ANZCTR search results

This study will investigate the safety of Complete Freund’s Adjuvant (CFA) in Patients with Refractory and Relapsed Solid Tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have a histologically or cytologically confirmed locally advanced or metastatic solid tumor (melanoma, head & neck, sarcoma, renal and other cancers) for which no curable therapy exists. Study details This study involves the use of an investigational drug called CFA. "Investigational" means that the drug has not yet been approved by the Therapeutic Goods Administration (TGA) for treatment of cancer. CFA consists of three ingredients: mineral oil, surfactant, and heat-killed mycobacterium. Injection of CFA into tumour creates a localised depot of killed bacteria, which are slowly released over weeks. This causes an influx of immune cells to the site on injection, and initiates a powerful immune response. The other drug (pembrolizumab) is an approved novel agent for the treatment of metastatic melanoma. Participants in the study will receive CFA in combination with pembrolizumab. CFA will be administered in 42 day cycles starting at a dose of 0.5 ml for the first cohort of three patients. These patients will be monitored closely and provided there are no safety concerns additional patients will be enrolled and treated with 1.0 ml of CFA and subsequently a third cohort will be enrolled with a starting dose of 2.0 ml of CFA. Once a participant experiences an adverse event as a result of the CFA dose, this dose level will be expanded with three additional patients enrolled. If two of the six participants experience a reaction the dose will be decreased to the previous level and three additional patients will be added. If one of the six patients experience a reaction that dose will be declared the maximum tolerated dose for CFA. Pembrolizumab will be administered following approved guidelines (2mg/kg) on day 2 of the first cycle and then every three weeks. Safety of CFA will be assessed at Day 1 of each 42 day cycle. Participants will be followed for up to 30 days after removal from treatment to determine therapeutic benefit and anti-tumour effect of CFA. Patients removed from treatment for unacceptable adverse events will be followed up until resolution or stabilization of the adverse event.

Most nurses work shifts, and those who work night shifts have poorer lifestyle behaviours than those who work day shift only, placing them at increased risk of cardiovascular disease (CVD) and diabetes. There is strong evidence to show that shift workers have a 40% higher risk of CVD than non-shift workers. Regular physical activity (PA) is associated with reduced risk of CVD and has been shown to improve vascular function. However, shift workers have less opportunity to participate in leisure time PA and have poorer health seeking behaviours than non-shift workers. This research will investigate the impact of physical activity (PA) on intermediary vascular function and CVD outcomes in nurses who work night or rotational shifts. This will be achieved by: (1) measuring current PA patterns and vascular function, and comparing these in nurses who work night or rotating shifts with those who only work day shift; (2) conducting a feasibility trial of a PA intervention program for nurses who work night/rotational shifts. We hypothesise that participants in the intervention group will have increased levels of PA, significantly greater improvements in vascular function, and reduced risk of CVD compared with those in the control group. Intervention and comparison groups: Nurses who work night/rotational shifts and who participate in less than 150 minutes of physical activity per week, will be invited to participate in the intervention. The 8-week intervention will comprise a one-on-one information session during which a research assistant will provide participants with feedback for their baseline results and set physical activity goals. The nurses will also receive an educational leaflet and self-monitoring device (Fitbit Flex) to track physical activity. The shift workers in the control group will also meet with the research assistant (exercise physiologist) to receive feedback on their baseline results and receive the educational leaflet. These participants will not receive the Fitbit flex to monitor physical activity, and will not receive any encouragement to change their physical activity behaviour. Outcome Measures: The main outcome measure is a change in vascular function (assessed using ultrasound) and physical activity (assesed using acelerometers). Secondary outcomes include change in sedentary behaviour, cardiovascular disease risk score and Body Mass Index. These measurements will take place at baseline (Phase 1) and then at 2 (vascular function only) and 8 weeks in the intervention group. The comparison group will have measurements performed at baseline and 8 weeks.

During or after a major operation (such as bones or joints operations, also known as orthopaedic operations), our body increases its heart rate as a response to the stress of the surgery. As the heart pumps faster to manage the stress, it can sometimes damage itself in the process. As previous study observed that up to 52% of patients undergoing major orthopaedic operations demonstrated some evidence of injury to the heart, and these patients have poorer clinical outcomes. This has led to previous studies examining the benefits of heart rate lowering agents to prevent damage to the heart after surgery, to improve clinical outcomes. Unfortunately, many heart rate lowering agents have a common side effect of lowering the blood pressure as well. Hence, whilst these trials demonstrated promising benefit in reducing damage to the heart, they caused significant problems with low blood pressure. Ivabradine is an agent that reduces heart rate, but does not drop blood pressure. It is currently approved for use in Australia for another condition called chronic heart failure. But given its unique properties, we postulate that it can reduce damage to the heart after a major operation as well, without the negative effect of causing low blood pressure. As a result, this trial was conceived to examine this effect.

