ANZCTR search results

Our landmark trial published in The Lancet in 2011 demonstrated that facilitated implementation of nurse-initiated protocols to manage fever, hyperglycaemia (sugar) and swallowing difficulties (FeSS Protocols) resulted in significantly reduced 90-day death and dependency for stroke patients. However, ten years on, a significant gap remains in translation of the FeSS Protocols into standard stroke care across Australia, particularly notable in rural and remote settings. A program of systematic Australia-wide implementation is urgently needed. To date, systematic implementation of the FeSS Protocols has not occurred in New Zealand. Therefore, the specific aims of this study are: 1) To determine the effectiveness of a large scale intervention with varying intensities of external remote facilitation in enhancing simultaneous multi-site delivery to promote multi-national uptake of the FeSS Protocols to improve management of fever, hyperglycaemia and swallowing difficulties in the first 72 hours of stroke unit/stroke service admission. Specifically, we will compare the effectiveness of: a) low intensity versus high intensity external remote facilitation. b) low intensity versus no external remote facilitation. c) high intensity versus no external remote facilitation. 2) To determine whether post-intervention implementation changes in monitoring and treatment for fever, hyperglycaemia and swallowing differ between metropolitan and rural/remote hospitals. 3) To determine whether post-intervention changes in monitoring and treatment for fever, hyperglycaemia and swallowing differ between stroke units and stroke services. 4) To describe the potential cost-effectiveness of the different facilitation methods (economic evaluation). 5) To identify clinicians’ views regarding factors that influence uptake of the FeSS Protocols in metropolitan and rural/remote hospitals (process evaluation). A three-arm cluster randomised controlled trial, process evaluation and economic evaluation (sub-study) will be undertaken. Hospitals will be randomised to one of two intervention (low and high intensity external remote facilitation) or control (no facilitation) groups. Australian and new Zealand hospitals with a pre-existing stroke unit/service will be eligible. Multi-national implementation of the proven FeSS Protocols into innovative policy and practice will result in better outcomes for survivors of stroke, particularly in rural and remote Australian and New Zealand settings.

This is an observational, longitudinal registry of paediatric, adolescent, young adult (AYA) and rare adult tumour patients from a select group of tumour streams treated with radiotherapy. The registry is designed to describe the patterns of care for patients receiving photon versus proton radiation treatment. Who is it for? You may be eligible for this study if you are receiving radiotherapy for cancers of the following types: Base of Skull Meningioma, Chordoma, Chondrosarcoma, Tumour of the vertebral column or bony pelvis, Chordoma, Chondrosarcoma, Osteosarcoma, Ewing’s sarcoma of pelvis, Adenoid cystic carcinoma of the salivary or lacrimal gland, CNS, Medulloblastoma, Ependymoma, Glioma, Astrocytoma, Orbit, including retinoblastoma, Retinoblastoma, Axial skeleton or close proximity to axial skeleton, including bone or soft tissue sarcoma Ewing Sarcoma, Rhabdomyosarcoma, Osteosarcoma of axial skeleton, Craniopharyngioma, Intracranial germ cell tumour, Neuroblastoma, or Nephroblastoma Study details There are no clinical interventions required for participants enrolled onto the registry. All enrolled participants will receive treatment, and follow-up care as pre-determined by their treating clinician, in accordance with the standard of care at the treating institution. All treatment interventions that participants receive, and all outcomes will be recorded on the registry database from the patient medical record. It is hoped that the development of this registry will assist in describing the long-term effects and disease control outcomes for patients having radiotherapy as part of their cancer treatment.

