ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31212 results sorted by trial registration date.
  • Sedentary Time Elimination with Periodic activity Snacks study in people with mental illness

    People with severe mental illness are much more sedentary than the general population, and therefore more susceptible to life limiting diseases such as cardiovascular disease and clinical obesity. This study aims to assess the feasibility and usability of an app and wrist wearable to promote physical activity snacks (<10min in duration) in people with severe mental illness. We hypothesis that the app will be feasible and acceptable for people with severe mental illness. We also hypothesise that prompting people with severe mental illness to do activity 'snacks' will increase their physical activity levels, decrease sedentary behaviour, and improve quality of life.

  • An investigation into the impact of plan characteristics on plan complexity measures in HyperArc Stereotactic Radiosurgery (SRS) plans

    This study aims to investigate the impact of plan parameters and optimisation approaches on plan monitor units (MUs) and corresponding physics quality assurance (QA) results. Who is it for? Patients who have been diagnosed with intact brain metastases and/or post-operative cavities after resection of brain metastatic disease, and planned with HyperArc and treated on the stereotactic linear accelerator at Canberra Region Cancer Centre from September 2022 to March 2025 will be retrospectively analysed for this study. Study details Once participants are deemed eligible, their existing radiation treatment plans will be randomly selected to provide a wide range of plan characteristics such as number of lesions, size of lesions, shape of lesions, distance from isocentre, proximity to healthy organs and use of optimisation structures. These plans will be de-identified and replanned, changing one variable at a time to observe the results on plan complexity (MUs) and physics QA results. These plans will be ensured clinical acceptability by the principal investigator. After replanning, the impact of plan characteristics on plan complexity and physics QA results will be observed and from that data, MU limits will be developed which are tailored on specific plan characteristics. It is hoped that the results from this study will provide a better understanding of the change in complexity of HyperArc SRS plans depending on particular plan characteristics and see the implementation of MU limits result in a more seamless SRS planning workflow which balances clinical acceptability with deliverability and safety.

  • Allied Health Assistant Care for Patients with Acute Hip Fracture and Cognitive Impairment

    This randomised controlled trial will investigate the feasibility of an allied health assistant providing physiotherapy to people with cognitive impairment following hip fracture surgery. The allied health assistant will provide all therapy to people in hospital. All therapy will be prescribed by a physiotherapist and will include daily walking, standing and seated exercises. We hypothesise that it is feasible for allied health assistants to provide physiotherapy to people with cognitive impairment after hip fracture surgery.

  • Implementation of a PAthway of CarE for people with chronic musculoskeletal conditions living in rural, regional and remote Australia using allied telehealth (PACE-RURAL)

    PACE-RURAL introduces a novel, risk-based pathway designed to ensure that people with musculoskeletal conditions receive appropriate care which matches their needs. PACE-RURAL is about getting the right care to people at the right time. For example, people with reasonably straightforward presentations who should recover well are supported through a musculoskeletal e-hub featuring guideline-based resources and simple exercise programs, enabling effective self-management. Those at greater risk of persistent pain or disability will be referred to expert musculoskeletal clinicians (e.g., specialist physiotherapists) for a comprehensive assessment. Depending on their needs, care may involve shared management with primary healthcare providers (using telehealth when appropriate), specialist-led care, or referrals for services such as psychology or surgical opinions.

  • Examining the efficacy of a self-guided ultra-brief digital treatment for depression and anxiety

    The aim of this project is to examine whether a self-guided version of the ultra-brief digital treatment, the Single Session Course, is effective at reducing symptoms of depression and anxiety. People will be randomly allocated to receive treatment immediately or after 9-weeks. The primary outcomes are depression and anxiety symptoms, and the primary timepoint is 9-weeks. We expect the treatment to be associated with larger symptom reductions compared to a waitlist control.

  • Stereotactic ablative body radiation therapy with Nodal Irradiation for ProstatE canceR(SNIPER)

    This study aims to evaluate the toxicity and quality of life (QOL) outcomes associated with 5-fraction stereotactic ablative radiotherapy (SABR) for high risk and/or node positive prostate cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have high risk and/or node positive prostate cancer. Study details: Traditional radiotherapy for high risk and/or node positive prostate cancer typically involves four to eight weeks of daily treatment, with androgen deprivation therapy, Recent studies have shown that using fewer but larger doses of radiation, i.e. 5-treatment SABR, is just as effective and safe, and this has now become one of the standard radiotherapy schedules for intermediate risk prostate cancer. The question then is whether we can further reduce the number of treatments for prostate SABR while maintaining the cancer control rate and minimizing side effects for high risk and/or node positive prostate cancer. This is an appealing option from a patient convenience and healthcare cost-saving point of view. In this Australian phase 2 trial of 5-treatment prostate and pelvic SABR, we aim to evaluate the efficacy, toxicity and quality of life outcomes of this treatment.

