ANZCTR search results

The purpose of this study is to determine if a targeted therapy (a drug called trametinib) has an effect on tumour response in children, teenagers and young adults with neurofibromatosis type 1 (NF1) associated Plexiform Neurofibromas and Optic Pathway Gliomas. Who is it for? You may be eligible for the treatment arm of this study if you are between 3 months and 25 years old and have NF1 associated plexiform neurofibromas or progressive optic pathway gliomas. You may be eligible for the control arm of the substudy if you are between 3 months and 25 years old with NF1. Study details All participants in the main part of this study will receive the targeted therapy (trametinib) and are expected to take this drug daily for two years. The medication will be provided as either an oral tablet or an oral solution. Participants taking trametinib will be expected to complete some assessments at enrolment and attend monthly hospital visits for general health reviews. Additionally, every three months for two years, assessments will include MRI scans, and cardiac and vision testing. These assessments will measure whether trametinib is effectively treating the tumour and will also monitor any side effects. There is also a sub-study occurring within this study to find out if trametinib can improve learning, behaviour and well-being for those with NF1. For this part of the study, an untreated control group will be enrolled to compare to the trametinib-treated group described above. The untreated control group will be children, teenagers and young adults with NF1 who do not have a tumour that requires trametinib treatment. All participants in the trametinib-treated and the control groups will attend four Neuropsychology Clinic Visits over a two-year period. During these visits they will complete a number of questionnaires and tests to measure their cognitive function (thinking skills), behaviour and quality of life. It is hoped this research will help determine if trametinib has an effect on tumours and if there are any additional impacts to cognitive function, behaviour and quality of life.

The purpose of this study is to determine the possibility of adding a one-time PIPAC procedure (spraying chemotherapy drug into the abdomen) to the standard treatment of gastric cancer Who is it for? You may be eligible for this study if you are aged 18 years or older, with diagnosis of gastric adenocarcinoma and undergoing or being recommended for the standard treatment. Study details Participants in this study will undergo a procedure with a camera is inserted into the abdomen to check for metastatic disease. During this procedure, chemotherapy drug will be sprayed into the abdominal cavity. The patient will spend one night in hospital for observation and be discharged home in the morning. Participants will be expected to complete some assessments. Assessments will include clinic visits and quality of life questionnaires. It is hoped that this research will help to determine whether patients will be able to tolerate the additional the standard of care regime without increased toxicity or a need to spend more than one extra day of time in hospital.

Currently an estimated 1,250 Australians are living with Inclusion Body Myositis (IBM), a rare, chronic and incurable neuromuscular disease. IBM causes progressive muscle weakness and disability, compelling major life changes for patients and their families. There are no current disease-modifying treatments available for IBM. We are planning a clinical trial of a re-purposed drug (Sirolimus), to stabilise or slow progression of IBM, allowing patients to retain mobility, independence and quality of life for longer, as well as reducing healthcare costs. Sirolimus (Rapamycin) has been identified in pre-clinical studies as a strong treatment candidate based on its known mechanisms of action and our understanding of the pathogenesis of IBM. A small monocentric pilot study in France of Sirolimus in IBM demonstrated disease stabilisation in a cohort of 44 patients. This is an international, investigator-led Phase III trial of Sirolimus in 140 IBM patients. The trial will be led from Australia, and conducted as a double-blind, randomised, controlled Phase III trial (dbRCT). The study team includes leading IBM specialists across the globe, facilitating rapid translation into clinical care worldwide.

The aim of this project is to develop and evaluate whether a digital monitoring and support tool, called Workplace Wellbeing Assist (WWA), is effective in promoting a workplace culture that enhances the mental wellbeing of RAC staff working at a facility located in the Barwon South West region of Victoria, Australia. Direct care staff, managers and the general public will first be invited to participate in a 2-week unmoderated usability trial of WWA to test the digital tool and determine whether there are any problems. Direct care workers and managers will then be invited to participate in a 24-week in-situ evaluation of WWA. Specifically, this project seeks to: (1) Determine whether WWA increases perceptions of psychosocial safety in the RAC workplace from pre- (week 0), to mid- (week 12), to post-evaluation (week 24). (2) Determine whether WWA can successfully promote RAC direct care workers’ mental wellbeing and quality of life, and reduce psychological distress and workplace risk factors from pre- (week 0), to mid- (week 12), to post-evaluation (week 24). (3) Use quantitative and qualitative evaluation data to further explore the acceptability, usability, and usefulness of WWA, and to allow for future optimisation of WWA in the RAC sector. The results of this research will be used to determine whether a digital intervention can effectively promote a mentally healthy workplace that enhances staff mental wellbeing within RAC facilities and how it could potentially be optimised for other workplaces.

