ANZCTR search results

This study aims to explore whether participating in exercise during adjuvant chemotherapy can improve treatment tolerance and more specifically chemotherapy completion rates. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with a stage I-III solid tumour and are scheduled to receive chemotherapy. Study details Participants will be offered twice-weekly supervised small group exercise sessions for the duration of their adjuvant chemotherapy, or for a maximum of 8 months. Exercise sessions will last approximately 60 minutes and involve a combination of aerobic, resistance, and balance exercises. Participants will also be encouraged to engage in additional aerobic exercises at home with the goal of reaching a total of at least 150 minutes of moderate to vigorous intensity aerobic exercise each week. Data on chemotherapy completion, physical and mental wellbeing will be collected before, during and after the intervention. It is hoped that information from this study will help determine whether participating in exercise during adjuvant chemotherapy has a beneficial effect on chemotherapy completion rates and physical and mental wellbeing in people diagnosed with cancer.

VIHSP is a state-wide universal newborn hearing screening program in Victoria, Australia. Approximately 0.8% of infants receive a positive (‘refer’) result on their hearing screen and are referred to one of approximately 13 Victorian diagnostic audiology clinics for further assessment of their hearing. As part of routine clinical care (usual care), parents of infants referred to diagnostic audiology are contacted by VIHSP Area Managers to discuss the referral and assist to organise the initial diagnostic audiology appointment. Parents are then contacted by a member of the VIHSP ESS team. The VIHSP ESS assign a dedicated case-facilitator who provides preparatory written/verbal information about the diagnostic audiology appointment. The ESS facilitator is available to support each family prior to the diagnostic audiology appointment right up to enrolment into early intervention (as required). ESS is available to be contacted by the family at any time in the diagnostic and intervention pathway. Parents also speak with, and may receive, written/verbal information about the diagnostic appointment from the audiology clinic they attend. As an additional resource, VIHSP have developed an information video to help prepare parents for their infant's diagnostic audiology appointment. The information video follows a mother and her infant as they attended the infant’s initial diagnostic audiology appointment. This information video is approximately six-minutes in length and provides the viewer with both visual and auditory information about the audiology equipment, the likely sequence of events, the purpose of each test, and how best to prepare their infant for the appointment. This is a single site randomised controlled trial, embedded in clinical care, with an active control group. One parent/caregiver per infant referred to diagnostic audiology during the recruitment period will be invited to participate. Participants will be randomly allocated to either a control (usual care) or intervention group (usual care + intervention) and asked to complete one online survey prior to their infant's audiology appointment. Those in the intervention group will also be asked to view the six-minute information video embedded within the online survey. This study aims to explore if, in addition to usual care, providing an information video prior to an infant's diagnostic audiology appointment has an impact on: • parent/caregiver knowledge and understanding about the diagnostic process • parent/caregiver anxiety • the number of infant diagnostic audiology appointments required to reach a diagnosis It is hypothesised that: •Parents/caregivers in the intervention group will have higher knowledge scores and lower anxiety scores compared to the control (usual care) group •Infants of parents/caregivers in the intervention group will require fewer diagnostic audiology appointments to achieve an audiology diagnosis compared to infants of parents in the control group

The results of the recent pragmatic RCT of the Interdisciplinary Home-bAsed Reablement Program (I-HARP) have shown that a structured, evidence based and person-centred rehabilitation program delivered in the community improved daily functioning of people with mild dementia, enabling them to live longer at home. This NHMRC partnership project, Optimising functional independence of older persons with dementia: Implementation and evaluation of the Interdisciplinary Care Home-bAsed Reablement Program (I-CHARP), builds on I-HARP in order to transfer the program logic of I-HARP to residential aged care settings. This protocol provides detailed steps as to how I-HARP is translated and evaluated in residential aged care using a model called I-CHARP. This project I-CHARP integrates evidence based strategies into a person centred interdisciplinary rehabilitation package. The aim of the trial is to evaluate a co-designed I-CHARP model in residential aged care homes by examining whether (and, if so, how) I-CHARP implementation produces its intended effects and how this program can be adapted, sustained and scaled up across aged care homes. The I-CHARP study uses a hybrid design involving testing of the implementation strategy (REACH network) while observing/gathering information on the clinical intervention (I-CHARP) and related outcomes. The evaluation takes place in three cycles over four years using a cluster quasi-experimental design and qualitative methods. During the initial phase of the project, the delivery model for I-CHARP is co-designed with the partnering residential aged care providers to ensure the study is feasible within their context and staffing arrangements. This I-HARP protocol details Phase II of the project, a cluster quasi-experimental design and qualitative methods. I-CHARP uses the same principles and procedures as I-HARP delivered by OTs and RNs that consists of 20 weeks of delivery over four months integrated into residential aged care services as a model of care.

