ANZCTR search results

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.

This study aims to compare the use of a robotic-assisted system and the current standard of care ultrasound-guided method for taking lung biopsy samples. Who is it for? You may be eligible for this study if you are aged 18 years or older and you are eligible to undergo an elective lung nodule biopsy at the Royal Brisbane & Womens Hospital. Study details All participants who choose to enrol in this study will have had a lung/chest CT scan taken prior to their enrolment. This scan will be used to plan how best the lung catheter and camera (bronchoscope) can be directed to collect samples of their lung tissue using the robotic-assisted bronchoscope (ION) System. Participants will be admitted as day patients at the Royal Brisbane & Womens Hospital and will undergo general anaesthesia in order to have the biopsy samples taken. It is anticipated that the procedure will take up to 45 minutes to complete. Once participants have recovered from the anaesthesia they will be able to go home. The samples taken by the robotic-assisted system will be processed to determine the likelihood that the tissue contains cancer cells. The results from an historical group of patients who had lung biopsies taken using the standard of care ultrasound-guided method will be used as a comparator to determine the safety and efficacy of the robotic-assisted method. It is hoped this research will determine whether use of the robotic-assisted system is able to provide more accurate tissue samples for assessment compared to the ultrasound-guided system. If the robotic-assisted system is found to be more effective and just as safe, if not safer, than the current standard of care method, use of the robotic-assisted system may be tested in a larger number of patients.

This study aims to determine whether patients with a high level of Amphiregulin/epiregulin (AREG/EREG) cancer cell markers for advanced stage colorectal cancer have a better treatment response to a combined chemo- and biological regime. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with right-sided RAS/BRAF wild type advanced stage colorectal cancer that has not been responsive to an initial treatment regime and you have previously provided a tumour sample for testing. Study details All participants who meet the inclusion criteria will firstly have their previously collected tumour sample tested to determine the level of AREG/EREG cancer cell markers present. Participants who have a high level of AREG and/or EREG cell markers will then begin a treatment regime that combines chemotherapy- irinotecan and biological therapy cetuximab. Treatment will occur every 14 days, in either of two ways- Intravenous infusion on Day 1, or intravenous infusion on Day 1 accompanied by 48 hr infusion pump. The treatment will be at physician discretion. The treatment will continue until disease progression, unacceptable toxicity or withdrawal of participant consent. Participants will be followed up for 3 years after beginning the treatment, unless they choose to withdraw from the study prior to that time. Participants who have a low level of AREG and EREG cell markers will be considered ineligible for participation in this study. It is hoped this research will determine whether the combination of cetuximab and irinotecan based treatment is effective for patients with a high level of AREG/EREG cancer cell markers of advanced stage colorectal cancer. If this treatment is found to be effective for participants with a high level of these markers, this method of screening colorectal patients may then be used more frequently to better prescribe treatments to specific patients.

In Australia, approximately one in ten children meet criteria for a neurodevelopmental condition. Neurodevelopmental conditions (NDCs) include Autism, Cerebral Palsy (CP), intellectual and learning disabilities. Impairments in cognition, communication, perception, and behaviour also frequently accompany both autistic individuals and those with CP. It is also common for children to have more than one NDCs. For example, of the one in 36 children that are diagnosed on the autism spectrum 88% will have additional co-occurring disability, commonly another NDC. Autism is also more prevalent in children with CP than it is in population studies, with studies estimating between 2% to 30% of children with CP also meet criteria for autism. Rates of mental health problems in adolescents with NDCs have also started to be explored. While 14% of all young people in Australia will experience a mental health condition, this compares to approximately 70% of autistic young people, over 40%-46% of young people with CP. However, unlike NDCs, most mental health conditions have the potential to be preventable, reversable or improved. Despite the additional support needs, interventions aimed at promoting wellbeing and mental health in adolescents with NDCs are extremely limited. The Westmead Feelings Program (WFP) was the first therapy program for children with NDCs aimed at improving emotional development skills with a focus on preventing mental illness. The Feelings Program for Adolescents (TFP-A) is the first program targeted at autistic adolescents with co-occurring mild ID and has also included adolescents with more significant communication and learning support needs. Previous studies of WFP and TFP-A report the programs to be feasible and enjoyable, and demonstrate improvements in emotional competence, and an increase in confidence for the parent and teacher in supporting social-emotional development. The present study involves The Feelings Program for Adolescents being delivered in a home-based setting, facilitated by parents. The primary purpose of the study is to explore the feasibility of TFP-A delivered in a home-based setting, and efficacy of TFP-A in impacting emotional competence, social skills, problem behaviours, wellbeing and mental health of adolescents with NDCs. It is hypothesised that parent-mediated TFP-A will be found to be feasible, and will correlate with improvements in outcome measures including emotional competence, wellbeing and mental health in adolescents with NDCs.

