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Trial registered on ANZCTR


Registration number
ACTRN12621000933853
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
16/07/2021
Date last updated
16/07/2021
Date data sharing statement initially provided
16/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Will priming intravenous administration sets with monoclonal antibodies reduce chair time in the outpatient setting? (The priming practice study)
Scientific title
Will priming intravenous administration sets with monoclonal antibodies reduce chair time in the adult outpatient oncology setting? (The priming practice study)
Secondary ID [1] 303776 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Myeloma 321277 0
Lekaemia 322611 0
Lymphoma 322612 0
Lung Cancer 322613 0
Melanoma 322614 0
Condition category
Condition code
Cancer 320226 320226 0 0
Myeloma
Cancer 320227 320227 0 0
Leukaemia - Chronic leukaemia
Cancer 320228 320228 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 320229 320229 0 0
Lung - Non small cell
Cancer 320230 320230 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 320084 0
Treatment: Other
Comparator / control treatment
The comparator/control group is not priming the IV administration sets with the drug. Once the drug is connected to the IV line, the drug will be commenced at the appropriate rate with normal saline or a compatible fluid in the line.
Control group
Active

Outcomes
Primary outcome [1] 326958 0
Chair time, this will be collected through a data collection form. This form has been designed specifically for this study.
Timepoint [1] 326958 0
Chair time will be measured by duration of infusion. (From the time the infusion commenced until the time the infusion completed)
Secondary outcome [1] 393289 0
Incidence of hypersensitivity reactions assessed by the data collection form and patient medical records. The data collection form has been designed specifically for this study.
Timepoint [1] 393289 0
Infusion reactions will be collected during the infusion
Secondary outcome [2] 394052 0
The time of onset to infusion related hypersensitivity reactions assessed from the data collection form. The data collection form has been designed specifically for this study.
Timepoint [2] 394052 0
This will collected during the infusion
Secondary outcome [3] 394053 0
Incidence of medical emergencies as a result of hypersensitivity reactions assessed from patient medical records
Timepoint [3] 394053 0
This data will be collected during the infusion
Secondary outcome [4] 394054 0
Admissions to hospital due to hypersensitivity reactions assed from patient medical records
Timepoint [4] 394054 0
This will be captured after participants complete their treatment. Monitored from randomisation until the final treatment day.
Secondary outcome [5] 394055 0
And any delays in treatment regimens due to hypersensitivity reactions assessed from patient medical records
Timepoint [5] 394055 0
This will be captured after participants complete their treatment. Monitored from randomisation until the final treatment day.
Secondary outcome [6] 394056 0
Patient experience surveys. This survey has been designed specifically for this study.
Timepoint [6] 394056 0
Patient experience will be collected on the day of treatment
Secondary outcome [7] 397627 0
Any reductions in treatment regimens due to hypersensitivity reactions assessed from patient medical records.
Timepoint [7] 397627 0
This will be captured after participants complete their treatment. Monitored from randomisation until the final treatment day.

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be via a telephone-based service to conform with best practice standards for randomisation and allocation concealment until study entry.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by telephone will be on a 1:1 ratio between groups with randomly varied block sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Mean chair time will be compared between groups using General Estimating Equations to account for episodes of care within the same person, with adjustment for drug type. Means and 95% confidence intervals will be reported. Residuals of models will be checked for the assumptions using descriptive statistics and plots. If assumptions are violated the data will be log transformed or bootstrapped as appropriate.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 308178 0
Hospital
Name [1] 308178 0
.Cancer Care Services Research Advisory Group
Country [1] 308178 0
Australia
Primary sponsor type
Hospital
Name
.Royal Brisbane and Women's Hospital
Address
.Royal Brisbane and Women's Hospital
Butterfield Street, Herston
QLD, 4029
Country
Australia
Secondary sponsor category [1] 308957 0
None
Name [1] 308957 0
.
Address [1] 308957 0
.
Country [1] 308957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308163 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 308163 0
Royal Brisbane & Women's Hospital
Butterfield Street, Herston
QLD, 4029
Ethics committee country [1] 308163 0
Australia
Date submitted for ethics approval [1] 308163 0
22/10/2020
Approval date [1] 308163 0
14/12/2020
Ethics approval number [1] 308163 0
HREC68664

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109758 0
Miss Francesca Boyte
Address 109758 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street, Herston
QLD, 4029
Country 109758 0
Australia
Phone 109758 0
+61 7 36465833
Fax 109758 0
Email 109758 0
[email protected]
Contact person for public queries
Name 109759 0
Nicole Gavin
Address 109759 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street, Herston
QLD, 4029
Country 109759 0
Australia
Phone 109759 0
+61 7 36465833
Fax 109759 0
Email 109759 0
[email protected]
Contact person for scientific queries
Name 109760 0
Nicole Gavin
Address 109760 0
Centre for Clinical Nursing
Royal Brisbane and Women's Hospital
Butterfield Street, Herston
QLD, 4029
Country 109760 0
Australia
Phone 109760 0
+61 7 36465833
Fax 109760 0
Email 109760 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11286Ethical approval    381675-(Uploaded-07-04-2021-11-50-24)-Study-related document.pdf
11287Study protocol    381675-(Uploaded-07-04-2021-11-51-55)-Study-related document.pdf
11288Informed consent form    381675-(Uploaded-07-04-2021-11-52-05)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.