ANZCTR search results

This study aims to evaluate the accuracy of an imaging technique called contrast enhanced spectral mammography (CESM) for assessing the extent of Ductal Carcinoma in Situ (DCIS). Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with ductal carcinoma in situ (DCIS), a non-invasive form of breast cancer where abnormal cells are contained within the milk ducts, on core biopsy, for which you are undergoing pre-surgical assessment at Royal Perth Hospital in Western Australia. Study details All participants in this study will undergo contrast enhanced spectral mammography (CESM) in addition to standard imaging and histopathology. CESM is a special type of mammogram performed after injection of intravenous x-ray dye (contrast). The CESM images will be independently read by two radiologists, and compared to standard imaging. If there are additional findings on the CESM images, these may be used to change subsequent surgical treatment. All participants will be followed up 12 months following their treatment as per standard of care for patients who have had breast conserving surgery. Cost effectiveness of the addition of CESM to standard imaging will also be evaluated. It is hoped that CESM will be more accurate than standard imaging at demonstrating the extent of DCIS – this may improve surgical planning and reduce the need for re-excision.

This study will determine whether a new relatively non-invasive glucose monitoring system (Flash Libre) helps adults with diabetes who have a severe glucose reaction to avoid further such episodes. The hypothesis is that the non-invasive system will be superior to usual care in preventing both severe and non-severe hypoglycaemia after the index severe hypoglcyaemic event.

To use continuous glucose monitoring (CGM) to profile the glycemic impact of commonly prescribed GC regimens.

Endobronchial ultrasound (EBUS) is a procedure performed to extract tissue from the lung to aid diagnosis of lung cancer, infections and sarcoidosis. To tolerate this procedure, which involves a camera on a tube being inserted into the lung, patients require sedation. The sedative medications commonly cause patients to hypoventilate, and a reduction in oxygen saturation and increase in carbon dioxide level is commonly seen, necessitating the interruption of the procedure, and occasionally putting patient’s lives at risk. An intervention to reduce the rates of these problems may make the procedure safer. The OptiFlow THRIVE device delivers high flow oxygen via the nose, and may reduce the rate of desaturation and limit the rate of increase in CO2 level. The device has been trialed in anaesthesia in morbid obesity surgery, difficult airways in ENT and during awake fibreoptic intubation, which is a conceptually similar procedure to EBUS. The device has been used safely for many years to assist intubation in the emergency department and intensive care unit. There is no data currently using the device during EUBS, or any endoscopic procedure for that matter. This study will randomize participants to either oxygen therapy during sedation with standard care (being a gutter mask) or OptiFlow THRIVE. The research question is: In adults undergoing endobronchial ultrasound, does oxygen therapy provided using the OptiFlow THRIVE device reduce the frequency of desaturation and hypercarbia compared to standard oxygen therapy using a gutter mask?

The main purpose of this study is to assess whether MRI (including MRI with contrast) and PET can predict response to treatment in patients with locally advanced rectal cancer. 'Who is it for?' You may be eligible to join this study if you have been diagnosed with rectal cancer and are undergoing treatment consisting of chemoradiotherapy followed by surgery. 'Study details' Participants will have standard treatment, consisting of neoadjuvant chemoradiotherapy followed by surgery. There will be no change to treatment by participating in this study. Patients participating in this study will have multi-parametric MRI (diffusion weighted imaging (DWI) and dynamic contrast enhanced (DCE)) and PET/CT at the following 3 time-points: 1. Prior to chemoradiotherapy 2. During the third week of chemoradiotherapy and 3. Post chemoradiotherapy, within 1 week prior to surgery. Patients will be followed up for 2 years. Correlations between MRI and PET biomarkers with tumour response and survival outcomes will determine whether multi-parametric MRI and PET can predict treatment response.

The SupportME is a pragmatic, multicentre, single-blinded, parallel-group, randomised controlled trial to determine the effect of mobile phone text messaging intervention on blood pressure for patients with diabetes and cardiovascular diseases. This study was funded by NSW Translational Research Grant. It aims to recruit 1000 patients with coronary heart diseases and/or type 2 diabetes. Patients will be randomised to text messaging intervention or standard-of-care. The primary outcome is the difference between groups in systolic blood pressure at 6 months.

