ANZCTR search results

The study is assessing the costs and patient related outcomes associated with chemotherapy delivered at home versus chemotherapy delivered in the hospital setting for breast cancer patients. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who is scheduled to receive at least four cycles of chemotherapy for breast cancer and are suitable for day-case administration. Study details All participants in this study will receive their first two cycles of chemotherapy in a hospital day unit as per standard care. Provided that the participants do not experience any severe adverse events, they will then be randomly (by chance) allocated to receive their next two chemotherapy cycles either in the hospital day unit or in their home setting. In the home setting, chemotherapy will be administered intravenously by a trained nurse. Your chemotherapy treatment regime will not change. All participants will be asked to complete a number of questionnaires before, during and after chemotherapy treatment in order to evaluate their patient experience, quality of life, anxiety and depression, nausea and vomiting, and treatment safety. Treatment-related costs will also be analysed. It is thought that treatment at home may provide not only a better patient experience, but may deliver a more sustainable health service model of care for the WA Health Department.

Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered. The main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.

Phase 2a open label, randomised study to evaluate the pharmacokinetics and safety of MicroCor hPTH(1-34) Administered via Transdermal Delivery and Subcutaneous Injection [Forteo Registered Trademark (teriparatide)] in healthy postmenopausal volunteers

High blood pressure is a leading risk factor for mortality. Diet and lifestyle change, which can reduce the need for costly blood pressure medication, can have the largest potential impact on high blood pressure in the community. Large randomised controlled trials demonstrate that consumption of diets rich in plant foods (fruits, vegetables, legumes and whole grains) lower blood pressure. We propose that the amount and type of vegetables consumed is important for blood pressure, and that focused advice to consume nitrate-rich vegetables will result in lower blood pressure. Acute and very short-term studies clearly demonstrate that an increase in nitrate intake can significantly reduce blood pressure. The objective of this study is to establish if these effects on blood pressure are sustained over a 4 week period. In a separate investigation we also wish to determine if daily consumption of nitrate-rich vegetables can lower the cardiovascular response to stress. Secondary objectives of this study are to explore the role of nitrate-rich vegetables in improving blood vessel stiffness and cognitive function and mood.

It is well recognized that low back pain (LBP) is a significant public health problem. The total cost of chronic LBP in Australia is estimated at $9.17 billion yearly. Expenditures are expected to grow with the increasing obesity crisis and ageing population. Although randomised controlled trials (RCT) investigating the efficacy of conservative interventions for chronic LBP have found improvements in pain and disability associated with interventions, but patients exhibit a rapid decline in clinical outcomes after treatment discharge. These patients are likely to have recurrences of LBP and therefore seek additional care and costly, invasive procedures such as spinal surgery. Our previous research has shown that patients with chronic LBP who engage in moderate to high levels of recreational physical activity have better prognosis of pain, disability, and quality of life than those who fail to maintain adequate levels of activity. However, adherence to such lifestyle modifications is crucial and difficult to achieve. Interventions to increase physical activity based on communication technologies are becoming popular because they facilitate patients’ access and adherence to health interventions. The use of patient-centred approaches, where patients have the opportunity to share healthcare decisions, are becoming popular in LBP and have been found to be more effective than general non-specific approaches to help patients to engage in physical activity. Surprisingly, no studies have investigated the effectiveness of a physical activity intervention, particularly with the support of mobile-health (m-health) tools on long-term outcomes in patients with chronic LBP. We propose a RCT to investigate the effectiveness of an m-health patient-centered physical activity intervention for patients with chronic LBP after discharge from hospital. Patients in the experimental group will receive feedback from affordable and unobtrusive activity monitors to allow them to maintain leisure activity levels through lifestyle modification and use an m-health tool to monitor and motivate their progress. We hypothesise that the use of m-health monitoring and patient-centred lifestyle modification will reduce symptom recurrence, unnecessary spinal surgery and care seeking. We will evaluate this approach in patients receiving treatment in an outpatient physiotherapy department of Liverpool Hospital in the South-western health district of Sydney.

The study will be a randomised, placebo-controlled, double-blind parallel-group trial over a 12 week period. The primary objective is to examine the clinical efficacy of the add-on treatment of sodium benzoate for persistent symptoms in patients with early psychosis. Specifically, it is hypothesised, that participants allocated to the active arm (1000mg (500mg twice daily)) Sodium Benzoate treatment will have significant reductions in the Positive and Negative Syndrome Scale (PANSS) total score at week 12 compared to individuals taking placebo.

