ANZCTR search results

This study is investigating the feasibility, safety and effectiveness of delivering targeted radiation therapy using a device with in-built magnetic resonance (MR) imaging to identify and deliver the radiation doses specifically to the prostate tumour. Who is it for? You may be eligible for this trial if you are a male aged 40 years or over, you have been diagnosed with a solid prostate tumour that is appropriate for radiation treatment and the cancer has not spread to any other organs. Participants will also need to be able to undergo MR imaging, additional criteria for MR imaging will apply. Study details Participants will receive radiation to the prostate gland using a Linear Accelerator device with MR imaging capability. The intervention is intended to be delivered as 2 sessions over 2 weeks. Participants will be asked to provide blood samples to check the PSA level throughout the study to assess the response to treatment. Data on prostate specific antigen (PSA) response to treatment, as well as any changes to the participants' urinary/bowel habits and sexual function will also be collected. It is hoped that this study will determine whether an MRI-guided approach to radiotherapy is a feasible, safe and effective method for the treatment of prostate cancer that has not spread to other organs.

Many Aboriginal and Torres Strait Islander families and communities face significant challenges. Contributing to these challenges are historical and ongoing dispossession, marginalisation, and racism, as well as the legacy of past policies of forced removal and cultural assimilation. These challenges impact negatively on Aboriginal and Torres Strait Islander people’s health and social outcomes. In terms of physical health, Aboriginal and Torres Strait Islander males are one of the most marginalised groups in Australian society. There is a 10.6 year lower life expectancy in comparison to non-Aboriginal and Torres Strait Islander males. Cardiovascular disease (CVD) is the leading contributor to premature deaths among Aboriginal and Torres Strait Islander people (25% of all deaths), with Aboriginal and Torres Strait Islanders dying from this condition at 1.5 times the rate of non-Aboriginal and Torres Strait Islander people. Modifiable risk factors for CVD are common among Aboriginal and Torres Strait Islander males; only 13% meet national physical activity recommendations and 5% meet dietary guidelines for fruit and vegetables. Further, Aboriginal and Torres Strait Islander adults were 1.2 times as likely as non-Aboriginal and Torres Strait Islander adults to be living with overweight or obesity. In Aboriginal and Torres Strait Islander children, those aged 2–14 years are twice as likely as non-Aboriginal and Torres Strait Islander peers to have a heart or circulatory condition (2.0% compared with 0.9%). In general, fathers’ beliefs, behaviours, and parenting practices can have a large impact on children’s eating and activity behaviours. However, a review of 213 family-based programs targeting children’s lifestyle behaviours, identified that fathers accounted for just 6% of participating parents. Of these studies, none targeted Aboriginal and Torres Strait Islander fathers. There is a need for Aboriginal and Torres Strait Islander men to regain control and understanding of their roles as fathers, uncles, brothers and sons. This includes caring for their children and role modelling healthy behaviours in a safe family environment. To support this goal, evidence- based, culturally appropriate programs, such as Healthy Dads, Healthy Mob: biya yadha gudjagang yadha can play an important role. The aims of our proposed project are: • To determine the preliminary efficacy of the Healthy Dads, Healthy Mob: biya yadha gudjagang yadha (HDHM) program to improve the cardiovascular health of Aboriginal families living on Darkinjung Country; • To assess feasibility of this program, specifically with reference to recruitment capability, fidelity of program delivery, attendance, compliance, program satisfaction and retention. • To collect quantitative and/or qualitative data from fathers and children to inform future iterations of the program.

