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Table 1 Summary of primary and secondary outcomes

From: Ambulatory Toxicity Management (AToM) in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer - a pragmatic cluster randomized trial protocol

Type Outcome Measurement
Primary Outcome Cluster-level mean number of ED + H visits per patient Counts extracted from healthcare administrative data
Patient Reported Outcomes
(Secondary Outcomes)
Severity of chemotherapy treatment toxicities National Cancer Institute Patient-reported Outcomes Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE)
Self-care for management of chemotherapy toxicities Leuven Questionnaire for Patient Self-Care during Chemotherapy (L-PaSC)
Self-efficacy (confidence) for managing symptoms Stanford Self-Management Self-Efficacy
Quality of life (including anxiety and depression) − Patient Health Questionnaire (PHQ-9)
− Generalized Anxiety Disorder (GAD-7)
− Functional Assessment for Cancer Therapy for Patients with Breast Cancer (FACT-B)
− EQ-5D-3 L
Coordination of care Adapted Picker Survey
Cost-effectiveness of pro-active toxicity management compared to routine care (control arm) − Healthcare administrative data
− EQ-5D-3 L