ANZCTR search results

Study background The WISER Study aims to investigate an educational intervention designed to support sexual health in women with anal cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or older, have been newly diagnosed with anal cancer (any stage), and are planned to receive chemoradiotherapy treatment. Study details All participants will receive a Women’s Initiative for Sexual health, Education and Raising awareness of anal cancer (WISER)-developed educational resource. This resource has been designed to address the sexual health, sexual function, and intimacy information needs of women with anal cancer. The resource will be provided by a healthcare professional (HCP) at the beginning of treatment and revisited during a follow-up consultation before the end of treatment. Feasibility and the impact of the information on patient needs, sexual health, and quality of life will be assessed in participants for up to 6 months after treatment begins. The impact of WISER on HCP awareness and confidence in discussing the sexual health effects of anal cancer treatment will also be evaluated at the end of the study. It is anticipated that this research will contribute to improved supportive care by addressing unmet sexual health information needs and enhancing person-centred care for women with anal cancer.

This study is a randomised, open-label, parallel-group trial evaluating the use of the OmniPod 5™ automated insulin delivery system compared with usual diabetes care in adults with type 2 diabetes undergoing elective hip or knee arthroplasty. The primary aim is to determine whether automated insulin delivery improves peri-operative glycaemic control, measured by percentage of time spent in glucose target range (3.9–10.0 mmol/L) during the two weeks immediately prior to surgery. Sixty-four participants will be randomised 1:1 to automated insulin delivery or usual care, with follow-up extending through hospital admission and post-discharge to 10 weeks. Secondary outcomes include additional glycaemic metrics, peri-operative clinical outcomes, device adherence, psychosocial measures, and health service utilisation. The findings will inform the feasibility, safety, and potential clinical benefits of automated insulin delivery in the peri-operative management of type 2 diabetes.

Brief description of the study purpose The COMPRES study aims to test whether wearing compression gloves and stockings during oxaliplatin chemotherapy is feasible, safe, and may help reduce chemotherapy related nerve damage (peripheral neuropathy) in patients with gastrointestinal cancers. Who is it for? You may be eligible for this study if you are male or female, aged 18 years and older with gastrointestinal cancers who are scheduled to receive oxaliplatin based chemotherapy, are well enough to participate, and are willing to provide informed consent. Study details Those who choose to participate will wear compression gloves (two surgical gloves per hand) and lower limb compression stockings starting 30 minutes before chemotherapy, during the infusion, and for 30 minutes after each oxaliplatin treatment, for a minimum of 12 weeks. This is a non randomised study, meaning all participants will receive the compression intervention during their routine chemotherapy care. Participants will complete questionnaires about nerve symptoms, comfort, and quality of life, and clinical information about side effects and any treatment changes will be collected. No additional blood tests are required beyond standard cancer care. It is help the results from this study will help determine whether a simple, low cost intervention can safely reduce oxaliplatin related peripheral neuropathy and support better quality of life for patients receiving chemotherapy.

The aim is to assess the feasibility and acceptability of delivering Social Rhythm Therapy (SRT) over 12 weeks in an online setting for adults diagnosed with schizophrenia or schizoaffective disorder. SRT is an evidence-based psychological therapy designed to reduce depressive mood and suicidality in people with bipolar disorder, however it has not been tested in people with psychotic disorders (schizophrenia, etc.). Participants will be recruited through social media and through our research group's existing participant pool of individuals with psychotic disorders who have provided consent to be contacted about research opportunities. Primary outcomes are the feasibility and acceptability of SRT delivered online. Secondary outcomes are the intervention’s impacts on social rhythm regularity, mood symptoms, and suicidality.

AIM: The overall aim of the feasibility study is to investigate the effect of a plant-protein and animal-based diet on healthy ageing. OBJECTIVES: 1) The primary objective, in the context of preserving musculoskeletal health as a key component of healthy ageing, is to assess the effect of plant-based and animal-based protein-source diets on muscle fractional synthesis rates in overweight elderly over time. 2) The secondary objectives, aligned with broader determinants of healthy ageing, are to evaluate the difference in plant-based and animal-base protein-source diets on metabolic function (inflammatory markers, glucose variability and lipid profile), cardiovascular outcomes (vascular function and stiffness), feasibility, acceptability and compliance, dietary composition (macronutrients/micronutrients/amino acids/dietary protein quality), and greenhouse gas emissions (life cycle analysis). 3) The exploratory objectives are to evaluate differences in plant-based and animal-based protein-source diets on chemical and activity-based biological ageing markers (proteomic, metabolomic, lipidomic, and physical activity). This study addresses the knowledge gap on the real-life effects of a plant- and animal-protein whole-food diet on muscle protein synthesis and functional health outcomes in elderly and may lay the foundation for more extensive research. The study can guide sample size calculations, methodology, and feasibility of future intervention studies in the same field. The study can help find barriers and refine strategies to reach the target group. Findings may further help guide recommendations for protein intake in the elderly population, and help understanding of the biological mechanisms of the global transition to a more plant-based protein-source diet in the elderly population. Investigation of the exploratory outcomes can help generate hypotheses to inform future research, by providing insight into how molecular pathways affect healthy ageing, thereby supporting the primary aim

