ANZCTR search results

This study will assess the effect of a trauma-informed cognitive rehabilitation program - Tri-eReCog - on the cognitive and distress symptoms in a group of cancer survivors. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have been diagnosed with non-central nervous system cancer, completed your primary treatment for cancer at least 6 months prior to enrolment (excluding ongoing hormone therapy), you feel that you have distress symptoms (either post-traumatic stress, depression and/or anxiety symptoms) and cognitive impairment (e.g., forgetfulness, inability to concentrate, trouble with multi-tasking), and you have no anticipated cancer treatments - apart from hormonal medications. Study details Participants who choose to enrol in this study will be randomly alloacated by chance (similar to flipping a coin) to either receive access to the Tri-eReCog online program, or join a waitlist to access the program after 6 weeks. Participants allocated to the Tri-eReCog program will be asked to complete 5 modules over 5 weeks (one module per week). It is expected that each module will take between 30-60 minutes to complete. Participants allocated to the waitlist group will not receive access to the program during the main study, but all participants will be asked to complete questionnaires before and after they interact with the Tri-eReCog program (or after 6 weeks have passed if in the waitlist group). It is hoped this research will demonstrate that use of the Tri-eReCog program leads to reductions in depression, anxiety and/or post-traumatic stress symptoms as well as reductions in self-reported cognitive impairment. If this study shows that Tri-eReCog is beneficial for cancer survivors, the program may be expanded to enable a greater number of cancer survivors to access the modules.

This study will assess the effect of a trauma-informed cognitive rehabilitation program - Tri-eReCog - on the cognitive and distress symptoms in a small group of cancer survivors. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have been diagnosed with non-central nervous system cancer, completed your primary treatment for cancer at least 6 months prior to enrolment (excluding ongoing hormone therapy), you feel that you have distress symptoms (either post-traumatic stress, depression and/or anxiety symptoms) and cognitive impairment (e.g., forgetfulness, inability to concentrate, trouble with multi-tasking), and you have no anticipated cancer treatments - apart from hormonal medications. Study details All participants who choose to enrol in this study will be given access to the Tri-eReCog online program. The Tri-eReCog program consists of 5 modules that participants will be asked to complete once per week for 5 weeks. It is expected that each module will take between 30-60 minutes to complete. Participants will also be asked to complete questionnaires before and after they interact with the Tri-eReCog program. It is hoped this research will demonstrate that use of the Tri-eReCog program leads to reductions in depression, anxiety and/or post-traumatic stress symptoms as well as reductions in self-reported cognitive impairment. If this small study shows that Tri-eReCog is beneficial for cancer survivors, a larger study involving more cancer survivors will be launched.

This study aims to establish a clinical registry, encompassing patient data from men with prostate cancer undergoing focal IRE. Who is it for? You may be eligible for this study if you are man aged between 40 and 85, with a diagnosis of Prostate cancer, clinical stage T1c or T2a. Study details The study visits will be 6 weeks following treatment, then three-monthly for 24 months following treatment, then six-monthly until five years following treatment. At these visits, various clinical assessment and blood tests will be performed. In addition, the study will also involve collecting data from multi-parametric-MRI scans, biopsies and questionnaires relating to quality of life and functional outcomes, particularly in the domains of urinary, gastro-intestinal and sexual function. It is hoped that the registry can establish an evidence base for the national uptake of focal IRE, in addition to provider greater insight into the global body of data regarding primary focal therapy for PCa.

Chest binding uses compressive garments to flatten the chest and is common among transgender and gender diverse people. Health and community guidance advises against binding during exercise, but no physiological evidence supports this advice, and it may deter physical activity. This randomised, counterbalanced crossover trial tests whether wearing a chest binder changes maximal exercise performance in binder-naïve, recreationally active adults presumed female at birth. Each participant completes two testing sessions, with and without a binder, measuring maximal oxygen uptake (primary outcome), upper body strength, lung function, range of motion and perceived exertion, breathlessness and comfort. The results will inform evidence-based guidance on exercising while binding and help remove an unfounded barrier to physical activity.

Background: High blood pressure (hypertension) is very common, and is a major cause of human disease and death. In particular high blood pressure is a major cause of heart disease, kidney disease and stroke. The body's control of blood pressure is very complex. The kidney, the blood vessels, the heart and a number of hormones are known to be involved in blood pressure control. Recently, there has been speculation about a possible role for bacteria within the large bowel (colon) in the control of blood pressure. Specifically, short-chain fatty acids ( acetate, butyrate, priopionate) produced by colonic bacteria are theorised to have a possible role in BP control. This experiment: We will study 30 healthy adults under the age of 40. Each participant will take part for two weeks. Each research participant will consume 20mL twice per day of a sugary liquid - either glucose or lactulose syrup for the first week. The participant will then swap to consume the other syrup for the second week. This is called a cross-over design study. At three times during the study, each participant will be weighed, and will undergo a 24 hour blood pressure monitor and will also have blood drawn for measurement of substances relevant to the experiment, including acetate. This will be on days 0, 7 and 14 of the study. Statistical analysis: There are two end-points to be measured and analysed: acetate level in the blood, and blood pressure information. Specifically the following variables will be compared: 1. Serum acetate 2. Average systolic BP 3. Average diastolic BP. These will be compared for the three time points by a statistical test called ANOVA. We will analyse for differences in these data at the end of the lactulose week, and at the end of the glucose week. Potential significance: If the study does demonstrate elevation of acetate levels, and/or lowering of blood pressure then this may support the inclusion of larger amount of indigestible carbohydrate into the human diet.

