ANZCTR search results

This study will assess the feasibility of delivering a novel remotely monitored, dose measured cycling exercise rehabilitation program to patients following total knee arthroplasty (TKA). This new method uses a mobile cycling device with an in-built power meter remotely monitored by clinicians to prescribe and modify the post-operative exercise regimen, tailoring it specifically to the patient. The feasibility outcomes from this study will inform the acceptability and efficacy of a post-operative cycling exercise program and a larger randomised controlled trial on knee muscle strength, function and post-operative recovery outcomes of a cycling based protocol versus a standard exercise regimen post TKA.

The purpose of this study is to examine if a window of 7 to 21 days between radiotherapy and surgery is feasible for metastatic brain cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with non-small cell lung cancer (NSCLC) or melanoma, and have confirmed metastatic brain cancer. Study details All participants in this study will undergo radiation therapy to individual brain tumours. This will be performed as per standard clinical practice, and involves 1-5 outpatient visits to the Peter MacCallum Cancer Centre for treatment. In general, each treatment will take approximately 30 minutes. Blood tests will be performed before radiation therapy, and at 1 week, 4 weeks, and 3 months after radiation therapy. These blood tests will coincide with follow-up appointments with a doctor. After radiation therapy is completed, 7-21 days later there will be surgery to remove the radiation-treated brain tumours. The surgery will be performed as per standard clinical practice at the Royal Melbourne Hospital. There will be a few days of hospital stay after the surgery. Brain cancer tissue from surgery will be collected for this study. It is hoped that this research will reveal if having a window of 7 to 21 days between radiation therapy and surgery for brain cancers is beneficial, and lead to better outcomes for cancer patients.

Diabetes related foot ulcers are a condition with significant financial and physical burden. New guidelines highlight a concerning lack of evidence related to the role of exercise in the management of this condition and that, given the well-known benefits of participation in exercise, it should be considered an important area of future research. However, there may be a number of physical and psychological barriers which prevent patients participating in physical activity and exercise, particularly when admitted to hospital. This project aims to explore and describe current barriers to activity and exercise in this patient group. We will also investigate the feasibility and safety of prescribing an exercise programme to patients who are admitted to hospital with diabetes related foot ulcers.

Dysphagia is common in adults living in Residential Aged Care Homes (RACHs). It can lead to malnutrition, dehydration, reduced quality of life, aspiration pneumonia, choking and death. Timely instrumental swallowing assessment, specifically Flexible Endoscopic Evaluation of Swallowing (FEES), can help to minimise these complications. Adults living in RACHs in Australia do not have equitable access to FEES compared to older adults living in other settings. This study explored a mobile service model to increase older adults access to FEES. The hypothesis was that portable FEES delivered onsite in RACHs is a safe, well-tolerated, and practical service model that can increase access to timely, person-centered, high quality swallowing care.

The purpose of this study is to see if virtual reality immersion therapy can be further tested as a potential therapy for alleviating symptoms in palliative care patients while in hospital. The information obtained will help us to learn strategies, such as time and frequency of usage of therapy, to potentially help many patients in the future. Study participation: Participants will undergo virtual reality immersion sessions daily while in hospital. Twice daily symptom assessments will be done by the investigating team. Follow up questionnaire will be applied at day 3 since commencement of intervention (after discharge if that happens sooner). A small control group will also have symptoms assessments done twice daily. Symptom assessments: Participants will answer verbally a questionnaire grading symptoms from 0 to 10, which will happen twice daily. These will last between 5 to 20 minutes. From day 3 of participating, each participant will be asked, only once, questions related to their experience up until then including tolerability and the device and duration of therapy. This questionnaire will last 10 to 30 minutes. Risks and side effects of the therapy are uncommon, but include dizziness, vertigo nausea, vomiting, anxiety and discomfort. The benefits might include symptom improvement, but will certainly help us learning more about this possibly helpful therapy.

