None listed
Conditions
Brief summary
This study aims to investigate whether priming intravenous administration sets with monoclonal antibodies reduces chair time. Who is it for? You may be eligible for this study if you are an adult being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab at the Royal Brisbane and Women's Hospital. Study details Participants will randomly be allocated to one of two groups: one which has their IV line primed with the treatment drug, and one which is primed with diluent only before administration of the drug. Information on treatment duration, adverse reactions and patient experience will be collected on the day. Information from this trial will inform the optimisation of patient flow and decreased hypersensitivity reactions in oncology care.
Interventions
Before a patient is connected to an IV line, it is primed with normal saline or a compatible fluid to prevent the introduction of air. Once the IV line is connected to the patient, the drug they are receiving is then attached to the IV line. In the intervention group, the drug will then be primed 16 mls before the commencement of the drug at the appropriate rate.
The intervention will be conducted in the adult oncology outpatient setting. Specialist Cancer Nurses will deliver the intervention.
Before a patient is connected to an IV line, it is primed with normal saline or a compatible fluid to prevent the introduction of air. Once the IV line is connected to the patient, the drug they are receiving is then attached to the IV line. In the intervention group, the drug will then be primed 16 mls before the commencement of the drug at the appropriate rate. The intervention will be conducted in the adult oncology outpatient setting. Specialist Cancer Nurses will deliver the intervention. Adherence to the intervention will be assessed using a bedside completed Data Collection Tool and review of patient medical records. The intervention will be delivered over a 6 month period. Depending on the type and frequency of drug will depend how many times each participant may receive the intervention.
Sponsors
.Royal Brisbane and Women's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients attending the Oncology Day Therapy Unit or Oncology Procedure Unit 2. 18 years or older 3. Are being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab. 4. Any cycle of a patient’s treatment regime (e.g, 1st, 2nd, 3rd dose)
Exclusion criteria
The exclusion criteria: 1. Under 18 years of age 2. Patients receiving treatment with a monoclonal antibody as an inpatient or at North Lakes 3. Patients receiving any other monoclonal antibodies that do not meet the criteria of inclusion drugs, chemotherapy, supportive therapies or treatment as part of a pharmaceutical clinical trial 4. No funding to approach patients who require a translator
Outcome results
None listed