Month 1]
Average change from baseline to Month 1 in Patient Global Impression of Change (PGIC) (1-7 where higher scores mean better outcome)
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Advocate Aurora Health | Oshkosh | Wisconsin | United States | 54904 |
Sponsors and Collaborators
- Mansoor Aman, MD
Investigators
- Principal Investigator: Mansoor M Aman, MD, Advocate Health Care
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-820