ANZCTR search results

Purpose: The primary purpose of this study is to establish the electronic Prostate Cancer Australian database (ePAD), a national, multi-site, prospective cohort study. The data collected will be used to evaluate real-world patterns of care for Australians with hormone-sensitive prostate cancer (HSPC) and castration-resistant prostate cancer (CRPC), and to identify factors that may influence treatment decisions and outcomes. Who is it for? Patients will be 'recruited' at participating sites; these sites will submit an ethics application to enable them to collect patient data from routine clinical practice. This is a non-interventional study and purely data collection at the approved site/hospital. Study details: Data will be collected at baseline and updated at subsequent clinic visits. Information captured includes patient demographics, clinical and pathological characteristics at diagnosis, local treatments, use of androgen deprivation therapy, diagnosis of CRPC, systemic therapy use and effectiveness, survival outcomes, and the rationale for treatment selection or change. Factors such as comorbidities, disease burden, prior treatment responses, drug-specific considerations, and patient preference will also be recorded. Follow-up data will continue to be collected beyond the initial enrolment period to provide long-term insights into treatment patterns and outcomes. It is anticipated that findings from this study will improve understanding of how prostate cancer is managed in real-world clinical practice across oncology, urology, and radiation oncology. The results may also contribute to determining the optimal sequencing of systemic therapies and help guide more personalised treatment decisions for men with prostate cancer.

The purpose of this study is to determine the effectiveness of incorporating short sprints into current clinical practice guidelines for improving blood glucose management during exercise in individuals with Type 1 Diabetes. We hypothesize that incorporating shorts sprints into any sustained period of physical activity will reduce the incidence of exercise-mediated hypoglycaemia in individuals with Type 1 Diabetes in a free-living setting.

The primary objective was to determine the benefits of a pre-surgical exercise programme for rectal cancer patients scheduled for rectal resection. It was hypothesised that: i) between baseline and pre-surgery patients would demonstrate – higher physical functional performance, maintain higher levels of muscle strength and endurance, ii) during the weeks following surgery patients would demonstrate – reduced physical functional performance, reduced muscular strength and endurance iii) between baseline and post-surgery, patients would demonstrate – improved recovery with a higher physical functional performance, maintain higher muscular strength and endurance.

The primary purpose of this trial is to examine the detection rate of lesions using narrow band imaging (NBI bronchoscopy) with a computed tomography (CT) scan, in comparison to the standard white light bronchoscopy in head and neck cancer patients who completed treatment 3-5 years previously. Who is it for? You may be eligible to participate in this trial if you are aged 18 or over and have completed curative treatment for a head or neck cancer in the previous 3-5 years. Study details All participants will receive a bronchoscopy, CT scan of chest and spirometry . Bronchoscopy is a procedure done under a light sedative where we look at the bronchial tubes as well as the upper airway and voice box. In this we can use a normal "white" light as well as a "blue" light. The Blue light potentially helps to find the earliest changes in the upper airway and bronchial tubes. Where it looks abnormal we take a small sample, a biopsy. Any biopsied tissue will then be analysed in a laboratory to examine whether it contains abnormal/cancerous tissue. Researchers will compare the rate of lesion detection using both types of imaging.Also each patient will have a CT (CAT) scan of the chest in the Radiology (Xray) department to look for any supsicious areas there, as is usually done by ENT surgeons at this timepoint. We will use a computer to assist in the interpretation of the CT scan. All patients will have a simple breathing test (Spirometry) in the Lung function ldepartment which requires 2 or 3 deep breaths into a tube to record the lung capacity. This will give us information about the way lung capacity may be related to the risk of developing small additional cancers. It is hoped that the findings from this trial will provide information on whether NBI bronchoscopy may be beneficial in the detection of airway lesions in previous head and neck cancer patients, in whom these tumours are relatively common.

