Trial Outcomes & Findings for S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) (NCT NCT02728596)
NCT ID: NCT02728596
Last Updated: 2022-10-20
Results Overview
To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among participants registered at intervention components versus usual care components. Primary prophylaxis of CSF (PP-CSF) is defined as the initiation of granulocyte CSFs during the first cycle of myelosuppressive systemic therapy, given 24 to 72 hours after cessation of systemic therapy. Separate mixed effects logistic models will be fit to assess the effect of the intervention on PP-CSF use. The rate of CSF prescribing is defined as the percent of participants prescribed CSF as primary prophylaxis out of the total number of participants within each arm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3665 participants
Primary outcome timeframe
Baseline to up to 14 days
Results posted on
2022-10-20
Participant Flow
Participant milestones
| Measure |
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
707
|
644
|
1281
|
973
|
|
Overall Study
Treatment Completed
|
665
|
602
|
1158
|
905
|
|
Overall Study
COMPLETED
|
660
|
596
|
1151
|
898
|
|
Overall Study
NOT COMPLETED
|
47
|
48
|
130
|
75
|
Reasons for withdrawal
| Measure |
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
Preventive Intervention: Automated ordering system recommends prescribing or not prescribing CSF based on drug's risk level for FN
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|---|---|
|
Overall Study
Refusal unrelated to adverse event
|
3
|
6
|
7
|
7
|
|
Overall Study
Death
|
44
|
42
|
123
|
68
|
Baseline Characteristics
S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)
Baseline characteristics by cohort
| Measure |
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
n=707 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
n=644 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
|
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
n=1281 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
n=973 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
|
Total
n=3605 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.8 years
n=5 Participants
|
59.9 years
n=7 Participants
|
59.6 years
n=5 Participants
|
58.9 years
n=4 Participants
|
59.3 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
594 Participants
n=5 Participants
|
508 Participants
n=7 Participants
|
937 Participants
n=5 Participants
|
788 Participants
n=4 Participants
|
2827 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
113 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
344 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
778 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
110 Participants
n=4 Participants
|
377 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
692 Participants
n=5 Participants
|
599 Participants
n=7 Participants
|
1012 Participants
n=5 Participants
|
846 Participants
n=4 Participants
|
3149 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
408 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
622 Participants
n=5 Participants
|
500 Participants
n=7 Participants
|
1059 Participants
n=5 Participants
|
733 Participants
n=4 Participants
|
2914 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Febrile Neutropenia Risk Level
Low
|
121 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
209 Participants
n=4 Participants
|
707 Participants
n=21 Participants
|
|
Febrile Neutropenia Risk Level
Intermediate
|
202 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
542 Participants
n=5 Participants
|
304 Participants
n=4 Participants
|
1255 Participants
n=21 Participants
|
|
Febrile Neutropenia Risk Level
High
|
384 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
490 Participants
n=5 Participants
|
460 Participants
n=4 Participants
|
1643 Participants
n=21 Participants
|
|
Cancer Type
Breast
|
508 Participants
n=5 Participants
|
397 Participants
n=7 Participants
|
731 Participants
n=5 Participants
|
639 Participants
n=4 Participants
|
2275 Participants
n=21 Participants
|
|
Cancer Type
Colorectal
|
136 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
245 Participants
n=4 Participants
|
930 Participants
n=21 Participants
|
|
Cancer Type
NSCLC
|
63 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
400 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 14 daysPopulation: There was one participant in Arm 4, that was deemed as having an unavailable outcome and was excluded from this analysis population. Leaving Arm 4 with 972 analyzable participants rather than 973.
To compare the use of primary prophylactic colony stimulating factor (PP-CSF) according to recommended clinical practice guidelines among participants registered at intervention components versus usual care components. Primary prophylaxis of CSF (PP-CSF) is defined as the initiation of granulocyte CSFs during the first cycle of myelosuppressive systemic therapy, given 24 to 72 hours after cessation of systemic therapy. Separate mixed effects logistic models will be fit to assess the effect of the intervention on PP-CSF use. The rate of CSF prescribing is defined as the percent of participants prescribed CSF as primary prophylaxis out of the total number of participants within each arm.
Outcome measures
| Measure |
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
n=707 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
n=644 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
|
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
n=1281 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
n=972 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
|
|---|---|---|---|---|
|
Percentage of Participants With CSF Prescribed as Primary Prophylaxis
Low Risk Group
|
8.3 percentage of participants
|
5.5 percentage of participants
|
7.2 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With CSF Prescribed as Primary Prophylaxis
Intermediate Risk Group
|
37.1 percentage of participants
|
18.8 percentage of participants
|
37.1 percentage of participants
|
9.9 percentage of participants
|
|
Percentage of Participants With CSF Prescribed as Primary Prophylaxis
High Risk Group
|
93.0 percentage of participants
|
95.8 percentage of participants
|
91.8 percentage of participants
|
86.3 percentage of participants
|
|
Percentage of Participants With CSF Prescribed as Primary Prophylaxis
All FN Risk Groups
|
62.5 percentage of participants
|
53.1 percentage of participants
|
52.2 percentage of participants
|
45.1 percentage of participants
|
PRIMARY outcome
Timeframe: Within 6 months post registrationPopulation: There were 18 participants deemed as having an unavailable outcome and were excluded from the analysis population, leaving 3587 analyzable participants.
