ANZCTR search results

This is an observational study which aims to see if levels of circulating tumour cells (CTCs) mobilised during curative-intent radiotherapy (RT) for non-small cell lung cancer (NSCLC) can be used to predict disease progression and development of metastases. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been deemed eligible to receive RT for NSCLC after positron emission tomography (PET) staging. Study details All participants will have collection of blood samples to measure the level of CTCs, pre-treatment, up to 3 pre-defined intervals (24 hours after commencement of radiotherapy, midway through radiotherapy, and final week of radiotherapy) throughout treatment and at disease assessment. A further sample will be taken at the time of suspected relapse, should this occur. These samples are collected on days participants are already attending the hospital. This will then be analysed to determine the correlation with survival, metastasis, local disease progression, and thromboembolic events (i.e. the development of blood clots) as determined by a review of medical records. The DNA of CTC samples will also be assessed to determine whether this influences any of the above parameters. Participants will be followed up in clinic as per standard of care requirements at 3 monthly intervals from completion of radiotherapy (or more often if required clinically) until last patient enrolled completes one year follow up. It is hoped that this study may show whether changes in CTC or CTC DNA levels after radiotherapy may have prognostic significance. Although this will not influence your current treatment, this may be used to inform the treatment of patients with NSCLC in future.

Cancer Services at South Western Sydney Local Health District (SWSLHD) have a diverse spectrum of patients with 18.5% of patients coming from a culturally and linguistically diverse (CALD) background. However, previous investigations in this cohort determined that trial participation was significantly lower in CALD patients (5.7%) compared to non-CALD patients (8.4%). The radiation oncology department at SWSLHD has a number of recruiting clinical trials that involve investigations surrounding the incorporation of magnetic resonance imaging (MRI) into routine radiotherapy planning and delivery. Literature indicates that barriers to CALD participation in clinical trials include communication and health literacy concerns. Therefore, the aim of this study is to assess the feasibility of providing translated educational materials to CALD patients, and the effect that this has on CALD patient recruitment to clinical trials of MRI in radiotherapy. Who is it for? You may be eligible for this study if you are aged 18 years or older, are attending the Liverpool, Campbelltown, or Bankstown Cancer Therapy Centre Clinics for a Radiation Oncology Consultation, and are of Chinese, Arabic or Vietnamese background requiring interpretive services. Study details All participants will receive educational materials that are translated into their native language. The materials will be delivered face to face, and will include a 5-minute video and a brochure containing standard patient MRI information. Before and after receiving these materials, participants will be administered a survey to assess their willingness to participate in clinical trials of MRI in radiotherapy. The recruitment rate of CALD patients to these trials will also be assessed at the end of the study, as well as the influence of the educational materials on recruitment rates. It is hoped that this study may show that providing translated educational materials to CALD individuals is feasible, and may improve rates of recruitment to clinical trials in this population.

Cerebral Palsy (CP) is the most common physical disability in childhood impacting 1 in 700 Australians. It is the 5th most costly condition at >AUD $5Billion p.a. CP is a disorder of movement and posture due to a static early brain lesion, however the musculoskeletal (MSK) sequelae are progressive. Major MSK complications are hip displacement, scoliosis and skeletal fragility, which lead to pain, disability and major orthopaedic surgery. Our Australian Cerebral Palsy Register has tracked the cause and severity of persons with CP. Our national Hip Surveillance Guidelines track progression of hip displacement which has shown a strong association with Gross Motor Function. Our Australasian Cerebral Palsy Clinical Trials network has implemented 3 international clinical practice guidelines on early detection, early intervention and efficacy of interventions to improve functional outcomes. Our team is well placed to develop a national program incorporating identification of hip displacement with scoliosis and fracture surveillance and to examine the inter-relationship between MSK complications. In a prospective cohort of n=500 children with cerebral palsy, our Australian CP MSK Health Network aims to: 1. Identify novel clinical outcome assessments and biomarkers of onset and progression of hip displacement, scoliosis deformity and osteoporosis/bone fragility to identify therapeutic targets and prevent progression; 2. Develop and integrate national hip, spine and fracture registries to develop practice guidelines that will lead to improved MSK health and wellbeing of children with CP; 3. Examine the inter-relationships between hip, spine and bone health on progression of MSK deformity to clarify the natural history of MSK complications and identify novel therapeutic targets; 4. Develop a fracture risk assessment and decision tool for children with CP to allow for accurate prognosis and timely intervention to reduce impact of skeletal fragility.

The purpose of this study was to assess the amounts of particular immune cells in tissue around a specific type of breast cancer in patients whose cancer had returned. The results were compared to the amounts of these immune cells in tissue from patients with the same type of breast cancer whose cancer had not returned to evaluate whether these immune cells could help to predict which cancers were more likely to return.

Domestic or intimate partner violence is defined as any behaviour within an intimate relationship that causes physical, psychological or sexual harm to those in the relationship. It is predominantly perpetrated by men against women, but it also occurs in same-sex relationships. In Australia, current responses to men’s use of domestic violence focus on men whose behaviour has became so severe that they enter the justice system. This project uses a novel approach to reducing domestic violence by engaging men in the community at an earlier stage in their use of domestic violence to seek help. This project builds on previous projects where we developed and successfully piloted BETTER MAN, an online healthy relationship tool. The aim of this project is to evaluate BETTER MAN, by randomly assigning 360 participants recruited online to either BETTER MAN or a website that gives information on healthy relationships. Specific objectives are to test whether BETTER MAN increases men’s help-seeking activities for use of domestic violence, increases men's identification of their behaviour as domestic violence and men's readiness to change regarding their abusive behaviours. Finally, we will explore whether BETTER MAN is cost-effective compared with the comparison website of resources.

