Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in context
Summary: Background: Current models of post-treatment cancer care rely heavily on hospital-based, medical specialists and do not sufficiently leverage primary care. Many breast cancer survivors face ongoing unmet needs that may benefit from a multidisciplinary, shared-care approach. We aimed to eva...
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2025-03-01
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author | Raymond J. Chan Fiona Crawford-Williams Chad Yixian Han Lee Jones Alexandre Chan Daniel McKavanagh Marissa Ryan Christine Carrington Rebecca L. Packer Megan Crichton Nicolas H. Hart Emma McKinnell Melissa Gosper Juanita Ryan Bethany Crowe Ria Joseph Carolyn Ee Jane Lee Steven M. McPhail Katharine Cuff Laisa Teleni Jon Emery |
author_facet | Raymond J. Chan Fiona Crawford-Williams Chad Yixian Han Lee Jones Alexandre Chan Daniel McKavanagh Marissa Ryan Christine Carrington Rebecca L. Packer Megan Crichton Nicolas H. Hart Emma McKinnell Melissa Gosper Juanita Ryan Bethany Crowe Ria Joseph Carolyn Ee Jane Lee Steven M. McPhail Katharine Cuff Laisa Teleni Jon Emery |
author_sort | Raymond J. Chan |
collection | DOAJ |
description | Summary: Background: Current models of post-treatment cancer care rely heavily on hospital-based, medical specialists and do not sufficiently leverage primary care. Many breast cancer survivors face ongoing unmet needs that may benefit from a multidisciplinary, shared-care approach. We aimed to evaluate the feasibility and preliminary effectiveness of implementing nurse-enabled, shared-follow-up care between the acute and primary care setting for early-stage breast cancer. Methods: In this single-centre, open-label, phase II, pilot, randomised, controlled trial, individuals diagnosed with breast cancer (Stage 0–III) were randomised 1:1 to either usual care or intervention, which includes a 1) Specialist Nurse Consultation to co-develop a survivorship care plan (SCP), 2) Pharmacist Consultation, 3) Case Conference with General Practitioner (GP), and 4) shared follow-up care arrangements. Feasibility and effectiveness outcome measures, including health-related quality of life (primary outcome), physical activity and nutrition, patient experience, and financial toxicity were collected at baseline, and at 3-, 6-, and 12-months, with health service utilisation data at 24-months. Bivariate and multivariable, intention-to-treat analyses were conducted. This trial is registered at Anzctr.org.au (ACTRN12619001594112). Findings: From 3rd December 2019 to 13th April 2021, 61 participants were randomised (intervention n = 29; usual care n = 32); mean age 62.9 standard deviation (SD) = 10.9 years. The intervention was feasible with 100% completion rates across all elements of the specialist nurse consultation and GP case conference. Evaluation of the 28 SCPs indicated the top three goals were exercise (n = 23), diet (n = 12) and mental well-being (n = 11). All care goals can be supported by GPs. No differences were observed between groups for health-related quality of life and the other effectiveness outcomes measures listed above at all timepoints (P > 0.05 for all). There were significantly fewer average post-treatment radiation oncology appointments per patient in the intervention group compared to the control group (0.69 versus 1.27, P = 0.013) at 24-months. Number of unplanned hospital presentations at 24-months were low across both intervention (n = 7) and control (n = 4) groups. Interpretation: Nurse-enabled, shared-care arrangements for women with early-stage breast cancer is feasible, and is as safe as specialist-led model of care. It may provide a more sustainable model of care in a longer term. GPs can meet the survivorship care needs identified breast cancer survivors. This trial can inform a large, pragmatic, hybrid effectiveness-implementation trial. Funding: Metro South Health Research Support Scheme Project Grant. |
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spelling | doaj-art-570a73b5746b4925a04413aa8e104ccb2025-02-07T04:48:06ZengElsevierEClinicalMedicine2589-53702025-03-0181103090Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in contextRaymond J. Chan0Fiona Crawford-Williams1Chad Yixian Han2Lee Jones3Alexandre Chan4Daniel McKavanagh5Marissa Ryan6Christine Carrington7Rebecca L. Packer8Megan Crichton9Nicolas H. Hart10Emma McKinnell11Melissa Gosper12Juanita Ryan13Bethany Crowe14Ria Joseph15Carolyn Ee16Jane Lee17Steven M. McPhail18Katharine Cuff19Laisa Teleni20Jon Emery21Caring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia; Cancer and Palliative Care Outcomes Centre, School of Nursing, Queensland University of Technology, Brisbane, QLD, Australia; Princess Alexandra Hospital, Metro South Health, Brisbane, QLD, Australia; Corresponding author. Caring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia.Caring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, AustraliaCaring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, AustraliaCaring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia; QIMR Berghofer Medical Research Institute, Herston, QLD, AustraliaDepartment of Clinical Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, University of California, Irvine, USAPrincess Alexandra Hospital, Metro South Health, Brisbane, QLD, AustraliaPrincess Alexandra Hospital, Metro South Health, Brisbane, QLD, AustraliaSchool of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, QLD, AustraliaSchool of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, QLD, AustraliaCancer and Palliative Care Outcomes Centre, School of Nursing, Queensland University of Technology, Brisbane, QLD, AustraliaCaring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia; Cancer and Palliative Care Outcomes Centre, School of Nursing, Queensland University of Technology, Brisbane, QLD, Australia; Human