To compare the rate of febrile neutropenia (FN) among participants, at any risk level, registered at intervention components versus usual care components. Febrile neutropenia is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) as an absolute neutrophil count (ANC) \< 1000/µL and a single temperature of \> 38.3°C (101°F) or a sustained temperature of ≥ 38°C (101°F) for more than one hour.
Outcome measures
| Measure |
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
n=707 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
n=640 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
|
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
n=1275 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
n=965 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
|
|---|---|---|---|---|
|
Incidence of Febrile Neutropenia
All FN Risk Groups
|
5.5 percentage of participants
|
3.1 percentage of participants
|
4.1 percentage of participants
|
4.6 percentage of participants
|
|
Incidence of Febrile Neutropenia
Low Risk Group
|
1.7 percentage of participants
|
0.8 percentage of participants
|
1.6 percentage of participants
|
1.5 percentage of participants
|
|
Incidence of Febrile Neutropenia
Intermediate Risk Group
|
5.9 percentage of participants
|
2.9 percentage of participants
|
3.7 percentage of participants
|
3.7 percentage of participants
|
|
Incidence of Febrile Neutropenia
High Risk Group
|
6.5 percentage of participants
|
4.2 percentage of participants
|
5.7 percentage of participants
|
6.6 percentage of participants
|
PRIMARY outcome
Timeframe: Within 6 months post registrationPopulation: The analysis population includes only participants that are classified as having intermediate risk of FN. Seven participants were deemed as having an unavailable outcome and were excluded from the analysis population.
To compare the rate of FN among intermediate risk participants registered at intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). Febrile neutropenia is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) as an absolute neutrophil count (ANC) \< 1000/µL and a single temperature of \> 38.3°C (101°F) or a sustained temperature of ≥ 38°C (101°F) for more than one hour.
Outcome measures
| Measure |
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
n=202 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
n=205 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
|
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
n=540 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
n=301 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
|
|---|---|---|---|---|
|
Incidence of Febrile Neutropenia Among Intermediate Risk Participants
|
5.9 percentage of participants
|
2.9 percentage of participants
|
3.7 percentage of participants
|
3.7 percentage of participants
|
SECONDARY outcome
Timeframe: Within 6 months of registrationPopulation: The analysis population includes only participants deemed 'low-risk' within each of the clinic groups.
To compare the rate of FN among low-risk participants registered at intervention components versus usual care components. Febrile neutropenia is defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) as an absolute neutrophil count (ANC) \< 1000/µL and a single temperature of \> 38.3°C (101°F) or a sustained temperature of ≥ 38°C (101°F) for more than one hour.
Outcome measures
| Measure |
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
n=111 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
n=120 Participants
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
|
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
n=229 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
n=196 Participants
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
|
|---|---|---|---|---|
|
Incidence of Febrile Neutropenia Among Low Risk Participants
|
1.8 percentage of participants
|
0.8 percentage of participants
|
1.8 percentage of participants
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to up to 14 daysTo compare the FN-related health-related quality of life (HRQOL) among low-risk participants registered at intervention components versus usual care components. Assessed using the Functional Assessment of Cancer Therapy - Febrile Neutropenia (Version 4) (FACT-N). Includes FACT general cancer score and FN-related score. A linear mixed effects model will be fit to assess the effect of the intervention on HRQOL. Component-level characteristics, patient-level clinical and demographic variables will be adjusted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 14 days after the completion of first course of therapyTo compare adherence to PP-CSF prescribing among participants registered at intervention components versus usual care components. Participant adherence rates are obtained from the proportion receiving PP-CSF among those for whom PP-CSF was ordered by the physician. The primary adherence measure will be obtained from the participant's chart; secondary adherence will be measured via self-report on the Follow-Up Participant Survey. For the home and clinic settings, separate mixed effects logistic models will be used to assess the effect of the intervention on adherence to PP-CSF orders, treating adherence after the start of the study. Component-level characteristics, participant-level clinical and demographic variables will be adjusted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 14 daysTo compare participant knowledge of the indications for, efficacy of, and side effects associated with PP-CSF between the initiation and conclusion of the first cycle of myelosuppressive systemic therapy among participants registered at intervention components versus usual care components. Linear mixed effects model with a time variable and an interaction between randomized group and time will be used to analyze change in the patient knowledge score. Random effects will be used to accommodate both the correlation among measures from the same patient as well as the correlation among patients from the same component. Component-level characteristics, participant-level clinical and demographic variables will be adjusted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 monthsTo compare the proportion of participants completing the initial systemic therapy regimen at planned duration and at planned dose intensity among participants registered at intervention components versus usual care components.Two separate mixed effects logistic models will be used to assess the effect of the intervention on completion of the initial systemic therapy regimen (i) at planned duration and (ii) at planned dose intensity. Component-level characteristics, patient-level clinical and demographic variables will be adjusted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within 30 days of therapyTo compare antibiotic use both as prophylaxis and as treatment for FN among participants registered at intervention components versus usual care components. Prophylactic and FN-related antibiotic use will be measured as total number of antibiotic agents used and duration of antibiotic use. A linear mixed effects model will be fit to assess the effect of the intervention on duration of antibiotics use with number of days. Mixed effects Poisson models will be used to assess the effect of the intervention on total number of antibiotics agents used. Three separate models will be fit, with the following outcomes: (i) the number of times antibiotics were used as prophylaxis, (ii) the number of times antibiotics were used as treatment for FN, and (iii) t