Australian data shows that 20-25% of newly diagnosed myeloma patients who are treated with standard of care relapse within the first 12 months of starting treatment and their survival rate is lower than that of patients who relapse after 12 months of starting treatment. This group of patients are deemed to be at ‘high-risk’. The purpose of this study is to optimise treatment of newly diagnosed multiple myeloma (MM) patients who undergo autologous stem cell treatment (ASCT) by using diagnostic techniques to guide whether selinexor should be added to standard care, whether it is and beneficial to do so. Who is it for? You may be eligible for this study if you are aged 18 or older, you have been recently diagnosed with multiple myeloma. If must meet additional heart, liver and kidney health criteria prior to commencing treatment. [Study details] All participants who choose to enrol in this study will have a bone marrow sample taken and assessed to determine whether they are at high risk or standard risk disease. These details will then be used to allocate participants for ‘induction’ therapy, to either standard of care treatment (consisting of bortezomib, lenalidomide and dexamethasone), or standard of care treatment with added selinexor. This is a risk-adaptive approach to treatment, meaning your treatment is guided by the results of your myeloma risk profile. Participants will continue with their allocated treatments for 4-5 months. After this time, all participants will then undergo preparation for an autologous stem cell transplant, where healthy stem cells will be harvested from each participant and expanded externally, before being re-implanted back to stimulate further stem cell growth. At 5-6 months after the transplant, all participants will be required to provide a second bone marrow sample to undergo a second test to check how they are responding to treatment and assess if there is a very small but detectable number of myeloma cells. For standard risk patients, if there isn’t any detectable myeloma cells, you will continue treatment with only lenalidomide. If there are detectable cells, you will be given lenalidomide and selinexor. High-risk patients will be given lenalidomide and selinexor regardless of the results. This is called 'maintenance' therapy. Participants will then continue taking their second allocation of medications for maintenance for until the treatments are no longer effective. This could range from months to years. Further bone marrow samples will be required at 6 and 12 months after commencing maintenance treatment to test for detectable myeloma cells. The trial is intended to run over 4-5 years. You will be asked to complete short questionnaires about your multiple myeloma treatment and your health-related quality of life every month prior to the transplant, about 4-5 months after transplant and within 12 months after commencing maintenance therapy.

This study aims to evaluate the acceptability of a self-guided online parenting program for parents of adolescents who refuse school in the context of clinical-level anxiety or depression. The program aims to increase parental self-efficacy to support their teenage child by providing personalised feedback about their current parenting and equipping them with evidence-based parenting strategies to respond to school refusal, anxiety and depression. The intervention is delivered online and comprised of up to 13 parent-led, online modules covering different topics related to parenting an adolescent with depression, anxiety, and/or school refusal. In this study we aim to understand how acceptable the program was to parents, and how the acceptability of the program could be enhanced. We also aim to gather preliminary indications of how effective the program was in improving 1) parental self-efficacy to respond to school refusal, 2) parenting behaviours to reduce teen anxiety and/or depression, and 3) teen school attendance. Due to the exploratory and mixed-methods nature of the study, no hypotheses have been specified.

RAPSODI-AUS aims to find the best type of joint replacement for the treatment of painful OA of the shoulder by investigating if reverse Total Shoulder Replacement is better than anatomical Total Shoulder Replacement at improving shoulder pain and function. This is a sister trial with the United Kingdom - RAPSODI-UK - following similar protocols. The study will recruit a total of 430 participants across all participating sites and surgeons in Australia, 215 patients will be randomised to each surgery type. At the end of the study we aim to provide clinical evidence to assist surgeons and their patients to choose the most appropriate replacement procedure to treat their Painful Osteoarthritis of the Shoulder.

Recreational exercisers often participate in weight training to increase their strength and muscle size. Cow’s milk has been suggested as a suitable recovery drink following weight training due to its high protein and carbohydrate composition which can help build muscle strength. Although, cow’s milk may not be appropriate for many as it contains lactose, a sugar many individuals are intolerant or allergic to. Plant-based milks such as soy milk might provide an alternative recovery drink. Soy foods are associated with many health benefits, but some athletes participating in weight training believe soy to be disadvantageous for building muscle as soy milk contains phytoestrogens. Phytoestrogens are naturally occurring components of many plant foods and are especially concentrated in soy. The concern arises as estrogen can influence muscle adaptions and body composition and some resistance athletes worry the phytoestrogen found in soy could similarly inhibit muscle adaptions. Whilst the phytoestrogens found in soy have a similar structure to human estrogen, their effects appear to be substantially weaker. On the other hand, the estrogen concentrations in cow’s milk is considerable. Limited research has compared the influence of soy milk and cow’s milk on reproductive hormones, particularly after resistance exercise which is the aim of this study.

1. AIM OF STUDY / RESEARCH QUESTIONS • To determine the proportion of patients that participate in a virtual ED consultation who are able to be safely diverted from needing to be physically transported to attend the Emergency Department, and • To compare the characteristics of patients for whom a virtual ED consult resulted in not physically attending an ED with patients who, following a virtual ED consult, physically attended an ED. STUDY DESIGN : Retrospective and Prospective cohort study. From the date of Ethics approval, data will be collected prospectively until the 27/01/2023. Data from patients who have been seen in the Virtual ED between the 27/01/2022 and the date of Ethics approval will have the same data retrospectively collected. 2. ELIGIBILITY CRITERIA Inclusion criteria: • Patient referred to Virtual ED by Ambulance Victoria Exclusion criteria: • Nil 3. STUDY OUTCOMES Primary Outcomes • Proportion of virtual ED consults that were able to be diverted from requiring ambulance transport to The Emergency Department for in-person ED attendance. Secondary Outcomes • Secondary outcomes include: duration of time taken for virtual ED consult, COVID-19 status of virtual ED patient attendances, ED disposition destination for patients who physically attended the ED.