Social anxiety disorder (SAD) is a common and debilitating mental illness, with sufferers frequently experiencing chronic anxiety in anticipation of, and during and following exposure to, social situations. Currently, group cognitive therapy is efficiacious for SAD, but some 80% fail to achieve normative functioning. The current project will investigate the utility of a novel treatment approach for SAD, namely imagery-enhanced cognitive behavioural group therapy (IE-CBGT). In this approach, imagery-based techniques are used to enhance existing evidence-based techniques within a 12-session treatment package. In this trial participants will be randomised to one of two conditions: i) IE-CBGT, or ii) a ‘gold-standard’ treatment, verbally-based CBGT (VB-CBGT, which relies on identifying and challenging anxiety-provoking beliefs predominantly within the verbal cognitive mode). A minimum of ninety-six individuals with SAD will be recruited through established referral pathways to the Centre for Clinical Interventions (CCI) from general practitioners, psychiatrists and psychologists and randomised into one of the two treatment groups. Between 6-12 patients will be admitted per group. The objectives of the project are threefold: i) to compare outcomes of IE-CBGT and current gold-standard VB-CBGT for SAD, across cognitive, behavioural, psychophysiological and emotional measures (i.e., questionnaires, behavioural tasks and physiological monitoring), ii) to evaluate unique and common mechanisms of change across the two treatments to inform theory and future treatment innovations, and iii) to compare the cost-effectiveness of the treatments to ensure that IE-CBGT has broader cost benefits in a health sector with limited resources and increasing demand. A standard battery of self-report questionnaires will be administered at baseline, and prior to each treatment session in line with current practice at CCI. Additional self-report questionnaires will be administered following sessions 4 and 8 and after the final treatment session. A routine CCI (group) follow-up appointment will be made 1-month after treatment completion with the treating psychologist. An additional individual assessment appointment will be made 1-month after treatment completion so that a diagnostic interview and self-report questionnaires can be administered. Another follow-up appointment will be made 6 months after treatment, allowing for fine-grained assessment of mechanisms of change to be assessed. Psychophysiological responses will be recorded during a social stress task at baseline and upon completion of the treatment sessions (at the individual assessment 1-month follow-up).

The primary aim of this study is to determine whether short activity breaks incorporating upright simple resistance activities can improve blood vessel (endothelial) function compared to 5 hours of prolonged, uninterrupted sitting. Secondary outcome measures will also provide information on the potential signalling pathways (insulin and SNS-mediated vasoconstriction pathways) that are contributing to the decline in vascular function with prolonged sitting. For this, we propose to undertake a randomised crossover trial in twenty five inactive and injury-free overweight/obese adults aged between 35-75 years. This study will involve two acute experimental conditions (each of 6 hours duration), separated by a minimum 5-day washout period to account for any residual physiological effects of the intervention. Each participant will complete two conditions, involving (i)Uninterrupted Sitting - 5 hours of prolonged sitting; and (ii) Simple Resistance Exercises + Interrupted Sitting: 5 hours of sitting with 3 minutes of simple resistance activity breaks every 30 minutes. Standardised breakfast will be provided for the test. Lunch and dinner will also be provided following each condition. Vascular function will be directly measured using Flow Mediated Dilation (FMD). FMD is a widely-used non-invasive method to describe endothelial function and vasodilation of an artery following ischaemia. Venous blood samples will be collected every 30 minutes and blood markers of endothelial function will also be measured, including nitric oxide and endothelin-1 production. Changes in Sympathetic Nervous System (SNS) activity may help to explain any differences in FMD over the day and between conditions. SNS activity will be indirectly measured via catecholamine levels in the blood; and directly measured using microneurography, where a microelectrode will be inserted under the skin to sit on top of the peroneal nerve (behind the knee) and record electrical activity. The SNS also helps to mediate the baroreflex, which regulates acute blood pressure changes by controlling heart rate, contractility and peripheral artery resistance. Spontaneous baroreflex responses will be assessed using ECG and a beat-to-beat finger BP cuff. Plasma markers of cardiovascular health and inflammation will also be measured. At the conclusion of each condition, participants will be fitted with both a 24 hour ambulatory blood pressure monitor (ABPM) and a continuous glucose monitoring system (CGMS).

Patients with diagnosed hypogonadism will be studied at baseline and then after 2 weeks of testosterone replacement initiation at usual therapeutic doses (10 g Testogel). The study will involve measurements of urea metabolism, and whole body protein breakdown and oxidation, and how much of the amino acids are being recycled for new protein synthesis.

