ANZCTR search results

Brief description of the study purpose The study aims to Investigate the psychosocial and behavioural impact of genetic testing for familial melanoma. It also evaluates a training program for clinicians to provide genetic testing for familial melanoma, based on participant satisfaction. Who is it for? You may be eligible for this study if you are 18 years or older, with 3 primary melanomas and/or a family member with 1 or more invasive melanomas and 2 or more other invasive melanomas and/or pancreatic cancer among first-degree or second-degree relatives on the same side of the family. Study details Participation in the study will involve a pre-testing genetic counselling and education visit. You will be seen by either a genetic counsellor (standard practice of care), or by a clinician who has received training to provide genetic testing (the 'intervention group'). Participants will then have their saliva collected for genetic testing, and will attend a second visit to receive their test results. At both visits, participants will be asked to complete questionnaires (approx 30 mins). One month after receiving their genetic test results, participants will asked to complete a phone interview where questions about their experience in the study will be discussed. Participants will also be required to answer questionnaires about the psychological impact of genetic testing and regarding their sun protective behaviour after results have been received. A link to the questionnaires will be emailed to participants at 1 week, 3 months and 12 months after receiving their results, and can be completed online. It is hoped this study will provide greater insight into the role of genetic testing and the impact on mental health, and sun protective behaviour.

The Alfred Hospital is an adult major trauma centre, and receives in excess of 65,000 patient presentations per year. This study is an open-label randomised controlled trial of one dose of Methoxyflurane (3mL) administered after streaming to eligible patients compared to standard care. The primary outcome will be defined as the proportion of participants achieving significant pain reduction. We consider significant pain reduction as at least a 50% drop in the initial pain score at 30 min from presentation to the ED. Secondary outcomes will be the mean pain score at 30 min, the proportion of participants achieving a drop in pain scores of at least 3 standard points on the numerical 11-point pain scale, and the use of any opioid analgesia. Participants will be asked to indicate the intensity of pain at 30, 60, and 90 min after administration of analgesia, with a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available. Participants’ reported pain scores will be recorded contemporaneously and the participants will not be reminded of the previous score.

Workplace injuries have a major impact upon workers, employers and society in general. While most work-related injuries heal within a few weeks, a considerable proportion of workers have ongoing pain and disability for months and years following the injury (e.g., Henschke et al., 2007, Social Research Centre, 2018). A common corollary following a workplace injury is chronic pain. In 2007 the estimated total cost of chronic pain in Australia due to absenteeism and lost productivity while at work was $11.7 billion (Access Economics Report, 2007, and their latest report, 2019, indicates these figures have multiplied in the intervening period). Chronic pain is often associated with markedly reduced quality of life, high levels of distress and often co-occurs with mental disorders, such as depression and anxiety (e.g., Arnow et al., 2006). Furthermore, there is only a brief window of opportunity to prevent these sorts of outcomes for injured workers. The longer injured workers are away from work, the greater their risk of never returning (e.g., Landstad et al., 2009). In Australia chronic back pain has been identified as one of the major reasons middle-aged workers drop out of the workforce (Schofield et al., 2011).

This is a feasibility study of normothermic machine perfusion technology in human DCD kidneys deemed suitable for transplantation. If preliminary results are encouraging a larger prospective RCT will be required to confirm whether this technology improves Kidney transplant outcomes in the clinical setting. Experimental data and early non randomised clinical studies from Europe appear to show a significant benefit, by reducing the need for post transplant dialysis.

Achilles tendinopathy is a common, painful and disabling musculoskeletal condition. There is a treatment called radial shockwave therapy (rSWT) that produces a pressure wave that enters the Achilles tendon. Some studies report positive findings for this treatment in insertional Achilles tendinopathy but it is not certain whether rSWT is better than placebo. The proposed study is a two-arm, parallel group, double-blind randomised prospective trial. Participants will be block-randomised into sham rSWT or rSWT groups with a 1:1 ratio. All participants will receive weekly rSWT (sham rSWT or rSWT) once per week over a three-week period, and will also receive an identical evidence-based exercise intervention to be completed for the duration of the trial, which removes ethical concerns of withholding treatment. Participants and outcome assessors will be blinded to treatment allocation.

Falls are a debilitating and common problem in Australian hospitals and it is estimated that between 310 falls occur per 1,000 bed days in Australian hospitals. Even though they are associated with increased length of stay and injuries, falls mitigation strategies have not had a great deal of success to date in hospital environments. Previous attempts to prevent falls have focused on clinician education and environmental modifications. The current project will use qualitative methods for a series of interviews with patients and clinicians to understand their views and knowledge on falls prevention educational interventions.

