ANZCTR search results

The study will assess the effects of different doses of green tea amino acid L-Theanine supplement (placebo, 100mg, 200mg and 400mg) in healthy individuals with mild to moderate sleep disturbances. It is hypothesized that the consumption of L-Theanine supplement will improve the quality of sleep via the improvements in markers associated with stress. This study is a 3 week (1 week baseline and 2 weeks intervention), double-blinded, placebo controlled, four-arm, parallel pilot trial.

Colorectal cancer is the third most common cancer globally, with rectal cancer accounting for over a third of colorectal cancer diagnoses and deaths. A common treatment for rectal cancer is surgery. While many patients who have undergone a low anterior resection report good outcomes, patients often experience a variety of disruptive bowel symptoms and poor bowel control following surgery. These symptoms can include painful bowel motions, diarrhoea and involuntary loss of stool and is collectively termed low anterior resection syndrome. One treatment for this condition is pelvic floor muscle training. This involves patients doing pelvic floor exercises aimed at improving the function of the pelvic floor and therefore reducing the symptoms of the condition. While this has proven to improve symptoms, there is limited research into the preventative role of pelvic floor muscle training on low anterior resection syndrome. Therefore, we aim to assess if pelvic floor muscle training can be used to prevent low anterior resection syndrome and improve quality of life. This study aims to assess if pelvic floor muscle training can be used to prevent low anterior resection syndrome following surgical treatment of colorectal cancer, and improve quality of life for patients. Who is it for? You may be eligible for this study if you are an adult colorectal cancer patient who has undergone a low anterior resection and received a diverting ileostomy, and are now waiting for an ileostomy reversal. Study details Participants located at centres that have resources to provide a physiotherapy-based intervention will be randomly assigned to one of two groups: pelvic floor muscle training or standard care. Participants in the pelvic floor muscle training group will perform pelvic floor exercises until six weeks after their ileostomy reversal. Standard care will not involve any pelvic floor muscle training. All participants will be asked to complete questionnaires at several timepoints following their ileostomy reversal regarding bowel function and quality of life. Information from this study will help inform clinical practice regarding optimisation of surgical treatment for colorectal cancer patients.

Colorectal cancer is the third most common cancer globally, with rectal cancer accounting for over a third of colorectal cancer diagnoses and deaths. A common treatment for rectal cancer is surgery. While many patients who have undergone a low anterior resection report good outcomes, patients often experience a variety of disruptive bowel symptoms and poor bowel control following surgery. These symptoms can include painful bowel motions, diarrhoea and involuntary loss of stool and is collectively termed low anterior resection syndrome. One treatment for this condition is pelvic floor muscle training. This involves patients doing pelvic floor exercises aimed at improving the function of the pelvic floor and therefore reducing the symptoms of the condition. While this has proven to improve symptoms, there is limited research into the preventative role of pelvic floor muscle training on low anterior resection syndrome. Therefore, we aim to assess if pelvic floor muscle training can be used to prevent low anterior resection syndrome and improve quality of life. This study aims to assess if pelvic floor muscle training can be used to prevent low anterior resection syndrome following surgical treatment of colorectal cancer, and improve quality of life for patients. Who is it for? You may be eligible for this study if you are an adult colorectal cancer patient who has undergone a low anterior resection and received a diverting ileostomy, and are now waiting for an ileostomy reversal. Study details Participants at centres that do not have enough resources to provide the physiotherapy-based intervention, will be randomly assigned to one of two groups: app-based pelvic floor muscle training or standard care. Participants in the app-based pelvic floor muscle training group will be provided through a mobile application to guide them through exercises and record participation in these exercises. Standard care will not involve any pelvic floor muscle training. All participants will be asked to complete questionnaires at several timepoints following their ileostomy reversal regarding bowel function and quality of life. Information from this study will help inform clinical practice regarding optimisation of surgical treatment for colorectal cancer patients.