The purpose of this study is to determine the effectiveness of a nurse-led survivorship care intervention (PCEssentials), relative to usual care, for improving health-related quality of life in men with prostate cancer undergoing androgen deprivation therapy (ADT). The study will also evaluate whether the intervention is cost-effective, acceptable, appropriate, and feasible compared to usual care. Who is it for? You may be eligible for this study if you are aged 18 years or over, have been diagnosed with prostate cancer, are commencing or within 3 months of commencement of ADT, and are expected to continue ADT for a minimum of 12 months. Study details Participants will be randomised (i.e. allocated by chance) to receive the PCEssentials intervention, or usual care. The PCEssentials intervention will involve five 1-hour psychoeducation sessions delivered via telehealth by a trained prostate cancer specialist nurse. These sessions will occur weekly for four weeks with a booster session at 3 months after recruitment, and will involve one-to-one psychological support, treatment education, tailored strategies to help manage distress, decision making and self-management. Participants in the intervention group will also be provided with a home-based exercise activity program tailored to their need and ability. Participants allocated to usual care will receive their standard management that is minimally enhanced with a package of evidence-based resources containing patient education materials about the use of ADT to treat prostate cancer; and advice about referral to support services. All participants will answer a number of questionnaires at the time of recruitment, and at 3, 6, and 12 months after recruitment to assess for changes to quality of life, self-efficacy, psychological distress, sleep, fatigue, and physical activity levels. Interviews will also be conducted to assess for acceptability of the intervention, and a health service use diary will be used to perform cost-effectiveness analysis. It is hoped that this research will demonstrate that the PCEssentials intervention is feasible, acceptable, and effective in improving quality of life, self-efficacy, and sleep, and reducing distress and fatigue in individuals with prostate cancer being treated with ADT.

This quantitative project will involve a cross-sectional study which will measure self-stigma (SS) prevalence and severity among the Western Australian youth (16 -24 years) mental health population. It will also profile SS by exploring its relationship with several measures of demographic, mental and physical health, behaviours, and wellbeing. A minimum of 436 youth with a mental illness are required for the cross-sectional survey. It is hypothesised that moderate to severe internalised stigma will affect approximately 25% of youth with a mental illness. Additionally, it is hypothesised that those with lower SS severity will present as relatively more recovered, demonstrate stronger self-orientation towards empowerment and have better quality of life.

COVID-19 has multiple facets including cytokine storm, thromboembolism, renal impairment, and mucinous secretions. It is known that oxygen exchange is the main problem in patients with COVID-19 and hypoxia is one of the most serious effects, in which patients succumb to acute respiratory distress syndrome (ARDS). The development of mucinous sputum plugs in individuals infected with SARS-CoV-2 in addition to cytokine storm is of great clinical importance, correlating with negative outcome. Bromelain and Acetylcysteine (BromAc) is a potent mucolytic applied in highly mucinous tumours of the appendix. Previous research has shown that BromAc cleaves the glycoproteins of the SARS-CoV-2 virus (antiviral), is a mucolytic, dissolving COVID-19 and other respiratory sputum in clinically relevant times, and down regulates cytokines and chemokines in sputum from ventilated COVID-19 patients. The investigators now seek to examine the safety of nebulised BromAc in healthy volunteers to assess any symptoms or side effects prior to progressing towards a potential treatment option in patients with severe COVID-19.

This is a proof of concept study with the purpose of examining the anti-tumour immune response after local irreversible electroporation (IRE) in patients with prostate cancer. Who is it for? You may be eligible for this study if you are male, aged 18 years or over, have prostate cancer, and scheduled for either IRE or radical prostatectomy. Study details There will be two groups of participants: patients scheduled for IRE, and patients scheduled for radical prostatectomy. Both groups of participants will undergo their scheduled treatment as usual. In addition, both groups will have blood samples collected before treatment, and on days 3, 14 and 30 after treatment. It is hoped that this research will improve understanding of systemic anti-tumour immune response after IRE, and thus offer insight for future cancer treatment strategies.

The overarching primary research question for the QoVAX SET Statewide study is; In the Queensland community statewide, what level of short-term vaccine humoral immunity induced at one to three months post vaccination is associated with i) protection from community acquired SARS-CoV-2 infection with known or emergent variants of concern, and ii) severe health outcomes of community acquired COVID-19. The QoVAX Statewide study will address these specific research questions; 1. What are the host intrinsic (level of antibody response, , HLA type) and extrinsic factors (socio-economic health determinants, environmental exposures e.g. smoking) associated with i) vaccine efficacy, and ii) severe COVID-19? 2. Do members of the community who identify as Aboriginal and/or Torres Strait and/or South Sea Islander, or as being from diverse ethnic backgrounds, show similar vaccine responses, and associations with i) vaccine efficacy, and ii) severe COVID-19, and the general Queensland population? 3. Do certain pre-existing health conditions (autoimmunity, cancer, immunodeficiency), and medication use effect i) vaccine efficacy, and ii) vulnerability to severe COVID-19? A statewide recruitment campaign will be undertaken and participants will self-enrol via the study website. A questionnaire will be completed and blood samples collected at 1 - < 3 months following the last dose of a COVID-19 vaccine or at enrolment for unvaccinated participants. Participants will be followed over the long term via both repeat questionnaires and data linkage with administrative health datasets to ascertain study outcomes.

