Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a study protocol for a phase II randomised controlled trial (the EMINENT trial)

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Chan, RJ; Emery, J; Cuff, K; Teleni, L; Simonsen, C; Turner, J; Janda, M; Mckavanagh, D; Jones, L; McKinnell, E; ...Date
2020-10-15Source Title
TrialsPublisher
BMCUniversity of Melbourne Author/s
Emery, JonathanAffiliation
General PracticeMetadata
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Chan, R. J., Emery, J., Cuff, K., Teleni, L., Simonsen, C., Turner, J., Janda, M., Mckavanagh, D., Jones, L., McKinnell, E., Gosper, M., Ryan, J., Joseph, R., Crowe, B., Harvey, J., Ryan, M., Carrington, C., Nund, R., Crichton, M. & McPhail, S. (2020). Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up: a study protocol for a phase II randomised controlled trial (the EMINENT trial). TRIALS, 21 (1), https://doi.org/10.1186/s13063-020-04740-1.Access Status
Open AccessOpen Access at PMC
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7558254Abstract
BACKGROUND: Due 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. METHODS: We 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. DISCUSSION: 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. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry ACTRN12619001594112 . Registered on 19 November 2019.
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