Clinical Trial: Study Investigating How Physicians Assess the Risk of Patients Developing Febrile Neutropenia During Chemotherapy.

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: 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%

Brief Summary:

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.


Detailed Summary:

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 guidelines.

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
Sponsor: Amgen

Current Primary Outcome:

  • Percentage of Investigators Who Ranked Age and Chemotherapy Regimen as a Risk Factor for Febrile Neutropenia [ Time Frame: Baseline (prior to participant enrolment) ]
    During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet, and asked to rank the risk factors that they considered to be the most important when assessing overall febrile neutropenia (FN) risk. Age and chemotherapy regimen were specified in the protocol as risk factors of interest. Reported are age and chemotherapeutic agents ranked individually, chemotherapy agents detailed by specific factors, and age and chemotherapy agents jointly ranked. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.
  • Percentage of Investigators Who Ranked Each Factor as a Risk Factor for Febrile Neutropenia (FN) [ Time Frame: Assessed at Baseline, prior to participant enrolment. ]
    During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of risk factors on a source document worksheet and asked to rank the risk factors that they considered to be the most important when assessing overall FN risk. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group
  • Percentage of Participants for Whom Age and Chemotherapy Regim

    Original Primary Outcome:

    • 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 [ Time Frame: 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 [ Time Frame: Up to 30 days post-enrolment, prior to chemotherapy initiation. ]


    Current Secondary Outcome:

    • Percentage of Investigators Who Ranked Each Factor in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important [ Time Frame: Assessed at baseline, prior to participant enrolment. ]
      During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
    • Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Clinical Specialty [ Time Frame: Assessed at baseline, prior to participant enrolment. ]
      During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group. Subgroup analyses were performed where a subgroup contained at least 40 investigators. Results are reported for medical oncologists as this was the only specialty that contained at least 40 investigators.
    • Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Number of Years in Clinical Practice in Oncology / Hematology [ Time Frame: Assessed at baseline, prior to participant enrolment. ]
      During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.
    • Percentage of Investigators Who Ranked Each Factor in the G-CSF PP Decision as Important by Institution Type [ Time Frame: Assessed at baseline, prior to participant enrolment. ]
      During the baseline investigator assessment (prior to identification of participants), investigators were provided a list of factors on a source document worksheet, and asked to rank the factors that they considered to be the most important when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between investigators at the same sites, two-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. Subgroup analyses were performed where a subgroup contained at least 40 investigators. ECOG = Eastern Cooperative Oncology Group.
    • Percentage of Participants for Whom Each Factor Was Ranked in the Granulocyte Colony Stimulating Factor (G-CSF) Primary Prophylaxis (PP) Decision as Important [ Time Frame: At enrolment, prior to chemotherapy initiation. ]
      For each participant, the investigator ranked the factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not. To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals. ECOG = Eastern Cooperative Oncology Group.
    • Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Country [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

      For each participant, the investigator ranked the risk factors that they considered to be the most important factors that they considered when deciding whether to use G-CSF PP treatment or not.

      To account for the expected correlation between participants with the same investigators and between investigators at the same sites, three-level, empty (no explanatory variables) multilevel models were used in the estimation of the percentages and 95% confidence intervals.

      ECOG = Eastern Cooperative Oncology Group.

    • Percentage of Participants for Whom Each Factor Was Ranked in the G-CSF PP Decision as Important by Clinical Specialty [ Time Frame: At enrolment, prior to chemotherapy initiation. ]

      For each participant,

      Original Secondary Outcome:

      • Proportion of times each factor in the G-CSF PP decision is ranked as important during the Baseline Physician Assessment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Up to 30 days post-enrolment, prior to chemotherapy initiation. ]


      Information By: Amgen

      Dates:
      Date Received: January 8, 2013
      Date Started: December 2012
      Date Completion:
      Last Updated: February 7, 2017
      Last Verified: February 2017