The purpose of this substudy is to better understand the effects of exercise on a number of the body’s responses to complex cancer surgery, including immune effects and the performance of certain organs, such as the heart and brain. Who is it for? You may be eligible for this study if you are an adult who is undergoing complex surgery for treatment of cancers of the gastro-intestinal tract and has already been enrolled in the PRIORITY trial (as described in registration ACTRN12621000617864). Study details In addition to taking part in the PRIORITY trial, participants in this sub-study will be asked to provide blood samples before and after their operation. They will also be asked to complete additional questionnaires before and after their operation to assess for any changes to brain function. Participants will then be asked to complete those questionnaires again one year after their surgery. It is hoped that this study will help researchers to understand the biological reasons why exercise and fitness influences a person’s ability to recover from major surgery, including whether or not they suffer complications following their operation. The ability to answer this question is an important research target because it will advance an understanding of interventions that can be offered to patients to reduce the risks associated with undergoing complex surgery.

Automated insulin delivery can assist in achieving the metabolic goals of people living with type 1 diabetes while at the same time reducing the heavy intellectual and psychological burden of care. The Medtronic 780G is a second generation closed loop (artificial pancreas) system incorporating several enhancements to the currently commercially available 670G hybrid closed loop (HCL) system. Modifications include an advanced hybrid closed loop (AHCL) algorithm with adjustable glucose targets, automated correction boluses, software modifications allowing greater persistence in closed loop with fewer alarms in conjunction with smartphone connectivity. The initial pivotal trials of the 780G have demonstrated promising clinical and safety outcomes. The success of these automated devices moving forward hinge upon their ease of use and ability to reduce and relieve the burden of living with type 1 diabetes. The Melbourne cohort of twenty-two participants with type 1 diabetes using pumps with the AHCL algorithm include individuals that were involved in early feasibility studies, and some have had over two years of experience with the same AHCL algorithm used in 780G. They are currently enrolled in an extension study (ACTRN12620000687998) with their glucose levels managed by the MiniMed™ AHCL system (Medtronic, Northridge, CA), consisting of a MiniMedTM 600 series insulin pump with the AHCL algorithm in conjunction with a Medtronic GuardianTM Sensor 3. The system utilizes RF connectivity requiring initiation and implementation of data upload by the user. The sensor configuration requires calibration at least twice daily using a capillary blood glucose reading using a blood glucose meter. The 700 series Medtronic pumps utilize blue-tooth connectivity transmitting insulin delivery and glucose data seamlessly to the cloud and there is no requirement for the user to implement download of the pumps data. Also, very recently, further technical advances including a seven-day extended wear infusion set and an improved sensor form factor reducing intrusiveness and the requirement for calibration fingersticks have the potential to improve the experience of those using Closed Loop Technology. Aim: To determine feasibility and acceptance of the Next Generation Medtronic HCL System (780G; Synergy Glucose Sensor; and Extended wear infusion set)

The purpose of this study is to determine the safety and efficacy of the addition of an anti-nausea drug called prochlorperazine to current standard of care treatment for patients with HER2-positive breast cancer. By administering a high dose of prochlorperazine as an infusion directly into your veins over a short period of time (20-30 minutes), the process by which cells absorb molecules may be blocked. When this absorption process is blocked, it is thought that individuals may respond better to one of the drugs used to treat HER2-positive breast cancer. Who is it for? You may be eligible for this study if you are an adult who has metastatic HER2-positive breast cancer and you haven’t chemotherapy treatment yet. Study details All patients in this study will receive a high dose of prochlorperazine 3 weeks after the commencement of their chemotherapy. After this, all patients will receive the prochlorperazine weekly with their usual chemotherapy. There will be different doses of the prochlorperazine given to participants depending on when the participant joins the study, with the doses starting at the highest dose and then decreasing over time dependent upon any safety concerns. It is hoped that this research will help determine if the high dose prochlorperazine is safe in combination with chemotherapy to treat patients with HER2-postive breast cancer, while also testing whether this has an effect on improving health outcomes.