Fasting plasma triglycerides are currently one of the most used measures to determine the risk of cardiovascular disease. However, we spend 18 hours or more of our day in the post absorptive state and elevated postprandial plasma triglyceride levels have also been linked with increased risk for atherosclerosis and consequently cardiovascular disease. Dietary choices have been demonstrated to modulate postprandial lipemia. Furthermore, manipulation of food structure and composition has the potential to increase or reduce postprandial triglycerides. Therefore, food choices are important targets in the improvement of postprandial lipemia. In this project we aim to determine the effect of three food products with different structures and similar nutrient composition on postprandial blood triglyceride levels. This is a pilot project for the development of a tool to measure the effect of different food products on postprandial lipemia. Healthy adults will be recruited from the community in Newcastle (NSW, Australia) and in Palmerston North (Manawatu, New Zealand). Following an overnight fast participants will attend our clinical facilities and have blood samples collected using finger prick; subjects will then consume a single high fat test meal. Blood samples will be collected again 30, 60, 120, 180, 240 and 360 minutes after meal consumption. After one week wash out, participants will attend our clinical facilities again and repeat the procedure following consumption of the alternative test meal. Blood samples will be assessed for glucose levels and lipid profile (triglyceride, total cholesterol, high density lipoprotein cholesterol and low density lipoprotein cholesterol) using a portable whole blood test system. Participants will also provide information on their medical history, physical activity, usual food consumption and eating attitudes at the start of the intervention.

Using a non-randomised design, this project will investigate the effectiveness of a universal, primary prevention program (WISE Teens) based on principles of the existing DBT STEPS-A Framework to promote greater social and emotional well-being amongst young people. Between four to six high schools from NSW will participate in the trial with each school providing a year group to complete the intervention, with another year group serving as the control condition (class as per usual). The primary aims of the current study are as follows: a) To examine the effectiveness of applying DBT principles within a universal, primary prevention approach to promote academic, social and emotional resilience in addition to greater quality of life and psychological well-being in Australian high school students. The study will also investigate the following secondary aims: a) Does level of program compliance (via completion of homework tasks and practice) affect social and emotional outcomes? b) Are the effects of the program mediated via increased levels of emotional awareness, more positive beliefs about emotions and reduced emotion dysregulation? c) Are the results of the program moderated by initial levels of clinical severity as determined at baseline? The following outcomes are hypothesised: a) The WISE Teens program will be effective in promoting more positive social and emotiona outcomes in addition to greater academic resilience compared with participation in PDHPE class as per usual. b) This effect is expected to be mediated by increased emotional awareness, more positive beliefs about the role of emotion and reduced emotion dysregulation. c) This effect is additionally expected to be moderated by clinical severity status, with those showing greater clinical severity of symptoms showing more marked improvements on social and emotional outcomes relative to those showing reduced clinical severity of symptoms.

The Victorian Liver Transplantation Unit at Austin Hospital is a collaborative service providing liver transplant services to residents in Victoria, Australia. Retrospective intra-operative data collection from our institution shows that 72% of patients undergoing liver transplantation are hypothermic prior to reperfusion of the donor liver, despite intense and standardised measures taken to maintain temperature homeostasis. This study is a prospective, single centre, blinded, randomised pilot trial to test the feasibility and efficacy of whether, in addition to the standard temperature measure undertaken to prevent intra-opeartive hypothermia, the additional use of the Fisher & Paykel Humigard (Registered Trademark) Open Surgery Humidification System will prevent hypothermia in adult patients undergoing orthotopic liver transplantation. Adult patients undergoing orthotopic liver transplantation will be included. The primary end point will be core temperature measured five minutes immediately prior to reperfusion of the donor liver.

Laparoscopic (‘keyhole’) surgery is used to perform many different types of gynaecological surgery. These include diagnosis of reasons why pregnancy has not been possible, diagnosis of abdominal pain, and treatment of endometriosis (which is painful, abnormal tissue in the abdomen (belly). It also includes procedures using a robot to aid surgery, and removal of organs or abnormal growths. There are several causes of pain after this sort of surgery. One cause of pain is local damage to the wall of the abdomen due to the tubes that run into the abdomen that make keyhole surgery possible. For a long time surgeons have used local anaesthetic in small amounts that is injected into the holes or ‘port sites’ where these tubes are inserted. More recently a different way of giving local anaesthetic has become popular. This is called the ‘TAP block’ which stands for “transversus abdominis plane” block. The name simply means that it is injected alongside the transversus muscle in the wall of the abdomen. Anaesthetists tend to use an ultrasound probe to take a picture and place this at the right depth, but for surgeons to place it laparoscopically while they operate is also a recognised technique. This study will investigate whether the infiltration method or TAP method of giving local anaesthetic is more effective by measuring pain on a scale of 1 to 10 just after surgery and 24 hours after surgery. The surgeon will be instructed to perform either the TAP block or infiltration based on the patient’s randomisation. The anaesthetist, recovery staff, and patient will be blinded, so unaware of what the patient has received. The surgeon, who is not blinded, will not be involved in any measurement of pain scores. Patients undergoing any type of gynaecological keyhole surgery will be accepted. TAP blocks have been looked at in many trials now. There are some aspects to this trial which would be novel in combination and would add to our knowledge base. The surgeon would be giving the block. This approach has been used relatively rarely. By doing away with the need to keep the patient asleep while the anaesthetic performs the block and gets set up with an ultrasound machine, the block can be performed with minimal delay to the list. This is a ‘real-world’ trial which compares two commonly-used techniques, rather than comparing TAP blocks to injection of saline, which means that a convincing result would guide the choice to use one or the other. This trial is not restricted to some subgroup of gynaecology patient; it would look at a cross-section of any day-case or inpatient laparoscopic gynaecology population.