  • BLiPD: Assessing the feasibility and tolerability of bright light therapy for delirium prevention in hospitalised adults with advanced cancer

    This study aims to investigate the feasibility and tolerability of bright light therapy for delirium prevention in hospitalized adults with advanced cancer. Who is it for? You may be eligible to participate in this study if you are a male or female 18 years or older, have diagnosis of advanced cancer and are admitted to a palliative or oncology unit at participating investigational sites and do not present with delirium upon admission. Study details Eligible participants will be randomized to one of two groups: Group 1 - Re-Timer group and Group 2 - Standardized supportive care. Group 1 will have the Re-Timer device applied for a single continuous time of 60 minutes between 7am to 10am daily, until delirium occurrence, discharge death or a minimum of seven days if participants remain in hospital. In addition, standardized supportive care, according to NICE delirium clinical guidelines will be provided, as well as standardized evening light exposure, defined as dimmed hospital room lighting from 11:00pm until the next morning at 6:30am, will be applied for the duration of treatment. Participants randomized to Group 2 will receive Standardized supportive care only. Participants in Group 1 will be followed up daily to assess feasibility and tolerability of Bright light therapy, preliminary efficacy, melatonin, sleep and economic feasibility. It is hoped that this research project will determine whether bright light therapy is effective at regulating circadian rhythms and delirium prevention in people with advanced cancer.

  • An alternative model of care for liver health care for First Nations patients living in remote communities

    Colonisation has, and continues to, negatively impact the health and wellbeing of First Nations peoples, which is further exacerbated by unequal access to health services especially in rural and remote communities. Liver disease and liver cancer are growing concerns for First Nations peoples due to increasing incidence rates. Disparities in liver disease outcomes, especially for those residing in rural and remote communities, are exacerbated by key barriers such as the lack of access to specialist care and the need to travel substantial distances Off-Country to access testing and treatment. This project aims to address these health inequities by exploring new ways of diagnosing and managing liver disease in rural and remote communities using non-invasive technologies On-Country. Who is it for? You may be eligible to participate in the liver check phase of this study if you are an Aboriginal and/or Torres Strait Islander person aged 25 or older and has at least one risk factor for liver disease. You will be eligible to participate in the liver monitoring phase if you have been identified during the screening phase of having compensated advanced chronic liver disease. Study details In the liver check phase, eligible participants will have a liver health assessment alongside their routine annual health check. This phase will include simple fibrosis tests that will help identify anyone at potential risk of liver disease complications. This risk will be confirmed by an On-Country scan (using a FibroScan) that will enable diagnosis of advanced liver disease. Participants identified to be at risk of liver cancer in Phase 2 will be invited to take part in Phase 3, the liver monitoring phase. This phase of the project will be a stepped-wedge randomised trial to compare two models of liver cancer surveillance — the current model of care and the study On-Country model of care. The new model of care will allow participants to have 6 monthly ultrasounds On-Country (performed by an experienced ultrasonographer) in conjunction with serum biomarker tests for liver cancer. Yarning circles will be incorporated at the end of Phase 2 and Phase 3 to explore participant experiences in the study, their knowledge of liver disease and views on the different models of care. It is hoped that the result from this study will help to demonstrate the feasibility of providing quality liver health care On-Country to First Nations peoples living in remote communities.

  • Type 1 Diabetes National Screening Pilot: General Practice Feasibility and Acceptability Study

    DESCRIPTION: This is a follow-on study from the Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study (ACTRN12622000381785). In this study we will explore the feasibility and acceptability of embedding general population screening for type 1 diabetes into primary care in Australia, by pairing it with routine immunisation +/- health check appointments (6 weeks to 6 months of age). Participating children will be screened for their genetic rick of developing type 1 diabetes in childhood (using a polygenic risk scrore (GRS2)), and those at increased risk will be monitored for type 1 diabetes autoantibodies annually from ages 1 to 5 years. The primary outcome is uptake rate, and recruitment will be capped at 300 children. HYPOTHESIS: General population screening for type 1 diabetes in primary care is feasible and acceptable, without causing significant parental distress.

  • Investigating the impact of normal tissue objectives in treatment planning for stereotactic body radiation therapy

    This study aims to provide a dosimetric comparison between plans using the Stereotactic Body Radiation Therapy Normal Tissue Objective (SBRT NTO) feature in Eclipse version 18 (v18.0) planning system and those using the standard NTO settings currently utilised in our department. Who is it for? Ten lung and ten nodal/bone metastasis stereotactic body radiation therapy (SBRT) plans that were previously treated at our institution from July 2022 until December 2024. The study may include patients with one or two targets. Study details: Once the participants are deemed eligible they will be randomly selected and anonymised. The de-identified datasets of the selected patients and corresponding plans will be sent to an Eclipse v18.0 test system where they will be replanned using the SBRT normal tissue objective (NTO) feature by the PI. After replanning, the impact of SBRT NTO on plan metrics for lung and nodal/bone metastasis SBRT plans and the effectiveness of Eclipse 18 will be compared to previously clinically accepted plan. It is hope that the results from this study will provide a solution to automate the process of enforcing sharp dose fall-off around the target and eliminates the need for time-consuming manual contouring of optimisation structures.

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