ANZCTR search results

The aim of this study is to determine if a single session of LymphaTouch® treatment is as effective, than standard manual lymphatic drainage (MLD) in improving lymphoedema outcomes. Who is it for? You may be eligible to join this study if you are a female aged 18-75 years and have secondary arm lymphoedema in one arm only following axillary node dissection from either breast cancer or melanoma of between 6 months and 5 years duration. Study details Study participants will be assigned on a 'chance' basis to receive standard care or an intervention. Those allocated to standard care will receive one session of manual lymphatic drainage. Intervention group participants will be treated with LymphaTouch device during one session. LymphaTouch uses negative pressure, medical technology designed to lift tissues upwards through a vacuum force. Before treatment, immediately after completion of treatment and 24-48 hours later, tissue softness, patient reported outcomes and participant’s satisfaction with treatment will be measured. It is hoped that this study will determine if LymphaTouch® treatment is as effective, than standard manual lymphatic drainage (MLD) in improving lymphoedema outcomes.

The purpose of this study is to investigate whether a new drug called PIN-2 is safe and activates the immune system in patients with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a histologic diagnosis of an advanced solid tumor. Study details All participants in this study will receive one cycle of chemotherapy treatment with the drug, PIN-2 (Precision Immune Stimulants). PIN-2 will be administered intravenously (i.e. directly into the vein) 3 x per week for 2 weeks followed by a one week rest period. If tolerated and deemed beneficial, a second identical course may be administered. No more than 2 courses in total will be given. Participants will be regularly monitored for safety, and asked to provide a number of blood samples across a 5 week period to assess how the body processes and responds to the drug. Tissue samples (tumor and/or lymph node) will also be obtained, if possible, at pre-treatment and again at the conclusion of each treatment cycle for evaluation. Patients who are eligible for and agree to participate in the biopsy will have tumor biopsy prior to treatment and at week 3. This study will help find new methods of treatment for the patients with solid tumors.

There is a great deal of variability in neurodevelopmental outcomes for babies and children born very preterm. A number of antenatal and neonatal complications have been associated with increased risk for adverse neurodevelopmental sequelae. Yet currently there is a paucity of evidence surrounding the effect of parent developmental literacy as a protective enabler for optimal neurodevelopment following very preterm birth. This pilot study seeks to address this knowledge gap by exploring whether a parent education program for mothers and fathers of very preterm infants is effective in improving parent developmental literacy. Our aim is to build practical evidence regarding PEDaL program efficacy, acceptability and feasibility that is specific to the Australian health care service. The study setting is a large metropolitan Neonatal Nursery in South Australia, comprising intensive care and special care units. Sample size = 20 families with babies born at less than 32 completed weeks' gestation and 20 multi-disciplinary staff employed within the Neonatal Nursery. Recruitment period is 4 months. Parent participants will undertake an education program designed to improve their understanding of their baby’s development, and how they can support this in the first months after preterm birth. The program begins early, whilst inpatient in the Neonatal Nursery, and continues until 4 – 6 weeks post discharge. We will use a pre-test post-test study design. Primary outcome is parent developmental literacy. Secondary outcomes include parent sense of competence, parent mental health, program acceptability and satisfaction as assessed by parents and multi-disciplinary neonatal staff. Length of stay and infant readmission to hospital within 30 days of discharge are also secondary outcomes for the study.

The PARTNER project aims to implement and evaluate a new model of service delivery to improve the health of people with knee osteoarthritis (OA) in Australia. Currently, the day-to-day care of people with OA in Australia is inconsistent with care recommended in established clinical guidelines. Our new model focuses on both the person with OA and their general practitioner (GP). Firstly, the intervention will support GPs to gain an understanding of the effective conservative, non-surgical management options available for treatment of patients with OA. GPs will be provided with professional development and training including audit/feedback, and electronic medical record decision support. Secondly, patients will receive advice and support on issues related to the management of OA including exercise, weight loss, pain management and other self-management behaviours. The intervention will be delivered remotely by a centralised, multidisciplinary team of health professionals trained in best-practice OA management. This ‘Care Support Team’ (CST) will also have skills in health coaching and behavioural change which will support patients to manage their knee OA, and will help the GP facilitate additional healthcare services if required. This project will implement and evaluate the proposed model of service delivery (PARTNER model) in a mixed methods study including a randomised controlled trial (RCT) in two Australian states with economic and qualitative evaluations. This trial will help us to better understand the effectiveness, feasibility, acceptability, sustainability and cost-effectiveness of the model. We are partnering with a range of academic, industry and professional health organisations to ensure optimal delivery of the model and to facilitate long-term implementation into the Australian healthcare system.

The primary objective of this project is to examine the response of isolated rural carers for older people with dementia to a videoconference based peer support and information program. Will participation in the program improve self-efficacy, quality of life, and mental health? Secondary objectives are to develop a videoconference based peer support program for isolated rural carers for older people with dementia, using a co-design approach; and to demonstrate the feasibility of videoconference technology for enhancing social support to family caregivers in their homes. This project will combine the evidence from two recent research projects to collaboratively co-design and evaluate a facilitated videoconference peer support and information program to carers of people with dementia within rural areas. Carers will be recruited through local community health and care providers. Program development will focus on using an information sharing approach to facilitate social interaction. The project will use off-the-shelf technology which will be more accessible than specialised bespoke solutions that are currently popular in this area of research. A mixed methods repeated measures randomised wait list design will be used to evaluate the project. The primary outcomes are self-efficacy, quality of life, and mental health. Secondary outcomes are perceived social support and user satisfaction with the technology and intention to continue videoconference interaction.

