ANZCTR search results

To improve health literacy, it is important to develop resources that are easily accessible and simple to understand, that assist adults of all ages to improve their health. Successful Ageing does not occur once a person reaches age 65. To achieve Successful Ageing, it is essential to lead a healthy life throughout adulthood and this MOOC is designed to assist with that. The purpose of this study is to evaluate the effectiveness of the Successful Ageing MOOC in improving health literacy in adults 18 years and over using a wait-list randomised controlled trial. The successful ageing MOOC has 8 modules that will take around an hour each to complete over 8 weeks. At four time points we will measure each participants' health literacy to see if the MOOC helps to improve it or not.

EphA2 Chimeric Antigen Receptor (CAR) T cell Therapy for Children with Bone Tumours: A Phase I Clinical Trial Brief description of the study purpose: This study aims to assess the safety and feasibility of EphA2 CAR-T cell treatment for osteosarcoma and Ewing sarcoma in children where the sarcomas have either not responded to (refractory) or returned after (recurrent) standard treatment and no longer responding to standard treatment and no alternative treatment option exists, or the location of osteosarcoma prevents first time standard treatment. CAR T-cell therapy (Chimeric Antigen Receptor T-cell therapy) is a type of immunotherapy that uses a patient’s own genetically modified immune cells (T-cells) to fight certain cancers. Who is it for: Stage 1: You may be eligible for Stage 1 of this study if you are male or female age less than or equal to 21 years, with documented refractory or recurrent Ewing sarcoma or osteosarcoma no longer responding to standard treatment and no alternative treatment option exists, or osteosarcoma where disease location precludes standard first line treatment and you have enough previously collected tumour previously to testing for the EphA2 protein on your tumour cells. Stages 2 & 3: You may be eligible for Stages 2 & 3 if you have EphA2 protein on your tumour cells, measurable MRI, CT or PET scans, a life expectancy of at least 12 weeks (at least 8 weeks at Stage 3), sufficient heart, kidney, lung, liver and blood function, you have recovered from acute toxicities caused by any previous treatments, and your immune (T) cells have been successfully collected and made into EphA2 CAR-T cells. Study Details: Eligible participant's own immune (T) cells will be collected by filtering the participant's blood (leukapheresis) then genetically modified in a laboratory to a Chimeric Antigen Receptor (CAR) targeting the tumour associated antigen, EphA2. Approximately 14-21 days following leukapheresis, participants will receive lymphodepletion chemotherapy, then 7 days later, a single intravenous infusion of autologous EphA2 CAR T cells according to dose escalation trial design and subject to a maximum 50kg body weight. Cohorts of 3 to 6 participants will be treated at a dose level to determine the maximum tolerated or maximum administered dose. CAR T cell manufacturing feasibility will be determined by whether the manufactured CAR T cells meet quality acceptance criteria. CAR T cell safety will be determined by adverse events occurring after CAR T cell infusion. After CAR T cell infusion, follow-up assessments will include participant clinical assessment, including blood assays to determine anti-tumour efficacy, and to determine the rates of disease response, disease progression, and survival. It is hoped this study will improve treatment outcomes for these patients with otherwise limited treatment options, and increase knowledge of CAR T cell treatment of solid tumours.

This pilot study evaluates the feasibility, acceptability and appropriateness of a brief, structured intervention modelled on Good Psychiatric Management (GPM) for adults diagnosed with borderline personality disorder (BPD) who present to Eastern Health (EH) emergency departments (EDs) in crisis. Up to fifteen patients will be recruited through referrals from EH clinicians at EDs or Crisis Assessment and Treatment Teams (CATT) or Psychiatric Assessment and Planning Units (PAPU) to receive GPM from a trained clinician at an EH site. Each patient will receive 10 individualised GPM sessions focused on psychoeducation, crisis management, and the development of alternative help-seeking strategies. Survey data on patients’ treatment acceptability and engagement will be collected. Up to fifteen Eastern Health ED staff members – clinicians, nurses, and administrative staff – involved in implementing the assessment, recruitment and/or referral steps will be surveyed to provide quantitative and qualitative data on the intervention’s feasibility, acceptability and appropriateness as a post-crisis support for patients diagnosed with BPD. Data on fidelity and preliminary clinical outcomes will also be collected.

