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Hospitalised cancer survivors are very physically inactive, placing them at risk of weakness, medical complications and long hospital stays. This study is investigating if providing people with brief physical activity advice and a fitness tracker (Fitbit) to facilitate goal setting and provide feedback improves cancer survivor’s physical activity, reduces hospital stay and prevents complications. Who is it for? Participants will be patients with cancer who are admitted to the oncology/haematology ward at Box Hill Hospital who are medically stable to exercise. Study details Participants will be randomly allocated to one of two groups: 1) Physical activity advice with Fitbit in addition to usual inpatient care; or 2) usual inpatient care. At hospital discharge, and 30 days after, data relating to physical activity levels, physical function, confidence and hospital readmissions will be collected. It is hoped this study will determine the effectiveness of providing additional behavioural support including Fitbits on a hospital cancer ward.

The purpose of this study is to determine whether integrative approaches of exercise and psychosocial interventions may best address the needs of cancer survivors experiencing Cancer-Related Fatigue. Who is it for? You may be eligible for this study if you are aged 18 or over, have a fatigue score of greater than or equal to 4/10 and have completed definitive primary adjuvant cancer treatment (surgery and chemotherapy, targeted therapy and/or radiotherapy) for early stage cancer, within the previous 6–60 months, with no evidence of recurrence. Participants will be randomised to either a 12-week combined program of Physical Activity (PA) and standard Mindfulness Based Stress Reduction (MBSR), or PA alone. All sessions are delivered via Zoom by an Accredited Exercise Physiologist and Clinical Psychologist. The exercise will involve aerobic exercise (walking, cycling in the gym) or resistance training (weights). The mindfulness will involve group discussion, mindfulness practice, meditation and gentle yoga. Sessions will be in a group format. The mindfulness session is scheduled to occur after one of the Exercise sessions, for a total combined session of 3 hours. All sessions will be a group activity. You will be given resources to use at home, to help you practice. These resources may include: - handouts / audiorecording guides relating to mindfulness technique and practice (which you may keep) - wearable technology, such as a fitbit (which would be on loan from Concord Cancer Centre) - activity log for you to record your home practice Before and after the trial, participants will answer questionnaires about their quality of life, fatigue, fear of recurrence, sleep duration/quality, depression, physical fitness and patient experience. It is hoped this study will help improve Cancer related fatigue in cancer survivors, including their quality of life.

Background: The Hey Lemonade mobile app is in the development phase having attained initial seed investment to make the MVP (minimum viable product). The objective of the app is to tackle smaller mental health issues before they become bigger through the on demand delivery of situation-specific pep or motivational talks. The app contains a series of 2–3-minute talks designed to circuit break and help people alleviate common everyday stress. The content of the talks have been developed by the Hey Lemonade team in collaboration with professional writers and two clinical psychologists. The app developers have also drawn on design, user experience and user interface research to identify the most effective means of delivering the app content. The app currently has 30-40 uniquely written talks recorded by well-known voice actors or public figures such as Zoe Terakes, Susie Youssef, Dylan Alcott, Chief Brabon and Tony Armstrong. Aims / Objectives: While commercial mobile apps designed to promote health and well-being are becoming more and more popular, few are subject to rigorous testing to support the benefits they claim to deliver. The current project aims to quantify how engagement with the Hey Lemonade mobile app effects mood and stress in a real world setting as well as evaluate user experience. To do this the research team are proposing an uncontrolled two-arm randomized control trial recruiting participants identified by the Hey Lemonade app developers as their key demographic targets (women aged 25 – 50 years). Outcomes from the research would be used to refine the mobile app to maximize impact and usability. Key Research question(s): 1. Does use of the Hey Lemonade app (intervention condition) result in a significant improvement in coping self-efficacy or well-being in users compared to participants who do not use the app (control condition)? 2. How do participants in the intervention condition engage with and rate the user features or functions of the Hey Lemonade app? This includes objective components such as page views for specific app components and any in-app ratings of this content. It may also include duration of interaction within these. Hypothesis: Use of the Hey Lemonade app results in improvement in mood and perceived stress levels.

