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Abstract
BackgroundPopulation-based studies suggest that emergency department visits and hospitalizations are common among patients receiving chemotherapy and that rates in routine practice are higher than expected from clinical trials. Chemotherapy-related toxicities are often predictable and, consequently, acute care visits may be preventable with adequate treatment planning and support between visits to the cancer centre. We will evaluate the impact of proactive telephone-based toxicity management on emergency department visits and hospitalizations in women with early stage breast cancer receiving chemotherapy.MethodsIn this pragmatic covariate constraint-based cluster randomized trial, 20 centres in Ontario, Canada are randomly allocated to either proactive telephone toxicity management (intervention) or routine care (control). The primary outcome is the cluster-level mean number of ED + H visits per patient evaluated using Ontario administrative healthcare data. Participants are all patients with early stage (I-III) breast cancer commencing adjuvant or neo-adjuvant chemotherapy at participating institutions during the intervention period. At least 25 patients at each centre participate in a patient reported outcomes sub-study involving the collection of standardized questionnaires to measure: severity of treatment toxicities, self-care, self-efficacy, quality of life, and coordination of care. Patients participating in the patient reported outcomes (PRO) sub-study are asked to provide written consent to link their PRO data to administrative data. Unit costs will be applied to each per person resource utilized, and a total cost per population and patient will be generated. An incremental cost-effectiveness analysis will be undertaken to compare the incremental costs and outcomes between the intervention and control groups from the health system perspective.DiscussionThis study evaluates the effectiveness of a proactive toxicity management intervention in a routine care setting. The use of administrative healthcare data to evaluate the primary outcome enables an evaluation in a real world setting and at a much larger scale than previous studies.Trial registrationClinicaltrials.gov, NCT02485678. Registered 30 June 2015.
Highlights
Population-based studies suggest that emergency department visits and hospitalizations are common among patients receiving chemotherapy and that rates in routine practice are higher than expected from clinical trials
We describe the protocol for a pragmatic, cluster randomized controlled trial to evaluate the effect of proactive, nurse-led telephonebased symptom management on cluster-level number of ED + H visits in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer using healthcare administrative data. We have targeted this population as breast cancer is a leading cause of morbidity and mortality in women worldwide [14, 15], and many women diagnosed with breast cancer require systemic treatment in the adjuvant or metastatic setting [16,17,18,19] which has been associated with high rates of acute care utilization [1, 2, 6]
Patients with early stage breast cancer tend to be treated with some combination of surgery and systemic therapy often involving chemotherapy
Summary
Study design overview The pragmatic covariate constraint-based cRCT involves 20 centres in Ontario, Canada that provide care to women with breast cancer (Fig. 1). Cluster randomization A covariate constraint-based randomization methodology proposed by Moulton [21] was used to randomly allocate the 20 participating centres to either intervention arm or control arm using a healthcare administrative dataset for early stage breast cancer patients diagnosed between January 1, 2010 and June 30, 2013 who received either adjuvant or neoadjuvant chemotherapy. All patients with early stage breast cancer at the participating centres who initiated adjuvant or neo-adjuvant chemotherapy during the intervention period will be identified from the New Drug Funding Database (NDFP) and/or Activity Level Reporting (ALR) database which include information on drugs received, dates of treatment and institution where treatment was given. Questionnaires completed by patients participating in the PRO sub-study will be linked to administrative data housed at ICES using the Ontario Health Insurance Plan (OHIP) numbers provided by individually consenting patients. While provision of a patient’s OHIP number is voluntary, at least 500 consenting patients are needed to provide adequate statistical power for the analysis of secondary outcomes
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