ANZCTR search results

In this protocol, mitozantrone as a single-agent will be compared with combination CMFP chemotherapy as initial chemotherapy in patients with advanced breast cancer. At the point of disease progression, patients will cross over to the other treatment arm. Comparison of treatment arms will be evaluated in terms of time to disease progression, overall survival, quality of life, toxicity and objective response rates. The design of this study allows the primary objective of determining optimal use of existing therapies with particular emphasis on improving quality of life.

The study aims to: identify the safety and acceptability of monoamine precursor provision in the management of psychostimulant withdrawal; explore the impact of monoamine precursor provision on engagement and retention in treatment; research the effect of monoamine precursor provision on the clinical course and severity of psychostimulant withdrawal; and, explore the impact of monoamine precursor provision in improving abstinence rates.

This trial investigated the effectiveness of opportunistic referral of smokers by their GP to telephone cessation counselling by a trained nurse to improve quit rates and shifts in stage of change at six and twelve months. The trial also investigated the acceptability of the intervention to patients and GPs. Intervention group patients were offered a telephone-based program delivered by a nurse comprising assessment and stage-based behavioural advice, written information and follow-up. Control group patients received ‘usual care’.

Standard of care post surgery for GBM is concurrent radiotherapy/chemotherapy followed by 6 months of chemotherapy (temozolomide). We have previously shown that the combination of Temozolomide with liposomal doxorubicin (caelyx) has activity in recrurrent GBM and is well tolerated. This study aims to assess whether the addition of liposomal doxorubicin to six months of post RT temozolomide is efficacious and well tolerated

The proposed study will determine the effect of a public health strategy (ie. increased sun light exposure and increased calcium intake) to reduce falls in older people in residential care using a randomised trial. The primary hypothesis of the trial is that increased appropriate sun light exposure will reduce falls, improve 25 hydroxy vitamin D (25OHD) levels and lower parathyroid hormone (PTH) levels. Secondary hypotheses are that the intervention will reduce accelerated bone turnover, reduce fractures, improve motor function and improve mood.

The aim of this study is to develop and test a model of service delivery that will screen patients in the acute stages post traumatic injury and then monitor and treat patients identified as at risk for mental health problems, particularly PTSD, depression and anxiety, following traumatic injury, using a trauma focused cognitive behavioural intervention.

The study aims to test the effectivenss of a patient education program whixch includes breathing exercises and psychosocial support for helping patients with lung cancer to control their dyspnoea. The study will test whether the intervention reduces a patient's feelings of breathlessness, improves their ability to funtion and minimises their emotional distress and in addition the study will examine the effectiveness over time. The information gained will provide more specific guidance to practitioners for targeting intervention approaches to each individual patient's needs.

Post surgical patients often display instability in their blood pressure and flow (haemodynamic circulation) which, if not stabilized, can lead to a range of side effects such as reduced urine output, kidney failure, fluid in the lungs, disorganized and ineffective pumping of the blood by the heart, and stroke. These side effects usually require an extended hospital stay, additional investigations and medications, and all lead to additional cost. Navigator software has been developed to link with the patient’s bedside monitor and acquire and process data collected by the monitor. This data is then displayed graphically relative to target ranges for a variety of heart measurements that were determined by the physician specifically for the patient and entered into Navigator at the start of monitoring. This provides the physician with a real time picture of the patient’s blood pressure and flow, in comparison to the prescribed values he would like to achieve and provides unique guidance as to what fluid and medication treatments could be administered to make the patient more stable. The aim of the study is to demonstrate that the real time acquisition and subsequent processing and display of data produced by Navigator provides the clinician with appropriate data and guidance to achieve and maintain a prescribed target blood pressure and flow stability in the post operative patient when compared to conventional care in an ICU setting. The study will be conducted in 100 post-cardiac surgery patients male and female aged 18 and over that have undergone coronary bypass grafting and/or heart valve repair or replacement whilst utilizing heart lung perfusion pump (50 patients per study group). Patients that meet all of the inclusion / exclusion criteria will have a 50:50 chance of being randomized to one of two study groups, Navigator or control (conventional care). All patients will be connected to a bedside monitor which in turn is connected to an Avantech computer with the Navigator software installed. Those patients randomized to the Navigator group will have the full Navigator functions available; for those patients randomized to the control group the physician will still determine target values for the heart measurements, however once control is selected on the Navigator screen the graphical part of the screen will go blank. Each patient will be connected to Navigator for as long as their doctor wishes to have their heart function closely monitored by their heart catheter. Once this catheter is removed, Navigator will be disconnected. This will be between the day after surgery and around a week after surgery, depending on the speed of recovery. All patients will undergo standard treatments during their hospital stay. The aim of this study therefore, is to demonstrate that real time aquisition and subsequent processing and display of data produced by Navigator provides the clinican with the appropriate data and guidance to acheive and maintain a prescribed target haemodynamic stability in the post operative patient when compared to conventional care in an ICU setting. Acheiving early haemodynamic stability in the post operative cardiac patient as it is hoped will lead to improved patient outcome and reduced associated costs.

We have developed two user-friendly decision aids (DAs) for patients with incurable breast or bowel cancer. These include an instrument used by doctor and patient in the consultation, and a take-home booklet and audiotape for patients. The DAs outline treatment options, benefits and likely side effects. Information is presented in different visual formats. This should help patients participate in their cancer treatment decisions. Patients and doctors have reviewed the DAs, and their usefulness will now be tested in a randomised trial. Hypotheses being examined in this study (in the randomised trial): Patients receiving DAs at the time of making a treatment decision about management of advanced cancer compared to patients not receiving DAs at this time will have enhanced achievement of their involvement preference, participate in decision-making more actively and have improved understanding of their prognosis, treatment goals and side effects, as well as be more satisfied with their care. Doctors using the DAs in consultations will have enhanced satisfaction with treatment decision-making. This project is also being run in Toronto, Canada. The recruitment target of 210 includes 105 from Canada. Recruitment is complete in all sites and analysis is underway.

Hypertension is the commonest problem managed in general practice. In this setting as in others control remains less than ideal. As there is a linear relationship between blood pressure level and risk of death any change in standard management that leads to improved blood pressure control is likely to be beneficial. CRAB will compare the measurement and management of sequential adults attending a general practice over a week. It will use the endpoints of digital preference, the number of individuals who have a blood pressure measurement, the number of measurements an individual has, mean systolic and diastolic blood pressure, and drug management where hypertension is treated. It is a trial of clinical effectiveness in general practice where the majority of hypertension is managed. This study will provide evidence for the potential changes in blood pressure recording and hypertension management of the introduction of new devices not containing mercury which are inevitable due to occupational health and safety concerns of this toxic material. The OMRON HEM-907 device is a validated blood pressure measurement device. We hypothesize that the use of automated measurement devices will increase the number of people who have a blood pressure measurement, the number of recordings per individual and will improve the management of individuals with hypertension.