ANZCTR search results

The purpose of this study is to explore an alternate delivery modality for mindfulness that may account for deficits in mental imagery, a necessary component for effective mindfulness practice. It is predicted that mental imagery ability will mediate the relationship between treatment modality and mindfulness outcomes. It is also predicted that participants with poorer mental imagery will have improved outcomes within the VR condition compared to the Traditional mindfulness condition. Pending our hypotheses are correct, this study will provide a foundation for researchers to build upon. A successful intervention will provide a blueprint for improved service delivery, strengthen the status of mindfulness as a transdiagnostic treatment that can be effective for a diverse range of populations and encourage researchers to explore novel virtual reality approaches for mental health improvement.

Outpatient hysteroscopy stands out as a safe, effective, and well-tolerated modality for investigating and treating intrauterine pathology. However, despite its advantages, outpatient hysteroscopy accounts for less than 0.5% of all hysteroscopies performed in Australia, largely due to the prohibitive upfront capital costs associated with setting up these services. This study aims to overcome this barrier by evaluating the LiNA OperaScope, an innovative all-in-one single-use hysteroscope device, to determine its patient and clinician acceptability and its cost-effectiveness compared to traditional methods. We hypothesise that single use hysteroscopy will be comparable to reusable hysteroscopy in effectiveness and may provide a most cost-effective option for clinicians to offer outpatient hysteroscopy to their patients.

What is the project about? The TMaC study aims to permanently reduce nerve pain caused by bowel cancer treatment, a condition called chemotherapy-induced peripheral neuropathy (CIPN). CIPN has no effective treatments, so we are testing a non-invasive brain modulation therapy called repetitive transcranial magnetic stimulation (rTMS). We will be the first to determine the duration of pain improvement using TMS and work towards further expanding this approach for cancer survivors. Who is it for? You may be eligible for this study if you are an adult (aged from 18 to 85 years old) experiencing chronic pain and/or changes in sensation in your hands or feet following chemotherapy treatment for bowel cancer. What are the study details? Participants will be randomised to receive four sessions of rTMS or sham stimulation, with each session lasting 15 minutes and separated by at least seven days. The brain stimulation procedure is non-invasive and painless. You will be asked to rate chemotherapy-induced pain intensity before and after intervention. You will be followed up at 8 weeks after completion of all treatment sessions to see whether analgesic effects of rTMS are maintained. If so, there will be an additional follow-up at 6 months to assess long-term effectiveness of the intervention. It is hoped that the findings from this study will deepen our understanding of the long-term analgesic effects of rTMS, potentially offering a permanent solution to the debilitating CIPN-associated pain in cancer survivors.

RoBiN (Risk of Breast Neoplasia) is a study about tailoring breast cancer screening recommendations to a women's personal risk. The study involves using a risk assessment to combine multiple risk factors known to influence someone's chance of developing breast cancer, to provide personalised screening recommendations such a different imaging test or additional (supplemental) screening. Who is it for? You may be eligible for this study if you are a woman aged 40 to 59 years who is attending the BreastScreen Burgundy Street clinic for a scheduled mammogram. Study details: If you have a mammogram booked at BreastScreen Burgundy Street clinic, you may be contacted by BreastScreen Victoria and made aware of the study. If you are interested in taking part you will be provided flyer with link to complete an eligibility questionnaire. Eligible and potential participants will receive an email confirming an appointment with the study researcher 30 minutes ahead of the schuldes mammogram to discuss the study and the multifactorial risk assessment. The risk assessment includes your family history of breast cancer, breast density information from your mammogram and the results of a DNA test (using a mouth swab) to understand your personal risk of developing breast cancer. Consenting participants and a nominated general practitioner (GP) or practice clinic will then receive a risk report within 4 weeks summarising individual breast cancer risk, recommendations for any additional imaging tests or changes to frequency of subsequent screening. A study genetic counsellor will be available to discuss any concerns as required. Participants will be followed up for 6 months after receiving the risk report and asked to complete a questionnaires regarding their views on the acceptability, feasibility and impact of this report and screening initiatives at one and six months after receiving the risk report. Data generated from RoBiN will be used to inform future larger implementation trials, and ultimately inform policy and practice in the Australian screening program.

This study is a two-armed, multi-centre, pragmatic, randomised clinical trial designed to examine the effect of osteopathic care (OMT) on breastfeeding dyads experiencing breastfeeding difficulty. The trial will be conducted in two stages: preliminary and full. Both stages have the same design. The preliminary stage will pilot the design at a single clinic in Melbourne by recruiting 16 mother-infant-dyads (MIDs) experiencing breastfeeding difficulty. The full stage will extend the pilot to multiple clinics across VIC, TAS, ACT, NSW and QLD. Participants in both stages will be randomly allocated to one of two groups: international board-certified lactation consultant (IBCLC) - Standard care (Control) or IBCLC plus osteopathic intervention (OMT) (Experimental). The full stage will continue the pilot stage and see a further 54 MIDs (total N=70) experiencing breastfeeding difficulty randomly allocated to the same two groups. Recruitment for this stage will be from osteopathic clinics, maternal health centres and breastfeeding drop-in centres across metropolitan Melbourne and Canberra. Each participant will undergo 4 weeks of intervention with a follow-up phone call one-month post-intervention. The primary outcome of the study is change in infant breastfeeding function as measured by the Bristol Breastfeeding Assessment Tool (BBAT). Secondary outcomes include maternal breastfeeding confidence, as measured by the Breastfeeding Self-efficacy Scale – Short from (BSES-SF) and changes in breastfeeding symptoms such as maternal breastfeeding-related pain, infant ability to latch and maintain latch to the breast and feeding noise at the breast measured using a series of visual analogue scales (VAS).