This study aims to improve the scientific understanding of the effects of intramuscularly (IM) administered 5-MeO-DMT on human brain activity as well as other indexes of well-being as assessed through psychological, physiological, and biological markers. Finally, we aim to further our understanding of the tolerability and safety profile as well as dose-dependent effects of different doses of 5-MeO-DMT or placebo administered per intramuscular administration and to uncover its phenomenological characteristics.

Children with Developmental coordination disorder (also known as Dyspraxia) or DCD have considerable difficulties undertaking essential everyday tasks requiring movement (e.g., using utensils, toothbrushing). Up to 50% of children with DCD also have attention deficit hyperactivity disorder (ADHD), causing difficulties with attention and hyperactivity, which can further worsen these movement problems. Recent research by our team suggests pairing physical activity with a combination of action observation (AO; when one observes and imitates movement) and motor imagery (MI; when one mentally rehearses movement without physically performing that action) may help children with DCD perform activities of daily living (ADLs) better. While promising, these benefits have only been observed in a narrow range of motor tasks. Therefore, the question remains as to whether these effects can be observed across a broader range of difficult ADLs (e.g., balance and walking). Further, no research has investigated if AO+MI training, which may be mentally demanding, can also help improve movement in children with concurrent DCD+ADHD, as ADHD may impact their ability to focus on, and use, these techniques. The current study will address these issues, which are important for determining the generalizability of AO+MI effects in DCD, and their usefulness across the broader DCD population. Additionally, while AO+MI training appears to improve movement ability in children with DCD, not all children benefit from this intervention to the same degree. There are currently few accurate and affordable methods to help clinicians identify children who are more or less likely to benefit from these interventions. This significantly impacts treatment planning for children with movement problems. The second aim of this project will address this gap by using a newly developed electroencephalography (EEG) method to determine whether neural communication in the brain can predict the effectiveness of AO+MI training in those with DCD, and if these results differ for those with DCD+ADHD. This will help improve the development of interventions, treatment planning, and quality of life for these vulnerable children. It is hypothesised that task completion time and performance errors will significantly reduce at the progress-test, post-test and retention test compared to pre-test for the intervention group, in comparison to the physical activity only group. Further, it is hypothesised that alpha frequency bands will predict treatment outcomes in the intervention group.

The aim of this overall research is to evaluate the implementation, clinical and economic impact of a service model (intervention) delivered by community pharmacists in NSW, and 5 pharmacies in ACT, managing UTIs for a specific patient cohort (women aged between 18 years and 65 years) presenting with symptoms consistent with an uncomplicated UTI. Specific objectives are to: 1. Assess implementation uptake of the intervention including the reach, fidelity and adoption of the intervention in community pharmacies, participant characteristics, and variation in uptake by geographic region. 2. Assess the clinical and experience outcomes for patients managed and/or treated by community pharmacists. 3. Assess the safety of the intervention and identify any risks that need to be addressed for future implementation. 4. Evaluate acceptability and feasibility of the intervention to pharmacists, other care providers and participants using the service. 5. Identify contextual enablers and constraints to access, adoption, fidelity delivery, impact, sustainability, and generalisability of the intervention. The service will be tested with the aim of understanding the effectiveness of the service, appropriate use of antibiotics, impact on use of other health service resources and impact on supporting self-care. The implementation process and potential for future sustainability of the intervention will be investigated using an implementation science framework. The study will use a cohort study design to assess the clinical and economic and implementation of the intervention in NSW and ACT over a 10-month study period. The intervention is multicomponent including Pharmacist training and support and a Pharmacy consultation applying a clinical management protocol. Pharmacies and pharmacists must meet the criteria of an 'approved pharmacy' and an 'approved pharmacist' outlined in the NSW Health Authority to participate. The primary outcome will be self-reported 7-day symptom resolution rate. Secondary outcomes include rates of primary care utilisation, medication utilisation, hospital service utilisation, patient experience, and safety outcomes. Implementation outcomes will also be assessed to examine the fidelity, reach and adoption of the new service. Sub-group analyses will look at variation in outcomes based on participant demographics, geography, and clinical characteristics as well as pharmacy level characteristics. Semi-structured interviews with pharmacists and other stakeholders will be conducted to better understand barriers and facilitators to implementation of the service.