Preterm birth (PTB) is a major problem of global importance. Although it has been known for some time that PTBs at the very early gestational ages are often associated with intrauterine inflammation and infection, clinical strategies to treat the infection have largely been unsuccessful. This study aims to undertake a prospective, open-label, randomised clinical trial of a ‘screen and treat’ program aimed at preventing infection-driven spontaneous PTB (sPTB). The design is built upon an earlier European trial which achieved a 40% overall reduction in sPTB rate, and we have added improved efficacy in risk-identification and treatment strategies. The single centre, multi-site study will recruit women with singleton pregnancies, asymptomatic for vaginal infection, attending antenatal clinics at 14-20 weeks’ gestation in two public hospitals within the Perth metropolitan area. A total of 6174 women will be recruited over a 2 year period, randomised after recruitment to either a control or intervention group (n=3087/group). Participants will self-collect a vaginal swab to be screened for microbial risk factors using a unique DNA-based assay. Participants in the control group will receive normal care and results of the tests will not available until after the pregnancy is completed. Intervention group participants will be informed of their result and mailed their antimicrobial therapy plus a vaginal probiotic to reduce relapse rates; re-screening will occur at 22-28 weeks’ to assess treatment efficacy. The primary endpoint is reduction in sPTB <37 weeks’ gestation; secondary endpoints included additional delivery outcomes, maternal morbidities and neonatal mortality and morbidities. The trial is conservatively powered to detect a 30% reduction in overall sPTB rate from 4.83 to 3.38% (80% power, alpha=0.05). If this success were to be translated nationally, the reduction in number of PTBs each year would be approximately 4500 cases.

To conduct a prospective, randomized, double-masked pilot study testing the hypothesis that near-infrared (NIR) laser acts as a neurorecoverant and improves contrast sensitivity in glaucoma patients. This is a pilot study designed to provide motivation (or not) to proceed to further research. It would be inappropriate to proceed without a pilot study of this nature. WHAT IS THE PURPOSE OF THE STUDY? We are trying to assess the effectiveness of a new type of low-energy laser. This laser is currently being studied in diabetic eye disease and we believe that it may be effective in glaucoma. The laser improves the energy supply to sick nerve cells at the back of the eye, especially those affected by glaucoma. We are hoping that this laser may actually improve vision in glaucoma. It is a very safe laser and if successful is likely to be used in conjunction with eye pressure lowering treatment. The purpose of this study is to establish a proof of a principle known as neuroprotection. Neuroprotection: refers to the ability to directly promote survival of the optic nerve. The optic nerve is the nerve that transmits visual information from the retina to the brain. Contrast sensitivity: is the ability to differentiate between light and dark (contrast). This study is to assess whether low doses of Near Infrared (NIR) laser light are beneficial in improving contrast sensitivity in glaucoma patients. Lasers are routinely used and are approved in Australia for treating a variety of eye diseases these lasers are called Thermal Lasers and are usually green in colour. They are applied to the retina through a special type of microscope and many laser spots are individually placed over the affected area. In all cases, these lasers work by burning small areas of the retina in order to trigger the required healing response that, with time, decreases the amount and extent of the swelling. We are trying to assess the effectiveness of a new type of NIR laser that is about 100 times lower in power density than a Thermal Laser. The NIR laser causes no burn; however, it appears to stimulate a healing response to injured cells and reduces edema and enhances cellular function. Hypothesis NIR laser improves contrast sensitivity in glaucoma patients

This study is a multi-centre, mixed method, retrospective, observational study in children aged 0 to 16 years presenting to an Emergency department with head injuries of any severity. We are assessing the use of CT scanning of the brain in the diagnosis of head injury and exploring the clinician and organisational related factors influencing the use of CT scanning by conducting interviews with clinical staff employed in Emergency departments.

The primary purpose of this trial is to evaluate the efficacy and safety of a new radionuclide therapy (177Lu-PSMA617) for advanced prostate cancer, in comparison to the standard care, cabazitaxel. 177Lu-PSMA617 is a radioactive molecule that specifically attaches to cells with high amounts of PSMA on the surface of the cells. This allows the radioactivity to be delivered mainly to the prostate cancer cells wherever they have spread, while sparing most normal tissues. Who is it for? You may be eligible to participate in this trial if you have been diagnosed with metastatic castration resistant prostate cancer for which you have previously received docetaxel. Study details All patients enrolled into this trial will be randomly allocated (by chance) to receive either 177Lu-PSMA617 or the standard care cabazitaxel chemotherapy. Patients in the 177Lu-PSMA617 arm will receive up to six six-weekly doses of 177Lu-PSMA617. Patients in the cabazitaxel arm will receive up to ten three-weekly doses of cabazitaxel. Treatment in both arms will continue until your cancer progresses, you have unmanageable side effects or until the maximum number of treatments has been reached. All patients will complete scans and questionnaires as part of this trial, up to every 3 weeks, to assess the impact of the treatment on your cancer, on your pain levels and your quality of life. It is hoped that this trial will provide further information on the risks and benefits of 177Lu-PSMA617 treatment compared with cabazitaxel in men with advanced prostate cancer.

The Australian health care system is facing many challenges as a result of an ageing population, rising rates of chronic and complex disease and a strong demand from consumers for more and higher quality health care services. A high performing and adequately resourced primary health care sector is needed to address these challenges and produce better population health outcomes and sustainable health care funding into the future. Flinders QUEST will test whether Australian general practices that are assisted (logistically and financially) to deliver enhanced services can produce better patient health outcomes and improved health service use.