ANZCTR search results

The primary objective of this randomised controlled trial is to quantify the effect of tDCS and exercise on pain, disability and QoL in people with hip OA. Our secondary objectives include: 1) quantifying the influence of motor cortex excitability and CPM on treatment effects, and 2) quantifying the economic cost/ benefit of tDCS for improving health-related QoL in people with hip OA.

This study will determine the effect of highly targeted exercise on the bone health of people with multiple myeloma. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with multiple myeloma and you are currently taking bisphosphonates (bone active medication). Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will be given an individual exercise program that consists of two supervised sessions and one at-home session per week. Participants in this group will be asked to complete these weekly sessions for 9 months. Participants allocated to the second group will be asked to continue with their current care program which may include exercise but will not include the weekly program described above. Participants in the second group will also be given information sheets to review from Myeloma Australia. All participants will be asked to undergo a series of assessments, including bone scans and exercise assessments at 3-months and 9-months after enrolment. It is hoped this research will demonstrate that bone-targeted exercise will not only maintain bone health but may delay the progression of bone tumours by altering the behaviour of bone cells. It is also hoped that this exercise program can increase muscle strength and physical function, and reduce pain, improving quality of life in people with multiple myeloma.

Currently, there is a critical lack of established mental health services or treatment programs for burnout, let alone services or programs tailored specifically for health professionals. Burnout is a work-related syndrome characterised by emotional exhaustion, disengagement from work, and a reduced sense of accomplishment. Burnout is notably prevalent among health professionals, especially due to the COVID-19 pandemic. Burnout is a cause for concern as it is related to poor mental health among health professionals, increased staff turnover, and reduced patient safety. To help address this, the Black Dog Institute (BDI) created an online self-guided cognitive behavioural program designed to support health professionals experiencing burnout. The “Navigating Burnout” program sits within BDI’s dedicated health professional support service – The Essential Network (TEN) – where health professionals can access a both digital and person-to-person services. In this study, we will conduct a 10-week randomised-controlled trial to examine the effectiveness and acceptability of a “blended care” version of Navigating Burnout in supporting doctors experiencing burnout, in which a clinical psychologist will work through Navigating Burnout with the participant. This blended care Navigating Burnout will be compared to (a) a self-guided version of the digital program where the participant will work through the program online by themselves and (b) an active attention control where participants will be provided with digital self-care.

Trans and gender diverse young people face an alarming rate of mental health difficulties. Due to their unique experiences, the lack of available tailored mental health interventions, and their preference for trans-informed digital delivery formats, there is a pressing need for an engaging and effective, evidence-based prevention intervention, designed with and for trans youth specifically. The aim of this project is to evaluate the efficacy, acceptability and feasibility of a mobile serious game adapted specifically for and with trans young people (SPARX-T) in preventing the onset and exacerbation of depressive symptoms, compared to a waitlist control.

Despite all treatment guidelines recommending exercise, 9 of 10 Australians with knee osteoarthritis (OA) are inactive. Most undergo surgery without trying exercise, despite evidence that exercise can delay/prevent surgery. However, exercise often hurts, reducing initial/sustained exercise engagement. Clinicians promise that pain will reduce over time as fitness increases/weight reduces. While evidence supports this promise, sustaining exercise is difficult. Arthritis Australia's Exercise Report identifies improving exercise engagement as key to improving osteoarthritis outcomes and Australia's National Arthritis Strategic Action Plan calls for new ways to increase uptake of exercise in people with arthritis. New virtual reality technology holds promise and may assist with reducing exercise barriers to increase exercise uptake/engagement. Using a parallel-group, randomised controlled trial, participants will be randomised to one of two active treatment groups. Both groups will receive 2 weekly in-person treatment sessions with a physiotherapist for a period of 6 weeks. Primary outcomes include the WOMAC and perceptually-regulated exercise.

