In the REaCT-Vascular Access Her2 negative study, 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. Determining the optimal vascular access strategy remains an important medical issue for patients, nurses, physicians and society. A novel method to allow comparison of established standards of care is needed as part of an increasing internationally mandated incentive to perform more pragmatic clinic trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
150
Participants will receive a venous access prior to starting chemotherapy
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Accrual rates
Percentage of patients who receive (neo)adjuvant IV systemic therapy for Her 2 negative breast cancer compared to the number of participants who agree to randomization. The total number of new patients receiving (neo) adjuvant IV systemic cytotoxic therapy will be provided by the local chemotherapy pharmacy and Oncology Patient Information System records.
Time frame: One year
Patient compliance
Percentage of participants who are randomized who accept randomization, and percentage of patients who cross-over to receive a central line while on study will be calculated using the chemotherapy treatment documentation in the designated hospital electronic patient record program
Time frame: One year
Physician engagement
Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial.
Time frame: One year
Rates of thrombotic events
2\. Rates of documented thrombotic events need for anticoagulation, line infections, phlebitis, and extravasations during chemotherapy.
Time frame: One year
Number of attempts at cannulation
3\. For those patients randomised to peripheral access information on the number of attempts at cannulation will be collected and site of cannulation. (ipsilateral to surgery vs contralateral to surgery)
Time frame: One year
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