ANZCTR search results

Prostate cancer is the most common cancer in men, accounting for 25% of all cancer, with approximately 75% of those cancers arise posteriorly in the peripheral zone of the gland just adjacent to the rectum. Dose escalation in prostate cancer radiotherapy leads to improved tumor control rates however a dilemma arises in the balance between radiation dose and unacceptable rectal adverse effects (including diarrhoea and bleeding) which can complicate therapy in up to 20% of patients (due to the proximity of the prostate and the rectum). In some cases symptoms may evolve into a chronic course, negatively impacting on patients long term quality of life. Researchers have tried various technologies to protect rectal tissue when radiation is being delivered to the prostate. One such paradigm is the use of an inert protective synthetic hydrogel (made up of 90% water) called SpaceOAR, that is currently the only commercially available product for prostate-rectum separation. SpaceOAR is a transperineal inserted spacer (TIS) that is injected as a liquid into the anterior perirectal fat. When it solidifies, it forms a small protective barrier and space between the rectum and the prostate for the duration of radiotherapy treatment. Over a few months SpaceOAR dissolves and is absorbed by the body. A reasonable body of accumulated published literature has reported on the clinical utility of rectal spacers in phase II cohorts involving men undergoing external beam and brachytherapy to standard doses, with significant decrease in rectal toxicity. These results are echoed by the experience of Epworth Radiation Oncology, using conventional doses. The current trial is a prospective, non-randomized, single arm open-label study aimed at assessing the safety and efficacy of treating men with clinically localized prostate cancer to 82Gy using Intensity modulated Radiotherapy following the insertion of rectal SpaceOAR® hydrogel. The primary aims of this trial are to assess the inicidence of clinically notifiable toxicity and impact of health-related quality of life up to 36 months following radiotherapy.

We will evaluate the effects of a 10-week obesity prevention intervention Healthy Conversations @ Playgroup, to promote healthy lifestyle behaviours (dietary intake, physical activity, screen time and sleep) and support autonomy supportive parenting practices related to the four obesity risk behaviours in young children attending community playgroups. It is expected that children randomized to the Healthy Conversations intervention playgroups will show significantly better diet quality, physical activity, screen time, and sleep behaviours immediately after the intervention at 10 weeks and at 6-months follow-up, and significantly lower BMI z-scores at 6-months follow-up, than children randomized to the wait-listed control playgroups. Additionally, it is expected that parents of children randomized to the intervention playgroups will show significantly better parenting practices related to child obesity risk behaviours immediately after the intervention at 10 weeks and at 6-months follow-up, than children randomized to the wait-listed control playgroups .

This study aims to determine the effectiveness of a practice change intervention in increasing the provision of recommended gestational weight gain care by antenatal services. Relative to usual antenatal appointments, it is hypothesised that the intervention will achieve increases in the proportion of post intervention appointments in which gestational weight gain care is consistent with guideline recommendations: assessment (predicted 15% increase); brief advice (predicted 14% increase); referral (predicted 9% increase). The study will be conducted as a stepped-wedge controlled trial, with staggered implementation of the intervention across maternity services in three health sectors within Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidence-based, locally tailored practice change strategies including guidelines and procedures, system prompts, leadership support, training, and audit and feedback. The prevalence of woman-reported assessment, advice and referral for gestational weight gain will be the primary outcomes of interest. Cross-sectional measurement of outcomes will occur via telephone interviews with a random sample of women who attend the services each week. An intervention effect will be determined by an increase in recommended care delivery across the sites. Economic analyses will be undertaken to assess the cost, cost effectiveness and budget impact of the practice change intervention. Women’s weight gain during pregnancy, diet, physical activity and intervention acceptability will also be measured.