DEAKIN UNIVERSITY HUMAN RESEARCH ETHICS COMMITTEE approved the following study design: There are two phases to this study. Phase 1 will involve all respondents to study advertisements to complete a brief screener to determine their eligibility. Those who meet eligibility criteria will then complete an online questionnaire battery that will ask them about their demographics, eating behaviour, self-esteem, body image, and attitudes and acceptability of online interventions. Participants who complete this questionnaire battery will then be randomly allocated via a computer-generated sequence to one of two conditions (Mind-2-Body or wait-list). Participants allocated to the online program will have access to the content of the program immediately and will be asked to practice the exercises as often as they like, and whenever they feel it would be useful. Mind-2-Body is a single-session program that can be completed via an online platform in about 60 minutes. It consists of 5 lessons designed to help people improve their body image, with each step offering a key exercise grounded in cognitive, behavioral, or mindfulness principles. Participants allocated to the wait-list will be notified that they will have access to the program 8-weeks after baseline. Phase 2 will occur at the end of the 4-week intervention phase. For both groups, phase 2 involves completing the baseline questionnaire again 4-weeks after the baseline assessment was completed. This will be to assess for the acceptability and efficacy of Mind-2-Body. Participants allocated to the immediate intervention group will also be asked some brief questions about their experiences with the intervention and will be offered an opportunity to debrief about the study with the Principal Investigator (Dr Messer), either via email or telephone. All participants will complete a final follow-up survey at 8 weeks from baseline. The entire study is therefore done online, and no face to face contact with participants is required. All participants will be reimbursed $25 for the 4-week post survey, and $25 for the 8-week post-survey. It is hypothesised that those allocated to the body image intervention will show lower levels of negative body image, lower levels of binge eating and eating disorder psychopathology, higher levels of positive body image (appreciation/functionality, flexibility), self-esteem and mental health, and improved attitudes to help-seeking at 4 and 8 weeks post-intervention compared to the control group.

The role of inflammation has been described in the aetiology, early detection and prognosis of cancer as reflected by a range of inflammatory makers. Inflammation is also thought to play a significant role in the expression of cancer-related symptoms. Examples include elevation of CRP and TNF in head and neck cancer pain, CRP and Interleukin (IL)-1 receptor antagonist in fatigue during radiation therapy, and IL-6 and MIP1 alpha reflecting symptom burden in myeloma. This study proposes to investigate the inflammatory markers and immune cells as a pilot sub-study within our main MRFF funded randomised controlled trial of 1:20 THC:CBD medicinal cannabis product versus placebo in symptomatic patients with advanced cancer. Who is it for? You will be eligible for this study if you consent and pass eligibility to MedCan 3 - THC/CBD 1:20 Study details The study is a single site study. Serum is collected at baseline and day 14 in the current study. In participants consenting to the sub-study, blood for inflammatory markers will be taken at baseline, days 14 and 28. Serum will be frozen and stored until samples from 30 participants have been collected. All samples will be analysed for inflammatory markers. If there is a positive result showing an improvement in inflammation markers it may lead to a larger, adequately powered study of the anti-inflammatory effects of THC/CBD 1:20 in cancer patients.

