Study investigating how physicians assess the risk of patients developing febrile neutropenia during chemotherapy.
Study Details
This is a prospective observational study investigating how physicians assess the risk of febrile neutropenia (FN) developing in patients who will receive chemotherapy.
Approximately 150-200 investigators will take part in about 100 sites in Europe, Canada and Australia. Approximately 1000 subjects will be studied, all of whom will have non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), non-Hodgkin's lymphoma (NHL) or breast cancer and will be due to receive one of the specific chemotherapy regimens of interest.
Investigators' approach to FN risk assessment will be studied using lists of possible risk factors they may consider during their assessment. Investigators will be asked to select and rank the factors they consider the most important when assessing the overall FN risk of a subject and when making the decision whether to treat with granulocyte-colony stimulating factor (G-CSF) primary prophylaxis (PP). They will be asked to make these selections based initially on their own routine clinical practise and subsequently relating specifically to each subject recruited.
This is a non-interventional study that involves no procedures outside normal care for the subjects; all data collection will be completed prior to chemotherapy administration.
Protocol Summary
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
Timeframe: Assessed at baseline, prior to subject enrolment.
Proportion of times that each FN risk factor is ranked as important during the Subject Assessment; occurence of age and chemotherapy regimen among the ranked risk factors are of particular interest
Timeframe: Up to 30 days post-enrolment, prior to chemotherapy initiation.
Proportion of times each factor in the G-CSF PP decision is ranked as important during the Baseline Physician Assessment
Timeframe: Assessed at baseline, prior to subject enrolment.
Proportion of times each factor in the G-CSF PP decision is ranked as important during the Baseline Investigator Assessment by investigator characteristics and country
Timeframe: Assessed at baseline, prior to subject enrolment.
Proportion of times each factor in the G-CSF PP decision is ranked as important during the Subject Assessment
Timeframe: Up to 30 days post-enrolment, prior to chemotherapy initiation.
Proportion of times each factor in the G-CSF PP decision is ranked as important during the Subject Assessment by investigator characteristics, tumour type, and country
Timeframe: Up to 30 days post-enrolment, prior to chemotherapy initiation.
Proportion of times each FN risk factor is ranked as important during the Baseline Investigator Assessment, by investigator characteristics and country
Timeframe: Assessed at baseline, prior to subject enrolment.
Proportion of times each FN risk factor is ranked as important during the Subject Assessment by investigator characteristics, tumour type, and country
Timeframe: Up to 30 days post-enrolment, prior to chemotherapy initiation.
Proportion of subjects with an investigator-assessed FN risk at or above the investigator self-reported FN-risk intervention threshold that are receiving G-CSF PP
Timeframe: Up to 30 days post-enrolment, prior to chemotherapy initiation.