ANZCTR search results

The purpose of this study is to investigate the effect of utilisation of an internet-based personalised decision support (PDS) tool on screening behaviour for Colorectal Cancer. Our hypothesis is that individuals who are provided access to the PDS will be more likely to participate in screening than those who are not provided access. The study fits in with the aim of improving participation in CRC screening nationally, and if effective the PDS can be implemented on a large scale; for instance, as part of the Department of Health and Ageing's national screening program.

Ultrasound guided Transversus Abominis Plane (TAP) blocks are an effective technique to provide analgesia after lower abdominal surgery. TAP blocks are performed by injecting local anaesthetic around the nerves in the Transversus Abdominis Plane on both sides of the abdomen. This project seeks to examine the duration and distribution of sensory changes over the patient’s abdomen after bilateral TAP blocks. The study will also compare the standard TAP block technique to a refined technique which may provide superior analgesia. Each patient in the study, while anaesthetised will receive a standard and a refined TAP block and then will be assessed by a researcher at 1 hour, 3 hours and then 2 hourly until full sensation returns to the abdomen.

At present there is no standard 2nd line chemotherapy regime for patients with advanced malignant pleural mesothelioma (MPM) who progress after treatment with standard first line chemotherapy (i.e. pemetrexed and a platinum compound). BNC105P is a novel chemotherapy agent which has shown activity in MPM. In this study, BNC105P will be studied in a single arm, 2 stage, multi-centre design to determine its efficacy and safety as 2nd line chemotherapy for patients with MPM. All subjects will receive BNC105P on Day 1 and Day 8 of a 21 day cycle until unacceptable toxicity or disease progression. The primary endpoint will be tumour response, and secondary endpoints include progression-free survival, overall survival, adverse events, and quality of life. Correlative substudies will examine associations between potential biological markers and outcomes.

The purpose of this study is to investigate the effectiveness of a combination of two drugs, called AMG 102 and panitumumab, for patients with brain tumours that have returned after previous treatment. In addition, the study will investigate the side-effects that might be associated with the combination of these two drugs when treating brain tumours. Research has shown that AMG 102 is effective at treating brain tumours in a small proportion of patients, and preliminary results in the laboratory show that panitumumab could make AMG 102 more effective at treating brain tumours. Therefore this study will be testing this combination of drugs. The combination of AMG 102 and panitumumab has previously been tested in 8 patients with bowel cancer, and is continuing to be tested in an ongoing bowel cancer study, but has not previously been tested in patients with brain tumours. Because very few patients have been treated with the combination of AMG 102 and panitumumab, the study will be conducted in two phases. Initially 3 patients will be treated at least one week apart. Once these 3 patients have completed 4 weeks of treatment each, and if there are no concerns with side effects, a further 3 patients will be treated at the same dose. If unacceptable side effects are observed, a lower dose will be tested, again treating 3 patients at least one week apart. If unacceptable side effects are still observed at the lower dose, an even lower dose will be tested. Using this system, the dose for the second phase will be identified, or if an acceptable dose cannot be identified, the study will not continue. A total of 6 to 18 patients will participate in the first phase of the study. The second phase of the study will enrol patients until a total of 42 patients have been treated at the dose identified in the first phase.

The incidence of neurodegenerative diseases such as Alzheimer’s (AD) and Parkinson’s (PD) disease are expected to rise in the next 30 years as a result of Australia’s ageing population. However, conclusive diagnostic tests and impact of dietary status for neurodegenerative disease risk are not clearly defined. Therefore, it is important to identify potential genome damage biomarkers and micronutrients associated with these diseases that may aid in the design of potential preventative measures. The hypothesis is mild cognitive impairment, Alzheimer’s disease, and Parkinson’s disease exhibit increases in genome damage and cell death biomarkers relative to each other, and to healthy age matched controls.

