Abstract
BackgroundDue to advances in early detection and cancer treatment, 5-year relative survival rates for early breast cancer surpass 90% in developed nations. There is increasing focus on promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care are heavily reliant on hospital-based specialist-led care. This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up.MethodsWe describe a protocol for a phase II, randomised controlled trial with two parallel arms and 1:1 allocation. A total of 60 patients with early-stage breast cancer will be randomised to usual, specialist-led, follow-up care (as determined by the treating surgeons, medical oncologists, and radiation oncologists) or shared follow-up care intervention (i.e. EMINENT). EMINENT is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities divided between cancer centre specialists (i.e. surgeons and oncologists) and general practitioners. The primary outcome is health-related quality of life as measured by the Functional Assessment of Cancer Therapy—Breast Cancer. Secondary outcomes include patient experience, acceptance, and satisfaction of care; dietary, physical activity, and sedentary behaviours; financial toxicity; adherence; health resource utilisation; and adverse events.DiscussionThe trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment. Results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system.Trial registrationAustralia and New Zealand Clinical Trials Registry ACTRN12619001594112. Registered on 19 November 2019
Highlights
Background and rationale {6a} In Australia, breast cancer is the most common cancer in females with an estimated 19,535 new cases annually [1]
The trial is designed to identify the barriers to implementing a shared-care model for breast cancer survivors following treatment
Results of this study will inform a definitive trial testing the effects of shared-care model on health-related quality of life of breast cancer survivors, as well as its ability to alleviate the growing demands on the healthcare system
Summary
Background and rationale {6a} In Australia, breast cancer is the most common cancer in females with an estimated 19,535 new cases annually [1]. Many cancer survivors need management of comorbidities as they are 2.5 times more likely to develop mental and behavioural problems and almost 1.5 times more likely to develop musculoskeletal conditions, circulatory conditions, and endocrine system disorders compared with non-cancer patients [5]. These health concerns highlight the importance of a comprehensive, well-integrated, patientcentred model of care for people following completion of breast cancer treatment. This study aims to test the feasibility of the EMINENT intervention for implementing an integrated, shared-care model involving both cancer centre specialists and community-based general practitioners for early breast cancer post-treatment follow-up
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