This study is being undertaken to understand the feasibility of generating clinically meaningful patient reported outcome measures using app-based approaches in a population of HR+, HER2– advanced or metastatic breast cancer patients. As well as for assessing virtual decentralised approaches for recruitment. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with HR+, HER2– advanced or metastatic breast cancer, you have recently started taking palbociclib as a treatment for your cancer and you are able to use a smartphone or other compatible device for the duration of the study. Study details All participants who choose to enroll in this study will be directed to download the Pippa study app (aka ClaimIt) to their smartphone or other compatible device, where participants can consent if they want to take part of the study. Immediately after enrolment, participants will be asked to provide demographic and clinical information related to breast cancer. Participants will then be asked to complete three questionnaires about their treatment regime and their health and abilities using the study app, at 1 month, 3 months, 6 months, 9 months and 12 months post-recruitment. It is anticipated that it will take 10-15 minutes for participants to enter these details at each timepoint. Participants may also be asked to complete a survey about their experience using the app at the completion of the study, or if they withdraw from the study at an earlier time. It is hoped this research will determine whether it is practical and acceptable to collect patient health-related information via a specially designed app. If the app is found to be useful, it may be made available on a larger scale so that all breast cancer patients can report their health status regularly and without needing to attend face-to-face appointments.

Elevated lipids called ceramides are associated with poorer outcomes in men with prostate cancer. Statins, a class of drug that reduces lipid levels, have been shown to be somewhat helpful in reversing this poor prognostic lipid signature, however only in a subset of men with metastatic castration-resistant prostate cancer (mCRPC) (i.e. those that are resistant to anti-androgen treatment). Therefore, other more potent or targeted lipid lowering drugs such as the anti-proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibody (PCSK9) inhibitor evolocumab may be required. This study aims to assess whether evolocumab reduces ceramide levels in men with mCRPC commencing chemotherapy or androgen receptor signaling inhibitors (ARSI) therapy. Who is it for? You may be eligible for this study if you are aged 18 years or over, have been diagnosed with mCRPC, and are planned to commence chemotherapy (docetaxel or cabazitaxel) or ARSI therapy (abiraterone or enzalutamide). Study details All participants will receive 420mg of evolocumab administered subcutaneously (i.e. injected under the skin) every 4 weeks for 12 weeks, commencing on day 1 of the first dose of chemotherapy or ARSI therapy. After each dose of evolocumab, participants will be monitored for any side effects. Blood samples will also be taken at baseline and after 12 weeks of treatment to assess for changes in the circulating lipid profile (i.e. ceramide levels) and prostate-specific antigen (PSA) levels. It is hoped that this study may show that evolocumab reduces ceramide levels associated with poor prognosis in men with mCRPC.

The purpose of this study is to assess the use of a 3D-printed scaffold, which is designed and tailored for each person, for the purpose of re-growing jaw bone. This may allow a more appropriate bone height for placement of dental implants, and could assist in making the future plate/denture fit better and be easier to clean. Who is it for? You may be eligible to join this study if you are aged between 18 years and 60 years old; have had head/neck ablation and reconstruction surgery within the previous 6-24 months; have a discrepancy between the old and new jaw bone; and have NOT undergone any radiation treatment previously. Study details Participating in this study involves having an operation to place the 3D printed scaffold under a general anaesthetic, which is likely a 2-3 hour procedure. The reconstruction plate used to heal your mandible after your initial tumour removal surgery will be removed at the same time. A small amount (2-3mls) of bone will be taken from your hip, and cells from your blood will be taken and placed in the scaffold to encourage bone formation. This operation will need an overnight stay to make sure you are healing well before going home. Once the scaffold is in place, a repeat CT scan will be performed 9 months after scaffold insertion to measure the amount of extra bone formation. Another 1-2 hour operation will then be performed to place dental implants, which is the next key step in getting teeth after your tumour surgery. This procedure is a day surgery procedure, so you will be going home on the same day. You will be asked to fill out surveys at various stages of the treatment to help us determine the best way to provide this care for future patients. It is hoped that this study will show that using this tailored, 3D-printed scaffold can help regenerate bone in the jaw; and thus improve dental rehabilitation outcomes for patients who have had ablation and reconstruction surgery.

