ANZCTR search results

This study aims to assess the effect of notifying women participating in population-based breast cancer screening of their breast density on their psychosocial outcomes and health services use; and to determine whether using different modes of communication (hard-copy vs online) alters these effects. Study details: You may be eligible for this study if you are a woman attending BreastScreen Queensland Sunshine Coast Service for a mammogram and are found to have dense breasts (BI-RADS category C or D - heterogeneously dense or extremely dense). Please note that this study is not enrolling women who have been diagnosed with breast cancer or ductal carcinoma in-situ. Participants will be randomly allocated to one of three arms: 1) standard care in BreastScreen Australia (no notification of breast density) vs. 2) notification of breast density plus a hard-copy written health literacy sensitive information vs. 3) notification of breast density plus online written and video-based health literacy sensitive information. Participants will then be followed up for over 2 years and be asked to complete questionnaires assessing their anxiety, health service usage and changes in knowledge and breast screening habits. It is hoped that findings from this study will help determine the utility and effects of providing breast density information to women as part of population-based breast screening.

The ROSEND clinical trial aims to compare standard of care dermatological treatment with a specialised type of radiotherapy called volumetric modulated arc radiotherapy (VMAT) in patients who suffer from chronic, recurrent rosacea. The study hypothesis is that VMAT will lead to a significantly lower rate of return of rosacea in the treatment area within 12 months of randomisation. Who is it for? You may be eligible for this study if you are an adult over the age of 60 who has been diagnosed with chronic, recurrent, moderate to severe rosacea for at least 10 years and have relapsed following treatment with at least one systemic therapy and one topical therapy. Study details Participants will be randomly assigned to either standard of care dermatological treatment or VMAT as part of this study. In Arm A, called the current standard of care, treatment will be one or a combination of the standard dermatological treatments which will involve; topical therapy applied for a minimum of 16 weeks (Metronidazole (0.75%) gel or cream, applied once or twice daily or Ivermectin (1%) cream applied once daily), and/or Vascular laser or Intense pulse light treatment – limited to three episodes of treatment, with a maximum of four weeks between each episode, and/or Oral antibiotic therapy (Doxycycline 50-100 mg per day or Minocycline 50-200 mg per day) taken for a minimum of eight weeks. All patients will complete quality of life and a medication diary. In Arm B, called Volumetric Modulated Arc Therapy (VMAT), participants will be given 20 treatments in once daily fractions delivered within a period of eight (8) weeks in total inclusive of a mid-treatment break of a minimum of two (2) weeks. Each treatment will take around 15 to 20 minutes. A medication diary (for arm A patients only) and questionnaires will be completed at the initial assessment, last day of treatment, 4 weeks after radiotherapy and at 3, 6, 9, 12, 18 and 24 months following the date of randomisation.

This project will test the implementation and clinical utility of neonatal brain MRI at Townsville University Hospital and Cairns Hospital for infants at high-risk for adverse neurodevelopmental outcomes. Infants born preterm, with low birth weight, who have a hypoxic event at birth and/or a brain injury are at high risk for adverse neurodevelopmental outcomes. An MRI can provide detailed and accurate information about brain injury and growth impairments to assist with risk stratification, however, currently, the timing of MRI is variable, with the MRI often performed at an age when general anaesthesia is required (>4 months), posing additional risks and costs. Neonatal MRI performed at term-age (without sedation) diminishes the risks and costs associated with later MRI under general anaesthesia and provides the opportunity to identify infants’ risk status early, enabling earlier and personalized treatment plans. This project aims to test the feasibility and use of neonatal MRI (at term-age) for 42 infants identified as high risk based on the cranial ultrasound or clinical grounds, making use of the learnings from the successful implementation of neonatal MRI protocols at Royal Brisbane Women’s Hospital.

The primary aim is to assess in adults with hypertension, the efficacy of a remote wearable BP-based care strategy to reduce BP in primary care over 12 months, compared to usual care. The secondary aims are to determine if this remote wearable BP-based care strategy: * is acceptable to patients and GPs * is cost-effective * improves medication adherence * improves patient engagement, * is safe, compared to usual care Hypothesis: The remote wearable BP-based care strategy will be superior to usual care in terms of efficacy in BP reduction, acceptability to patients and GPs, and cost-effectiveness.