The purpose of this study is to investigate the feasibility, safety and acceptability of a Pilates exercise intervention for adults living with advanced cancer. Additionally, the aim is to also understand the impact of a Pilates exercise intervention on the strength, balance, physical activity, quality of life and sleep quality of adults living with advanced cancer. Who is it for? This study is for adults aged 18 years and older living with a confirmed diagnosis of an advanced cancer who are able to attend and perform Pilates in-person and on-line (telehealth) across 8 weeks. Participants must not currently be engaging in structured exercise for more than 2x per week over the previous 3 months. Study details Participants will be randomised to either attend Pilates intervention or to continue to receive usual care. Participants allocated to the Pilates intervention will undertake 2x 60 minute supervised mat-based Pilates sessions per week for 8-weeks, delivered by a certified Pilates instructor who is also an accredited exercise physiologist. Sessions are in a small group format of up to 3 participants per class, and each week one of the two sessions will be delivered in-person (face-to-face) while the second session will be delivered on-line (telehealth). Participants in this study will completed a variety of physical tests, including but not limited to: grip strength test, sit-to-stand test, up-and-go test, balance. Participants will also be asked to complete questionnaires to assess quality of life, sleep, and physical activity. It is hoped that the findings from this study will help determine whether Pilates could become a practical component of cancer rehabilitation programs and inform the design of a larger clinical trial.

Mobile phones are ubiquitous in healthcare settings as patients, visitors and healthcare workers use them frequently. Mobile phones can carry harmful microbes in healthcare settings, especially in the intensive care unit, and may potentially be putting patients at risk of contracting healthcare-associated infections. Therefore, mobile phone sanitisation solutions are required for healthcare settings, and ultraviolet-C (UV-C) devices offer a promising solution to this problem. However, it is yet to be investigated whether healthcare workers will be willing to use UV-C devices frequently to disinfect their phones at work. Hence, this study aims to implement a UV-C device in a real-world intensive care unit, and evaluate whether it is accepted and utilised by healthcare workers.

The aim of this study is to investigate the dentoskeletal effects of Align Technology™ Invisalign treatment with Mandibular Advancement with Occlusal Blocks (MA-OB) in comparison with historical data on a traditional functional appliance, the Twin-block, in growing adolescents with a small jaw. The study hypothesis is that there is a significant difference in dental and skeletal effects from the Invisalign MA-OB orthodontic appliance, compared to effects from using conventional functional appliances. There are no studies to date which have investigated the efficacy of the updated Invisalign MA-OB appliance. Therefore, the aim of the present investigation is to evaluate the effects of Invisalign MA-OB and compare it with the conventionally used functional appliance, the Twin-block.

Many people with diabetes develop nerve damage in their feet and lower legs that causes ongoing pain, often described as burning, stabbing or electric shock-like, which is frequently not well relieved by medication. This study is testing whether adding a simple flashing light, synchronised with the pulses of a TENS (Transcutaneous Electrical Nerve Stimulation) machine, changes people's experience of that pain compared with TENS on its own.

The aim of this study is to determine the immediate impact of flexible adhesive film on CPRS-related allodynia. The key study questions for this project includes: 1) For patients with allodynia as a result of CRPS, does applying flexible adhesive film to part of affected upper limb immediately impact: a. tolerance of light touch with tissue (assessed via numerical scale questionnaire) b. pressure-pain threshold (assessed via pressure algometer) 2) For patients with allodynia as a result of CRPS, does flexible adhesive film immediately diminish the response to thermal stimulus: a. thermal detection threshold (QST machine) 3) For patients with allodynia as a result of CRPS, does applying flexible adhesive film immediately influence ability to complete a patient-identified functional task: a. Patient rated functional scale (0-10)

Who is it for? This study will investigate whether breathing muscle strength training can be safely and successfully completed before major head and neck cancer surgery. You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with head and neck cancer and the planned treatment for your cancer is surgery followed by radiotherapy. This study will specifically enrol people who already have a respiratory condition and those who are expected to need a tracheostomy as part of their surgery. Study details All participants who choose to enrol in this study will be given a small handheld device to strengthen the muscles used for breathing and coughing before surgery. Participants will be shown how to use the device and will then be asked to complete 5 sets of exercises using the device each day before their surgery. At 4-6 weeks after surgery, participants will be asked to start using the device to complete exercises each day for the duration of their radiotherapy. This may be as few as 3 weeks or up to 6 weeks, depending upon the radiotherapy course. It is hoped this research will determine whether breathing muscle strength training can be safely delivered to people undergoing surgery for their head and neck cancer and whether this training is able to improve breathing, swallowing and tracheostomy-related outcomes after surgery.

This study evaluates MiM Primary Care, an online training programme designed to help GPs, nurses, pharmacists, and rural generalists better engage men in their care. Men are less likely to seek help early for health problems, and this training aims to build practitioners' knowledge, confidence, and skills in recognising and responding to men's health needs. We expect that completing the training will improve practitioners' knowledge and confidence in engaging male patients, measured using a purpose-built survey. All participating practitioners complete the training and are surveyed before training, immediately after, and again 12 weeks later, with no separate comparison group. The study will also examine whether the training is practical, acceptable, and likely to be adopted across different primary care settings.