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)

Raymond J. Chan, Jon Emery, Katharine Cuff, Laisa Teleni, Camilla Simonsen, Jane Turner, Monika Janda, Daniel Mckavanagh, Lee Jones, Emma McKinnell, Melissa Gosper, Juanita Ryan, Ria Joseph, Bethany Crowe, Jennifer Harvey, Marissa Ryan, Christine Carrington, Rebecca Nund, Megan Crichton, Stephen McPhail

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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
Original languageEnglish
Article number855
JournalTrials
Volume21
DOIs
Publication statusPublished - 15 Oct 2020
Externally publishedYes

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