Mental health disorders bear a significant burden on the health and well-being of young people in Australia and worldwide. Prevention during adolescence is critical for reducing immediate related harms but also preventing the development and onset of chronic mental health disorders through adulthood. The current study aims to evaluate the efficacy of an updated version of the OurFutures Mental Health program by conducting a two-arm cluster randomised controlled trial (RCT) with Year 8 students from 14 secondary schools in NSW. OurFutures Mental Health is a six-lesson, online cartoon-based intervention. It draws on cognitive-behavioural principles and incorporates psychoeducation and self-management and interpersonal skill acquisition. The intervention aims to increase mental health knowledge and, for those who report anxiety and depression symptoms at baseline, reduce anxiety and depression symptoms. This module also aims to improve important secondary social, emotional, and behavioural outcomes, including general well-being and help-seeking. The OurFutures Mental Health module is in the process of being refined to be more LGBTQ+ inclusive and trauma-informed. This cluster randomised controlled trial will involve 7 secondary schools allocated to receive the OurFutures Mental Health intervention, and 7 secondary schools allocated to a control condition who will receive their usual health education curriculum as usual (N=1400 secondary school students). Students will be followed-up for 1 year, with surveys at baseline, and 6- and 12-months. We hypothesise that compared to students in control schools, students in intervention schools will show: i) improved mental health knowledge at 3-months post-baseline ii) reduced depressive symptoms at 3-months post-baseline iii) reduced anxiety symptoms at 3-months post-baseline. We further hypothesise that: iv) compared to students in control schools who report elevated symptoms of depression and/or anxiety at baseline, students in intervention schools who report symptoms of depression and/or anxiety at baseline will show reduced depressive symptoms and reduced anxiety symptoms at 3-months post-baseline

This study looks at how helpful a mindfulness app is in improving a woman’s mental health over the period of when she is pregnant and after birth. We will also see if this app can promote her quality of life and bond to her baby, as well as reduce the cost to the healthcare system. We will also interview women to receive feedback on this approach. The study hypothesis is that regular use of the intervention (mindfulness app) will be found to be a cost-effective intervention that will reduce measures of postnatal depression, and improve mother-baby bonding.

This is an international study that aims to determine if there is a decline in neurocognitive function in children having scoliosis surgery. The trajectory of the child’s neurocognitive function will be assessed using well validated psychometric testing at regular intervals; baseline, 2 weeks post-operatively, 6 weeks post-operatively and 6 months post-operatively. The following aspects of neurocognition will be assessed: reaction time, attention, inhibition, and memory including working memory. The incidence and time course of post-operative delirium will be assessed in the first 48 hours or until discharge after surgery. Blood will be sampled for biomarkers during the immediate peri-operative period, for future analysis. We aim to enroll 50 children aged between 10 and 16 years. Currently we have no data on which to base recommendations for when children should return to school, what to expect in terms of functioning at school or when to sit exams after surgery. This study targets what could plausibly be a high risk group – major surgery. The findings from this study should have an immediate impact on what we tell parents as well as being an example for similar studies for other surgeries. The study will also provide data to understand aetiology, potential risk groups and possible targets for future interventions.

The sub-study MR-CASPER will incorporate MR Imaging and clinical assessments to examine the effect of long-term low-dose colchicine on cerebrovascular disease progression and cognitive decline using a Composite CerebroVascular Disease Burden (CCVDB) outcome measure. The aim of this study is to examine low-dose colchicine’s potential effect on the inflammatory vascular injury responsible for both recurrent stroke and post-stroke cognitive decline. Selected sites in the CASPER (ACTRN12621001408875) trial will participate in this MR-CASPER sub study, with an aim to recruit up to 200 participants who will undergo MRI for the MR-CASPER study, while concurrently participating in the CASPER trials (ACTRN12621001408875) study.

Adequate folic acid intake is a widely accepted preconception behaviour to improve fetal health and viability. Recent research has highlighted that women in preconception and pregnancy do not meet the required level of folate to support pregnancy from their diet alone and therefore to support a viable pregnancy they do need to take a prenatal multivitamin containing folate (Ledowsky et al., 2022). Prenatal multivitamins predominantly contain the synthetic form of folate, folic acid and contain upwards of 800mcg in each dose (Bailey et al., 2019; Masih et al., 2015; Murphy et al., 2021). The amount of folic acid therefore may exceed the upper tolerable limit as set by the Institute of medicine. The purpose of this study is to evaluate the feasibility of a larger trial to test a new form of folate (5-methyltetrahydrofolate (5-MTHF)) to reduce the incidence of miscarriage in those couples that have experienced recurrent miscarriage. The hypothesis is that unlike folic acid, 5-MTHF does not build up, does not mask a Vitamin B12 deficiency and can be better utilised by the body to support a healthy pregnancy, thereby reducing the risk of miscarriage.

This study will assess whether treatment with a biofactor-combination helps delay progression or worsening of symptoms of Mild Cognitive Impairment (MCI). This study will also assess whether treatment with the investigational product influences surrogate markers of cognitive impairment and vitamin and mineral blood levels.