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In the REaCT-Vascular Access Trastuzumab study (REaCT-VA), the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial. The investigator wishes to address a non-pharmacologic issue regarding standard of care vascular access devices. Peripherally inserted central catheters (PICC lines) versus subcutaneously implanted devices (PORTs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peripherally inserted central catheter | Other | PICC line will be inserted for the delivery and duration of chemotherapy. |
|
| portacath | Other | PORT will be inserted for the delivery and duration of chemotherapy and trastuzumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICC | Device | Participants will be randomized to a PICC for vascular access during chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accrual rates | Percentage of patients who receive (neo)adjuvant IV systemic therapy with trastuzumab compared to the number of participants who agree to randomization. | one year |
| Patient compliance | Percentage of participants who are randomized who accept randomization will be calculated. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Physician engagement | Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial. | One year |
| Rates of events |
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Inclusion Criteria
Exclusion Criteria
• Contraindication to central line placement.
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| Name | Affiliation | Role |
|---|---|---|
| Mark Clemons, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32002617 | Derived | Clemons M, Stober C, Kehoe A, Bedard D, MacDonald F, Brunet MC, Saunders D, Vandermeer L, Mazzarello S, Awan A, Basulaiman B, Robinson A, Mallick R, Hutton B, Fergusson D. A randomized trial comparing vascular access strategies for patients receiving chemotherapy with trastuzumab for early-stage breast cancer. Support Care Cancer. 2020 Oct;28(10):4891-4899. doi: 10.1007/s00520-020-05326-y. Epub 2020 Jan 30. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 29, 2022 | |
| Reset | Aug 11, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 29, 2022 | Aug 11, 2023 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| PORT | Device | Participants will be randomized to a PORT for vascular access during chemotherapy |
|
Rates of documented thrombotic events, need for anticoagulation, line infections, phlebitis, and extravasations during systemic therapy.
| One year |