Lung cancer is the largest cause of cancer related death in the world. Low dose computed tomography (LDCT) is a scan that reduces deaths from lung cancer by detecting early disease, which is currently being investigated as a screening program for current or former smokers as part of the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital. Physical activity is a potentially modifiable risk factor for the development of lung cancer. Therefore, the purpose of this study is to see if it is feasible to implement an exercise program as part of lung cancer screening to modify an individual’s risk profile. Who is it for? You may be eligible for this study if you are aged 55 to 80 years, are already enrolled in the International Lung Screening Trial (ILST) at the Royal Melbourne Hospital (NCT02871856), and are a current or former smoker estimated to be at a high risk of lung cancer. Study details Participants will be randomised (i.e. allocated by chance) to either the intervention group, which will receive a home-based exercise program, or to a control group that will not receive the exercise program. The home-based exercise program will involve an 8 week unsupervised program consisting of education, aerobic exercise, and resistance training, with weekly progress reviews and goal setting. Weekly progress reviews and goal settings involves a telehealth or telephone consultation of up to 30 minutes per week. Targets for aerobic exercise over the week will range up to 300 minutes per week divided over multiple sessions. Resistance training will be up to two 30 minute sessions per week. Participants allocated to the exercise program will also receive written materials describing Australia’s physical activity and sedentary behaviour guidelines, and will continue to receive usual care, defined as their current medical, nursing and allied health support. Participants in the control group will receive usual care and access to the written materials only. 9 weeks after commencing the intervention or control treatments, all participants will be assessed for feasibility of the intervention by adherence to exercise sessions, as well as for safety of the intervention by number of adverse events occurring during or within 60 minutes following the intervention. Participants will also be assessed for any changes in known contributors to lung cancer risk, including physical activity levels, exercise capacity, muscle strength, body composition, and overall health and wellbeing at 9 weeks and 6 months after commencing the intervention or control treatments. It is hoped that this study may show that the addition of a home-based exercise program to lung cancer screening is feasible, safe, and is able to improve the lung cancer risk profile of current or former smokers.

Closed Loop Medical has developed a neuromodulation and recording system capable of recording the electrophysiological response to each stimulus pulse. Closed Loop Medical have adapted a commercially available Spinal Cord Stimulation system approved for treatment of chronic intractable pain of the trunk and/or limbs to provide a fully implantable SNS system akin to those commercially available but, which can also use the recorded electrophysiological response from the sacral nerves to drive a feedback-controlled closed-loop therapy and aid in nerve targeting. This study is designed to assess the feasibility and safety of the Closed Loop Medical SNS System in the treatment of symptoms of OAB.

Anxiety and depressive disorders, which frequently co-occur, are the most common mental disorders in older adults (Beekman et al., 2000; Sunderland et al., 2015). The co-occurrence of anxiety and depression in older adults is associated with worse outcomes than either disorder alone, including increased risk of cognitive decline and dementia (de Beurs et al., 2009; Paterniti et al., 2002; Wetherell et al., 2004). Anxiety and depression can be successfully treated in community-dwelling older adults using psychological interventions, with the strongest evidence for cognitive behavioural therapy (CBT) (Wuthrich et al., 2021). When symptoms cannot be managed in the community or when individuals are at risk of self- harm, older adults are managed in inpatient wards. With the population rate of overnight mental health-related hospital stays for older Australians increased by a striking 82.4%, from 2006–07 to 2018–19 (Australian Institute of Health and Welfare, 2020), more needs to be done to assist older adults in inpatient wards. However, there are no evidence-based psychological interventions in inpatient settings that target anxiety and depression in older adults. Instead, psychotropics are used, including benzodiazepines which increases risk of falls and cognitive decline. Therefore, interventions developed using evidence- based practice that are feasible in this challenging setting are needed. Challenges to psychological management include disorientation of patients in these settings, variable attendance, and admission durations. Therefore, this project brings together experts in older adult mental health across multiple disciplines (clinical psychology, biostatistics, primary care) with clinical practitioners in inpatient services to co-design a group therapy intervention and evaluation procedure.

Tranexamic acid is an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, which has also been shown to affect immune function and inflammation. There is a strong biological rationale suggesting that tranexamic acid may reduce micrometastases at the time of surgery and so reduce the risk of longer term cancer-recurrence. Therefore, the aim of this nested study is to assess the cancer-free survival of a subpopulation of participants involved in the TRIGS trial (NCT04192435) undergoing surgery for gastrointestinal cancer, who are planned to receive either tranexamic acid or placebo. Who is it for? You may be eligible for this study if you are aged 18 years or over, are enrolled in the TRIGS trial, and are scheduled for elective or semi-elective (inpatient) open or laparoscopic-assisted (i.e. keyhole) gastrointestinal cancer surgery (oesophageal, gastric, hepatobiliary, pancreatic, colorectal). Study details All participants will be assessed for cancer-free survival at 5 years after gastrointestinal surgery using state cancer registries to determine the incidence of all-cause mortality and overall survival at 5 years post-surgery. It is hoped that this study may show tranexamic acid improves cancer-free survival, improves overall survival, and reduces all-cause mortality when administered at the time of gastrointestinal cancer surgery, which may help to guide the treatment of gastrointestinal cancer patients in future.