A mental health disorder (MHD) affects how a person thinks, behaves and interacts with others. People diagnosed with MHDs have poorer health than the general population, which is concerning as MHDs affect approximately one in seven children/adolescents each year. Physical activity (PA) participation is fundamental to good health, with benefits including increases in strength, plus improved bone, heart and mental health. Developing good PA habits throughout childhood is important, as active children are more likely to become active adults. This project therefore aims to develop, implement and evaluate an exercise program designed to improve the PA levels of children with a MHD through developing their physical literacy. Physical literacy is a concept surrounding the motivation, confidence, physical ability, knowledge, and understanding required to value PA and take individual responsibility for PA throughout life. Physically literate individuals are more likely to be physically active because they enjoy movement, and have a positive attitude towards PA. Children diagnosed with a MHD often have many barriers to being physically active including poor movement skills, and low strength and fitness compared to their peers. These barriers can negatively impact PA therefore, improving a child’s physical literacy, may assist them in becoming more physically active, resulting in a positive effect on their overall health. This exercise intervention, will be implemented into the Pathways therapeutic day program, a specialist unit within the Child and Adolescent Mental Health Service (CAMHS). The Pathways day program is for primary school-aged students with anxiety, behavioural and mood MHDs. Children will be allocated to one of two groups; Group 1 will continue the normal Pathways program; and Group 2 will participate in a 10-week exercise intervention in addition to their normal Pathways program. The exercise intervention will include 20 group sessions, with a focus on physical competence, knowledge, understanding and motivation for PA. Family involvement will be encouraged through education sessions and ‘homework’ exercise sessions. The primary outcomes include PA levels and physical literacy (physical competence; motivation and confidence for PA; knowledge and understanding). Using a knowledge translation plan the outcomes of this research will be implemented into clinical practice across CAMHS. Project partners (patients/families, the public, clinicians, policy makers, mangers) will be engaged through all stages of the research process. The outcomes of this study will assist in improving the PA levels of children with MHDs.

This HAPPY Study aims to examine the relationship between physical activity and on-task behaviour in primary school students, and to understand the environmental and societal factors that encourage physical activity in primary school students. To do this, an intervention will be developed and implemented, to increase physical activity, and enhance the social support provided to student, encouraging them to be physically active in schools. This study will aim to address physical activity levels in students, behavioural and psychological well-being in students, and how effective the intervention used is. In order to demonstrate how increased physical activity during school time can lead to improved on-task behaviour in primary school students, a study is required that measures both physical activity levels in students, and their behaviour in classes following this physical activity. Physical activity data will be collected before, during, and after the intervention to measure the impact that environmental modifications, social support and teacher training has on physical activity levels. This data will be analysed in relation to behavioural and on-task behaviour, collected through a survey and direct observations in class time following breaks. Comparison of these data sets should allow for any trends between physical activity, and psychological well-being in students identified and explored. This study will provide unique insight in how schools might address the educative and public health nexus of physical activity is a cost effective and sustainable way. The study will measure the effectiveness of an intervention, it's efficacy and scalability.

High-intensity interval training (HIIT) characterises many team and field sports (eg. basketball and soccer) and spontaneous play in children. It involves alternating periods of high-intensity exercise and periods of recovery. Exercise-induced hypoglycaemia and increased glucose variability are barriers to exercise participation in many people with Type 1 diabetes (T1D). Trials of single-session HIIT generally show that blood glucose decreases to a smaller extent during HIIT compared to continuous aerobic exercise, suggesting that HIIT may be a preferred form of exercise for people with T1D. Overnight basal insulin reduction can reduce the risks of nocturnal hypoglycaemia following afternoon continuous moderate-intensity aerobic exercise in children with type 1 diabetes. Guideline recommendations for preventing post-exercise nocturnal hypoglycaemia after HIIT are generally based on those for continuous aerobic exercise, however it is unclear whether these two exercise types can be treated similarly. The effects of a basal insulin rate reduction to prevent nocturnal hypoglycaemia after HIIT has not been systematically studied. To our knowledge, this study will be the first study to investigate the effects of different dose-reductions in basal insulin to reduce the risks of overnight hypoglycaemia after high-intensity interval training in adults with type 1 diabetes, in comparison to non-exercising control day, and continuous moderate-intensity aerobic exercise. This will allow evidence-based recommendations to be developed to allow adults with type 1 diabetes to safely undertake HIIT exercise with reduced hypoglycaemia risk. Primary Objective: To determine appropriate dose-reduction in basal insulin to minimise overnight hypoglycaemia and hyperglycaemia following afternoon HIIT exercise Hypothesis: An evening basal insulin dose reduction of 20% will similarly minimise hypoglycaemia, and result in the greatest % of glucose in target 4-10mmol/L overnight, compared to 10% reduction and 30% reduction. Secondary Objective: To compare glucose response to single-session HIIT compared to single-session continuous moderate-intensity aerobic exercise. Hypothesis: HIIT with 20% basal dose reduction will be associated with a similar duration of overnight hypoglycaemia and glucose nadir compared with continuous moderate-intensity aerobic exercise of similar energy expenditure with 20% basal dose reduction.