Despite a wealth of research examining muscle fat infiltration (MFI) and its relationship with outcomes, the aetiology of its progression is unclear. To date, studies that have tracked the time-course of MFI have not prospectively examined the effect of different treatment modalities on its trajectory. By extension, prior works have not investigated the relationships of structural or functional outcomes with three-dimensional MFI. Given that subjective two-dimensional evaluations of MFI have demonstrated poor inter-rater reliability for muscle quality, there is reason to believe that our tentative confidence in preoperative MFI’s prognostic power for surgical outcomes is erroneously underpinned by baseline measures that lack reliability and validity. In fact, there have been conflicting results between qualitative and semi-quantitative measures. This is a prospective cohort study that aims to track clinically meaningful changes to image-derived features of rotator cuff tear management over nine months. Muscle quality measures on MRI will be collected at baseline and at 9-months along with biopyschosocial measures and patient reported outcomes of pain satisfaction, function and activities of daily living. All consecutive patients indicated for rotator cuff tear management will be considered for eligibility. After reading the information sheet and signing the consent form, they will be invited to enrol. Baseline characteristics of age, sex, hand dominance, medications, body mass index, prior surgeries, alcohol/tobacco use, and relevant comorbidities will be recorded along with tear characteristics, pre-operative 3 x Patient Reported Outcome Measures (PROMs) and 2 x VAS scores: the American Shoulder and Elbow Society (ASES) Score – Patient, the Patient Health Questionnaire 9-item (PHQ-9), the Tampa Scale of Kinesiophobia 11-item (TSK-11), Visual Anolog Scale (VAS) Pain, VAS Satisfaction. Enrolled participants will be referred for a preoperative MRI shoulder scan which will be collected prior to their treatment commencement dates. During and after treatment, all participants will receive standard care for the rotator cuff, including several usual care orthopaedic consultations. The assessments will be re-administered at a 9-month follow-up appointment with their treating surgeon which will include the same baseline measures of range of motion and scores from the 3 x PROMs and 2 x VAS. Finally, participants will be asked to undertake a follow-up MRI scan of the shoulder to evaluate muscle fat infiltration, muscle volume and tear characteristics. There are two primary outcome measures. Firstly, it is hypothesised that MFI of the rotator cuff will significantly change within the first nine post-treatment months regardless of treatment group. Secondly, it is hypothesised that 3D MFI measures will significantly differ between participants with an intact and torn rotator cuff (i.e., surgical vs non-surgical/re-tear).

This project represents a partnership between the Lifeline Research Office, Lifeline Australia and the Centre for Mental Health, The University of Melbourne. Men represent approximately 40% of callers to Lifeline, however they account for 75% of suicide deaths in Australia. Past research has highlighted that many men struggle to engage with mental health services such as helplines due to the influence of traditional masculine norms, such as the expectation that men be self-reliant and in control of their emotions. These norms also influence the way men experience mental distress, making them more likely to experience anger, irritability, substance misuse, and risk-taking. In interviews with Lifeline Crisis Supporters, we found that Crisis Supporters felt they would benefit from further training around understanding male presentations of distress, and how to engage with callers to Lifeline. The objective of the trial is to determine the impact of the Engaging Men in Crisis Support professional development (PD) program on male callers’ outcomes at Lifeline measured via a caller outcome survey. Lifeline have partnered with The University of Melbourne’s Centre for Mental health to develop a world-first training program Crisis Supporters, called Engaging Men in Crisis Support. The development of this training was guided by lived/living experience interviews with Crisis Supporters and male consumers of helplines, subject matter experts, and best-practice guidelines. This training aims to inform Crisis Supporters regarding common presentations among male-identifying help-seekers and provide the skills to effectively engage and support these help-seekers It is hypothesised that male callers who receive care from a Crisis Supporter (CS) who has completed the Engaging Men in Crisis Support training will report lower ratings of feeling distressed than male callers receiving standard care following a call to Lifeline.