Preclinical studies and clinical trials involving cannabidiol (CBD) have suggested potential efficacy in treatment of psychosocial stress, situational anxiety, and nausea. This study is a randomised, double-blinded, single-dose experimental trial that use a series of customised virtual reality (VR) experiences to investigate the effects of purified, oral cannabidiol (CBD) on subjective, endocrine, and physiological markers of: (1) acute psychosocial stress during a simulated public speaking task, (2) situational anxiety when walking a narrow plank above a sheer drop, (3) acute motion sickness induced by a virtual reality rollercoaster ride and (4) cybersickness induced by exposure to VR in healthy individuals. Participants will complete one experimental sessions involving either (1) CBD or (2) Placebo. Trials will be conducted at the Brain and Mind Centre, Camperdown. We hypothesise that CBD will improve ratings of psychosocial stress, situational anxiety and nausea.

This is a single-centre, randomised, double blind, single and multiple ascending dose study to assess the safety of ZE46-0134, and how this drug acts in the body in healthy volunteers. ZE46-0134 may be indicated for use in patients with leukaemia, but a trial of the drug in healthy volunteers is needed before trials in cancer patients can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. People who have been diagnosed with cancer will not be eligible for this study. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or double dose of ZE46-0134 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of ZE46-0134 or placebo, followed by blood and urine testing. This will continue until a maximum safe dose is determined. It is hoped this research will determine the maximum dose of ZE46-0134 that can be administered safely without causing severe reactions. Once the dose of ZE46-0134 has been determined in healthy volunteers, a trial investigating the efficacy of ZE46-0134 as a treatment for patients with leukaemia may proceed.

Perceived cognitive difficulties are prevalent in people with mood and complex trauma. This includes difficulties in concentration, attention, planning and organisation, capacity to multitask, processing speed, and recall. The consequences of cognitive impairment include reduction in self-esteem, capacity to absorb information, and procrastination, as well as increases in the time necessary to complete tasks and avoidance of decision making. Such impairments can consequently impact individuals' performance at work, in relationships and in hobbies, and diminish the benefits of therapy. These circumstances necessitate the development of affordable and accessible interventions that can be offered to individuals experiencing cognitive function deficits associated with mood and trauma disorders. Cognitive training has been shown to be efficacious in aging populations, and populations with mild cognitive impairment, psychosis, and mood disorders. There is clear scope to develop and implement cognitive training for mood and complex trauma disorders in women's mental health. The research activities outlined in this application will specifically address the mental health needs of women with mood and complex trauma disorders. Gender differences in mental ill health are well documented. The proposed project seeks to improve symptoms of mood and complex trauma disorders in women by improving underlying problems in cognitive abilities. The outcomes of this cognitive training research will directly benefit women. The broader benefits of this research activity will help retain females in work and study, including perimenopausal women who often reduce their engagement in the workforce. Hence, this research activity will aid age and gender diversification and expertise in the modern workforce. The aim of this research is to design and implement a cognitive training program (COGtrain) tailored toward women’s mental health. That is, incorporating education about the influence of sex hormones and reproductive life events on mood and cognition. This research activity will employ an open-label feasibility trial design with the aims of (a) examining the feasibility of utilizing COGtrain among women with mood and complex trauma disorders and (b) determining whether COGtrain leads to significant improvements on measures of perceived cognitive impairment; neuropsychological and psychological functioning, and individual goal setting.