Testing the clinical performance of hs-cTn assays from different manufacturers in the assessment of acute myocardial infarction is crucial. The Siemen’s Atellica hs-cTn assay has previously been evaluated using only two patient cohorts, one in Scotland and one in the United States. Each of these evaluations tested a different strategy for ruling in and ruling out heart attack. As such, there is limited data available around how well this assay will be perform for a Queensland population of patients with suspected acute coronary syndrome. We propose an observational study to evaluate the performance of the Siemen's Atellica hs-cTn assay. To complete this research, two sources of data will be used. First, we will prospectively collect data from five Queensland Health sites. The data collected will include clinical data and a small amount of additional blood taken during the routine blood test. Second, we will use existing blood samples stored as part of a previous research project. The combined data will be used to identify the diagnostic accuracy of the Siemen's Atellica hs-cTnI assay for 30-day cardiac outcomes of AMI and cardiac death in patients presenting to emergency departments.. We hypothesise that this study will identify an appropriate low level cut-off value for safe rule out of AMI on index presentation specific for this assay.

Patients near the end of life may suffer from an array of distressing symptoms, including pain, nausea, agitation, confusion and distress. Many patients will be delirious, with up to 88% of palliative care inpatients suffering a terminal delirium. When patients are distressed at the end of life, and other targeted symptomatic management has been unsuccessful, or when patients are struggling with confusion or distress, the treatment offered may be sedation, in order to relieve symptoms of anxiety, restlessness, emotional anguish and distress. Patients who require sedation at the end of life often appear comfortable to treating clinicians, but the loss of biographical life and interaction is often difficult and distressing to family and loved ones, and to patients themselves. Whilst comfort does appear to be maintained, the use of alternative sedation to allow meaningful biographical interaction with a patients loved ones could be considered desirable, especially if comfort could be preserved. Dexmedetomidine is an imidazole alpha-2 receptor agonist utilised commonly in the intensive care and anaesthetic environments. Dexmedetomidine was investigated in a clinical trial setting at the Port Kembla Palliative Care Unit (Joint University of Wollongong and Illawarra Shoalhaven Local Health District Human Research Ethics Committee (2018/247) as a potential therapeutic option for terminal delirium and rousable sedation, with results showing a trend to interactive sedation and decreased delirium. Standard care for distress at the end of life has typically involved benzodiazepine infusions, in Australia the most commonly utilised is midazolam. Despite this, the evidence base for benzodiazepine infusions at the end of life is not robust, with usage predominantly predicated on professional consensus and guidelines. Small-scale observational studies and retrospective analysis have been performed, but there is minimal evidence in the literature for actual efficacy trials, especially in patients treated with midazolam in the terminal phase of life. Given the gap in knowledge, the investigators propose a randomised controlled trial into the use of dexmedetomidine versus midazolam via continuous subcutaneous infusion (CSCI) in patients for sedation at the end of life. The subcutaneous (SC) route is chosen for this study as the preferred route of delivery as this conforms to the current standard of care for medication infusions given within the ISLHD for palliative care patients, and in NSW.

Penicillin allergies are a major burden on patients and hospitals. Currently, up to 1 in 4 Australian patients admitted to hospital will report an antibiotic allergy, many of which limit appropriate antibiotic usage and lead to inferior health outcomes. In many instances, patients will report what is considered a “low-risk” penicillin allergy and are appropriate for a penicillin re-challenge (i.e. a simple test dose) to determine if they are still allergic. We have developed assessment tools and a protocol for performing this test dose which has been safe and effective in over 98% of Austin inpatients. However, at present the safety and efficacy of performing oral penicillin re-challenge in the intensive care unit (ICU) setting is unknown, despite significant potential benefits to patients. This study will determine if penicillin oral re-challenge can be feasibly and safely performed in a small number of ICU patients to allow for future studies to examine the potential benefits of such testing in a larger group of patients.