This study will examine the effect of Fibre-fix (dietary fibre supplement) on the human gut microbiome and faecal metabolites of people with Irritable Bowel Syndrome (IBS) who consume a diet low in fermentable oligosaccharide, disaccharides, monosaccharides and polyols (FODMAP). A low FODMAP diet reduces the intake of fermentable fibres, leading to insufficient fermentation by the gut microbiota. This can thereby reduce the production of short chain fatty acids (SCFA, e.g. butyrate) in the large intestine and influence on modulation of sleep and mental health. A randomized double-blind placebo controlled study design is proposed to examine whether Fibre-fix supplement, added to an existing low FODMAP diet may help modulate gastrointestinal function, improve markers of sleep and mental health and promote increased quality of life in IBS patients. Participants will provide stool samples, and complete questionnaires about sleep and mental health before and after the 3-week intervention. Gut health biomarkers: faecal microbiome composition, faecal pH and butyrate levels, and alteration of sleep and mental conditions will be examined. A repeated measures ANOVA using the Statistical Package for the Social Sciences (SPSS) version 25.0 will be used to assess the differences between groups after adjustment for confounding variables. We expect a shift in the diversity of the microbiota and associated increase in the butyrate levels and improvement in general mental health and sleep in those who receive Fibre -fix compared to those who receive control. In addition, the benefits of RS are likely to reduce IBS symptoms and improve gut health whilst on a low FODMAP diet, proposing a long-term dietary solution for those with IBS. The proposed mental health and sleep benefits may have a flow-on effect in terms of lowering the occurrence of other comorbidities, such as depression and work absenteeism which have economic costs, thereby lowering the burden on the healthcare system and reducing healthcare costs for those with IBS.

The primary purpose of this project is to determine whether the use of melatonin improves the quality of sleep in patients undergoing major abdominal surgery. Melatonin is a natural hormone secreted by the pineal gland. Melatonin when given at night works to promote sleep by helping to regulate the body's bio clock and sleep-wake cycles. It is well known that sleep quality in hospital is poor and can cause insufficient sleep which reduces natural immune function. Major abdominal surgery leads to the release of both pro-inflammatory and anti-inflammatory chemical in the blood.. Melatonin could be an effective adjunct medication not only to assist in improving sleep but to dampen the inflammatory response after surgery.

The focus of this project is the treatment of adults with Major Depressive Disorder (MDD) using group psychotherapy. It will examine Cognitive Behaviour Therapy (CBT), an effective type of psychotherapy with outcomes comparable to if not better than medication. In spite of these results, only about 50% of depressed people improve with CBT, and many relapse. Over the years, much effort has gone into exploring ways to improve treatment outcomes for MDD with CBT. Drawing on past and current research, this project combines various components of CBT into a unique and somewhat shorter treatment package. This project aims to answer two key questions: 1. Does this 10 session CBT treatment, delivered in a group format, achieve comparable results with benchmark studies that have primarily used Behavioural Analysis, Cognitive Therapy or CBT treatment over more sessions? 2. Does CBT with the addition of hypnosis (CBTH) achieve better outcomes for MDD than CBT without hypnosis ?

Obesity-related type 2 diabetes (T2D) is increasing in prevalence in Australia and globally, We have shown that there is considerable inter-individual variability in weight loss and glucose benefit in response to a given dose of exercise in adults with obesity, Therefore, the ‘one-size-fits-all’ approach to exercise prescription, which is the basis of current exercise recommendations for obesity-related disease management, is inadequate. This study will employ a ‘Stepped Care’ methodology to meet the need for tailored, individualised strategies for the management of obesity and related conditions. Participants will be randomised into either the Stepped Care arm or a Comparator group (n=80, randomised in 2:1 ratio for Stepped Care: Comparator). All participants in the Stepped Care arm commence on the ‘lowest dose’ prescription, which is incrementally increased based on individual response as defined by predetermined clinical targets. Step 1: = 150 minutes of moderate to vigorous exercise per week; Step 2: = 300 minutes of moderate to vigorous exercise per week; Step 3: = 300 minutes of moderate to vigorous exercise per week including 3 sessions/week of high intensity interval training (HIIT) (4 x 4 min at 85-95% maximal heart rate, interspersed with 3 min recovery bouts at 60-65% maximal heart rate, 3 days/week, with one session/week supervised). The primary AIM of this study is to determine the overall difference between the proportion of individuals with central obesity and type 2 diabetes who achieve the target health outcomes (that is, = 3% weight loss and/or HbA1c = -0.4%) in the Stepped Care and the Comparator groups. The secondary AIMs of this study are to determine the overall difference between the proportion of individuals with central obesity and type 2 diabetes who achieve the target health outcomes in the Stepped Care and the Comparator at i) follow up (6 months), and ii) at each step in the Stepped Care intervention, and iii) determine the magnitude of change in body mass and HbA1c between the Stepped Care and the Comparator groups.