This study is pioneering in its investigation of ketamine for the treatment of Post Traumatic Stress Disorder (PTSD). We will do this by reactivating traumatic memory via a short writing task. Ketamine will then be administered following the retrieval of these unpleasant, traumatic memories. When a stored memory is reactivated, it may transition from a consolidated state to a more malleable one, where its content or meaning can be modified. This altered memory is then re-stored through a process called reconsolidation. This mechanism is particularly relevant to PTSD, as theories suggest that the disorder is connected to the processes of fear learning and memory updating. Theoretically, by pharmacologically disrupting this reconsolidation process with ketamine, specific memories can be selectively weakened. This temporary window of memory instability following reactivation provides a novel opportunity to directly alter trauma-related memories and reduce their potential to trigger relapse.

Brief description of the study purpose This study is testing a new portable brain scanner, called the Micro-X Stroke Scanner (MXS), to see whether it can reliably detect brain conditions that would prevent clot-busting treatment for suspected stroke, compared with a standard hospital CT scan. Who is it for? You may be eligible for this study if you are aged 18 or over and admitted to hospital with a known brain condition seen on imaging (such as stroke, brain bleeding, or brain tumour), or if you have stroke-like symptoms but a normal brain scan, and you are already clinically suitable for a CT brain scan. Study details Participants will have one scan with the Micro-X Stroke Scanner, in addition to their routine hospital brain CT scan. There is no randomisation; all participants receive both scans, and the new scanner will not be used to guide their medical care. The brain images from both scanners will be reviewed independently by multiple specialist readers to compare how well the two scanners detect important brain findings. It is hoped that the results from this study will support the future use of portable brain scanning in ambulances or remote settings, which could improve access to timely stroke treatment, particularly for people in regional and rural areas.

This study will explore the feasibility and acceptability of the Living Well after Hospital program for frail older adults leaving hospital, and the feasibility of a future randomised controlled trial to test the effectiveness of this program in increasing time spent living in the community after leaving hospital. Findings from the feasibility study will be used to refine the Living Well after Hospital program and study procedures ahead of the randomised controlled trial. Forty patients and their support persons from three general medical and geriatric medicine wards at the John Hunter Hospital will receive the Living Well After Hospital program for 60 days after leaving hospital, comprising a dedicated Living Well nurse, targeted education, routine follow-up calls, and active linking with the patient's GP. Participants will be sent a follow-up survey 30 days after leaving hospital. Interviews will be completed with a selection of participants and Living Well nurses to further explore the feasibility and acceptability of the intervention. It is expected that the intervention will be feasible and acceptable to participants and project staff, and that the recruitment and data collection methods for the randomised controlled trial will be feasible.

Brief description of the study purpose This study aims to understand how Australian men use general practice (GP) healthcare over time, including how often they return for follow up visits and how many stop attending care after an initial visit. Who is it for? Males or females aged 16 years or older who has at least one recorded GP consultation between 2015 and 2025, with at least 12 months since their last visit, at an Australian general practices participating in the MedicineInsight program and who consented to share their medical information Study details This research uses existing, deidentified electronic health record data from MedicineInsight, a national database that collects information from consenting general practices across Australia. There is no direct involvement required from participants, as no new appointments or treatments are provided as part of this study. All information analysed has already been recorded during routine GP visits. By examining patterns of GP attendance, reasons for visits, and follow up care over time, this study aims to identify factors that help keep men engaged in healthcare. It is hoped findings from this study will support the development of better strategies to keeping men engaged in care until their health needs are met, in order to reduce preventable illness, and improve long term health outcomes for Australian men.

A Randomised Control Trial (RCT) to compare a Therapeutic Goods Administration (TGA)-approved product (Buzzy device) to current standard practice. The Buzzy device is a small plastic device that vibrates and has a small cold pack attached. The Buzzy device is theorised to reduce pain (and therefore the negative association) with cannulation. It has been proven effective in children but the role of the Buzzy device in adults is less clear.