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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
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The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes every 3 months rather than every four to six weeks.
It is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using salt solution followed heparin if needed. This study examines the effectiveness of port flushes at an alternative interval of 3 months, reducing the number of visits to the health-care provider.
This is a phase II, non-blinded, non-inferiority prospective cohort trial of patients with ports (PAC) after a systemic therapy to evaluate the safety and effectiveness of PAC flushes in 3 months intervals. Patients with any type of cancer are eligible. The study will extend 1 year from enrollment of the last patient. Each enrolled patient will have his or her port flushed five times in 3 month intervals.
Patients will be enrolled after the completion of systemic therapy and after completion of the restaging follow up, which is the time period from 4 weeks to 3 months after discontinuation of the chemotherapy. Once patients are enrolled to extended interval PAC flushes, they will be followed for one year. At the end of the year patients will return to standard PAC flushes. If patients experience any PAC malfunction, it would be considered a PAC failure and the flushing will reverted back to the schedule recommended by the manufacturer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-month flushing schedule | Experimental | 3-month port-flushing schedule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced port-flush schedule | Other | 3-month port-flushing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to port complication | The short-term endpoint is time to port complication (EFP- event free port-complication). The long term end point will be time to port failure requiring removal of the port (OAP - overal port failure) and will be used to determine the efficacy of port flushes every 3 months. | Every 3 months for 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of toxicity | Frequency and severity of toxicity will be monitored to describle incidence rates of toxicity. | every three months |
| Cost effectiveness | Cost effectivenss will be estimated taking into consideration level of patient compliance and reduction in patient visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goetz H Kloecker, MD | James Graham Brown Cancer Center, University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Graham Brown Cancer Center | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28084883 | Derived | Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23. |
| Label | URL |
|---|---|
| James Graham Brown Cancer Center, Louisville, KY | View source |
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| ID | Term |
|---|---|
| D001821 | Blushing |
| ID | Term |
|---|---|
| D009633 | Nonverbal Communication |
| D003142 | Communication |
| D001519 | Behavior |
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| every three months |