This platform trial will initially enrol patients to the ALLG National Blood Cancer AML Registry (NBCR) which acts as an umbrella screening framework for AML trials conducted by the ALLG. Patients unfit for intensive chemotherapy will receive VEN-AZA. The NBCR will allow clinical data collection, storage of baseline samples for future research and MRD determination as part of standard of care. If at any stage the patient becomes eligible for participation in the AMLM28 ADAPT study, the patient will be invited to sign the applicable AMLM28 ADAPT consent form to enable trial registration and screen for one of the interventional therapy domains. Who is it for? You may be eligible for this study if you are aged 18 and above and have been diagnosed with AML, elderly and un-fit for intensive chemotherapy. A summary of proposed AMLM28 ADAPT domains are detailed below ADAPT-STOP Domain • Patients enrolled to the NBCR, receiving VEN-AZA and achieving CR/CRi/CRh MRD negative status and still negative 10-14 months after commencing VEN-AZA will be eligible to consent to “ADAPT-STOP” Domain. Patients must have completed at least 8 cycles of VEN-AZA before ceasing therapy in this domain Alternatively, patients may also be considered for eligibility to the ALLG AMLM26 INTERCEPT study (Registration number: ACTRN12621000439842p). ADAPT TP53 domain If a patient enrolled to the NBCR and receiving VEN-AZA, is found to have one or more TP53 aberrations (defined as TP53 mutation (at any variant allele frequency (VAF)), del17p or monosomy 17), the patient will be eligible to consent to “ADAPT TP53” Domain. This should occur after the first cycle of VEN-AZA. If a patient is TP53 and FLT3-ITD positive, this patient will be assigned to the TP53 domain. ADAPT FLT3 domain Patients enrolled to the NBCR, receiving VEN-AZA is found to have a FLT3 mutation, the patient will be eligible to consent to “ADAPT FLT3” Domain. This should occur prior to day 7 of VEN-AZA. ADAPT MRD domain If a patient enrolled to the NBCR, receiving VEN-AZA, after cycle 4, is found to have les than 10% blasts with positive MRD. E.g. equal to 0.1% aberrant cells by flow cytometry, the patient will be eligible to consent to “ADAPT MRD” domain. Cycle 4 will need to have been completed within 8-months from Cycle 1 Day 1. Patients can be co-enrolled to INTERCEPT monitoring phase and not INTERCEPT treatment phase. If patient has MRD relapse and goes on INTERCEPT treatment, AMLM28 will follow them up for survival via the NBCR Registry database. It is hoped this research will deliver adaptive interventions to improve clinical outcomes in patients receiving frontline VEN-AZA for newly diagnosed AML.

This study aims to compare the efficacy of two types of Self-Expandable Metallic Stents (SEMS) in the treatment of gastric malignancies. Who is it for? The study is looking for participants that are required to have stents inserted for treatment of malignant gastric outlet obstruction (or “GOO”). Purpose of the study Self-Expandable Metallic Stent (or SEMS) are placed to open a stricture or tightening within the small bowel that is causing your symptoms, as food cannot pass through from the stomach into the small bowel. Uncovered stents (U-SEMS) are often placed to open this but there is the risk of tumour growing into the stent. When the stent is covered (C-SEMS), the tumour cannot grow into the stent. However, there is the risk of the stent moving (migrating). Though there have been multiple studies assessing the difference between C-SEMS and U-SEMS, and there are both advantages and disadvantages to using either, newer comparison studies are needed, as the introduction of recent technological developments have allowed for better SEMS fixation it is not clear which type of technique is preferred. Study Details We aim to compare the differences of two types of Self-Expandable Metallic Stents (SEMS) for GOO relief: • “Covered” SEMS (C-SEMS), and • “Uncovered” SEMS (U-SEMS). These two types will be assessed in terms of stent patency, technical success, clinical success, and safety. These will be assessed at the day of the procedure, and three follow-up visits. We are particularly interested in comparing the stent patency rate between groups; the percentage of participants with stents that do not require re-intervention at 3- and 6-months post placement.

The aim of this study is to conduct a 12-week feasibility and pilot randomised controlled trial of a co-designed home-based personalised reablement strategy program delivered via Voice-Controlled Intelligent Personal Assistants (VIPAs) in older adults aged 60-89 years with mild cognitive impairment (MCI) and/or dementia. The primary aims are to assess study processes including acceptability, retention rates and adherence to the personalised reablement strategy program. The secondary aims are to compare changes in scores on the Short Form Geriatric Depression Scale, the Illness Cognition Questionnaire, the Multifactorial Meta Cognition Questionnaire, Bayar Activities of Daily Living Scale, Everyday Cognition Scale and Zarit Burden Scale. The primary hypothesis is that a 12-week VIPA-delivered home-based personalised reablement strategy program will be feasible and acceptable, as evidenced by greater than 70% retention in the study, completion of greater than 66% of the personalised reablement strategy program, and by overall themes of acceptability expressed through participant interviews. The proposed study is significant as it has the potential to transform healthcare delivery for people with MCI and dementia. The novel VIPA lifestyle delivery method can reduce the need for regular face-to face care and increase implementation and adherence to evidence-based recommended care. This will ultimately lead to improved healthcare outcomes and reduced costs on a massive scale, especially given this telehealth method removes some of the barriers to implementation related to traditional telehealth and face-to-face methods and therefore is more easily scalable. It is anticipated that this research has the potential to support the need for future studies to explore cost-effectiveness of this telehealth approach in MCI and dementia. Future projects will explore the delivery of this project to reduce healthcare inequalities by providing high quality and cost-effective services to low-income individuals and people in remote and rural areas.

