ANZCTR search results

Targeted lifestyle interventions that include education, behaviour change and/or group support components could be effective in improving the lifestyle risk factors, increased falls risk and poorer mental health status associated with age-related macular degeneration (AMD). This study therefore aims to develop, implement and evaluate an online intervention through the Movement, Interaction and Nutrition for Greater Lifestyles in the Elderly (MINGLE) program. This will be achieved over two phases: 1) a small qualitative study (semi-structured interviews) with AMD patients to determine the barriers and facilitators to participating in such a program; and 2) applying the findings from phase 1 to inform the development of the MINGLE program, followed by a pilot study to evaluate its feasibility and acceptability. Participants will be recruited from a private eye clinic in Westmead NSW. Eligible Phase 1 participants will be: 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent in English, 3) verbally consent to participate in the study (including audio recording). Audio recordings will be transcribed verbatim by a transcribing service and analysed and coded iteratively to ensure analytic reflexivity. Key themes will be established relating to barriers and facilitators to participating in MINGLE. Eligible Phase 2 participants will be 1) aged >= 50 years with a diagnosis of any form of AMD, 2) fluent in English, 3) able to access a smart device with a front-facing camera; 4) technically capable to use Zoom or have someone to help; 4) cleared to safely participate in the physical activity components of the intervention (i.e. Physical Activity Readiness Questionnaire or written physician clearance for participation). Participants also agree to provided written informed consent to participate and complete the baseline questionnaire. For the intervention, participants will be divided into subgroups based on session timings (morning/afternoon). Sessions will run for 60-minutes once/week over ten-weeks with each session including 10 minutes informal socialising; 30 minutes physical activity session; 15 minutes nutrition education. Descriptive statistics will be used to assess the acceptability and feasibility of MINGLE. T-tests will be carried out to assess the pre-post intervention improvement in quality of life, falls efficacy, physical activity, and dietary intakes. The baseline questionnaire will be re-administered immediately post-intervention. The primary outcomes of the questionnaire are significant improvements in loneliness. The secondary outcomes are significant improvements in quality of life, attitudes towards the intervention, falls self-efficacy, physical activity level and diet. The primary process outcome of this study is the development of a novel holistic online intervention with a focus on socialisation, physical activity, and nutrition education to specifically improve the wellbeing of people with AMD.

This study will look at the feasibility of physiotherapists using digital devices to improve mobility and physical activity in an inpatient rehabilitation setting in addition to usual physiotherapy care. It will look at the feasibility of running a fully powered implementation study in a large public hospital in order to pave way for a larger study to implement digital devices in rehabilitation for additional dosage, if this study is successful.

Systemic Sclerosis (SSc) is an autoimmune disorder in which normal tissue is replaced with scar tissue. Normally, the immune system helps to defend the body against various infections and diseases. In SSc, the immune system stimulates the cells to produce excess collagen (protein). The excess collagen is deposited in skin and other organs (heart muscle, lungs, blood vessels, skeletal muscles and joints) causing hardening and thickening of normal tissues (similar to scar formation). The prevalence of SSc is 443 per million population, and women are more commonly affected. One of the major causes of SSc-related death is right heart (right ventricle, RV) failure, and thus assessment of its function is important in determining survival. The RV is affected through primary heart muscle involvement and/or due to involvement of blood vessels supplying the heart. RV dysfunction is silent until advanced and routine investigations do not detect it at an early stage. Hence, there is a need for a safe and sensitive non-invasive technique for early detection of RV dysfunction. Advanced imaging techniques like cardiac magnetic resonance imaging show potential in detecting early abnormalities in the RV, before symptoms present. We propose to utilize this technique to detect early RV abnormalities in patients with SSc. This will identify those at an increased risk and allow initiation of disease modifying therapy, thereby improving outcomes.

This study aims to determine whether the new drug fibroblast activating protein inhibitor (FAPI) can be used to detect pancreatic cancer when tracked using positron emission tomography (PET) scan. Who is it for? You may be eligible for this study if you are aged 18 or over and have confirmed pancreatic cancer or a suspicious pancreatic mass, and have not commenced treatment. Study details All participants will undergo pre-treatment positron emission tomography (PET) scan using the novel PET tracer Fibroblast Activating Protein Inhibitor (FAPI). Absorption of the tracer on PET scan will be evaluated by a nuclear medicine physician as part of the research team. The results of this scan will only be shared with your treating doctor if there could be a change to your treatment as a result. Information from this study will help evaluate the applicability of FAPI-PET for diagnosing and detecting deposits of pancreatic cancer. The results will also help determine if FAPI can be used to carry targeted radiation therapy directly to cancerous tissue. Although this study will inform further research into such a treatment, no participants in this study will receive targeted radiation therapy via FAPI.

