ANZCTR search results

The present study aim is to evaluate the safety, tolerability and feasibility of repeat SUSonly treatments in participants with AD using a bespoke low frequency transcranial SUS investigational device termed UltraTheraPilot.

Rationale: Multiple Sclerosis (MS) is a complex neurological disorder of the central nervous system which causes a wide variety of symptoms including problems with fatigue, mobility, muscle function, pain, cognition, speech, bladder function, and vision. Nearly a third of the total cost of MS in Australia results from a loss of income due to sickness and early retirement. An intervention that maximises work productivity and keep people with MS in the workforce for longer can provide a large societal cost saving and improve the quality of life of people with MS. Overall aim: Test the feasibility of delivering and evaluating a remotely delivered intervention called ‘MS WorkSmart’. Design: Two-arm randomised controlled trial (unblinded), comparing those receiving the MS WorkSmart package to those receiving usual care. Participants: Australians with MS who are employed (work 10 or more hrs/week, MS Work Instability Score>10, aged 18-60 years). Measures: Measures are assessed at baseline and 1-month post intervention. Primary measures include MS-related work productivity loss, and risk of job loss (using the MS Work Instability Scale). Secondary measures include MS work behaviour self-efficacy scale, health-related quality of life (EQ-5D-5L & QQ-5D-5L-Psychosocial), fatigue severity (MFIS-5), impact of symptoms on work, intention to retire due to MS, MS work difficulties (MSWDQ-23), and MS work change awareness scale. Feedback will be obtained 1-month post-intervention from those participating in the MS WorkSmart Program. Analyses: Descriptive analyses of the recruitment, adherence and fidelity; process evaluation of the experiences of participating in MS WorkSmart, and; calculation of measures of variations for future sample size calculations using linear mixed models.

ACCESS will investigate a novel model of care designed to address specific barriers to access to the services Aboriginal children need to reach their maximum potential in life, as is their right. This co-designed innovative model will support Aboriginal children and their families access and navigate prevention, early intervention and treatment services, and address underlying social determinants of health. It will establish a foundation on which Aboriginal Community Controlled Health Services (ACCHS) partners can build a sustainable model of care with potential to be expanded to other child health priority areas and to other ACCHS partners to improve Aboriginal child health outcomes at a national level. The Aboriginal Child Health Navigator can be described as an “educator, liaison, buffer, collaborator, and friend” and is “responsive to an Indigenous holistic health and social and emotional well-being model” (CI Sherwood). The health navigator will assist families to access services, navigate referral pathways, translate knowledge and provide holistic support.

Around 1 in 5 people have chronic musculoskeletal pain that frequently causes extreme suffering and incapability for individuals and substantial costs for society. People with chronic pain report high levels of pain-related emotional distress, suggesting it is critical to integrate mental wellbeing with chronic pain management. Mindfulness-Based Stress Reduction (MBSR) is a mind-body approach developed to help people manage the stress associated with long-term conditions. It promotes self-management via reducing anxiety, leading to improvements in pain intensity and pain self-efficacy. MBSR is typically delivered face-to-face in group sessions. However, in-person interventions restrict access. By offering MBSR online, people from any location can access the course at a reduced cost. The feasibility and acceptability of an online MBSR intervention have not yet been evaluated for chronic musculoskeletal pain. The proposed study aims to assess the feasibility and acceptability of an online MBSR program for people with chronic musculoskeletal pain. MBSR training is traditionally delivered via in-person group sessions. However, access to in-person group sessions can be difficult for many reasons, such as disability and poor accessibility, cost, availability, and COVID-19 physical distancing measures. The aim of this research study is to evaluate the feasibility and preliminary efficacy of an online MBSR training program for people with chronic musculoskeletal pain.

The primary purpose of this observational study is to check whether frailty predicts mortality/death in patients who are in the hospital for an upper gastrointestinal bleeding (UGIB) episode. We hypothesize that frailty is an independent predictor of death in patients with UGIB and other important hospital outcomes.

The Quit by Phone Study (QPS) is parallel, two-group, single-blind, randomised controlled non-inferiority trial with an aim of determining, in a low socioeconomic population of smokers, the effectiveness and cost effectiveness of a tailored text message (TTM) program at achieving 6-month continuous biochemically validated smoking abstinence rates, compared to standard Quitline support services (SQ). Secondary outcomes include self-reported abstinence, reduction in number of cigarettes between baseline and follow up, and the acceptance and maintenance rate of each intervention. The QPS aims to recruit 1246 participants from NSW that are at least 18 years of age; in receipt of a government pension or allowance (proxy for low-SES); current daily smoker wanting to quit tobacco smoking; willing and interested to make a quit attempt in the next week; own a mobile phone that can receive and send text messages; agree to use the allocated behavioural quit support service (TTM or SQ). The primary analysis is based on intention-to-treat and will compare the quit rates between groups (TTM "and" SQ) in a Bayesian framework. Participants lost to follow-up or not providing biochemical verification result or participants with a CO level > 5 ppm will be included as non-abstainers (smokers).

