Mark Clemons1,2,3, Carol Stober4, Anne Kehoe5, Debbie Bedard6, Fiona MacDonald6, Marie-Claude Brunet6, Deanna Saunders4, Lisa Vandermeer4, Sasha Mazzarello4, Arif Awan5, Bassam Basulaiman5, Andrew Robinson7, Ranjeeta Mallick8, Brian Hutton9,8, Dean Fergusson9,8. 1. Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada. mclemons@toh.ca. 2. Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada. mclemons@toh.ca. 3. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada. mclemons@toh.ca. 4. Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada. 5. Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada. 6. Department of Nursing, Ottawa General Hospital, Ottawa, Canada. 7. Division of Medical Oncology, Cancer Centre of Southeastern Ontario, Kingston, Canada. 8. Department of Medicine, University of Ottawa, Ottawa, Canada. 9. Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
Abstract
PURPOSE:Trastuzumab-based chemotherapy is usually administered through either a peripherally inserted central catheter (PICC) or a totally implanted vascular access device (PORT). As the most effective type of access is unknown, a feasibility trial, prior to conducting a large pragmatic trial, was undertaken. METHODS: The trial methodology utilized the integrated consent model incorporating oral consent. Patients receiving trastuzumab-based neo/adjuvant chemotherapyfor early-stage breast cancer were randomized to a PICC or PORT insertion. Feasibility was reflected through a combination of endpoints; however, the a priori definition of feasibility was > 25% of patients approached agreed to randomization and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis. RESULTS: During the study period, 4/15 (26.7%) medical oncologists approached patients about study participation. Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8%) were randomized to PICC and 27 (48.2%) to PORT access. Overall, 17.2% (5/29) and 14.8% (4/27) of patients had at least one line-associated complication in the PICC and PORT arms respectively. The study was terminated early due to slow accrual. CONCLUSION: The study met its feasibility endpoints with respect to patient and physician engagement. However, the slow rate of accrual (56 patients in 2 years) means that conducting a large pragmatic trial would require additional strategies to make such a study possible. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02632435.
RCT Entities:
PURPOSE:Trastuzumab-based chemotherapy is usually administered through either a peripherally inserted central catheter (PICC) or a totally implanted vascular access device (PORT). As the most effective type of access is unknown, a feasibility trial, prior to conducting a large pragmatic trial, was undertaken. METHODS: The trial methodology utilized the integrated consent model incorporating oral consent. Patients receiving trastuzumab-based neo/adjuvant chemotherapy for early-stage breast cancer were randomized to a PICC or PORT insertion. Feasibility was reflected through a combination of endpoints; however, the a priori definition of feasibility was > 25% of patients approached agreed to randomization and > 25% of physicians approached patients. Secondary outcomes included rates of line-associated complications such as thrombotic events requiring anticoagulation, line infections or phlebitis. RESULTS: During the study period, 4/15 (26.7%) medical oncologists approached patients about study participation. Of 59 patients approached, 56 (94.9%) agreed to randomization, 29 (51.8%) were randomized to PICC and 27 (48.2%) to PORT access. Overall, 17.2% (5/29) and 14.8% (4/27) of patients had at least one line-associated complication in the PICC and PORT arms respectively. The study was terminated early due to slow accrual. CONCLUSION: The study met its feasibility endpoints with respect to patient and physician engagement. However, the slow rate of accrual (56 patients in 2 years) means that conducting a large pragmatic trial would require additional strategies to make such a study possible. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02632435.
Authors: N LeVasseur; C Stober; K Daigle; A Robinson; S McDiarmid; S Mazzarello; B Hutton; A Joy; D Fergusson; J Hilton; M McInnes; M Clemons Journal: Curr Oncol Date: 2018-08-14 Impact factor: 3.677
Authors: N LeVasseur; C Stober; M Ibrahim; S Gertler; J Hilton; A Robinson; S McDiarmid; D Fergusson; S Mazzarello; B Hutton; A A Joy; M McInnes; M Clemons Journal: Curr Oncol Date: 2018-08-14 Impact factor: 3.677
Authors: Susan Dent; Dean Fergusson; Olexiy Aseyev; Carol Stober; Gregory Pond; Arif A Awan; Sharon F McGee; Terry L Ng; Demetrios Simos; Lisa Vandermeer; Deanna Saunders; John F Hilton; Brian Hutton; Mark Clemons Journal: Curr Oncol Date: 2021-12-03 Impact factor: 3.677