TY - JOUR
T1 - Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in breast cancer post-treatment follow-up
T2 - a study protocol for a phase II randomised controlled trial (the EMINENT trial)
AU - Chan, Raymond Javan
AU - Emery, Jon
AU - Cuff, Katharine
AU - Teleni, Laisa
AU - Simonsen, Camilla
AU - Turner, Jane
AU - Janda, Monika
AU - Mckavanagh, Daniel
AU - Jones, Lee
AU - McKinnell, Emma
AU - Gosper, Melissa
AU - Ryan, Juanita
AU - Joseph, Ria
AU - Crowe, Bethany
AU - Harvey, Jennifer
AU - Ryan, Marissa
AU - Carrington, Christine
AU - Nund, Rebecca
AU - Crichton, Megan
AU - McPhail, Steven
PY - 2020/10/15
Y1 - 2020/10/15
N2 - 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
AB - 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
KW - Early breast cancer
KW - Oncology
KW - Protocol
KW - Quality of life
KW - Randomised controlled trial
KW - Shared-care
UR - http://www.scopus.com/inward/record.url?scp=85092693297&partnerID=8YFLogxK
U2 - 10.1186/s13063-020-04740-1
DO - 10.1186/s13063-020-04740-1
M3 - Article
C2 - 33059741
AN - SCOPUS:85092693297
VL - 21
JO - Trials
JF - Trials
SN - 1745-6215
M1 - 855
ER -