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Anxiety and depressive disorders are amongst the most prevalent psychological disorders worldwide. Young people are at the highest risk of developing depression and anxiety as adolescence is a key developmental stage in which these disorders tend to emerge. Psychological intervention is the leading approach to treatment, however the efficacy of available approaches is limited and the right support is not available when and where it is needed most. Improving the efficacy of treatment might be achieved by providing access to digital interventions via smartphones which can provide support at key moments in daily life. Based on the above rationale, a novel smartphone intervention was developed called Mello. Mello is the world’s first smartphone intervention providing targeted, personalised support for young people with depression and anxiety in daily life. The primary aim of this pilot RCT is to evaluate the feasibility and acceptability of Mello in a community sample of young people who experience depression and/or anxiety, with secondary aims examining whether using the app leads to improvements in mental health symptoms.

Whilst high-grade atrioventricular block (HGAVB) occurs in a significant proportion of patients after transcatheter aortic valve implantation (TAVI), there are currently no sensitive and specific methods for predicting this adverse outcome. This study aims to determine the utility of both novel and previously published electrophysiological predictors of HGAVB including rapid right atrial pacing and HV interval testing before and after TAVI. This study will use implantable loop recorders to detect delayed HGAVB after TAVI.

The Enhance study is a randomised placebo-controlled double-blind proof of concept clinical trial to analyse whether using a daily supplement can improve egg quality. Women between the age of 36 and 42 requiring IVF trying to conceive will be randomised for the use of NR at the dosage of 250mg, 1000mg, or placebo, once a day for six weeks before the trigger (36 hours before the egg collection) in an IVF cycle. A primary outcome will be analysing the number of day 5 blastocysts and secondary outcomes: number of oocytes retrieved, final estradiol level, fertilisation rates, number of embryos surviving to D3, pregnancy rates and outcomes, and NR safety. We will also be evaluating the bioavailability of NAD in blood and follicular fluid and oocyte quality.

Rapid Syllable Transition Treatment (ReST; McCabe et al., 2017) is a motor speech intervention that aims to improve speech intelligibility. It involves the use of non-words to practice and improve the ability to say syllables and words fluently using the right sounds and beats. ReST uses principle of motor learning which have been shown to promote motor skill acquisition in motor speech interventions (Maas et al., 2005). This study aims to investigate if ReST improves speech intelligibility and the child’s ability to take part in daily conversations, referred to as communication participation. The hypothesis is that ReST will improve speech intelligibility and communication participation in children with cerebral palsy more than usual care.

The purpose of this study is to examine implementation of a tool for addressing fear of cancer recurrence (FCR) in oncologists who treat patients with early breast cancer. Who is it for? You may be eligible for this study if you are a currently practicing Medical oncologist, Radiation oncologist, or senior trainee with greater than 6 months training in clinical oncology, who treats women with early stage breast cancer. Study details All participants will be given access to online CIFeR training hosted on the Thinkific platform, featuring didactic material on the prevalence, severity, clinical features and outcomes of FCR, description of the CIFeR (the Clinician Intervention to Reduce Fear of Recurrence (CIFeR) intervention) intervention and evidence supporting its efficacy captured in short videos of the study team, and videos of clinicians and patients modelling intervention delivery. After they have completed the training, they will be asked to complete a post-training measure of self-efficacy to manage FCR. They will then be asked to use CIFeR with suitable patients for the next 6 months. Participants will complete a number of questionnaires at 3 and 6 months post-completion of the training, in order to assess clinician-rated adoption, acceptability, appropriateness, feasibility, fidelity, and self-efficacy. Barriers and facilitators to implementation of the tool will be assessed through semi-structured interviews. Cost of administering the tool and penetration of the intervention will also be determined. It is hoped that this research will demonstrate that the CIFeR tool is easily adopted and considered acceptable by clinicians for use in their treatment of patients with early breast cancer who have a fear of cancer recurrence.

he purpose of this study is to find out if patient experience can be improved by patient information cards. Who is it for? You may be eligible for this study if you are aged 18 or older, and are admitted under the Urology team at John Hunter Hospital. Study details Participants who consent to this study will be randomly allocated to either the group that receives the patient information card, or the group that undergoes routine clinical care (without the card). Participants who are given the card can write questions on the card regarding their hospital stay or surgery, and the questions will be answered daily. Relevant medical record information will also be automatically collected, and all participants will be surveyed at the end of the study. It is hoped that this research will demonstrate that patient information cards can improve communication and patient understanding about their health, and thus benefit patient experience.

Overview: This trial aims to determine whether the high-cost, highly specialised biologic, biosimilar and targeted synthetic disease modifying anti-rheumatic drugs (b/tsDMARDs), used to treat Australians living with severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA), can be safely reduced without compromising efficacy. The trial will concurrently address patient and clinician concerns regarding drug safety, efficacy and health system sustainability, with potential to lead to less harms and substantial individual and societal savings. The project will generate new knowledge on RA and PsA low disease activity state and/ or remission in the short to medium term while optimising long-term return on investment by following participants longitudinally as a clinical registry/biobank cohort. Clinical and biomarker predictors of successful (or failure) of down-titration strategies will be evaluated. Design: A multi-centre, open-label, non-inferiority, parallel-group randomised controlled trial of disease-modifying antirheumatic drug (DMARD) +/- conventional synthetic (cs)DMARD dose continuation (USUAL CARE) vs discontinuation after tapering (STOP) in adults with rheumatoid arthritis and psoriatic arthritis in sustained low disease activity at baseline. Comprehensive clinical, self-reported and administrative data and biospecimens will be collected throughout the study.

The current study aims to evaluate to what extent inclusion of bright light therapy as an adjunct to the treatment for depression, improves sleep and mental health outcomes for young people with depression.

Childhood eczema is one of the most common chronic health conditions among children. There is no cure, and it places an enormous burden on affected children and their families. Interventions to help parents develop the skills to handle challenging child behaviour, manage their own stress, and implement treatment consistently can improve children’s health outcomes. Brief parenting intervention is effective in targeting the child behaviour and parenting challenges that can make condition management more difficult for parents; however, face-to-face intervention delivery poses a barrier to many families and limits accessibility and reach. This research will examine whether a self-directed online parenting intervention can deliver the same outcomes as a face-to-face group program, leading to improvements in parenting practices, parents' self-efficacy with eczema management, child emotional and behavioural adjustment, health-related quality of life, symptom severity, and treatment adherence, with better accessibility and at lower cost. Given the current pandemic, it is essential that we harness online and telehealth approaches to ensure that evidence-based programs are able to be accessed by the families who need them. This research will examine a novel and unique application of an online parenting intervention that will complement existing health care services and make a significant difference to Australian children.

This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This study will assess the clinical activity of Sotorasib in adult patients with advanced cancers (excluding non small cell lung cancer and colorectal cancers) harbouring KRAS G12C mutations. Who is it for? You may be eligible for this study if you are an adult aged 18 years or over with and advanced and/or metastatic solid cancer. Study details: Participants will receive 960 mg of oral Sotorasib to be taken daily. The duration of the study is until disease progression. Participants will complete imaging, clinical and safety assessments throughout the study. Participants will undergo imaging assessments at screening, cycle 2 day 1, cycle 3 day 1 then 8 weekly intervals for 12 months and then 12 weekly, or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will be assessed at 4 weekly intervals. Each cycle is 28 days. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Sotorasib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study