Aim and hypothesis: This project aims to support the principles and aims of the Olympic Charter by developing and testing a preventative motivation theory informed and evidence-based intervention. Methods: The intervention will deliver anti-doping education and psychological training to support coaches’ in communicating with athletes in a needs supportive manner. The intervention will be compared against ‘usual practice’ (i.e., education programs run by National Anti-Doping Organizations). This is a multi-centre research project with sites in Western Australia, the UK, and Greece. The project is a cluster randomised control trial (2 arms; total across 3 countries: 60 coaches and 600 athletes in each arm). Athletes will be asked to complete a questionnaire package of psychological measures. The constructs of the questionnaire will include rating their willingness to take prohibited performance enhancing substances, their anti-doping attitudes, efficacy to resist doping-related temptations, and perceptions of coach behaviours. Similarly coaches will be asked to complete a separate package of psychological constructs and measures. The measures will ask coaches to rate their efficacy to foster anti-doping attitudes and deliver anti-doping information, and their efficacy to confront athletes about doping. Data collection and analysis: Baseline data (0 week) (video-recording of coaches, athlete/coach questionnaire packages) will be collected prior to the first workshop (control/intervention). Questionnaire packages will be repeated at the end of the intervention (12 week) and again at a follow-up (20 week). Interviews with coaches in the intervention arm will take place after the second workshop. We will use advanced statistical analysis (multilevel growth models) to account for both the longitudinal and nested (athletes within coaches) nature of the data. We will implement: 1) a process evaluation of the intervention, via coach interviews, coach questionnaires on ease and usefulness of the training material, and 2) fidelity to the protocol assessments, via coach observations, and 3) we will analyse the data and disseminate the results of the intervention via coach information sessions, printed material, policy briefings, media interviews, and social media engagement.

Obsessive-compulsive disorder (OCD) is a severe mental illness that can dramatically reduce quality of life. Despite use of best practise clinical management, many patients continue to experience symptoms and associated disability. Recent neuroimaging studies have shown that OCD is characterised by significant, yet specific, changes in the activity of macroscopic brain networks comprising of frontal and subcortical brain regions. Parallel to these developments, non-invasive brain stimulation techniques such as transcranial magnetic stimulation (TMS) have emerged as viable tools to modulate the activity of brain networks in both healthy and pathological populations. TMS has an established clinical role in the treatment of major depressive disorder. This project aims to assess the possible use of local TMS to selectively restore altered brain network activity and improve symptoms in people with OCD. To achieve this goal outpatient with OCD will be asked to undertake functional magnetic resonance imaging (fMRI) before and after a TMS intervention. If successful, the proposed project will represent the first demonstration that TMS can be used to selectively restore the altered function of widespread neural networks and improve symptoms in people diagnosed with OCD. Such an outcome will be instrumental to motivate larger clinical trials to test the efficiency of TMS as a treatment, or complementary treatment, for OCD.

The Unified Protocol for Adolescents (UP-A) is a transdiagnostic intervention for the treatment of anxiety and/or depressive disorders. The aim is to examine possible mechanisms by which the intervention produces change in participants (12-18 year olds with a primary anxiety or depressive diagnosis). 6-8 participants will be recruited and treated using the UP-A. Hypothesised mechanisms of change (e.g., improved emotion regulation) will be measured from session to session for each adolescent. Expected outcomes include: symptom reductions in participants and information about which treatment targets are associated with symptom reduction (i.e., mechanisms by which the intervention is working).

The Shake-a-Leg (SAL) health promotion program was developed by Hunter New England (HNE) Aboriginal Health Unit and has been implemented in primary schools across the Hunter New England Local Health District (HNELHD) over the last ten years. Shake-a-Leg has been developed as a culturally appropriate program for Aboriginal students and is delivered to whole classes, inclusive of both Aboriginal and non-Aboriginal students. The SAL program uses Aboriginal specific and mainstream materials and also features characteristics of effective school-based health promotion programs that are inclusive of being (1) Focused on health knowledge and health literacy competencies (2) Strategically planned to meet students’ developmental age, needs and local health issues, and (3) Informed by parents, community members and local health professionals. This proposed study aims to determine the effectiveness of the Shake-A-Leg program in improving health knowledge and behaviours in Aboriginal and Torres Strait Islander children attending government primary schools within the HNELHD. The primary outcomes are; change in knowledge and behaviours relating to nutrition and physical activity in Aboriginal students. The secondary outcomes include; increased self-efficacy as related to nutrition and physical activity, increased knowledge in oral health, alcohol and other drugs, identity, and bullying. Data from non-Aboriginal students will also be collected and analysed. This study will employ a cluster randomised controlled design. Eligible schools that agree to participate in the study will be randomly allocated to either an intervention or control group and stratified by school size and geographic location. The research will be conducted and reported in accordance with the requirements of the Consolidated Standards of Reporting Trials (CONSORT) Statement. All students both Aboriginal and non-Aboriginal in Years 5 and 6 attending schools allocated to the intervention group will receive the 6 week SAL program during school time. Outcome assessment via student surveys will be undertaken at baseline and post-intervention.