High blood pressure (hypertension) is an enormous global public health problem. The complications of poorly controlled hypertension can include stroke, heart failure, myocardial infarction and renal failure. There is evidence that a diet high in indigestible dietary fibre helps to lower blood pressure. This effect may be because bacteria in the colon ferment the undigested fibre and produce short chain fatty acid byproducts such as acetate, proprionate and butyrate. In 2022 we conducted a randomised study and found that ingestion of lactulose (which reaches the colon undigested) lowered the blood pressure and raised plasma acetate. Next we would like to determine whether plasma acetate is the direct cause of this blood pressure lowering effect. This will be done by directly raising the acetate levels in the blood by asking participants to ingest vinegar tablets (acetic acid) or inert placebo tablets. Acetate is absorbed from the upper gastro-intestinal tract, so this intervention will raise the plasma acetate level without any involvement of the colon. After ingestion of the tablets, we will measure blood pressure in the participants.

This study aims to evaluate whether the Cognitive Orientation to daily Occupational Performance (CO-OP) approach can improve everyday functioning for people living with Parkinson's disease. Participants will be randomly allocated to either receive the CO-OP program immediately or after a waiting period. The program involves 10 weekly sessions in participant's home environment with an occupational therapist. Sessions will focus on helping participants develop strategies to achieve personally meaningful daily activities and goals. The study will examine whether the intervention can improve performance in daily activities, satisfaction with performance, goal attainment, quality of life, self-efficacy, and wellbeing. Findings will help determine whether the CO-OP approach is an effective rehabilitation intervention for people with Parkinson's disease.

Contemporary heat policies use mathematical modelling to predict the level of heat strain, and thus the risk of heat illness. Sports Medicine Australia (SMA 2021) and the American College of Sports Medicine (Roberts et al. 2023) are two common heat policies that are designed to provide a risk rating according to the prevailing environmental conditions for a broad range of sports. Each policy provides graded mitigation strategies that range from relatively small changes to practice (i.e. additional breaks or changes in work/rest ratios) through to event cancellation. However, sport specific modelling provides a potentially more specialised option to determine the level of risk for a chosen sport. This sport specific modelling uses a human heat balance approach to estimate the level of an exercising individual. The underlying principles and guide to undertake the modelling was published by Cramer and Jay in 2019. This has been completed by our research team for the sport of rowing. However, observations of the actual physiological response of individuals in real-world competition is needed in order to validate the estimated response from the modelling. No data exists which has observed the core temperature response of rowers during a regatta. To date, this has meant that the rowing-specific modelling cannot be validated, demonstrating the need to conduct a field observational study.

The primary aim of this RCT is to evaluate the effectiveness of the IBFF Onwards and Upwards youth mentoring program in improving psychosocial and developmental wellbeing among year 9 Queensland secondary state students. The secondary aims are to examine whether participation in the program is associated with improvements in (1) positive youth development, (2) mental wellbeing, and (3) health-related quality of life compared with students receiving a waitlist control condition. It is hypothesised that compared with students in the waitlist control group, students who participate in the IBFF Onwards and Upwards youth mentoring program will demonstrate: 1. Primary hypothesis: significantly greater improvements in psychosocial and developmental wellbeing from baseline (T1) to post-intervention (T2) as measured by validated wellbeing scales. 2. Secondary hypothesis: significantly greater improvements in positive youth development characteristics including competence, confidence, connection, character, and caring; mental wellbeing; and health-related quality of life. 3. It is further hypothesised that the IBFF Onwards and Upwards youth mentoring program will demonstrate positive social value through a social return on investment analysis and will be perceived positively by students and school stakeholders regarding feasibility, acceptability and perceived benefit. A further secondary objective is to monitor and describe adverse events, participant distress and other unintended effects associated with participation in the trial and assess whether the intervention is associated with any harms compared with the waitlist control condition.

The EASSI-PC study is a cluster-randomised, open-label, pragmatic, parallel-group trial conducted in general practices in Queensland, Victoria, New South Wales and South Australia. The study aims to assess whether implementing an integrated, multifaceted package of high-resource-intensive antimicrobial stewardship interventions (enhanced support arm) reduces antibiotic prescribing in general practice compared with a low-resource-intensive package (standard support arm). The standard support intervention consists of passive, self-directed access to antimicrobial stewardship strategies and resources via the EASSI-PC website, while the enhanced support package includes additional implementation strategies and support activities. The co-primary outcomes are practice-level prescribing rates of all oral antibiotics and rates of all Pharmaceutical Benefits Scheme-subsidised oral antibiotics dispensed. The scalability and sustainability of these improvements have the potential to embed antimicrobial stewardship into routine general practice, ultimately resulting in better health outcomes and reduced healthcare costs associated with less antibiotic resistance.