Breast Cancer
Conditions
Keywords
Breast
Brief summary
The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.
Interventions
DRUGG-CSF
DRUGCiprofloxacin
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed primary breast cancer * Planned TC chemotherapy * ≥19 years of age * Able to provide verbal consent * Willing to complete a survey
Exclusion criteria
• Contraindication to either Ciprofloxacin or G-CSF
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of randomized patients in each physician's practice | every 4 weeks up to 2 years | The percentage of randomized patients will be measured by collecting reasons for NOT complying with, or opting-out of the randomized selection compared to the overall accrual. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rates of febrile neutropenia | Once when the last participant completes chemotherapy up to year 2 | Rates of febrile neutropenia will be compared between Ciprofloxacin and G-CSF |
Countries
Canada
Outcome results
None listed