ANZCTR search results

Concussion/mild traumatic brain injury represents a public health concern given its prevalence and potential long-term consequences, with up to 30% of people with concussion experiencing delayed recovery/persisting post-concussion symptoms (PPCSs). PPCSs can interfere with successful return to activities (e.g., school, work, sports) causing significant stress for months to years after injury. PPCSs are multifactorial and interdisciplinary treatments are recommended. Limited options for evidence-based interdisciplinary treatments exist, particularly in rural areas where concussion rates are higher. Our team of international leaders in concussion research, developed and piloted an Interdisciplinary Rehabilitation program for Concussion Recovery (i-RECOveR; ACTRN12620001111965) with positive results. Specialised interdisciplinary treatments such as i-RECOveR, however, are usually limited to urban cities and inaccessible in rural areas. Telehealth can increase access to treatments such as i-RECOveR, although the evidence for telehealth concussion interventions is unestablished. As well as increasing access to treatments such as i-RECOveR, a telehealth model may assist with accessibility issues relating to the injury itself. Our previous research identified the potential benefit of telehealth which included eliminating the need to travel to appointments, which for some individuals with debilitating PPCSs, often exacerbated their symptoms compounding anxiety and fatigue. In an Australian and possibly world first, this study will pilot an 8-week interdisciplinary intervention comprised of coordinated neuropsychology, physiotherapy and medical treatments via telehealth in 12 adults with PPCSs. Concussion symptoms will be assessed as well as treatment goal attainment. There is no comparator group. This research has the potential to establish a feasible, effective, and accessible intervention, increasing the reach of specialised concussion services to those living in rural and remote areas.

Mental health significantly impacts holistic well-being, affecting a large portion of the global population, with 42.9% of Australians aged 16-85 having encountered a mental disorder. Individuals with mental disorders often struggle with daily routines, including personal care like oral hygiene, leading to higher rates of dental issues such as decay, gum disease, and tooth loss. Factors such as psychiatric medication side effects, high sugar consumption, cognitive difficulties, lack of motivation, and limited access to oral care contribute to this vulnerability. This project aims to address these challenges by providing education, in-mouth toothbrushing demonstrations, and support for effective oral hygiene practices. By doing so, it seeks to empower individuals with mental health conditions and promote an integrated approach to oral and mental well-being.

Parents with an intellectual disability may experience challenges in relation to parenting skills. These challenges, in addition to potential bias from child protection staff, result in these parents being vulnerable to statutory child removal. Existing evidence demonstrates it is feasible to implement supportive programs that increase parenting skills for parents with an ID, however, there is a need for longer term evaluation of such programs to understand the impact on reducing statutory child removal over time. The proposed research intends to fill this gap and support improved practice by evaluating a 12 week parenting support program for parents with an ID where there is a risk of child protection involvement and child removal. Through a multi-agency service delivery, a randomised trial will evaluate statutory child removal outcomes after 12 months. It is intended that this evaluation will contribute to the field of research on what interventions can support a reduction in statutory child removal in families with parental ID. The research aim is to identify the long-term impact of a tailored parenting support program for parents with an intellectual disability or cognitive impairment (diagnosis is not required for participation in the program) on the rates of statutory child removal amongst these families, in comparison to the impact of a standard family services intervention. It is hypothesised that the Steps to Confident Parenting intervention will reduce the rate of child removals experienced by parents.

Sciatica affects many Australians every year, and half of the people who develop sciatica report having persisting pain of at least moderate intensity after 1 year. There are no simple, readily available treatments for patients with chronic sciatica. Identifying a simple low-cost treatment for chronic sciatica would be a major advance in the field. We have shown that the antidepressant duloxetine is a promising, accessible, low-cost treatment for chronic sciatica. However, the is considerable uncertainty about its efficacy. We will conduct the DREAM trial, which will provide a definitive answer about the efficacy duloxetine for chronic sciatica.

This study aims to investigate the usefulness of a new, experimental form of imaging known as HER2-PET (Human Epidermal Growth Factor Receptor 2 - Positron Emission Tomography) scanning in metastatic breast cancer. Who is it for? You may be eligible for this study if you are an adult female with HER2 positive or HER2 low metastatic breast cancer, and have not yet undergone treatment with the antibody-drug conjugate trastuzumab-deruxtecan (T-Dxd) in the metastatic setting. Study details Participants will be asked to undergo a standard-of-care FDG-PET (Fluorodeoxyglucose-PET) scan and a novel HER2-PET scan at baseline in the Nuclear Medicine Department at Fiona Stanley Hospital. These scans will each involve a radio-isotope injection followed by a 20-minute PET scan. Upon disease progression, participants will be asked to undergo a second FDG-PET and HER2-PET scan. Analysis of the imaging findings and treatment response to T-Dxd will be undertaken. It is hoped that findings from this study will help researchers determine the clinical utility of HER2-PET scanning for breast cancer imaging in Australia.