Background: Most workplace health promotion research with nurses has focused on mental health outcomes, occupational health and safety, or smoking cessation. Previous research shows that nurses are at increased risk of non-communicable diseases due to unhealthy lifestyles and would benefit from worksite interventions targeting lifestyle behaviors. Incentivising employee participation in worksite health promotion programmes has been identified as one of the components of successful interventions. Therefore, the aim of this study is to determine the efficacy of an incentivised physical activity (PA) intervention programme among nurses working in hospitals in Brisbane, Australia. Methods: Nurses who volunteer to join the research will participate in a 10-week pedometer-based programme. All participants will receive a Yamax SW 200 pedometer and will be asked to wear the pedometer every day during all waking hours, and record their daily step counts on log sheets that will be collected each week. The researchers will send bi-weekly text messages to encourage increases in daily step counts, with the overall target of 3000 more steps per day by week 10. Participants in the intervention group will receive a financial incentive in week 11 based on their increase in daily steps counts. Those in the comparison group will not receive an incentive. Nurses will be asked to complete a survey and objective measure of PA at baseline, 11 and 22 weeks. Nurses will wear the Actigraph GT3X accelerometer for 7 days to measure daily step counts, time spent in sedentary, light, moderate and vigorous intensity physical activity. The main outcome will be a change in daily steps counts, measured by the accelerometer, from baseline to 11 and 22 weeks. Discussion: This research is one of the few studies to investigate the role of incentives in increasing PA in nurses. The outcomes of this efficacy study will inform future health promotion programmes in both nurses and other shift workers.

The primary aim of this study is to show that an injection of 100 micrograms of Tenecteplase (TNK) into the back of the eye will dissolve the clot and restore venous outflow within a week in patients who have recently suffered a branch retinal vein occlusion (BRVO) (clot in a branch of the retinal vein). Laser treatment has been the standard treatment for BRVO, and is now superseded by injecting anti-VEGF antibodies into the back of the eye. The visual outcome in patients treated this way has improved, but vision does not always return and ongoing injections are often required. Attempts at breaking the clot have been tried using tissue plasminogen activator (tPA), but they have not been effective. TNK is a third generation thrombolytic developed to address some of the short comings of tPA. Our research has shown that TNK is less toxic than tPA, it has a shorter clot contact time to be effective and it is able to penetrate the retina. We have used TNK to treat sub-retinal macula haemorrhage in humans without any problems. In this study, forty patients with a BRVO of less than 3 weeks will be enrolled with a 1:1 randomisation to the TNK treatment (100 micrograms) or sham treatment. Patients will be recruited from the retinal clinics at Royal Perth Hospital and the Lions Eye Institute. At the Baseline visit, consent will be obtained before any study procedure occurs. The study procedures are: best corrected visual acuity examination, ophthalmic examination (eye examination), photography (includes fluorescein angiography, colour photos and optical coherence tomography (OCT)), optical coherence tomography angiography (OCTA) and flowmetry. If eligible, the study participant will be randomised and treated at Day 0. The study procedures outlined above will be repeated at Day 2, Day 7,Day 30 and Day 90. All participants will start anti-VEGF treatment at Day 7; the current standard treatment. The Day 30 examination will determine if there is evidence of the clot reforming. We aim to show the resolution of the clot and improved retinal blood flow over the area of the blocked vein within a week of the TNK injection using the data from the fluorescein angiography, OCT and flowmetry. If the results are promising, then an application for NH&MRC funding for a multicentre study will be sought.

Psychoeducation provided to individuals with bipolar disorder and their caregiver has strong research support but to date no studies have investigated the impact of providing psychoeducation to caregivers alone. This study aims to contribute towards filling this gap by evaluating a two-session group intervention for caregivers of individuals with bipolar disorder focussing on improving knowledge of the disorder and the development of self-care strategies. Participants will be randomised to either a waitlist control condition or intervention condition. Repeated measures of stress, depression, anxiety, self-efficacy, knowledge and burden will be taken at pre, post, and follow-up intervals. It is hypothesised that participants will report reduced symptoms of stress, depression, anxiety and burden at post intervention and follow-up, as well as improved knowledge and self efficacy, relative to controls. Those in the control condition will be offered the intervention immediately after the waitlist period.

The purpose of Balanced project is to examine the feasibility of a mobile device intervention, Balanced, to improve the physical activity and sleep behaviours of Australian adults (aged 18-55). Balanced will allow participants to keep track of their sitting, physical activity and sleep behaviours each day and will encourage them to make changes to daily routines to improve these behaviours. Following recruitment and completion of baseline assessments participants will be randomly allocated to one of two intervention groups. One group will be asked to wear an activity tracker on their wrist which will record daily activities, participants will be asked to return this monitor at the end of the study; the second group will be asked to recall and record their activities each day. Participants will complete follow-up assessments at 3,6 and 9 weeks post baseline assessment. Objective measures of behaviour and cardiometabolic risk will be assessed in addition to self-report measures of behaviour, physical and mental well-being and correlates of activity, sitting and sleep behaviours.