Breast cancer is the most commonly diagnosed cancer among women worldwide. Survivors often experience physical and psychological effects arising from breast cancer and its treatment, which can last months and years, adversely impacting quality of life. As the number of early breast cancer survivors increases, models of specialist-led follow-up care in hospital settings are not sustainable and evidence suggests that they may not meet survivors’ needs. Nurse-enabled, shared-care, follow-up models between cancer specialist and primary care teams have potential to address this need.

The proposed research is a multicentre, prospective, pragmatic, stepped-wedge cluster-randomised trial designed to test the effectiveness and implementation of IBIS-Survivorship, a follow-up care model for patients with early breast cancer who have completed primary treatment. The IBIS-Survivorship intervention involves a nurse-led consultation, development of a Survivorship Care Plan and case-conferencing between a breast care nurse and the patient’s primary care provider. This study seeks to recruit 1079 breast cancer survivors across six cancer centres (clusters) in Australia. Health-related quality of life at 12 months assessed by the Functional Assessment of Cancer Therapy - Breast Cancer questionnaire will be the primary endpoint, along with a range of patient-reported outcomes, safety indicators and cost-effectiveness measures as secondary endpoints. General and generalised linear mixed models will be used to assess the effectiveness of the intervention versus usual care. Implementation and process outcomes will be assessed using the Reach Effectiveness Adoption Implementation Maintenance framework.

Ethical approval was provided by the Metro South Hospital and Health Service Human Research Ethics Committee (HREC/2020/QMS/59892) and reciprocally across the other five trial sites under National Mutual Acceptance arrangements. Results will be disseminated through peer-reviewed academic journal publications and presentations at national and international conferences.

Australia and New Zealand Clinical Trials Registry (ANZCTR) Trial ID: ACTRN12621000188831.

Weight loss is often recommended as the primary intervention for infertility in individuals with high body mass index. However, focusing on body mass index might overlook other important factors like cardiometabolic health. This study aims to examine cardiometabolic health in patients seeking fertility treatment and its impact on reproductive outcomes.

A cross-sectional analysis of 800 systematically selected participants (400 couples) will be completed on a single visit to the study site. This session will involve taking blood samples to examine metabolic biomarkers, the completion of questionnaires assessing preconception health factors and an exercise ‘step test’ to assess cardiorespiratory fitness. Metabolic panels will be compared with target values and, where available, normative population data. Fitness data will be transformed into normative percentile values based on the participant’s age and sex. Patients will be followed for 2 years to allow yearly data collection related to conception, gestation and parturition. Associations between cardiometabolic health during the preconception phase and reproductive outcomes will be examined.

The Newfoundland and Labrador Health Research Ethics Board has provided ethical approval for this study (HREB #20230825). Each patient will be required to give written consent prior to any data collection. We will share study findings at conferences and submit manuscripts to peer-reviewed journals. Additionally, we will create knowledge translation presentations for Newfoundland and Labrador Fertility Services and Family Practice Clinics.