This study aims to evaluate the effectiveness and safety of combining prochlorperazine (PCZ) (Stemetil®) with cetuximab, an anti-EGFR (Epidermal Growth Factor Receptor) antibody used in cutaneous squamous cell carcinoma (cSCC) treatment. Who is it for? You may be eligible for this study if you are a male or female age 18 or older. Additionally, you are a solid organ transplant recipient (such as kidney, liver, lung, or heart recipients) with non-operable or locally advanced or metastatic cutaneous squamous cell carcinoma (cSCCC) who are not suitable for surgery, radiotherapy alone, or immune checkpoint inhibitors. Study details All participants will be premedicated with antihistamines and corticosteroids before receiving an intravenous infusion of 0.8mg/kg of prochlorperazine with cetuximab once per week for 6 weeks, extendable depending on tolerance and response. As each study follow up, participant's medical record will be reviewed for disease progression, toxicity and survival. It is hoped that the findings from this study will open a new therapeutic strategy for advanced cSCCs in Solid Organ Transplant Recipients without compromising their allograft.

Ulcerative colitis (UC) is a common debilitating chronic inflammatory bowel disease (IBD) of the large intestine, entailing inflammation and ulcerations in the lining of the large bowel. Recent research has shown that diet may play a role in contributing to the cause of gut inflammation involved in UC, and altering the diet may help manage UC. Therefore, we are investigating a new interventional diet to determine its clinical effects in UC. The results of this study will be able to help design dietary therapies to manage ulcerative colitis, especially as there is little information about the effect of diet on UC in humans. Hence, this study will conduct a 4-week long feeding study, where participants with diagnosed mild-to-moderate UC will be randomly given 1 of 2 diets: the intervention diet or a sham diet. All meals, including breakfast, lunch and dinner, and snacks for each diet will be provided to the participant. Blood and faecal samples will be collected, and participants will complete surveys to allow us to measure the effects of the new interventional diet on large bowel inflammation, changes in symptoms, quality of life and psychological well-being of UC, compared to the sham diet.

This trial aims to evaluate the feasibility and acceptability of a 10-week, individualised exercise-based wellbeing program designed for students with disability at an Australian university. Conducted through a mixed-methods pilot study, the program will be delivered by Accreditted Exercise Physiologists both online via Zoom and on-campus, collaborating closely with other student support services. The program being investigated is funded by the administrative division of the university and will assess various aspects such as program retention, adherence, resource requirements, and participant satisfaction. It is expected to improve participants' quality of life, psychosocial health, health behaviors, and physical health measures. The study will involve 20 participants, recruited through the university's accessibility and disability services, and will be conducted from July to November 2024.

Our study investigates how fibre is broken down by the microbiota of patients who have undergone ileoanal pouch surgery, a procedure where the colon is removed and the small intestine is reshaped to act as a new storage area for waste. We aim to understand how fibre fermentation varies among these patients and compare it to individuals with a healthy colon. This research is crucial because dietary fibre, known for its beneficial effects on gut function, may behave differently in the altered digestive anatomy of pouch patients, potentially influencing inflammation and symptom management. By clarifying these relationships, we hope to provide tailored dietary recommendations that can optimise the well-being and quality of life for patients with an ileoanal pouch.

This study aims to assess whether 5% 5-FU followed by CICAPLAST Baume B5+ on a twice daily application to the face or arms/hands will result in better tolerance and compliance as compared to 5-FU alone Who is it for? You may be eligible for this study if you are a male or female age 18 or older been prescribed a field therapy with Topical 5% Fluorouracil for actinic keratoses or in chemoprevention of SCC on the face or hands and/or arms. Study details Participants will be recruited from the Princess Alexandra hospital by treating trial physician during a clinical consultation at the dermatology clinic and followed up during weekly consultations for 4 weeks in clinic or via telehealth. They will receive either only Topical 5% Fluorouracil or Topical 5% Fluorouracil followed by Cicaplast Baume B5+ on a twice daily application to the face or hands and/or arms for 4 weeks. At the end of the study, participant's skin condition and adherence to the intervention will be assessed. It is hoped that the findings from this study will help doctors in the future treat patients being prescribed 5-FU for precancerous AK.