The OPTIMA Trial is still open to recruitment...
OPTIMA is a pragmatic de-escalation study in which approximately one third of patients avoid chemotherapy.
All treatment given to trial participants (chemotherapy, endocrine therapy and bisphosphonates) is standard of care that they would receive anyway. Once enrolled, all hospital attendance is therefore standard for the individual patients treatment regimen.
The core Trial Management Group advocates continued recruitment on the following grounds:
- OPTIMA reduces population exposure to chemotherapy in a controlled framework and by doing so reduces the risk of serious illness from COVID-19 whilst ensuring that patients are given effective breast cancer treatment.
- The one third of patients having endocrine therapy alone have fewer visits to hospital, thus reducing the risk of exposure to the virus.
- Patients having chemotherapy will be cared for according to your usual protocols.
Reduced burden on clinical resources
- Clinic attendance for chemotherapy treatment and consultant review will be reduced by around a third for recruiting sites.
- Typically 4-6 blood tests will be saved per patient avoiding chemotherapy.
- Fewer unplanned admissions are expected in OPTIMA sites given the reduction in chemotherapy use.
Flexible pragmatic trial design
- OPTIMA has been designed from the outset to be flexible with minimal impact on clinician and research staff workload.
- Follow-up is minimal and can be fitted into routine clinic appointments or done by telephone or email (where permitted).
- We will keep the study design and procedures under review and make adjustments if circumstances require this. We accept that trial deviations may arise.
Cancer diagnoses will continue unabated and cancer patients will need treatment. Continuing recruitment to OPTIMA and to other de-escalation trials will reduce the burden on hospital resources and your staff whilst ensuring that some patients are safely offered reduced treatment.