Type 2 diabetes (T2DM) is a very important chronic health condition that impacts Indigenous Australians disproportionately with devastating effects. T2DM is a major contributor to the reduced life span in Indigenous Australians. It is characterized by a younger age at onset and early and aggressive development of micro- (blindness, renal disease and lower extremity amputations) and macro-vascular (cardiovascular disease) complications. The risk of the complications of T2DM – both their development and the propensity for progression is markedly reduced if good glycaemic control can be achieved. Glycated haemoglobin (HbA1c) is traditionally used for assessment of glycaemic control in T2DM but fails to capture intra- and inter-day acute fluctuations in glycaemic excursions (glycaemic variability), which are associated with postprandial hyperglycaemia. Glycaemic variability is an independent predictor of cardiovascular mortality. Recently developed diabetes-related technology, continuous glucose monitors (CGM), can now easily estimate glycaemic variability by providing 24-hour data. Diet is a major aspect of an optimal glycaemic control strategy, but often subject to economic considerations, particularly in Indigenous Australians. The prevalence of food insecurity (a situation when availability of nutritionally adequate and safe foods or the ability to acquire acceptable food in socially acceptable ways is limited or uncertain) in Indigenous Australians is extremely high at 26%, 5-times the national prevalence. In response to food insecurity, individuals and households often develop ‘coping strategies’ including altered dietary patterns (choosing inexpensive high glycaemic simple carbohydrates over complex carbohydrates, fruits and vegetables or excessive food consumption when money is available and starvation when not). While these coping strategies are intuitively likely to impact glycaemic control adversely, the impact of food insecurity on glycaemic control, including glycaemic excursions in Indigenous Australians with T2DM is not known. We propose to investigate the glycaemic variability around pay cycles in Indigenous Australians with T2DM and with and without food insecurity using CGM. Both food insecurity and pay cycles are likely to affect glycaemic control adversely in Indigenous Australians with T2DM by increasing glycaemic variability. The impact of food insecurity and coping strategies on glycaemic control has apparently never been evaluated with 24-hour CGM data anywhere in the world. While this would be a preliminary study, the findings have the potential to make a major impact on both clinical practice (e.g. actively screening for food insecurity, further interventional studies designed to reduce glycaemic variability) and health policy (e.g. implementing food assistance programs and assessing impact on glycaemic variability).

The aim of this study is to evaluate a multimodal prehabilitation model of care, designed to support patients with head and neck cancer (HNC) to prepare for the physical and psychological impacts of radiotherapy (RT). Who is it for? You may be eligible for this study if you are aged 18 years or older and you are scheduled to receive radiotherapy as a treatment for your head and neck cancer. Study details All participants who choose to enrol in this study will be asked to complete a screening survey at a routine appointment with their specialist nurse consultant. This screening will involve completing a series of questionnaires. It is anticipated that this screening survey will take 5-10 minutes to complete. All participants will then receive access to the 'Preparing for Head and Neck Radiotherapy (Prep-4-RT)' self-management resources created by the Peter MacCallum Cancer Centre. Participants will be encouraged to engage with the resources at least once prior to their scheduled radiotherapy sessions. Information provided in the resources includes videos, written and pictorial information sheets and links to other relevant resources on the topics of “introducing prehabilitation”, “what is it like to go through radiotherapy?”, “preparing for radiotherapy: how do you do it?”, “guide to feeding tubes” and “guidance for carers and support people”. If during the screening process any participants are identified to be at risk of psychological distress, malnutrition, sarcopenia, eating difficulties or poor physical functioning, they will also be referred for a one-on-one appointment with a psychologist, dietitian, speech pathologist or physiotherapist for specialist prehabilitation. At least one appointment with each of the required disciplines will be scheduled prior to the participant's first radiotherapy treatment session and further appointments will be scheduled as clinically indicated. It is hoped this research will determine whether the self-managed patient resources and specialist prehabilitation sessions are acceptable to patients with head and neck cancer and the staff involved in their care. If these processes are found to be acceptable and helpful to patients and staff, a larger trial of these care pathways may be trialled in a greater number of patients.

This trial is exploring the efficacy of coating limb implants with a galvanised silver layer for the prevention of surgical site infection. Who is it for? You may be eligible for this study if you are an adult who has undergone resection of primary or secondary musculoskeletal malignancy, and require subsequent segmental bone reconstruction of the distal femur. In addition, there will be other participant groups recruited including those requiring reconstruction following trauma or implant failure. Study details Participants will be randomly allocated to receive implants with or without a galvanised silver coating. The surgery will be performed by an orthopaedic surgeon. Participants will be asked to attend follow-up appointments for up to 2 years after the surgery to establish whether any surgical site infection or other complications have occurred. It is hoped that information from this study will establish the utility of silver-coating limb salvage implants in reducing the risk of surgical site infection

