ANZCTR search results

The trial aims to determine the effectiveness of a self-directed 12-week online Tai Chi program plus online educational information supported by the “My Exercise Messages” app on the primary outcomes of knee pain during walking and physical function at 12 weeks when compared to an online educational information control for people with knee OA. Following baseline assessment, participants (people with knee osteoarthritis who meet eligibility criteria) will be randomly allocated to one of two groups i) intervention - 12-week self-directed online Tai Chi program “MyJoint Tai Chi program” plus online educational information and an exercise adherence support app (“My Exercise Messages” app), or ii) control - online educational information alone. The intervention group will have access to a self-directed online 12-week Tai Chi program guided by an instructor delivering the program in a pre-recorded video format. The study hypothesis is that the Tai Chi intervention plus online educational information group supported by “My Exercise Messages” app will have greater benefits in improving pain and function compared to the online educational information group for people with knee osteoarthritis.

The overarching goal of this research is to develop and evaluate a digital exposure-focused intervention (the Courage Quest intervention) for children aged 8 to 12 years with one or more anxiety disorders. We are aiming to answer the following research question: Does the Courage Quest intervention reduce high levels of anxiety symptoms and result in greater remission of anxiety disorders for children aged 8 to 12 years? We aim to evaluate this through a pilot case series intervention study. The “Courage Quest” intervention will be developed as a parent guided intervention with therapist support. The intervention will be pilot tested using a case series intervention design, the outcomes from which will refine the intervention. The study hypothesis is that there will be clinically significant reductions in children’s anxiety symptoms and disorders (parent and child reported) after completion of the intervention.

Recent studies have demonstrated that specific nutrients, including lauric acid and L-tryptophan, have energy intake-suppressant and blood glucose-regulatory effects via several pathways, including stimulation of gut hormones and motility, and the slowing of gastric emptying, in healthy individuals. We aim to investigate the hypothesis that the combined intraduodenal administration of lauric acid and tryptophan, compared with the individual nutrients, will more potently stimulate gut functions, including gut hormones, and gastric emptying, associated with reduced postprandial blood glucose in people with type 2 diabetes.

The CHeCCK study proposes to improve the pathway to care for people who record a high blood pressure at a self-check health station within the community. We propose to achieve this through the combination of two proven detection and health education methods. SiSU health check stations are located within Priceline pharmacies throughout Australia and have detected hundreds of thousands of Australians who recorded a high blood pressure reading. Combined with a text message-based health education program, previously clinically proven to improve health risk factors and be highly acceptable to the general public.

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