The ACUMEN trial will examine the effect of an exercise program on the physical and mental health-related quality of life in women treated for reproductive cancer, with the aim to promote regular exercise for these patients. Who is it for? If you are an adult woman who has been diagnosed with gynaecological in the 60 months, and it has been over a month since you finished an intensive cancer treatment (including surgery, radiotherapy, chemotherapy), you may be eligible to participate in this study. Study details Participants in this study will be randomly assigned to one of two groups. The first group will undergo an individual assessment with a trained accredited exercise physiologist or physiotherapist to determine their current fitness levels. Participants in this first group will then be prescribed a personalised exercise program that they will follow for the next 12 weeks. The exercise program will include both aerobic and resistance training and participants will be asked to complete 3x 60 minute sessions each week for the 12 week period which will include supervised and unsupervised sessions. The second group of participants will not be prescribed an exercise program and will continue to see their usual health professionals as required. Participants in the second group will be given written information regarding exercise as part of a healthy lifestyle and for cancer recovery, and a Fitbit activity tracker to monitor their physical activity over the 12 week period. Participants in both groups will complete a series of questionnaires, a blood sample and fitness assessments before and after the intervention. After the intervention, questionnaires, blood samples and fitness assessments will occur at two time-points (week 12 and week 24). It is hoped this research will determine whether a personalised exercise program can lead to improved long-term health outcomes for women who have been treated for gynaecological cancer.

This study will assess the feasibility and uptake of self-directed testing for COVID-19 and other seasonal respiratory viruses among patients undergoing treatment for their cancer. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been clinically and pathologically diagnosed with any cancerous malignancy, you are receiving active treatment for your cancer at one of the participating Icon Cancer Centres (VIC, NSW, QLD only) and you are able to self-collect and return samples to a Sonic HealthCare laboratory. Study details Participants who enrol in this study will be instructed to collect four test kits containing the specimen swab, tongue depressor, test tube for completed sample, educational pamphlet, a pathology request form and a list of dedicated COVID-19 testing centres. Participants will also be given a link to the Sonic HealthCare web page containing a “how to self-collect” tutorial video in order to ensure specimens are collected correctly and as a measure of ensuring maximum standardization among participants. Participants who are unable to access the web link will be referred to Sonic HealthCare for telephone training which is anticipated to take approximately 5 minutes. Participants will be asked to self-collect throat and nose sample specimens at home (throat and nose specimens will be collected with one swab). The frequency of testing is once weekly for a period of four weeks totally four test per participant. Participants will also be asked to keep a symptom score and temperature electronic diary which they will complete each day until the end of study (4 weeks). This will be done by emailing each participant an easy to use survey each day to track their symptoms. It is hoped this research will determine whether self-administered testing for COVID-19 and other respiratory illness by participants in their own home is feasible and effective. If this method of sample collection is effective, this method of testing may be used in the future, which could assist vulnerable patients including those with cancer.

Eating disorders are associated with significant personal and family costs. Research has shown that family involvement can help support treatment but little is known about what aspects of family involvement are most helpful with adults affected by eating disorders and their carers. How specific aspects of family involvement work, and which family interventions are more or less helpful, is not well understood. We also do not know enough about how adult clients and carers experience family interventionsand involvement in treatment. Some family interventions that support treatment have been identified but there can be barriers to these for the families of adults with eating disorders who are a diverse group. This can make services for family involvement difficult to plan. This current research will help by studying a multi-level approach to working with families of adults receiving treatment in a community eating disorders clinic as well as evaluating the effect a brief family consultation intervention on family issues as well as any effects on patients staying in the treatment program.. The results will inform treatment recommendations for adults affected by eating disorders as well as develop a model to guide ways of working with their families.

This trial is an open-label, single-arm safety and feasibility trial of lisdexamfetamine for the management of acute methamphetamine withdrawal. Participants presenting for inpatient management of methamphetamine withdrawal will receive a tapering dose of lsidexamfetamine, starting at 250mg on day 1, reducing by 50mg per day to 50mg on day 5. Participants will be encouraged to remain in treatment for another two days for ongoing monitoring and will be followed up weekly for three weeks post discharge. We hypothesise that lisdexamfetamine is safe and feasible for the management of acute methamphetamine withdrawal.