Anorexia nervosa (AN) is a serious psychiatric condition with high morbidity and mortality, for which existing treatment paradigms demonstrate suboptimal therapeutic efficacy and duration of treatment effect. Convergent lines of evidence point to the use of estradiol as a pharmacological treatment option for AN. Through restoring hormonal imbalances, estradiol can address many domains of AN including mood and cognition, bone density, and appetite regulation. The proposed study aims to investigate whether estradiol is more effective in reducing symptoms of AN than placebo. Previous studies in bone health have found significant bone mineral density improvements at 100mcg/day and 40mcg/day, however, no study to date has investigated the use of estradiol to address mood and cognition. Based on our clinical work, we propose to use 50mcg transdermal estradiol patch.

The application of pressure bandage, combined with immobilisation of the bitten limb, has been the standard of care for Australian snake bite since the studies by Straun Sutherland. The technique was shown to slow the systemic absorption of an analogue of the venom of the elapid family of snakes native to Australia by cessation of lymphatic flow carrying the venom from the affected limb. A recent systematic review by Bert Avau and others has recommended against the use of the pressure bandage for 2 main reasons: First that the venom of the crotalid family of snakes (found in many countries) has a different mechanism of action resulting in increased necrosis at the bite site and second because studies have demonstrated that lay application of pressure bandages exerts too little pressure to stop lymphatic flow. Avau et al cite multiple papers disputing the efficacy of the technique or the ability of first aiders to apply sufficient pressure.. The current study aimed to determine if experienced first aiders are able to apply sufficient pressure to stop lymphatic flow (estimated to be 40 - 70 mmHg for the upper limb and 55 – 70 mmHg for the lower limb)

The study aims to establish and evaluate Australia’s ‘Birthing on Country’ remote, demonstration site in Mparntwe, Alice Springs, Northern Territory. We will redesign the health service to increase continuity and quality of maternity care, and positively impact the health and wellbeing of First Nations women and babies in Central Australia. The clinical, cultural and cost effectiveness, and acceptability, of the new service will be systematically evaluated.

People with type 1 diabetes (T1D) need insulin for survival but hypoglycaemia (low blood glucose, also called ‘hypo’) is a common side effect. Untreated hypos can cause confusion, injury, coma, and sudden death. Living with the risk of hypo impairs mental health. For example 75% of people with T1D have mild fear of hypo and 25% have severe diabetes distress. Fear of hypo drives misguided coping strategies (e.g. skipping insulin or maintaining glucose above target), which increases risk for long-term health complications. HypoPAST (Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment), is the first Australian fully online self-guided psycho-education program. It aims to reduce fear of hypo through improved prevention and management of hypos. This study will evaluate the effectiveness, cost-effectiveness and acceptability of HypoPAST. We expect that HypoPAST will lead to lower fear of hypo and improvement in other psychosocial and clinical outcomes. We expect that HypoPAST will be acceptable to adults with T1D and cost effective.

This examiner-blinded, randomized controlled clinical trial will use a two-treatment, parallel design to assess the effects of the treatments on the severity of gingivitis, accumulation of supragingival plaque and changes in the microbial composition of supragingival plaque. Participants will be randomly assigned to one of two treatments with each treatment comprising 21 days. The two treatments will be as follows: A. Tooth brushing with GC MI Paste One Perio containing 10% CPP-ACP and stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days. B. Tooth brushing with Colgate Total SF containing stannous fluoride (1100 ppm F) three times a day (after breakfast, after dinner and before bed), with no other oral hygiene procedures over 21 days. During the treatment period, all participants will be requested not to brush with any other toothpaste and not to consume any antibiotics or antimicrobials including antimicrobial mints, lozenges, films and chewing gums.