ANZCTR search results

Metastatic breast cancer impairs quality of life (QOL), causes distress, and has a high health-system burden, yet few studies have examined interventions to address this. Our research group recently developed an online psychosocial program for women with metastatic breast cancer “Finding My Way-Advanced”. The purpose of this study is to test whether, compared to a control group, Finding My Way-Advanced leads to improved QOL, distress and health care use for women with metastatic breast cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older who has recently been diagnosed with metastatic breast cancer (MBC). Study details Participants in this study will be randomly allocated (i.e. allocated by chance) to one of two groups: Group 1: Participants in this group will be provided with an online intervention consisting of 6 modules which focus on improving the psychological well-being and quality of life of women diagnosed with metastatic breast cancer. Topics addressed by the modules include (1) Navigating healthcare (making decisions and communicating with my health care team), (2) Living well with a progressing illness: Managing fear of progression and coping with uncertainty; (3) Managing physical symptoms (particularly fatigue and pain); (4) Managing emotional distress; (5) Managing identity and role-changes; and (6) Social support: receiving support and supporting family. Participants will be able to access all modules immediately, and use them as much as needed during the intervention. They will receive weekly reminders to log in and use the program, over the 6 week study period. Group 2: Participants in this group will receive links to Breast Cancer Network Australia's 'gold standard' resource for women with metastatic breast cancer: “My Journey Online Tool”. This key resource will be supplemented with the static digital downloadable “Hope & Hurdles” kit specific to MBC which includes (a) an introductory booklet about MBC; (b) an information guide (which provides detailed information about diagnosis, treatments, support options, practical issues, and further contacts and resources), and (c) videos from a woman living with MBC and a health care provider. Links to optional online resources will also be provided. Participants in both groups will complete self-report measures of quality of life, distress, unmet needs and health service use, before they receive access to their program. They will then be followed up by researchers 6-weeks after receiving access to their program, and asked to complete the same online questionnaire assessing quality of life, distress, and health service use. Participants will be asked to complete these same research surveys 3 and 6 months later. It is hoped that this research will demonstrate that the Finding My Way-Advanced program improves quality of life, distress and health service use in women with MBC.

Nuclear medicine myocardial perfusion imaging is currently indicated in patients with symptoms of cardiac ischaemia, who have either failed a stress echocardiogram, are unable to exercise to the extent required to provide an adequate stress echocardiogram or have a body habitus or other physical condition that would prevent an adequate stress echocardiogram. A nuclear medicine myocardial perfusion scan consists of an intravenously administered radioisotope, which can then be assessed with either single photon emission computer tomography (SPECT) or positron emission tomography (PET). This allows the assessment of the underlying myocardium and the underlying coronary arteries. More recently coronary artery calcium (CAC) scoring has been developed to assess patients without known coronary artery disease who present with symptoms of acute ischaemia and are of low or intermediate risk, without electrocardiograph changes or elevation in cardiac biomarkers. As both investigations utilise computed tomography (CT), our aim is to assess the value of coronary artery calcium scoring on nuclear medicine myocardial perfusion scans, in order to improve the diagnosis and outcomes in patients with low to intermediate risk cardiac ischaemia. Currently there is no research available on the utility of coronary artery calcium scoring in myocardial perfusion scans. The investigators aim to show a correlation of the coronary artery calcium score between the computed tomography conducted for myocardial perfusion imaging and dedicated computed tomography imaging. This will then allow the assessment of the coronary artery calcium score retrospectively in participants who underwent myocardial perfusion imaging to assess the change in predefined outcomes when utilising the additional measure.

Critically ill patients are often unconscious and require airway support via a mechanical ventilator. This renders them able to eat, with nutrition most commonly provided by a gastric feeding tube (termed enteral nutrition [EN]) in the Intensive Care Unit (ICU). EN feeding interruptions are common in the ICU and may significantly impact nutrition delivery, with approximately 50-60% of energy and protein targets delivered in practice. Reasons for EN feeding interruptions are varied and may include fasting for airway procedures, including tracheal extubation (i.e. removal of the breathing tube used for ventilation). There is limited contemporary information on reasons for EN feeding interruptions in Australian ICUs, including the number of hours fasted prior to tracheal extubation. We are conducting an observational study (NUTRIENT-Fasting) using a pre-existing dataset from NUTRIENT (Nutrition practice in critically ill adults – an observational study; ACTRN12620001025921) to assist to better understand the current reasons for EN interruptions over the first seven days of ICU admission in critically ill patients that received mechanical ventilation and EN across 35 of the Australian ICU sites included in NUTRIENT.

