Study to Investigate Which Clinical Risk Factors Are Considered by Physicians When Conducting Overall Febrile Neutropenia Risk Assessments for Patients Receiving Chemotherapy With an Intermediate (10% - 20%) Febrile Neutropenia Risk.
Although a formal hypothesis will not be tested in this observational study, it is
hypothesized that the clinical risk factors ranked as the most important when conducting FN
risk assessments by investigators are aligned with international guidelines and published
data. Also, that the investigator's decision to treat with G-CSF PP is influenced by
clinical and non-clinical risk factors (such as distance from site, estimated subject
compliance, and access to fully reimbursed G-CSF).
Study Design: Prior to identifying eligible subjects, Investigators will be registered and
will record baseline information. During this Baseline Investigator Assessment investigators
will be provided with two lists of risk factors. Investigators must rank selected risk
factors that they consider to be the most important when assessing 1) overall FN risk (only
scientific factors will be included), and 2) when deciding on whether G-CSF PP treatment
will be used or not (this list will also contain non clinical factors). They will also
record their own FN risk intervention threshold, which is the FN risk threshold score at
which they would use G-CSF PP in their usual clinical practice.
Investigators will then prospectively and sequentially identify eligible subjects with NHL,
breast or lung cancer who are due to initiate one of the permitted standard dose
chemotherapy regimens listed in the protocol. The permitted chemotherapy regimens have an
estimated intermediate FN risk (10%-20%) documented in published data and/or international
For each enrolled subject, Investigators will complete a Subject Assessment prior to the
start of their chemotherapy. They will be provided with the same two lists of risk factors
as in the Baseline Assessment and asked to complete them based on each specific subject.
Investigators must rank selected risk factors that they consider to be the most important
when assessing 1) overall FN risk (only scientific factors will be included), and 2) when
deciding on whether G-CSF PP treatment will be used or not. They will also document their
final estimated FN risk score as a percentage based on the subject's medical history and
standard of care (SOC) assessments (their routine practice for assessing this risk), and a
decision as to whether G-CSF PP will be administered. Investigators will record which type
of G-CSF they plan to use if one will be used.
End of Study for a subject will occur once these activities have been completed, and a
prescription for the first cycle of chemotherapy has been written. The subject data
collected will only be historical subject information and laboratory data from SOC
assessments performed prior to beginning chemotherapy treatment. No data will be collected
after the initiation of chemotherapy.
The approach to the statistical analysis will be generally descriptive in nature. The
primary analysis will be conducted at two levels; investigator level and the subject level.
It is expected that the opinions of investigators at a single site (that is, a department
within a cancer treatment centre) will be correlated. Also, that the opinions about subjects
from a single investigator will be more alike than subjects of other investigators;
adjustments will be made in the analyses to account for this. Confidence intervals for the
investigator level analysis and the subject level data will obtained from Multi-level
Modelling (MLM) to allow for the expected intra-site and intra-investigator correlation of
investigators within sites and subjects within investigator. In general, categorical data
will be summarised by the number and percentage of subjects in each category. Continuous
data will be summarised by mean, standard deviation, median, lower and upper quartiles,
minimum and maximum values. Two-sided exact 95% confidence intervals (obtained using MLM)
will be presented, where appropriate.
Observational Model: Cohort, Time Perspective: Prospective
Proportion of times that each FN risk factor is ranked as important during the Baseline Investigator Assessment; occurence of age and chemotherapy regimen among the ranked risk factors are of particular interest
Assessed at baseline, prior to subject enrolment.
Australia: Human Research Ethics Committee