The transition of patients with chronic and complex conditions from hospital back into the community setting is a critical time with an increased risk of medication misadventure and re-hospitalisation. AIM: The aim of this study is to investigate whether a model of structured GP and pharmacist care reduces unplanned hospital readmissions in patients taking multiple medicines. METHOD: This study will include 2240 people who have been discharged from hospital taking 5 or more medicines and attend an enrolled medical centre. Participants will be recruited at discharge from hospital and the intervention will be in 14 different medical centres across South East Queensland. Depending on when the participant is discharged, they will be placed in the control or intervention phase. Participants in the control phase will receive usual care from their medical centre. This means the patient would consult their GP as per normal standards for that practice for a patient discharged from hospital. Participants in the intervention phase will be followed up after discharge by a pharmacist working in the medical centre they attend. The practice pharmacist will organise a time for the participant to come into the medical centre and to discuss the changes made during their hospital stay and review the participant’s medicines. After a consultation with the pharmacist, the participant will have a consultation with their GP to receive any new scripts they may need and to consider any changes recommended by the hospital or pharmacist. The practice pharmacist will follow up with the participant within five days of the first consultation. The practice pharmacists may also contact other health professionals involved in the participant's care as required. It is hoped that a pharmacist and GP reviewing a patient’s medicines and changes made during hospital will reduce the likelihood of the patient being readmitted to hospital.

MindExpressTM - the skills to build resilience - is an online risk-factor based tailored depression prevention and mentoring App targeting young people aged 16 to 25 years at elevated risk for mood disorders. The App delivery of MindExpressTM with tailoring to personal circumstances is an innovative approach to depression prevention, resilience-building and reduction of chronicity of mood disorders in youth. MindExpressTM was developed at the University of New South Wales in 2011-2013, funded by a beyondblue National Priority Driven Research Program grant. Custom web functions and design relevant to youth culture were developed through focus group consultations with the target demographic. A feasibility pilot study was completed in 2013 involving 30 participants aged 18 to 25 years. The feasibility study found MindExpressTM to be acceptable, useful and helpful to young people and indicated that it may be possible to reduce depression symptomatology by modifying risk factors through best practice cognitive and behavioural change. The results indicated a positive effect on coping skills with a substantial effect size and improvement in depression scores. The tailored design enables individuals to identify personal risk and protective factors and provides support and feedback to implement cognitive and behavioural changes in real life. MindExpressTM is intended as an adjunct to usual care and enables users to be linked dynamically to their support networks such as their support worker, mentor, carer or GP. If proven scientifically valid by the RCT, MindExpressTM can be translated as a primary prevention App for adolescents and young adults at risk for mood disorders.

Research has highlighted the high level of burden and distress experienced by individuals caring for a family member with an eating disorder (Treasure, 2008). The present study aims to evaluate a brief, two-session group psychoeducation and skills-based intervention for the carers of individuals with an eating disorder. This intervention aims to reduce carers’ distress levels whilst reducing their perceived burden of care, accommodating and enabling behaviours and level of expressed emotion and improving their knowledge of eating disorders and coping self-efficacy. The associated costs of caring for an individual with an eating disorder highlight the need for interventions to be both time efficient and cost effective (Highet, Thomson, & King, 2005). The brief and manualised nature of the proposed intervention makes it highly feasible and easy to disseminate, maximising access to necessary information and training. Criteria for inclusion in the study will be: a) aged over 18 years; b) able to read and speak English fluently; c) currently caring for an individual with a diagnosed eating disorder (for the purpose of this project, carer is defined as a parent, sibling, friend, or partner). Participants will be recruited directly through the Centre for Clinical Interventions and via interest groups (e.g., Butterfly Foundation) and media advertising (e.g., Curtin fm, social media). This evaluation will be run as a randomised controlled trial (RCT) comparing the intervention to waitlist controls. Participants allocated to the waitlist control group will still receive the intervention within 2 months of agreeing to participate in the project. Running this evaluation as an RCT, as opposed to a single group pre-post evaluation, will allow us to determine the efficacy of the intervention without the potential confounds associated with the passage of time. Each participant will attend two, 150-minute group sessions spaced one week apart. The outcome variables of the study will be: depression/anxiety symptoms, self-efficacy, perceived burden of care, accommodating and enabling behaviours, level of expressed emotion, knowledge of eating disorders, interpersonal caregiver skills. The study will also measure changes in the carers’ interpersonal skills as perceived by the individual with the eating disorder.