The preschool years are considered a critical time in which to establish healthy behaviours in childhood and into the future. One of the best opportunities to support physically active lifestyles among a large number of young children lies in the child care setting. The childcare centre has been shown to account for a significant proportion of the variability in children’s physical activity behaviour while in care and child care centres also have the existing infrastructure to support adequate physical activity. However research suggests children are unlikely to be sufficiently active whilst in care. To date there is little research examining the efficacy of physical activity interventions implemented in the childcare setting therefore the primary aim of this study is to assess the efficacy of a physical activity intervention in increasing physical activity levels among 3 to 6 year old children attending long day care services as assessed by pedometer step counts.

A randomised trial was conducted to assess whether daily application of a sun protection factor (SPF) 15+ sunscreen to the head, neck, arms and hands, or beta-carotene supplementation (30 mg/day) would prevent skin cancers and related tumours and premature skin ageing in comparison with discretionary use of sunscreen or a daily placebo supplement. The The hypothesis was that regular sunscreen use by adult Caucasians prevents the occurrence of skin cancers and related sun-related degenerative skin conditions

Depression, cardiovascular disease (CVD) risk factors and cognitive impairment are key causes of disability and poor health outcomes. Comorbidity of these leads to an even worse prognosis. The primary aim of this randomised controlled trial is to determine the effect of an evidence-based internet intervention program for depression on depressive mood symptoms in patients being treated for, or at risk of developing, CVD. Participants will be drawn from the longitudinal cohort study of healthy volunteers, the 45 and Up Study. Participants will be selected on the basis of self-reported history of CVD or multiple risk-factors for developing CVD and positive screen for depressive symptoms, as measured by the Kessler-10. The 12 week intervention will compare the effectiveness of online cognitive behavioural therapy (e-couch) with an attention control placebo (HealthWatch website). Follow-up will occur post-intervention and again at 6 and 12 months. Therefore, secondary aims of this trial are to determine the immediate and 12 month efficacy of the internet intervention on cognitive function and adherence to cardiovascular treatment and exercise.

This study aimed to investigate the hypothesis that following a 4-day very low calorie diet, the effects of intraduodenal nutrients on antropyloroduodenal motility, gastrointestinal hormone release and appetite in obese subjects, will be enhanced.

Comfort rooms are specialised rooms, often within an inpatient psychiatric unit, which have a range of comforting materials and resources in them to assist an individual who is distressed to relax and perform “self-soothing” routines (e.g., relaxation exercises, self-massage, use of weighted blankets / comfort wraps) Previous investigations have demonstrated the utility of comfort rooms in reducing levels of distress in clients and also in reducing the use of seclusion and restraint. The aim of this project is to evaluate the effectiveness of the introduction of a comfort room into and acute inpatient mental health unit. Outcomes will be measured by a number of indicators: (1) rate of utilisation of the comfort room; (2) average length of time individuals remain in the comfort room; (3) behaviours observed before and after use of the comfort room; (4) what resources were used by the individual whilst in the comfort room; and (5) rates of seclusion before and after the introduction of the comfort room. Additionally, clients will be asked to report their subjective level of distress before and after using the room. This will be done by way of two simple questions asked by a member of nursing staff following the client leaving the comfort room: “Before you went into the comfort room, how distressed were you feeling on a scale of 1 to 10” and “Now, how distressed are you feeling, on a scale of 1 to 10”. Asking clients to rate their level of distress prior to using the comfort room is considered inappropriate, as any such delay in accessing the comfort room is not in keeping with the philosophy of quick and early access to the comfort room to promote best self-management of distress. It is hypothesised that the introduction of the comfort room will reduce distress experienced by clients by providing a comfortable environment and resources to self-sooth and de-stress. This hypothesis will be tested in the following ways: (1) Does the use of the comfort room reduce the level of self-reported distress experienced by clients? (2) Are fewer disruptive / disturbed behaviours noted in clients following the use of the comfort room? (3) Do rates of seclusion reduce following the introduction of the comfort room? The potential significance of this study is large. Similar projects are readily implementable (with limited capital outlay) in a range of settings across Australia and the results of this study have the potential to inform and change clinical practice in inpatient psychiatric units, leading to better outcomes for a large number of individuals across Australia. The results of this study will also add to the developing knowledge base around interventions designed to reduce the use of seclusion in Australian psychiatric inpatient units.