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)

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

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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)

10.21203/rs.3.rs-28955/v1 ◽

2020 ◽

Author(s):

Raymond Chan ◽

Jon Emery ◽

Katharine Cuff ◽

Laisa Teleni ◽

Camilla Simonsen ◽

...

Keyword(s):

Breast Cancer ◽

General Practitioners ◽

Controlled Trial ◽

Shared Care ◽

Trial Registration ◽

Cancer Center ◽

Care Model ◽

Follow Up Care ◽

Shared Care Model

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 center specialists and community-based general practitioners for early breast cancer post-treatment follow-up.Methods: We describe a protocol for a phase II, randomized controlled trial with two parallel arms and 1:1 allocation. A total of 60 patients with early stage breast cancer will be randomized 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 center specialists (i.e., surgeons and oncologists) and general practitioners. 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 behaviors; financial toxicity; adherence; health resource utilization; 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: Trial registration: Australia and New Zealand Clinical Trials Registry, ACTRN12619001594112). Registered 19 November 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378690&isReview=true.

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Partnering with general practitioners to optimize survivorship for patients with lymphoma: a phase II randomized controlled trial (the GOSPEL I trial)

Trials ◽

10.1186/s13063-020-04945-4 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Raymond Javan Chan ◽

Stephanie Buhagiar ◽

Laisa Teleni ◽

Camilla Simonsen ◽

Jane Turner ◽

...

Keyword(s):

Controlled Trial ◽

Shared Care ◽

Cancer Center ◽

Patient Reported ◽

Follow Up Care ◽

Shared Care Model ◽

Related Quality ◽

Health Related

Abstract Background Survival rates for lymphoma are highest amongst hematological malignancies. In 2019, it was estimated that over 6400 Australians were diagnosed with lymphoma, a group of hematological malignancies with a high 5-year survival rate of ~ 76%. There is an increased focus on the promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care heavily rely on hospital-based specialist-led care. Maximizing the potential of general practitioners (GPs) in the ongoing management of cancer is consistent with the national health reform principles and the Cancer Council Australia’s Optimal Care Pathways. GPs are well positioned to provide guideline-based follow-up care and are more likely to address comorbidities and psychosocial issues and promote healthy lifestyle behaviors. This study aims to test the feasibility of the GOSPEL I intervention for implementing an integrated, shared care model in which cancer center specialists and community-based GPs collaborate to provide survivorship care for patients with lymphoma. Methods We describe a protocol for a phase II, randomized controlled trial with two parallel arms and a 1:1 allocation. Sixty patients with Hodgkin’s and non-Hodgkin’s lymphoma will be randomized to usual specialist-led follow-up care (as determined by the treating hematologists) or a shared follow-up care intervention (i.e., GOSPEL I). GOSPEL I is a nurse-enabled, pre-specified shared care pathway with follow-up responsibilities shared between cancer center specialists (i.e., hematologists and specialist cancer nurses) and GPs. Outcome measures assess feasibility as well as a range of patient-reported outcomes including health-related quality of life as measured by the Functional Assessment of Cancer Therapy—Lymphoma, patient experience of care, symptom distress, comorbidity burden, dietary intake, physical activity behaviors, financial distress/interference, and satisfaction of care. Safety indicators including hospital admission and unscheduled lymphoma clinic visits as well as process outcomes such as intervention fidelity and economic indicators will be analyzed. Discussion This trial is designed to explore the feasibility and acceptability of a new model of shared care for lymphoma survivors. Patient-reported outcomes as well as potential barriers to implementation will be analyzed to inform a larger definitive clinical trial testing the effects and implementation of a shared care model on health-related quality of life of lymphoma survivors. Trial registration Australia and New Zealand Clinical Trials Registry ACTRN12620000594921. Registered on 22 May 2020.

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Partnering with General Practitioners to Optimize Survivorship for Patients with Lymphoma: A phase II Randomized Controlled Trial (The GOSPEL 1 Trial)

10.21203/rs.3.rs-32868/v1 ◽

2020 ◽

Author(s):

Raymond Chan ◽

Stephanie Buhagiar ◽

Laisa Teleni ◽

Camilla Simonsen ◽

Jane Turner ◽

...

Keyword(s):

Controlled Trial ◽

Shared Care ◽

Cancer Center ◽

Patient Reported ◽

Follow Up Care ◽

Shared Care Model ◽

Related Quality ◽

Health Related

Abstract Background: Survival rates for lymphoma are highest amongst hematological malignancies. In 2019, it was estimated that over 6,400 Australians were diagnosed with lymphoma, a group of hematological malignancies with a high 5-year survival rate of ~76%. There is an increased focus on the promotion of wellness in survivorship and active approaches to reducing morbidity related to treatment; however, current models of follow-up care heavily rely on hospital-based specialist-led care.Maximizing the potential of general practitioners (GPs) in the ongoing management of cancer is consistent with the national health reform principles, and the Cancer Council Australia’s Optimal Care Pathways. GPs are well positioned to provide guideline-based follow-up care and are more likely to address comorbidities, psychosocial issues and promote healthy lifestyle behaviors. This study aims to test the feasibility of the GOSPEL 1 intervention for implementing an integrated, shared-care model in which cancer center specialists and community-based GPs collaborate to provide survivorship care for patients with lymphoma.Methods: We describe a protocol for a phase II, randomized controlled trial with two parallel arms and a 1:1 allocation. Sixty patients with Hodgkin’s and Non-Hodgkin’s lymphoma will be randomized to usual specialist-led follow-up care (as determined by the treating hematologists) or a shared follow-up care intervention (i.e., GOSPEL 1). GOSPEL 1 is a nurse-enabled, pre-specified shared-care pathway with follow-up responsibilities shared between cancer center specialists (i.e., hematologists and specialist cancer nurses) and GPs. Outcome measures assess feasibility as well as a range of patient reported outcomes including health-related quality of life as measured by the Functional Assessment of Cancer Therapy – Lymphoma, patient experience of care, symptom distress, comorbidity burden, dietary intake, physical activity behaviors, financial distress/interference and satisfaction of care. Safety indicators including hospital admission and unscheduled lymphoma clinic visits as well as process outcomes such as intervention fidelity and economic indicators will be analyzed.Discussion: This trial is designed to explore the feasibility and acceptability of a new model of shared-care for lymphoma survivors. Patient reported outcomes as well as potential barriers to implementation will be also analyzed to inform a larger definitive clinical trial testing the effects of a shared-care model on health-related quality of life of lymphoma survivors.Trial registration: Australia and New Zealand Clinical Trials Registry, Registration number: ACTRN12620000594921, Date registered: 22/05/2020, registration link: https://www.anzctr.org.au/ACTRN12620000594921.aspx

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