Currently, the health impacts on Australian Army trainees undergoing Infantry Initial Employment Training are unknown. Subsequently, the Australian Army has little evidence to guide prevention strategies in this population. Focused research is required to investigate health outcomes during infantry training and trial interventions to mitigate preventable health problems. With this evidence, the Australian Army can inform future policy and improve practice to preserve and optimise the health of the force, such as increasing nutrition support to trainees. Proper and adequate nutrition is imperative to achieve the aim of every army; to transform civilians into fit, capable and resourceful members. A major gap in the research conducted to date is the paucity of studies that have concurrently measured dietary intakes and physical performance and health indicators to understand whether any shortfalls in dietary intakes lead to reductions in military-relevant health and performance indicators. Moreover, there is a lack of studies that have employed an intervention informed by behaviour change theory while translating eating strategies that are widely used in elite sport to army initial training with the aim of improving training outcomes (such as performance in physical fitness assessments and measures of body composition such as fat-free mass) and reducing the risk of musculoskeletal injury. Thus, the primary aims of this study are to: • Determine the effectiveness of promoting performance nutrition behaviours (intervention) to significantly improve nutrition knowledge; increase dietary energy intakes; and/or enhance macronutrient intake ratios and/or diet quality during the 16 weeks of Infantry Initial Employment Training (IET) compared to usual practice (no intervention). • Determine the effectiveness of promoting performance nutrition behaviours (intervention) to significantly enhance body composition (in particular fat-free mass), physical fitness performance, blood markers of bone metabolism and sex hormones; and/or significantly reduce symptoms of gastrointestinal distress during the 16 weeks of Infantry Initial Employment Training (IET) compared to usual practice (no intervention). • Determine if increases in total energy and/or macronutrient intakes are associated with increases in: nutrition knowledge; fat-free mass; physical fitness assessment performance, blood markers of bone metabolism and sex hormones over the 16 weeks of Infantry IET. The secondary aim of this project is: • Determine the effectiveness of promoting performance nutrition behaviours (intervention) to reduce rates of musculoskeletal injury over the 16 weeks of Infantry IET. The exploratory aim of this project is: • Collect data from various musculoskeletal injury surveillance methods and systems in the ADF and compare injury estimates across methodologies.

This study is assessing a combined physical and cognitive intervention to improve the quality of life of men affected by prostate cancer receiving androgen deprivation therapy (ADT). Who is it for? You may be eligible for this study if you are are an adult male who has been diagnosed with prostate cancer currently receiving primary ADT for metastatic and nonmetastatic hormone-sensitive prostate cancer. Additionally, you commenced ADT at least six months prior to enrolment and are expected to receive for another 6 months. Study details Participants will be randomly allocated to one of four arms. Arm 1 will involve concurrent physical training (performed on a stationary bike) and cognitive training, Arm 2 will involve physical training only and Arm 3 will involve cognitive training only. These 3 treatment arms will be delivered as 2 x 60-minute sessions per week over 8 weeks. Arm 4 will be a waitlist control group, where participants will be able to select one of the treatment arms to participate in upon conclusion of the study period. All participants will be asked to complete questionnaires assessing their physical and cognitive performance at the start and end of the trial. It is hoped that results from this study will help develop better treatment guidelines for brain fog and fatigue for men undergoing treatment for prostate cancer.

The aim of testing this product to ensure its safety and dose before commencing a clinical trial for efficacy in participants experiencing dizziness and vertigo. The trial will enroll 20 healthy volunteers who will receive either 4 tablets a day or 4 tablets twice a day for 15 days and then have 15 days without the tablet to monitor for safety.

The past decade has seen a rapid increase in mobile smartphone ownership, particularly among adolescents. Smartphone has been associated with mental health disorders (such as anxiety and depression), cyberbullying, poor sleep habits, poor posture and neck problems, and problematic mobile phone use (smartphone addiction), together with a decrease in general wellbeing, ability to concentrate (including in school time) and lower levels of physical activity. There have been increasing concerns regarding smartphone use among adolescents and the potential impact on health and wellbeing, including some concerns on the impact of smartphone use at school on educational and health outcomes. For example, concerns have been raised regarding students’ mobile phone use during school hours (in the classroom and playground) as a significant source of disruption impacting on attention and learning. Banning or restricting access to smartphone use in schools has been recommended by Governments across the United Kingdom, France, Canada, and in some Australian states as a potentially effective strategy to improve student health, well-being, and learning. With a change of Government in NSW, the introduction of policy within Government secondary schools, to restrict access to mobile phones during school hours, has been announced to commence from Term 4, 2023 (October). However, despite the introduction of Government policy to address the concerns surrounding mobile phone use amongst adolescents, research examining the school and student level impact of such initiatives is sparse, and so the suggested benefits are largely speculative. Prior to the introduction of new policies, a unique opportunity exists to address a current international evidence gap and undertake rigorous research to quantify the school and student level impacts of smartphone restrictions in secondary schools as well as to understand key stakeholder (teachers, parents, and students) attitudes towards and barriers to the implementation of such policy. To date, no such research has been undertaken in Australia or internationally. This study aims: to evaluate the efficacy of a secondary school environmental intervention to Restrict Access to Mobile Phones (RAMP) during school hours on student wellbeing, educational and health outcomes, and to determine the acceptability, appropriateness, and feasibility of the intervention from a teacher, parent/carer, and student perspective. A parallel-group cluster randomised controlled trial (RCT) will be conducted in secondary schools located across New South Wales (NSW). Schools allocated to the intervention group will participate in an environmental intervention designed to support the implementation of a school-level policy to restrict access to mobile phones for secondary school students during school hours.