Performance Research Centre, INSIGHT Research Institute, University of Technology Sydney (UTS), Sydney, NSW, Australia; Exercise Medicine Research Institute, School of Medical and Health Sciences, Edith Cowan University, Perth, WA, Australia; Institute for Health Research, The University of Notre Dame Australia, Perth, WA, AustraliaPrincess Alexandra Hospital, Metro South Health, Brisbane, QLD, AustraliaPrincess Alexandra Hospital, Metro South Health, Brisbane, QLD, AustraliaPrincess Alexandra Hospital, Metro South Health, Brisbane, QLD, AustraliaCaring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia; Princess Alexandra Hospital, Metro South Health, Brisbane, QLD, AustraliaCaring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, AustraliaCaring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, AustraliaCaring Futures Institute, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, AustraliaCancer and Palliative Care Outcomes Centre, School of Nursing, Queensland University of Technology, Brisbane, QLD, AustraliaPrincess Alexandra Hospital, Metro South Health, Brisbane, QLD, AustraliaCancer and Palliative Care Outcomes Centre, School of Nursing, Queensland University of Technology, Brisbane, QLD, AustraliaDepartment of General Practice and Primary Care, University of Melbourne, Melbourne, VIC, Australia; Centre for Cancer Research, University of Melbourne, Melbourne, VIC, AustraliaSummary: Background: Current models of post-treatment cancer care rely heavily on hospital-based, medical specialists and do not sufficiently leverage primary care. Many breast cancer survivors face ongoing unmet needs that may benefit from a multidisciplinary, shared-care approach. We aimed to evaluate the feasibility and preliminary effectiveness of implementing nurse-enabled, shared-follow-up care between the acute and primary care setting for early-stage breast cancer. Methods: In this single-centre, open-label, phase II, pilot, randomised, controlled trial, individuals diagnosed with breast cancer (Stage 0–III) were randomised 1:1 to either usual care or intervention, which includes a 1) Specialist Nurse Consultation to co-develop a survivorship care plan (SCP), 2) Pharmacist Consultation, 3) Case Conference with General Practitioner (GP), and 4) shared follow-up care arrangements. Feasibility and effectiveness outcome measures, including health-related quality of life (primary outcome), physical activity and nutrition, patient experience, and financial toxicity were collected at baseline, and at 3-, 6-, and 12-months, with health service utilisation data at 24-months. Bivariate and multivariable, intention-to-treat analyses were conducted. This trial is registered at Anzctr.org.au (ACTRN12619001594112). Findings: From 3rd December 2019 to 13th April 2021, 61 participants were randomised (intervention n = 29; usual care n = 32); mean age 62.9 standard deviation (SD) = 10.9 years. The intervention was feasible with 100% completion rates across all elements of the specialist nurse consultation and GP case conference. Evaluation of the 28 SCPs indicated the top three goals were exercise (n = 23), diet (n = 12) and mental well-being (n = 11). All care goals can be supported by GPs. No differences were observed between groups for health-related quality of life and the other effectiveness outcomes measures listed above at all timepoints (P > 0.05 for all). There were significantly fewer average post-treatment radiation oncology appointments per patient in the intervention group compared to the control group (0.69 versus 1.27, P = 0.013) at 24-months. Number of unplanned hospital presentations at 24-months were low across both intervention (n = 7) and control (n = 4) groups. Interpretation: Nurse-enabled, shared-care arrangements for women with early-stage breast cancer is feasible, and is as safe as specialist-led model of care. It may provide a more sustainable model of care in a longer term. GPs can meet the survivorship care needs identified breast cancer survivors. This trial can inform a large, pragmatic, hybrid effectiveness-implementation trial. Funding: Metro South Health Research Support Scheme Project Grant.http://www.sciencedirect.com/science/article/pii/S2589537025000227Breast cancerModels of careNurse-ledShared-careSurvivorshipQuality of life |
spellingShingle | Raymond J. Chan Fiona Crawford-Williams Chad Yixian Han Lee Jones Alexandre Chan Daniel McKavanagh Marissa Ryan Christine Carrington Rebecca L. Packer Megan Crichton Nicolas H. Hart Emma McKinnell Melissa Gosper Juanita Ryan Bethany Crowe Ria Joseph Carolyn Ee Jane Lee Steven M. McPhail Katharine Cuff Laisa Teleni Jon Emery Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in context EClinicalMedicine Breast cancer Models of care Nurse-led Shared-care Survivorship Quality of life |
title | Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in context |
title_full | Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in context |
title_fullStr | Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in context |
title_full_unstemmed | Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in context |
title_short | Implementing a nurse-enabled, integrated, shared-care model involving specialists and general practitioners in early breast cancer post-treatment follow-up (EMINENT): a single-centre, open-label, phase 2, parallel-group, pilot, randomised, controlled trialResearch in context |
title_sort | implementing a nurse enabled integrated shared care model involving specialists and general practitioners in early breast cancer post treatment follow up eminent a single centre open label phase 2 parallel group pilot randomised controlled trialresearch in context |
topic | Breast cancer Models of care Nurse-led Shared-care Survivorship Quality of life |
url | http://www.sciencedirect.com/science/article/pii/S2589537025000227 |
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