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PRO-Health – A prostate cancer specific healthy eating and exercise program
This study is testing a new multifactorial online platform called PRO-Health which provides individualised educational material on prostate cancer, its treatment side effects, and individualised nutrition and exercise services delivered to you anytime, anywhere in Australia. Who is it for? You may be eligible for this study if you are an adult with a confirmed diagnosis of prostate cancer and have been receiving androgen deprivation therapy (ADT) for at least 3 months. You should also not be currently meeting the dietary and exercise guidelines for cancer survivors or under the care of a nutrition or exercise health professional. Study details Participants will be randomly assigned to either receive usual care from their treating practitioner, or receive individualised consultations from a dietitian (4 sessions) and exercise physiologist (4 sessions) over a period of 12 weeks. These will involve dietary and exercise prescriptions that are tailored to participants based on their medical history, and reflect guidelines for prostate cancer patients. The usual care group will also receive access to PRO-Health and a consultation from a dietitian or exercise physiologist after the 12 week period. Participants will be asked to complete a body composition scan (equipment couriered), physical function test over Zoom that is facilitated by a research team member, and asked to completed questionnaires over a 12-week period from baseline. It is hoped that findings from this study will help develop this PRO-Health platform to help prostate cancer patients manage side effects from androgen deprivation therapy.
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The CASSOWARY (CAncer genomic riSk ScOres in primARY Care) Trial
This study aims to evaluate the effect on risk-appropriate cancer screening of multi-cancer polygenic risk scores and tailored advice on risk-appropriate cancer screening in general practice. Who is it for? People aged 40-59 years old who are able to read and write in English and currently do not have any alarm symptoms or diagnosis of cancer. All participants must be under the care of a General Practitioner who is participating in the trial. Study Details Participants will be randomly allocated into the intervention or control group. The intervention group will receive an individualised cancer risk report and tailored advice for risk-appropriate screening for melanoma, colorectal, and breast or prostate cancer during a consultation with a researcher . The control group will receive the ‘Cut your Cancer Risk’ brochure and information about lifestyle factors that can impact cancer risk during a consultation with a researcher. This study will contribute to what we know about how individualised risk information can impact peoples' cancer screening behaviours.
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Effect of Yoga on neurocognitive function among individuals with symptoms of depression.
Depression is associated with moderate impairment in cognition, and this impairment is associated with functional impairment and even suicide. Second generation antidepressants and psychotherapies are first line treatment for depression. However, impairment in cognition among individuals with depression persists even after receiving conventional treatment, resulting in an urge to investigate alternative treatment modalities such as yoga. Yoga is known to improve cognition, neurobiological and psychological outcomes in various populations, however these studies are limited by study design, sample size, and heterogenous nature of population, and further randomized controlled trials are warranted. Hence, the present study is designed to assess the effect of yoga on cognition (i.e., neuropsychological tests), neurobiological (i.e., markers of stress, neuroplasticity, neurodegeneration and cortical inhibition) and psychological outcomes (i.e., psychological questionnaires) in individuals with depression. In this uneven two-arm randomized control trial, participants of both genders, aged 18 to 45 years and having moderate to severe depression as measured by ‘Quick Inventory of Depressive Symptomology Self-Report’, will be randomly allocated into 12 weeks yoga intervention (n = 34) or waitlist control (n = 17) groups. Participants in the intervention group will perform yoga, 3 days a week for 12 weeks, while participants in the waitlist group will be provided with yoga training after the 12 weeks follow-up. Outcome assessments will be done at baseline (t1), at the end of the 12 (t2) and 24 (t3) weeks. The primary outcome will be between group differences on global cognition from t1 to t2. Secondary and tertiary outcomes will assess between and within (yoga group only) differences in a number of cognitive functions, neurobiological markers and psychological outcomes associated with mental health and/or depression severity, across all time points.
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Pilot investigation of psychedelic-assisted psychotherapy for treatment of post-traumatic stress disorder (PTSD) in people diagnosed with co-occurring borderline personality disorder – a controlled before-and-after study
Traumatic experiences and consequent development of trauma disorder (PTSD, complex-PTSD) frequently occurs in people diagnosed with borderline personality disorder (BPD). The only evidence-based treatment for BPD is psychotherapy, however this does not directly address the impact of trauma disorder which reduces the likelihood of achieving remission and recovery. The recent decision of the TGA to approve the prescription of 3,4-methylenedioxy-methamphetamine (MDMA) as an adjunct to psychotherapy represents a break-through that could dramatically improving treatment outcomes for BPD and post-traumatic stress disorder (PTSD or Complex-PTSD) when they co-occur. Spectrum is a specialist public mental health service that provides treatment for people experiencing severe, complex, and high-risk clinical presentations of BPD and trauma throughout Victoria. In this pilot study, we will conduct a controlled before and after pilot study to assess the feasibility and acceptability of offering MDMA-assisted psychotherapy in our specialist public mental health service. Given that the efficacy and safety of MDMA for the treatment of PTSD has already been established, our study will assess efficacy, safety, and cost-effectiveness as secondary outcomes. MDMA will be administered within an evidence-based psychotherapy program. The pilot study will entail recruiting participants diagnosed with PTSD (or C-PTSD) and co-occurring BPD. There are two arms in the study. In the first, six to eight participants will receive psychotherapy + MDMA while in the second arm, six to eight matched participants will receive psychotherapy only. A wide range of assessment and evaluation measures will be used, utilising quantitative and qualitative approaches to examine clinician assessed and participant self-reported outcomes.
