Breast Cancer, Cancer
Conditions
Keywords
HER2 negative
Brief summary
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.
Interventions
DEVICEvenous access PORT or PICC
Participants will receive a venous access prior to starting chemotherapy
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed primary breast cancer * Planned to start either FEC-D, AC-D, dose-dense AC-T, TAC, or TC chemotherapy, in the adjuvant or neoadjuvant setting. * ≥19 years of age * Able to provide verbal consent
Exclusion criteria
• Contraindication to central line placement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accrual rates | One year | 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. |
| Patient compliance | One year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician engagement | One year | Percentage of medical oncologists who have agreed to participate in the trial compared to the percentage who approached patients regarding the trial. |
| Rates of thrombotic events | One year | 2\. Rates of documented thrombotic events need for anticoagulation, line infections, phlebitis, and extravasations during chemotherapy. |
| Number of attempts at cannulation | One year | 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) |
Countries
Canada
Outcome results
None listed