The immune checkpoint inhibitors (ICI) are a form of cancer treatment that have resulted in significant improvement in the outcomes of the management of a number of malignancies. They work by activating the immune system and thereby promoting the destruction of cancer cells. The use of ICIs is limited by a group of side-effects known as immune related adverse events (irAEs). One of the more common irAEs is the development of inflammation of the large intestine known as ICI colitis. The treatment of ICI colitis is mostly aimed at suppressing the immune system and ‘switching off’ the overactive immune cells that are causing the inflammation. The use of treatments that suppress the Immune system may themselves result in significant side-effects by increasing the risk of infection. Immune suppression may have a detrimental impact on the outcome of the cancer being treated, by reducing the ability of the patient’s immune system to control the cancer. Who is it for? You may be eligible for this study if you are an adult who is receiving treatment for a solid cancer, who has experienced onset of colitis symptoms within 6 months of treatment commencement. Study details Participants in this study will be able to choose if they wish to receive the intervention or are considered part of the 'control' group. Participants who choose to receive the intervention will undergo a colonoscopy where they will receive a faecal transplant. If a participant chooses not to receive the intervention, they will continue with standard treatment as determined by their doctor. All participants will then be followed up for 8 weeks and asked to complete questionnaires and provide additional blood and stool samples. It is hoped that this study will help assess the efficacy and safety of Faecal Microbiota Transplant as first-line therapy in the treatment of ICI colitis.

Management of cancer is a rapidly evolving field, and it occurs in 4 stages: phase 1 (P1) to phase 4. P1 clinical trials are designed to test drug pharmacokinetic profiles and toxicity. However, most often patients enrol in these trials for potential therapeutic benefits. P1 trials often require participants to frequently interact with the health care team for various investigations and treatment. This time they spend interacting with the health care team has the potential to reduce quality time that participants could have utilised otherwise. This is called 'Time Toxicity' and it is defined as the time a participant spends organising and obtaining treatment including in/out-patient visits, hospitalisations, emergency care for side effects, travel and wait times, and follow-up tests. TT reported in participants undergoing cancer treatment has shown to carry a substantial burden, but its impact on the quality of life in participants undergoing P1 trials is not well explored. As such, it is often overlooked as a deciding factor in the consenting processes for the P1 trials. We aim to measure TT and assess its impact on the quality of life of participants enrolled in P1 oncology clinical trials through patient-reported outcomes. Who is it for? You may be eligible for this study if you are an adult with cancer who is going to take part in a phase 1 cancer clinical trial. Study details All participants in this study will continue with their phase 1 clinical trial, and will be asked to complete a diary for 3 months to report their time toxicity. Participants will also be asked to complete questionnaires and take part in a one-on-one interview describing their experiences and expectations at the start of the phase 1 clinical trial and after the three months (or earlier). It is hoped that this study will provide data that can help clinicians, patients, and families make the right treatment decisions.

The PROPELLER registry is a database that collects clinical data on patients undergoing orthopaedic treatment for musculoskeletal injuries and disorders. It aims to monitor short and long-term patient outcomes associated with surgery and non-surgical treatments using patient reported outcomes, radiological findings, and rates of complications or revisions. The registry will support observational studies to identify factors that are associated with treatment success in patients undergoing orthopaedic treatment. The findings from the PROPELLER registry will inform future hypotheses and clinical research, potentially leading to changes in healthcare practices, systems or policies within the field of orthopaedics. By comparing its findings with those of other groups, the registry hopes to contribute to a broader understanding of musculoskeletal disorders.

People with severe mental illness (SMI) such as schizophrenia are among the groups most vulnerable for a severe course of COVID-19 illness. Factors that contribute to worse outcomes include concomitant medications, poorer premorbid general health, physical comorbidity, reduced access to medical care, and environmental and lifestyle factors such as lower socio-economic status, overcrowding, smoking, or obesity. The COVID-19 pandemic also highlighted the importance of the annual Commonwealth-funded programme of free influenza vaccination in people over the age of 65 years old and other vulnerable groups. Given that people with SMI are more likely at all ages to be eligible for the flu vaccination because of their high rate of physical comorbidity, reduced uptake will be especially clinically significant. Thus, in both COVID-19 and influenza, it is important to investigate whether vaccination has any effect on differences in subsequent COVID-19 & influenza-related morbidity and mortality between people with SMI and the general population.

Children and adolescents with ongoing medical conditions (example, epilepsy, asthma) often experience mental health problems due to their illness and other factors. A lot of the time when children are having mental health problems, they have symptoms of both anxiety and depression. Our project aims to test if a transdiagnostic therapy can help tackle this issue. Transdiagnostic means that the therapy can help treat the mental health problem that the child has (example, anxiety) and any other related mental health problems, like depression. Through this project, we want to learn whether this new therapy can help in reducing anxiety and depression symptoms in children and adolescents with these ongoing medical conditions. We are hoping to recruit 60 children and adolescents (8-17.11 years) with chronic medical conditions, who also present with anxiety or depressive symptoms. These children will be recruited from the Royal Children’s Hospital Clinical Psychology Service. By understanding its effectiveness, we aim to offer this therapy to more families who could benefit from it.