The 'Kick the smokes' research project is seeking to increase quit smoking rates. To achieve this, our project will develop a workbook and resources for South Australian Aboriginal and health professional participants, respectively. These educational resources are enhanced through the use of Augmented reality (AR) that is made accessible through the use of our bespoke smartphone App. Participant groups will be given the opportunity to access, use and review their respective resources; their feedback will be used to refine and improve these resources. This project will result in the completion of an AR enhanced workbook as designed by users that can safely support their quit smoking attempts; and, a series of AR enhanced resources for professionals that provides them with a concise and accurate quit smoking educational program.

The EMU (meaning “be happy”) program is designed to enhance the health and well-being of children, and their numeracy and literacy levels, through participation in an enjoyable and engaging PA program in the community/at school. The EMU program will specifically target the development of a positive learning environment through positive teaching practices i.e., through Aboriginal/Indigenous games. The overall aim of this study is to evaluate the impact of the EMU program on PA levels, well-being outcomes, and literacy and numeracy attainment in a sample of primary school-aged children. We hypothesise that students may receive various benefits to a variety of health outcomes i.e., resulting from participation in EMU.

This pilot study aims to examine the feasibility and acceptability of implementing a psychosexual and relationship education intervention for allogeneic haematopoietic stem cell transplantation (HSCT) survivors and their partners post-transplantation. Who is it for? You may be eligible for this study if you are aged 18 or older, you have received an allogeneic haematopoietic stem cell transplantation to treat a haematological malignancy (blood cancer) more than 3 months ago, you are in a sexual relationship and would like to receive assistance for identified sexual health issues. Study details All participants and their partners who choose to enrol in this study will receive one 60 minute educational session about medical and behavioural treatment options for sexual dysfunction delivered by a haematology nurse consultant. Enrolled couples will then also receive four 90 minute Emotionally Focused Therapy (EFT)-based relationship education sessions delivered by a clinical psychologist. Couples will be asked to complete a series of questionnaires before receiving the intervention sessions, and again after the final intervention session, It is hoped this research will demonstrate that a psychosexual intervention combining medical/behavioural management of sexual dysfunction and relationship education sessions will be feasible and helpful for patients with blood cancers. This may be used to improve sexual health outcomes for these and future patients and their partners.

The program Sport-HIIT will include a range of body weight and aerobic exercises that are designed to be enjoyable i.e., encouraging participants to work in pairs of their choice (with one participant undertaking the ‘work’ phase while their partner rests. The type of HIIT sessions players participate in may vary but will consist of a combination of aerobic and resistance exercises in a 30 sec: 30 sec rest to work ratio. Consenting coaches (after receiving instructions and resources) assists their players with a weekly HIIT session (10 minutes in total i.e., a 2 minute dynamic warm up and a 1 x 8 minute HIIT session), for 8 weeks. We hypothesise that students may receive various benefits to a variety of health outcomes i.e., resulting from participation.

A retrospective cohort study will review patient records to calculate a vasoactive-inotropic score for patients who have undergone heart and/or lung transplantation. Additionally in those patients who have has an abdominal CT scan in the preoperative period a psoas muscle cross sectional area (PMCSA) will be calculated. The objective is to assess the association between the VIS and the PMCSA and whether either measure is associated with post-operative outcomes.

This study is investigating whether it is safe to administer curcumin packaged into small biological spheres called liposomes, to patients with malignant pleural effusion via a long-term chest drain directly into their pleural (lung) cavity. Who is it for? You may be eligible for this study if you are aged 18 years or older with an existing diagnosis of malignant pleural effusion, and you have failed to respond to approved systemic therapies (chemotherapy, immune therapy or molecular targeted therapies), or you have progressive cancers following initial response to these therapies. Study details The first three participants enrolled in this study will be administered 100 milligrams of curcumin per metre squared of body surface area, delivered directly into the tumour site via a pre-existing long-term chest drain, once only. If these participants do not present with any adverse effects, a second group of participants will be administered 200 milligrams of curcumin per metre squared of body surface area via their long-term chest drain. If the second group show no adverse effects a third, and final, group of participants will be administered 300 milligrams of curcumin per metre squared of body surface area. If the third group show no adverse effects, the maximum tolerated dose will not be reached within this pre-determined dose range, and the study will stop. All participants regardless of the maximum dose received will be asked to provide blood and tissue samples at ten different timepoints over the 25 weeks of the study. Additionally all participant will be asked to attend a total of 5 follow visits over the 25 weeks of the study. It is hoped this research will determine whether curcumin given directly into the tumour site is safe, and whether it has any therapeutic effect on the cancer in the pleural cavity that is causing an MPE.