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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