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| ID | Type | Description | Link |
|---|---|---|---|
| EH21C1 | Other Identifier | Essentia Health | |
| EH22738 | Other Identifier | Essentia Health |
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| Name | Class |
|---|---|
| Minnesota Cancer Clinical Trials Network | UNKNOWN |
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Implanted port devices (IPD) play an essential role in the safe administration of cancer treatments by providing a device to safely administer caustic chemotherapy agents. The current recommended frequency of flushing the IPD per manufacturers guidelines is every 4-6 weeks. The purpose of this study is to find out if extending IPD flushes to every 12 weeks is safe and if it is just as effective as every 4 week flushing.
After being informed about the study and potential risks, all participants giving written informed consent will complete port specific histories, assessments and questionnaires within 14 days prior to registration. Eligible, consented participants will be registered to the study and randomized to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for an initial 12 week interval. If study participants agree to the continuation portion of the study, they will continue to receive either IPD standard maintenance flushes and port assessments every 4 weeks or every 12 weeks for up to an additional three 12 week cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4-week IPD Flushing Schedule | Active Comparator | IPD standard maintenance flushes and port assessments every 4 weeks. |
|
| 12-week IPD Flushing Schedule | Experimental | IPD standard maintenance flushes and port assessments every 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced IPD Flush Schedule | Device | IPD flush every 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of IPD patency | IPD patency without major complication | 12 weeks post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term rate of IPD patency in scheduled 4-week versus 12-week IPD flushes at 24,36 and 48 weeks post randomization. | Rate of IPD patency during long term follow-up | Up to 48 weeks post randomization |
| Difference in complication rates in scheduled 4-week versus 12-week IPD flushes at 12, 24,36 and 48 weeks post randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bret Friday, MD, PhD | Essentia Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System - Albert Lea | Albert Lea | Minnesota | 56007 | United States | ||
| Essentia Health St. Joseph's Medical Center |
The study protocol, statistical plan and consent form will be available on request. Data will be available on aggregate level; data will be deidentified, the full dataset and statistical code will be available upon request
6 months after study completion and for 36 months
A full description of the intended use of the data must be sent to the Project Direct for review and approval. Participant consent for data sharing is conditioned and new ethics approval may be required.
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The study is a prospective, randomized study to determine the non-inferiority of every 12 week IPD flushes compared to every 4 week flushes in participants on an IPD maintenance flush schedule.
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| Standard IPD Flush Schedule |
| Device |
IPD flush every 4 weeks |
|
Differences in specific complications such as occlusion, infection, mechanical as assessed by port assessments and adverse events |
| Up to 48 weeks post randomization |
| Difference in healthcare and patient cost in scheduled 4-week versus 12-week IPD flushes | Determine healthcare and patient cost differences based documented participant charges and participant reported responses to a 8 question financial burden questionnaire. The questionnaire gathers demographic information about employment, method of payment, estimated costs, education level, and smoking status. | Up to 48 weeks post randomization |
| Change in Participant Quality of Life and Satisfaction in Scheduled 4-week versus 12 week IPD flushes | Compare participant quality of life and satisfaction over time and between 4-week versus 12-week IPD flushes as assessed by participant responses to 7 question quality of life questionnaire. The questionnaire is specific to IPD flushing and uses a 5 point likert scale. | Up to 48 weeks post randomization |
| Impact of smoking, participant age, IPD age, and concomitant medications on complication rates in scheduled 4-week versus 12 week IPD flushes. | Impact of smoking, participant age, IPD age, and concomitant medications on complication rates as assessed by participant response smoking status and port assessments and adverse events | Up to 48 weeks post randomization |
| Brainerd |
| Minnesota |
| 56401 |
| United States |
| Essentia Health Deer River Clinic | Deer River | Minnesota | 56636 | United States |
| Essentia Health St Mary's Detroit Lakes Clinic | Detroit Lakes | Minnesota | 56501 | United States |
| Essentia Health Duluth Clinic | Duluth | Minnesota | 55805 | United States |
| Essentia Health Fosston | Fosston | Minnesota | 56542 | United States |
| Fairview Grand Itasca Clinic & Hospital | Grand Rapids | Minnesota | 55744 | United States |
| Essentia Health Hibbing Clinic | Hibbing | Minnesota | 55746 | United States |
| Fairview Range Medical Center | Hibbing | Minnesota | 55746 | United States |
| Mayo Clinic Health System - Mankato | Mankato | Minnesota | 56001 | United States |
| Monticello Cancer center | Monticello | Minnesota | 55362 | United States |
| Essentia Health Park Rapids | Park Rapids | Minnesota | 56470 | United States |
| Fairview Northland Medical Center | Princeton | Minnesota | 55371 | United States |
| Essentia Health Sandstone | Sandstone | Minnesota | 55072 | United States |
| Essentia Health Virginia Clinic | Virginia | Minnesota | 55792 | United States |
| Sanford Worthington Medical Center | Worthington | Minnesota | 56187 | United States |
| Essentia Health Fargo | Fargo | North Dakota | 58103 | United States |