In this prospective observational study, adult participants undergoing elective cardio thoracic surgery requiring cardiopulmonary bypass are assessed preoperatively by a kidney functional reserve test and by kidney damage biomarkers (i.e., urine DKK3) and postoperatively by kidney damage and stress biomarkers (i.e., urine KIM-1, urine NGAL, urine Nephrocheck) for the first 3 postoperative days. These will be assessed as predictors of AKI as per KDIGO guidelines within the first 3 postoperative days. Kidney function will be assessed by serum creatinine within 1 and 3 years after the surgery. The hypothesis is that the suggested preoperative assessment will help to identify people at higher risk of developing postoperative AKI and that postoperative AKI defined by kidney damage and stress biomarkers will identify people at higher risk of developing worsening kidney function at long-term (i.e.: 1 and 3 years after the surgery).

Cognitive impairments are common for individuals with brain conditions, however adequate assessment and intervention for such cognitive impairments continue to remain an area of high unmet need. In today’s era of resource-limited healthcare, it is becoming increasingly important to determine the value and impact of health services, including neuropsychology, through high quality clinical trial research to facilitate resourcing and allocation of such services. This trial therefore aims to evaluate the value and impact of neuropsychological assessment on improving outcomes for individuals with brain conditions and their families. Specifically, this project aims to evaluate whether comprehensive neuropsychological assessment with feedback, compared with brief cognitive screening with no feedback, results in: a. improved participant and/or support person understanding of the presenting cognitive and behavioural problems, and how to cope with and manage these problems; b. increased referrer satisfaction; c. more changes to clinical management; and/or more improvements to depression/anxiety symptomatology, self-efficacy, health-related quality of life, and carer burden.

The study aims to examine the effectiveness of a video-based CPR lesson plan to aid in classroom CPR video-based training delivered by existing school teachers in the Australian High Schools with a particular focus on students’ self-efficacy and ability to perform compression only CPR. The study will function as a pilot to establish the feasibility of classroom CPR training delivered by existing school teachers in the Australian High Schools. The study uses a prospective, non-randomised cohort design. It is hypothesised that the proposed video based lesson plan will be an effective and acceptable method of teaching school aged children CPR in an Australian practice context.

PCNSL is a subtype of diffuse large B-cell lymphoma (DLBCL) that affects the brain. While regular DLBCL (found outside the brain) responds well to treatments such as chemotherapy and immunotherapy, these approaches don’t work as well for PCNSL as the brain is protected by the blood-brain barrier. Past treatments such as stem cell transplants or whole brain radiation cause serious side effects and don't lead to good outcomes. There are many clinical trials testing new treatments for relapsed systemic DLBCL but these trials do not include patients with PCNSL. Patients with relapsed PCNSL have very few treatment options available. The NHL41 clinical trial is testing a new approach that combines three treatments across three phases; Zanubrutinib, CAR-T cell therapy and Tislelizumab. The main goal of this study is to assess if this combination is a safe and feasible treatment option. Who is it for? You may be eligible for this study if you are aged between 18 and 80, and have been diagnosed with PCNSL. Study details Participants who choose to participate in this trial will undergo treatment in three phases: Part I: Zanubrutinib induction therapy Patients will receive Zanubrutinib as induction bridging therapy until lymphodepletion prior to CAR-T cell therapy. Part II: Lymphodepletion chemotherapy and single CAR-T cell infusion Standard Lymphodepleting chemotherapy will be administered. On the day of CAR T cell infusion, CAR-T cells will be delivered fresh and infused intravenously. Part III: Tislelizumab followed by combination Tislelizumab and Zanubrutinib consolidation The first cycle of Tislelizumab will commence as a single agent. Zanubrutinib will be added in on day 1 post the 2nd infusion of Tislelizumab. This study aims to address this major unmet need by determining a safe and feasible treatment option for rPCNSL patients.

The primary objective of this project is to determine if balance-enhancing shoes are more acceptable than minimalist shoes in older women. The secondary objective is to determine if balance-enhancing shoes are more effective at improving balance performance and perceived risk of falls than minimalist shoes in older women. This study will utilise a randomised crossover study design. Participants will be women aged 65 years or older who are free from any conditions which may negatively impact their balance or ability to walk independently. Participants will be randomly allocated to two shoe conditions and will be required to wear the shoes from each condition for six weeks before crossing over to the alternate condition. Participants will attend the university for assessments over four sessions. We hypothesize that participants will find the balance-enhancing outdoor shoes more acceptable than the minimalist outdoor shoes.