The study hypothesis is that migraines are caused by the constriction of small blood vessels (capillaries) in the brain and that the use of natural, vessel-widening supplements will cause these small blood vessels to dilate and therefore reduce the frequency and severity of migraines. The aim of this study is to investigate whether oral treatment with L-arginine and/or aged garlic extract prevents/decreases migraines in Australian adults. The trial is specifically designed to provide evidence that treatment with these nutraceuticals dilates the small vessels of the brain, thereby improving blood flow and preventing the onset of migraines. This is a double-blind trial, meaning the participant and investigator will not be aware which group the participant has been randomised to. Approximately 240 men and women who have been diagnosed with migraines, will receive 1500 mg/day L-arginine and/or 1000 mg/day aged garlic extract and/or placebo for 14 weeks. Each participant will be required to take 5 capsules a day over the 14 weeks, and will be asked to monitor their migraine frequency and severity. At visit 1, participants will complete a series of daily diaries and questionnaires that will capture information about their pain experience, light-sensitivity and quality of life. We also complete anthropometric measurements. Participants will also receive a 2-week supply of study capsules and two weeks of migraine diaries to be completed daily. At visit 2 (2 weeks after visit 1), participants will provide a blood sample, complete a light-sensitivity test, and an OCTA (optical coherence tomography angiography) scan. Participants will then receive a 12-week supply of the study capsules and migraine diaries to be completed daily. At visit 3 (12 weeks after visit 2), participants will recomplete the questionnaires from visit 1, and will recomplete the measures from visit 2, After the 14 weeks (visits 1-3), we will compare each participant’s baseline (visits 1 & 2) and post-intervention (visit 3) results to examine the impact of L-arginine and aged garlic extract on migraine symptoms, and whether this corresponds with dilation of the small cerebral blood vessels.

Peripheral artery disease (PAD) involves blockages in the leg arteries, leading to exertional lower-limb pain and reduced physical capacity and quality of life. This research aims to improve the management of PAD through investigating the effectiveness of a holistic management program (PAD-medical) in improving PAD management, assessed through a new validated scoring system. Participants in this research will be Australian adults aged at least 18 with diagnosed PAD and have sub-optimal management of their PAD as indicated by a PAD-medical score of less than the maximum of 6. This research is a 2-year prospective, randomized, multicenter trial which will assign participants to the PAD-medical program, or usual care by their general practitioner and vascular surgeon. The PAD-medical program will run for the first 6 months and include: risk factor monitoring, optimisation of risk factors for PAD through medical management (prescribed medications and smoking cessation), an exercise program, and smoking cessation support. This program will be delivered entirely through telehealth. It is expected that this program will improve the management of PAD in participants assigned to the PAD-medical program, assessed through an improvement in their PAD-medical score. The final follow-up phone call for all participants will occur at 2 years after randomisation.

In Australia, 2.8% of children are diagnosed on the autism spectrum. Autism Spectrum Disorder is a lifelong neurodevelopmental condition which impacts social communication and is often characterised by restricted / repetitive behaviours. Additionally, 88% of autistic people are also reported as having additional co-occurring disabilities. For up to 70% of children and adolescents on the autism spectrum this can include mental health conditions including anxiety and depression. In addition to the impact of Autism, the mental health conditions they suffer from are of at least the same severity as that of their disability. However, unlike Autism, mental health conditions are reversible and preventable. While approximately half of autistic adolescents also have an Intellectual Disability, there is very little research or evidence-based programs aimed at this vulnerable population that aim to promote mental health, emotional development and social skills. For autistic adolescents with co-occurring ID there is no targeted intervention supporting the development of emotion-based skills. Previous implementation research on the Westmead Feeling Program, developed and researched by psychologists at the Children’s Hospital at Westmead, has established the effectiveness of emotion-based learning for primary school-aged children on the autism spectrum, with and without an intellectual disability, and adolescents without an intellectual disability, both in school and clinical settings, in improving emotional competence and reducing symptoms of mental disorder. Recently the Westmead Feeling Program authors conducted a pilot study to investigate the feasibility and experience of an adolescent adaptation of the Westmead Feelings Program, called The Feelings Program Adolescent Version (TFP-A; HREC/17/SCHN/386). The small pilot study found that adolescent participants, their parents and teachers all found the program, when delivered by the researchers, to be feasible and enjoyable. These positive results provide support for further research to investigate the impact of the intervention. In this study we aim to further address the current research gap in intervention by implementing a larger trial of the adapted program for autistic adolescents with mild ID, to be delivered in an Aspect school-based setting, delivered by teachers and psychologists. This study aims to assess the feasibility and efficacy of TFP-A that will inform a large scale evaluation of the program. This study aim to exploring the impact of the intervention on emotional competence, problem behaviours, and mental health. TFP-A involves adolescent participants attending intervention sessions held across a school year and a 1 hour booster session six months later. Parents are also invited to attend group emotion coaching sessions and access online content . Questionnaires and assessments completed by adolescents, their parents and teachers will provide data on outcomes.

