ANZCTR search results

Our study aims to understand the health, economic and social costs associated with caring for patients with advanced pulmonary disease (APD) and to determine health, economic and social impact of improving the skills of caregivers of patients with APD has on patients and their carers. Patients with APD are a large population at high risk of health resource use, unnecessary medication use and emergency admission to hospital or residential care facilities. Although previous research has identified difficulties experienced by caregivers of the elderly in general, very little research has been undertaken with carers of patients with APD. The study will compare the usual practice of educating patients with APD who commence home oxygen therapy (HOT), and their carers, against a more detailed and individually targeted education program that increases the skills of patients and carers. This study has the potential to reduce hospital/residential care readmission, reduce carer distress, improve patient outcomes, reduce adverse effects of oxygen therapy and medication use, and minimize inappropriate presentation to tertiary care emergency departments.

Phase 3 This is a trial of the drug E7389 (eribulin) versus oral capecitabine in advanced breast cancer which has been treated with an anthracycline drug and a taxane drug. Who is it for? You can join this study if you are a woman with breast cancer which is locally advanced or has spread to secondary distant sites (metastases), and this has been treated previously with an anthracycline drug and a taxane drug. Trial details Capecitabine given orally twice daily for 14 days followed by a week's rest is widely-used treatment for people with breast cancer with progressive disease after anthracycline and taxane treatments. E7389 (eribulin) is a new drug derived from a marine sponge which stops cancer cells growing in the laboratory and has slowed cancer growth in some cancer people. Participants will be randomly divided into two groups. One group receives oral capecitabine (standard treatment). The other receives E7389 (eribulin) given intravenously on Days 1 and 8 every 21 days. The study aims to look at the effectiveness of the new treatment compared with capecitabine, and measures patient survival, whether the tumour responds and for how long.

Over 22,000 pregnant women in Australia each year (7.7% of pregnancies) develop Borderline Gestational Diabetes Mellitus (GDM). The primary aim of the IDEAL Study is to assess whether dietary and lifestyle advice and treatment given to pregnant women who have borderline gestational diabetes on screening for gestational diabetes (defined as a positive oral glucose challenge screening test (OGCT) followed by a normal oral glucose tolerance test (OGTT)), reduces neonatal complications and maternal risks. The primary hypothesis of the study is that dietary and lifestyle advice and treatment given to women who have borderline gestational diabetes on screening for gestational diabetes will reduce the incidence of large for gestational age infants defined as birthweight above the 90th centile for gestation and fetal sex on standardised birthweight charts. If treatment of these women is effective this would reduce the burden of disease for women and their babies, with implications for improved health through childhood, adolescence and adulthood.

This is a study of a cancer vaccine known as Stimuvax for treating non-small cell lung cancer (NSCLC) at stage 3, where this cannot be operated on surgically. Who is it for? You may be suitable for this study if: • You have stage 3 non-small cell lung cancer that cannot be operated on. • You have received primary platinum chemoradiotherapy. • The cancer is stable or responsive. Trial details Participants will be randomly divided into two groups. Four weeks after the last chemoradiation treatment, one group receives one infusion of cyclophosphamide followed by weekly subcutaneous vaccination with Stimuvax for 8 weeks and then injections are given once every six weeks until any progression of the cancer. The other group will receive a non-active compound. The study aims to monitor survival time and time to any progression of symptoms. Currently there is no standard prescribed treatment for these people following chemoradiotherapy. Stimuvax is designed to stimulate the immune system to respond to a protein found in many cancers including NSCLC. This trial will determine if Stimuvax has beneficial effects after participants cease chemoradiation.

Hepatocellualr carcinoma (HCC) is a highly lethal disease with few effective treatment options. It has been established that clofazimine can control the growth of HCC cell lines in vitro and in pre clinical animal models. This study aims to treat patients with unresectable primary HCC with escalating doses of clofazimine delivered in Lipiodol and administered via the hepatic artery under computerised tomography (CT) guidance. The maximum tolerated dose will be established using cohorts of one to six patients. Safety and tolerability will also be assessed in eligible patients. Each cycle of treatment will be 28 days in length and patients may receive up to 4 additional treatments if the study treatment is well tolerated. This study commenced recruitment in January 2003 and is currently recruiting patients into the final dose level cohort.

The purpose of this study is to assess the virologic activity, safety, tolerability and pharmacodynmaic profile of SCH 532706 when codminstered with a dose of Ritonavir that could be observed during the treatment of patients with HIV.

Despite the importance of preventing overweight and obesity in children, few primary prevention interventions have been shown to be effective. We propose a randomised controlled trial (RCT) of an original community-based home visiting intervention designed to improve family and behavioural risk factors for childhood overweight and obesity for first-time mothers in the most socially and economically disadvantaged areas of Sydney. It addresses the key research question: Will an intensive home-based early intervention over the first two years of life increase healthy feeding and physical activity, enhance parent-child interaction and lead to reduced levels of overweight and obesity among children aged 3 years?

The purpose of the study is to evaluate a general-practice based referral strategy to improve access to community-based health organisations among people with chronic illness. It is hypothesised that greater access to these organisations is associated with a range of benefits in terms of chronic illness self-management and health related quality of life.

More than one in twenty Australians experience depression in a single year and it is commonly a relapsing disorder. At least 60% of people who have had a depressive episode will have another, the vast majority within two years of the index episode. For those who have had three episodes, the relapse rate is 90%. Even with guideline-based pharmacotherapy relapse is not uncommon so there is a need for non-pharmacological approaches to relapse prevention. The economic burden of depression in Australia has been estimated as perhaps 2.8 billion annually. Mindfulness-based cognitive therapy (MBCT) is an innovative psychological treatment, combining principles of cognitive therapy and mindfulness meditation. It is designed to prevent relapse in people who have recovered from depressive episodes. MBCT aims to teach people to become more aware of, and to related differently to, their thoughts, feelings and bodily sensations; in particular, to view these thoughts and feelings as passing events in the mind rather than identifying with them. Through gaining these skills in increased awareness of thoughts and feelings, participants in the treatment learn to avoid negative ruminations, which have a powerful role in triggering relapses of depression. This project will examine the effectiveness of MBCT for the first time in Australians with a history of recurring depression. The primary aim of this project is to determine if MBCT when added to existing treatment as usual (TAU) is more effective than TAU in preventing depressive relapse over a two-year period in people who have had at least three prior episodes of depression. The study also aims to establish whether the mechanisms by which MBCT is proposed to work – by decreasing rumination, increasing levels of mindfulness and self-awareness – do in fact operate. We also hope to establish whether MBCT also has any impact on anxiety, another disabling condition that commonly occurs with depression. Cost utility analysis will enable specific policy recommendations for Australia. Positive findings from this study would lead to MBCT having a high degree of evidence-based support examining its use, so that it could be considered as an intervention for which ‘high’, rather than ‘moderate’, levels of evidence exist. Hence, if outcomes are positive, this study would provide internationally significant findings to support consideration of inclusion of this treatment into guidelines for routine clinical management of the serious and disabling problem of recurrent depression.

To trial the administration of a new drug “rimonabant”, a selective cannabinoid receptor type I antagonist, to young people between the ages of 16- 30 who have a history of psychosis and have undergone a period of cannabis detoxification, to assess whether relapse to dependant cannabis use is reduced It is hypothesised that: 1.Rimonabant will reduce the effects of cannabis intoxication after cannabis detoxification. 2.In turn, this would reduce psychosis and depression, and hence reduce utilization of health services including hospitalization. 3.Rimonabant will reduce other substance use disorders including tobacco use