This is an exploratory study testing the Atmo Gas Capsule in 5 patients aged 18 years or over with active inflammatory bowel disease. The Atmo Gas Capsule is a novel swallowed capsular technology which measures gas concentrations (eg. oxygen, carbon dioxide, hydrogen, methane) in the gastrointestinal tract and sends data to an external receiver kept within 1.5 metres of the body. Intestinal gas composition is expected to reflect the gut microbiome composition. We will first exclude any intestinal strictures in patients with Crohn’s disease as strictures might increase the risk of capsule retention within the bowels. This will be done by demonstrating no strictures on a magnetic resonance enterography (MRE) scan within the past 3-6 months, or by first successfully passing a swallowed wax capsule containing a radiofrequency identifier. An externally held radiofrequency detector will be used to detect whether the wax capsule has passed out of the body after 5 days. If it does not pass within 5 days, the wax capsule will melt by itself and cause no harm, but these patients will not proceed with the study. Patients with Crohn’s disease who have a recent MRE with no strictures or have successfully passed the wax capsule will be able to proceed with the rest of the study. Patients with ulcerative colitis will not need this initial screening for strictures as ulcerative colitis does not predispose patients to intestinal strictures. Measurements will then be taken using the Atmo Gas Capsule before and after (8-12 weeks later) initial treatment of active inflammatory bowel disease and correlated with inflammatory bowel disease activity before and after treatment assessed clinically and by various means such as serum inflammatory markers, faecal calprotectin, or endoscopy. This will allow us to see if certain intestinal gas patterns can be correlated to disease activity and also see if gas patterns can help predict response to treatment.

This study aims to investigate whether priming intravenous administration sets with monoclonal antibodies reduces chair time. Who is it for? You may be eligible for this study if you are an adult being treated with the single agent monoclonal antibodies: Obinutuzumab, Daratumumab, Nivolumab, Pembrolizumab at the Royal Brisbane and Women's Hospital. Study details Participants will randomly be allocated to one of two groups: one which has their IV line primed with the treatment drug, and one which is primed with diluent only before administration of the drug. Information on treatment duration, adverse reactions and patient experience will be collected on the day. Information from this trial will inform the optimisation of patient flow and decreased hypersensitivity reactions in oncology care.

This study will evaluate the feasibility of Human Microbiota Transfer Therapy (HMTT) for depression in adults. We will aim to recruit 15 participants to recieve a HMTT enema (n=10) or placebo enema (n=5). We will follow up participants for 8 weeks for primary outcome, measures including recruitment, retention, acceptibility, tolerability, and 6 months for safety data. We hypothesise that HMTT will be a safe and feasible treatment for depression in adults. This pilot data will inform a larger randomised controlled trial evaluating efficacy of HMTT for depression, scheduled to commence in 2022.

The aim of this study is to examine whether Neisseria gonorrhoeae bacteria from the oropharynx will grow after using a mouthwash over a two-hour time period.

The purpose of this research is to explore the effect of stopping heart medication in cancer patients whose hearts have recovered from chemotherapy-related cardiac dysfunction (CTRCD). Who is it for? You may be eligible for this study if you are aged 18 or older, you have been previously diagnosed with asymptomatic CTRCD and you are currently taking CTRCD medications including Angiotensin Converting Enzyme inhibitors (ACEi) and/or Beta Blockers (BB). Study details All participants who choose to enrol in this study will be randomly divided into one of two groups by chance (similar to flipping a coin). One group will continue their heart medications as prescribed. The second group will cease their heart medications (Angiotensin Converting Enzyme inhibitors (ACEi) and/or Beta Blockers (BB)) under medical supervision, this will occur over a staged period. All participants regardless of their group allocation will undergo monthly clincial review. An echocardiogram (heart ultrasound, approximately one hour), Electrocardiogram (ECG), blood tests and cardiac magnetic resonance imaging (CMR) will be taken at the start and end of study involvement. It is hoped this research will determine whether completely stopping cardiac medications including ACE inhibitors and beta blockers is safe and whether this has any negative impacts on patients with previous chemotherapy related cardiac dysfunction. If this treatment cessation is safe it may be used to improve health outcomes for future cancer patients who are affected by chemotherapy related cardiac dysfunction.

Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart. After a PCI, it is recommended in medical guidelines that everyone should receive physical activity advice and referral to a cardiac rehabilitation program prior to discharge. However, physical activity levels have been found to be low in people following a PCI. The aim of this research is to investigate whether a 30-minute physiotherapist-led physical activity counselling session prior to discharge improves physical activity levels early in individuals recovery (first 3-weeks) compared to brief physical activity advice provided by nursing staff. Findings from this study will inform further investigation of physical activity advice after a PCI, to determine how we should deliver this information, and whether this has an impact on physical activity levels early in people's recovery.