Schwartz Rounds are a unique, organisation-wide interdisciplinary intervention aimed at enhancing staff wellbeing, compassionate care, teamwork, and organisational culture in healthcare settings. They provide a safe space wherein both clinical and non-clinical health staff can connect and share their experiences about the social and emotional aspects of health care. Although Schwartz Rounds have been assessed and widely implemented in the United States and United Kingdom, they are yet to be formally evaluated Australian healthcare settings. The purpose of this study is to evaluate the feasibility and impact of Schwartz Rounds on staff wellbeing, compassionate care and organisational culture, in a tertiary metropolitan hospital in Brisbane, Australia. Methods and Analysis This mixed methods repeated measures pilot study will recruit 24 participants in two groups from two departments, the Intensive Care Unit (ICU) and the gastroenterology department. Participants from each group will take part in three unit-based Schwartz Rounds. Primary outcomes will include the study and intervention feasibility measures while secondary outcomes will include Maslach Burnout inventory, the Schwartz Centre Compassionate Care Scale, and Culture of Care Barometer. Primary and secondary outcomes will be collected at baseline, post-round, and three-month follow-up. Two focus-groups will be held approximately two months after completion of the Schwartz Rounds. Descriptive statistics, t-tests, chi-square tests, and analysis of variance (ANOVA) will be used to compare quantitative data across time points and groups. Qualitative data from focus groups and free-text survey questions will be analysed using an inductive thematic analysis approach. This study was approved by the Mater Misericordiae Ltd. Human Research Ethics Committee (HREC), reference number: HREC/MML/71868, and the Griffith University HREC, reference number: 2021/025.

Children with critical illnesses are at high risk (> 20%) of developing seizures and brain injury. Each year, over 10,000 children in Australasia require paediatric critical care unit (PICU) admission. Significant advances in PICU mean more severely ill and injured children now survive, and subsequently go home to the community. However, these children remain at high risk of seizure. Therefore, it is essential that continuous improvements are made that address survivorship and morbidity, especially recognition of patients at risk and preventing further brain injury by monitoring appropriately to save brain function. The measuring of brain activity (electroencephalography/EEG) is the only available form of monitoring brain currents in patients with suspected seizures. Seizures are often invisible otherwise, as children often show no visible signs. Despite improvements in the field, recognising these seizures at the bedside in a timely way is not possible for the treating team. This can have serious effects (high risk of brain dysfunction), and potentially add to long term poor outcome or even death. We will perform a worldwide first cohort study to show that EEG monitoring using automated seizure detection software can lead to accurate and timely seizure detections by bedside clinicians..

The ReActiv8 Observational Registry is a multi-center, data collection registry in patients who are being considered for a ReActiv8 implant. At the time of implant, patients must meet the indications and not be contraindicated for ReActiv8. If it is determined that a patient will not be implanted, the patient will be exited from the Registry. Implanted patients will be followed for two years post-activation, at which point they will be exited from the Registry. The ReActiv8 device is approved by the TGA for use in Australia for the indications above and its implantation in participating centres is standard of care.

This study will explore the perspectives of patients with a chronic disease on the COVID-19 vaccination. Who is this study for? You may be eligible to take part if you meet all of the following criteria: • Aged 18 and above • Diagnosed with any of the following chronic diseases: a) cancer; b) diabetes and; c) multiple sclerosis • Receiving care or services for the chronic disease from one of the participating health services. Note: Some health services are only conducting the survey for one of the chronic diseases, please speak with your healthcare team for more information. Study details Participants in this study will be invited to complete a short anonymous online survey. The survey asks participants about their views towards the COVID-19 vaccination and how their chronic illness diagnosis may be affect these views. Participants will also be asked about basic non-identifiable information such as age, gender and chronic disease diagnosis. Upon survey completion, participants can register their interest to be randomly selected for a one-on-one interview. The interview will explore the views towards the COVID-19 vaccination in more detail, including where participants have received information about the COVID-19 vaccination. The data collected from the surveys and interview will provide knowledge of COVID-19 vaccine perspectives in Australian patients diagnosed with a chronic disease. The findings can help health services better understand how to support patients better with various COVID-19 vaccination needs.