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 6 monthsTo compare the rate of FN-related emergency department (ED) visits and hospitalizations among intermediate risk participants registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). FN-related ED visits and hospitalizations are defined as admission to ED or hospital with documentation of fever and decreased ANC. A mixed effects Poisson model will be used to assess the effect of the intervention on FN-related ED visits and hospitalizations. Robust variance estimation will be used to relax the strong assumptions about the variance made by Poisson regression. If a large number of zero counts is observed, then zero-inflated Poisson regression will be used.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to up to 14 daysTo compare the FN-related health-related quality of life (HRQOL) among intermediate risk participants registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). Assessed using the Functional Assessment of Cancer Therapy - Febrile Neutropenia (Version 4) (FACT-N). Includes FACT general cancer score and FN-related score. A linear mixed effects model will be fit to assess the effect of the intervention on HRQOL. Component-level characteristics, participant-level clinical and demographic variables will be adjusted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from date of registration to date of death due to any cause, assessed up to 12 monthsTo compare overall survival among intermediate risk participants registered to intervention components by component treatment assignment (administer PP-CSF to intermediate risk participants versus not). A Cox proportional hazards model will be used to model survival. Component-level characteristics, participant-level clinical and demographic variables will be adjusted. A separate analysis of cause-specific survival to address FN-related deaths will also be conducted.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time from registration to documented invasive local or regional recurrence, assessed up to 12 monthsTo evaluate the time to invasive recurrence in non-metastatic participants by component treatment assignment. Analysis will be exploratory and comparative.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 months post registrationTo characterize and descriptively report the differences among cohort components and the intervention and usual care components.
Outcome measures
Outcome data not reported
Adverse Events
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
Serious events: 3 serious events
Other events: 146 other events
Deaths: 44 deaths
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
Serious events: 0 serious events
Other events: 123 other events
Deaths: 42 deaths
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
Serious events: 0 serious events
Other events: 243 other events
Deaths: 123 deaths
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
Serious events: 1 serious events
Other events: 171 other events
Deaths: 68 deaths
Serious adverse events
| Measure |
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
n=456 participants at risk
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
n=350 participants at risk
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
|
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
n=694 participants at risk
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
n=448 participants at risk
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
|
|---|---|---|---|---|
|
Infections and infestations
Sepsis
|
0.22%
1/456 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.00%
0/350 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.00%
0/694 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.22%
1/448 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other
|
0.22%
1/456 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.00%
0/350 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.00%
0/694 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.00%
0/448 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.22%
1/456 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.00%
0/350 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.00%
0/694 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.00%
0/448 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
Other adverse events
| Measure |
Active Comparator: Clinic Group 1 (Clinics With Existing Automated System for CSF Prescribing)
n=456 participants at risk
CSF prescribing for patients taking anti-cancer drugs is based on existing automated system recommendations: CSF is recommended for drugs with high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Active Comparator: Clinic Group 2 (Clinics With no Automated System for CSF Prescribing)
n=350 participants at risk
CSF prescribing for patients taking anti-cancer drugs is based on existing clinical practice guidelines.
|
Experimental: Clinic Group 3 (Clinics With Automated System for CSF Prescribing)
n=694 participants at risk
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drugs with intermediate or high risk of FN; CSF is not recommended for drugs with low risk of FN.
|
Experimental: Clinic Group 4 (Clinics With Automated System for CSF Prescribing)
n=448 participants at risk
CSF prescribing for patients taking anti-cancer drugs is based on automated system recommendations: CSF is recommended for drug with high risk of FN; CSF is not recommended for drugs with intermediate or low risk of FN.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
2.2%
10/456 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
3.7%
13/350 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
6.3%
44/694 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
6.0%
27/448 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.2%
51/456 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
12.6%
44/350 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
11.7%
81/694 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
17.0%
76/448 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
24.1%
110/456 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
28.9%
101/350 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
29.5%
205/694 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
27.0%
121/448 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
1.3%
6/456 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
0.57%
2/350 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
3.5%
24/694 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
5.1%
23/448 • Adverse events were monitored/assessed through the end of first anti-cancer treatment cycle, an average of 21 days. While All-Cause Mortality was monitored/assessed for the entire duration participants are followed for the study, an average of 12 months.
Adverse events (AEs) are reported by CTCAE version 4.0. Only participants that received PP-CSF during the first cycle of anti-cancer treatment were evaluated for adverse events. Population at risk for all-cause mortality includes all eligible and analyzable participants regardless of if they received PP-CSF.
|
Additional Information
SWOG Statistician
SWOG Statistics and Data Management Center
Phone: 2066674623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60