The Tuned In program was developed in 2012 by Dr Genevieve Dingle as an experiential music-based program designed to increase emotion awareness and regulation for young people. Research to date indicates that the Tuned In program is effective in increasing emotion awareness, identification and regulation for young people (Dingle, Hodges & Kunde, 2016; Dingle & Fay, 2016; Vidas, Nelson, & Dingle, in prep). This research project will expand on work to date to examine the effectiveness of a modified version of Tuned In for university students. The program will be run via videoconferencing due to general health recommendations during the global pandemic. It is hypothesised that the Tuned In program, in comparison to the control group, will improve participant’s emotion regulation ability, improve wellbeing, and decrease emotional distress. This research will inform the existing evidence base regarding the efficacy of Tuned In as an emotion regulation program for university students with a variety of health and wellbeing presentations.

Fear of cancer recurrence (FCR) is the fear, worry or concern cancer will come back or progress. It is a significant unmet need for cancer survivors and has been consistently linked with psychological distress and lower quality of life. Over the past decade, a number of psychological treatments have been developed to better address FCR in cancer survivors, however, there are barriers to the uptake of these treatments, such as a lack of routine screening and limited availability of therapists. A stepped-care treatment model for FCR may help overcome these barriers, and involves offering treatments of differing intensity tailored to survivors' level of symptoms as identified through routine screening. The aim of this study is to assess the feasibility, acceptability, and efficacy of this approach in cancer survivors with early stage disease. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are a breast, head and neck, or gynaecology cancer survivor with early stage disease who has completed initial curative treatment. Study details Survivors who have completed FCR screening will be invited to take part in the stepped-care program and to complete a survey about the screening. Those with low FCR will receive treatment as usual, which will involve attending their usual appointments with medical/nursing teams, where they may be provided with details about how to access psychological services should they be required. Those with moderate FCR will be offered an educational self-management booklet designed specifically for this study. These participants will be posted the booklet and provided education on the booklet by phone by a clinical psychologist. These participants will also receive a phone call from the clinical psychologist at 3 weeks and 5 weeks after receipt of the resource to discuss their treatment needs and any follow-up support required. Participants with high levels of FCR will be offered ConquerFear therapy, which consists of five individual 60-minute sessions delivered by a clinical psychologist every 1-2 weeks over a period of 10 weeks. These sessions will focus on strategies for managing worry, changing unhelpful beliefs, education on follow-up care, and goal-setting. Participants will also be instructed to complete home-based practice of skills learned during the sessions and home reading to consolidate skill acquisition. For participants who receive the self-management booklet or undertake the ConquerFear therapy, follow-up assessments will occur via telephone to determine their level of FCR and any further supports needed. They will be asked to fill in a survey about the intervention they received. It is hoped that this study may show that a stepped-care approach is feasible, acceptable, and effective for managing FCR in cancer survivors, which may help to shape the care of other cancer survivors in future.

The EMBO-01 study is a first-in-human study of a new investigational device, the Distal Penetrating Embolic System (DPE), for pre-operative embolisation of a type of brain tumour that is hypervascular (has a lot of blood vessels) and extra-axial (not part of normal brain tissue). The purpose of this study is to assess the safety and feasibility of using DPE in patients with these types of brain tumours, and to assess whether embolisation can reduce blood loss during surgery and make the tumour easier to remove. Who is it for? You may be eligible for this study if you are aged between 18 and 80 years (inclusive), have been diagnosed with a hypervascular extra-axial brain tumour, and are planned for pre-operative embolisation and subsequent surgical removal of the tumour within the next 7 days. Study details All participants will undergo the embolisation procedure within 7 days of their surgery. Embolisation is a separate procedure in which a material known as an “embolic agent” is injected into the blood vessel(s) to form a plug within the vessels to stop blood flow to the tumour. The procedure will be done by a specialised doctor called a neurointerventional radiologist, and will take approximately 2 hours to complete. An x-ray will be performed before and after the embolisation process to document successful injection of the DPE into the target vessels supplying the tumour and the effects of this on blood supply to the tumour. During the surgical procedure to remove the tumour, data will also be collected such as blood loss, surgical time, and time taken to remove the tumour. The removed tumour may then be analysed by a pathologist. Additionally, participants will be asked to complete a number questionnaires for up to 90 days post-embolisation to assess for any complications of the procedure. It is hoped that this study may show that pre-operative embolisation using the DPE is safe and feasible in patients with hypervascular extra-axial brain tumours. It is also hoped that the procedure is able to reduce blood loss during surgery and reduce the time taken to remove the tumour, which may lead the way for a larger trial.

This project is a cross-over trial that will compare the effect of two approaches to lower limb manipulation on maximum strength and movement strategies during a weighted squat, using healthy participants with experience in strength training and with limited ankle mobility. Each participant will attend three sessions. The first session will involve familiarisation with the procedures and baseline tests. The second and third sessions will involve a series of different manipulations to the ankle and knee. After each treatment, participants will perform a weighted squat and strength and movement strategies will be recorded using video motion capture. We hypothesise that the ankle and knee manipulations will improve maximum squat weight, lower limb movement strategies, and ankle range of motion, with possible differences between the two approaches.