Strength 2 Strength is a group program developed and published in 2012. The program was designed to enhance the resilience of family members supporting a person who has acquired a brain injury. The group program provides family members with the chance to speak with others in a similar situation and share experiences. It also provides information on the ways of managing the changes and challenges after a family member sustains a brain injury and gives information about services and supports available in the community. People who participated in the face to face group have found it very useful and effective when run in a number of settings in metropolitan areas of NSW. It can be difficult to run the face to face group program in rural areas where people living with acquired brain injuries and the family members who assist them, are scattered over a wide area and struggle to consistently meet once a week for five weeks. As a result, a shortened version of the group program was developed in 2012 but its effectiveness was not established. The shortened program is facilitated by two people and the guidelines suggest that no more than 4 family participants be involved in each group if telephone conferencing is used. This study is designed to investigate the effectiveness of this shortened program which runs for about an hour once a w eek using discussion tools that have been sent to participants before each session. A number of questionnaires (administered pre- post and follow-up) will be used to investigate the outcomes (primary, secondary) for the participant family members.

AIM Metabolic and obesity surgery (MOS) is currently the most effective, durable strategy for weight management. Comprehensive outcome data following metabolic and obesity surgery is missing from the Australian bariatric population. This prospective long term cohort study aims to document and evaluate medical, psychosocial and behavioural factors linked to outcome measures. METHODS Recruitment will commence from April 2021 and continue until November 2023 or until 250 participants are recruited. The study will observe participants for 2 years with data collection commencing 1-2 months pre-MOS and at timepoints 3,6,12 and 24 months post-surgery. Participants include those undergoing surgery over 16 years of age, able to read and write English and give consent. All participants will receive usual care during the study period. Data collection will include demographics and family traits; medical history, mental health via the Depression, Anxiety and Stress Scale (DASS); Quality of Life via the Assessment of Quality of Life (AQoL-8D); dietary intake (via a dietitian assessment survey and a participant-completed food frequency questionnaire); dietary behaviour via the Eating Disorder Examination questionnaire (EDE-Q); social factors; weight stigma using the Weight Bias Stigmatisation Scale (WBIS); use of social support networks and beliefs using patient-completed surveys; and attendance at clinical appointments. The primary outcome of weight change will be reported in kilogram (kg) weight change, BMI (kg/m2) and percentage weight loss (%WL), secondary outcome measures will include health and psychosocial variables evaluated in the study. STATISTICAL ANALYSIS Descriptive statistics will be used to profile the baseline characteristics of the participants. Linear and generalised linear mixed models and survival models will be used for the longitudinal data analysis. The investigators plan to present and publish the findings of this study at scientific meetings, both nationally and internationally and in peer reviewed journals. Participants will be unidentifiable with results being anonymised. SUMMARY Obesity effects a third of Australians and MOS in Australia has become a popular tool for obesity management. This surgery is mainly performed in the private setting with minimal data available reporting on outcomes including that of health, psychosocial wellbeing, and dietary changes. This prospective observational study will add to the limited literature from the Australian setting, important real-world data on the long-term comprehensive outcomes following MOS. Results may assist clinicians in providing best practice individualised care.

The current project seeks to work with end-users, people caring for a family member or friend with dementia, and a small number of representatives from dementia and carer organisations) to undertake real world testing and co-development of an App, called Carers’ CARE, to assist dementia carers. The project will use participants’ feedback provided in the App and from a small number of interviews, to assess the App’s a) patterns of usage, and end-user feedback about App features, content, user friendliness and acceptability b) dementia and carer related services providers' perceptions of the implementation potential of the App with extant services The study will also examine preliminary information about the App’s potential helpfulness for carers’ coping and psychological well-being.

In children and adolescents with CP, MSK complications are severe and progressive, with life-long impact. Hip displacement, scoliosis and skeletal fragility are often not detected until orthopaedic surgery is required or the child has sustained a pathological fracture. We will collect trans-iliac bone biopsy samples from 30 children with cerebral palsy to evaluate the bone quality and histomorphometry. Having a detailed understanding of the bone phenotype will help us plan targeted therapies to improve bone health.

The primary purpose of this research project is to investigate community participation outcomes for adults with acquired brain injury (ABI) after discharge from post-acute rehabilitation. Community participation refers to the meaningful participation and engagement of an individual in life roles, occupations and activities conducted outside the home environment as well as actively being involved with society. The Brightwater 'Oats Street' Facility is a community-based residential acquired brain injury rehabilitation facility where clients live on-site to receive rehabilitation and support from a multidisciplinary team of health professionals. Rehabilitation at this facility is considered 'post-acute' rehabilitation. Community participation outcomes of Oats Street clients will be measured at discharge and then at 4, 8 and 12 months after discharge. Data from these outcomes will be analysed Phase 3 will then involve data analysis to analyse the changes in community participation outcomes.