This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.
The primary and secondary objectives of the study: PRIMARY OBJECTIVE: I. To compare the proportion of chemotherapy cycles with unplanned delays in patients receiving FOLFOX chemotherapy under standardized usual care (control) versus (vs) according to the PAGODA dose modification algorithm (intervention). SECONDARY OBJECTIVES: I. To compare the mean number of health care contact days (time toxicity) for patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms. II. To compare the incidence moderate-to-severe neutropenia (absolute neutrophil count less than 1000/mm3 in patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms. III. To compare the relative dose-intensity of bolus 5-FU, oxaliplatin, and infusional 5-FU in patients receiving FOLFOX chemotherapy according to assignment to the control vs intervention arms, both overall and among the subgroup of participants treated with curative intent. OUTLINE: This is an interventional study. Patients are randomized to 1 of 2 arms. ARM A: Patients receive chemotherapy delays and dose modifications at the discretion of the treating clinician during cycles 2-7 of SOC FOLFOX chemotherapy on study. ARM B: Patients receive chemotherapy delays and dose modifications based on PAGODA algorithm followed by treating clinician decision during cycles 2-7 of SOC FOLFOX chemotherapy on study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
420
use PAGODA algorithm to determine chemotherapy delays and dose modifications
Given IV
Given IV
Given IV
Cancer Center at Saint Joseph's
Phoenix, Arizona, United States
RECRUITINGMercy Hospital Fort Smith
Fort Smith, Arkansas, United States
RECRUITINGNEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas, United States
RECRUITINGCARTI Cancer Center
Little Rock, Arkansas, United States
Incidence of unplanned chemotherapy delays
Will employ a generalized linear mixed effects model with logit link function, with a random patient effect to account for clustering of cycles within patients. Will test if additional random effects are needed (e.g., provider or clinic level). Statistical significance will be assessed at the 5% level. Delays will be assessed over cycles 2 through 7, and a delay will be defined as an interval of \> 18 days since day 1 of the previous cycle. An unplanned delay will be defined as any delay that was not prospectively planned by day 3 of the previous cycle.
Time frame: From cycle 2 to 7 (Undelayed cycle length= 14 days)
Time toxicity
Will use health care contact days as a patient-level measure of time toxicity, as previously described by Gupta et al. Health care contact days will be assessed from electronic health record (EHR) data by recording the number of unique days on which the participant has any in-person contact with the health care system (e.g. for an office visit, chemotherapy treatment, laboratory study, emergency department visit, or other health care service). The mean number of health care contact days will be summarized and compared between the intervention arms using an independent two-sample t-test or Wilcoxon rank sum test. To adjust for multiple comparisons, statistical significance will be evaluated at the 1.25% alpha level.
Time frame: From registration to 120 days after registration.
Moderate-to-severe neutropenia
We will assess the patient-level occurrence of ANC less than 1000/mm3 through 30 days after day 1 of the last cycle of protocol treatment. The proportion of patients experiencing ANC less than 1000/mm3 will be summarized and compared between the intervention arms using a Chi-square test for independence or Fisher's Exact test.
Time frame: From the start of cycle 2 to 30 days after start of cycle 7 (undelayed cycle length= 14 days)
Chemotherapy relative dose intensity
Relative dose intensity (RDI) will be individually calculated for 5-FU bolus, oxaliplatin, and infusional 5-FU at the patient-level as the ratio of the delivered dose intensity (dose delivered divided by days elapsed between cycle 1 day 1 and cycle 6 day 14) and the standard dose intensity (standard dose divided by standard treatment interval). The RDI will be summarized and compared between the intervention arms using an independent two-sample t-test or Wilcoxon rank sum test. To adjust for multiple comparisons, statistical significance will be evaluated at the 1.25% alpha level. RDI will be calculated for the entire sample and within treatment intent. For subgroup analyses, statistical significance will be assessed at the 5% level and any positive findings will be considered hypothesis-generating.
Time frame: Time Frame: From the start of cycle 1 to day 14 of cycle 6 (undelayed cycle length= 14 days).
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