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Heart Attack Re-presentations Toolkit
This study aims to reduce the re-presentation rate by better supporting patients with their transition back to the community after being discharged from hospital with an AMI through the implementation of a personalised discharge toolkit.
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The effect of weight loss surgery on cardiovascular haemodynamics in adults with obesity
Obesity continues to be a major public health concern in Australia and overseas. In particular, obesity contributes to changes in the heart’s blood flow in the form of increased circulating blood volume, cardiac output, systolic blood pressure and pulmonary pressures. Long-term, these lead to the development of heart failure, atrial fibrillation and ischaemia. Furthermore, fat deposited around the heart is associated with the development of a specific type of heart failure common in individuals with obesity. Hence, obesity is considered an important risk factor for cardiovascular disease. However, there is growing evidence that effective management of obesity also improves cardiovascular outcomes for patients. Bariatric surgery, an established treatment for weight loss, has been shown to reduce the incidence of cardiovascular risk factors and heart attacks. In this study, we seek to assess the impact of bariatric surgery on the heart’s structures and blood flow using cardiac magnetic resonance imaging (CMR). Although ultrasound technology or echocardiography is widely used for assessing such features, challenges remain when acquiring accurate images in those with obesity. CMR offers an opportunity to overcome some of these imaging challenges. CMR is less user dependent compared to echocardiography and has demonstrated excellent feasibility in this population. We hypothesize that bariatric surgery will lead to a decrease in cardiac output, and reductions in the degree of fibrosis of the heart muscle and the volume of fat around the heart as measured by pre- and post-surgery CMR, thus reducing cardiovascular disease risk. Eighty participants will be recruited for this study. Assessments will include cardiac imaging scans, measurement of exercise capacity, blood tests, and quality of life questionnaires. These will be performed before and 12 months after their bariatric surgery.
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Comparing the effectiveness of using Optiflow Switch vs standard facemask during anaesthesia induction: a randomized controlled trial
In this study, we plan to compare two techniques of supplying oxygen to patients during general anaesthetic induction for surgery. The usual way of doing this procedure involves patient breathing about 10L/min oxygen through a standard facemask before being induced. Once the patient is asleep, the anaesthetist helps bag-mask ventilate the patient via the facemask while waiting for complete muscle relaxation for the intubation. During intubation, the facemask is removed. In this study, a computer program will randomly allocate patients to receive oxygen via one of the two devices: 1) Optiflow Switch or 2) standard facemask. The Optiflow Switch is a relatively new device, which can deliver oxygen at a very high flow rate (up to 70L/min) via two prongs in the nose. It also allows seamless transition to facemask ventilation by diverting nasal oxygen flow away from the patient when a facemask is applied on top of the nasal apparatus. Therefore, for the Optiflow Switch group, patients will receive high flow oxygen through the nasal prongs before going to sleep and during intubation, but bag-mask ventilation in between while waiting for complete muscle paralysis. The study aims to test if the Optiflow Switch provides a higher oxygen level compared to standard facemask when used during anaesthesia induction.
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Chronic pain following appendicectomy in children
Chronic post-surgical pain is an increasingly recognised condition which can have great impact on a child's quality of life. Appendicectomy is one of the most common surgeries performed on children, yet it is not well known how many children develop chronic pain as a result. This is a prospective cohort study using a questionnaire following paediatric appendicectomy at 3 and 12 weeks to determine the presence of chronic post-surgical pain. Where this is detected, further questionnaires and assessment by pain physician will be used to investigate the impact of and risk factors for chronic pain following paediatric appendicectomy.
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CanSTEP: Effect of cognitive-motor step exergame training on chemotherapy-induced peripheral neuropathy (CIPN) symptoms in cancer survivors
This study aims to determine the effectiveness and cost-effectiveness of a four-month home-based cognitive-motor step training intervention versus usual care in cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN). Who is it for? You may be eligible for this study if you are aged 18 years or over and have completed greater or equal to 6 months and less than 5 years post-completion of neurotoxic chemotherapy treatment for cancer, with CIPN symptoms impacting lower limbs function. You should also be able to walk 10 metres without the use of a walking aid. Study details Participants will be randomly allocated to either receive the home-based cognitive-motor step exergame training, or usual care with the option to receive the training program following completion of the study period. The exergame training will involve stepping/balance exercises and concurrent cognitive training on a wireless floor step mat, delivered over a few sessions per week with a target range of 80 to 120 minutes total training per week for 16 weeks. Participants will be asked to complete questionnaires about their symptoms' burden, quality of life and health service use, as well as to undertake assessments of balance and cognition at several timepoints throughout this study. Participants' daily physical activity will also be recorded at several time points, using a wrist-worn sensor. It is hoped that findings from this study will help develop management strategies to address the ever-increasing burden of CIPN-related disability in cancer survivors.
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Development of a website for family/friends of adults with depression
The aim of this study is to conduct a preliminary assessment of the acceptability, useability and usefulness of, and engagement with, a new psychoeducation website, Depression Assist, to assist adult family/friends of adults with major depressive disorder (MDD) to carry out their vital supportive role and maintain their wellbeing. In this formative evaluation, we aim to ask 30 family/friends participants to access the website over 3 months and respond to an initial screening and baseline survey and monthly online follow-up surveys (over the three months). The results of this formative evaluation will guide the refinement of Depression Assist and a dedicated rural version that is aimed at benefiting members of the public who care for a person with major depressive disorder.