ANZCTR search results

This study will investigate the treatment of head and neck lymphoedema in a head and neck cancer population. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have a previous diagnosis of oral, nasopharyngeal, oropharyngeal, laryngeal, or hypopharyngeal cancer treated with chemoradiation, postoperative radiation or definitive radiation with curative intent. Study details All participants will undergo measurements and lymphatic imaging of the head and neck using near infra-red fluorescence lymphatic imaging, in order to examine swelling. Participants will be randomly allocated (by chance) to receive either compression therapy or manual lymphatic drainage over a period of 6 weeks. Compression therapy involves wearing a compression neck/face support and a flat foam insert for up to 8 hours per 24 hours. Manual lymphatic drainage will be administered by a therapist twice a week and participants will also be trained to self-administer this therapy at home. Participants in both treatment groups will be evaluated after 6 weeks and 12 weeks of therapy in order to evaluate effect on lymphoedema. It is hoped that this study will help us to determine the most effective therapy modality to treat head and neck lymphoedema and will provide valuable information to inform future studies of this type.

This aim of this study is to evaluate the effects of acupressure on sleep quality of older persons living in residential care, within Australian context. Study participants will be older persons receiving services from aged care facilities and retirement village. They will be randomly assigned into intervention and control groups. The intervention group will receive acupressure (12-minute/session) three time a week for four weeks. Control group will receive routine care only. The primary outcome measures is sleep quality. The secondary outcomes are depression, anxiety and quality of life. The baseline data will be collected before commencing acupressure intervention (T0), followed by 4-week acupressure sessions. The outcome data will be collected at the end of intervention (T1) and two weeks after the intervention (T2).

The purpose of this project is to investigate the effect of a resistance exercise intervention on muscle structure and function, health-related quality of life, activity behaviours and self-reported pelvic floor function in advanced-stage ovarian cancer survivors who have completed first-line treatment. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who has a confirmed diagnosis of stage III or IV epithelial ovarian cancer, for which you have completed first-line surgical and chemotherapy treatment at least four weeks and no more than three months ago. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group (immediate exercise group) will immediately receive supervised and home based-exercise training for 12 weeks. Participants in the other group (delayed exercise group) will receive usual care for 12 weeks, after which time they will be offered supervised and home-based exercise training for 12 weeks. The individualised exercise program consists of resistance training and flexibility exercises, and involves two 60 minute clinic-based supervised sessions and one 30 minute home-based session each week. Supervised sessions are conducted in small groups of 2-4 participants. All participants will be required to undergo various assessments prior to and following the intervention, in order to evaluate muscle structure, function and quality of life. Assessments include two different types of muscle scans, physical function tests, and completion of questionnaires. It is hoped that the study will contribute important new information that will be useful to clinicians and survivors in the ongoing management of ovarian cancer.

Recent research in Chronic Pain (CP) has shown that the maintenance of CP is associated with how we react to it, and that the way with which we pay attention to pain sensations during mindfulness practice helps manage pain more effectively. The purpose of this research is to investigate the effectiveness of a brief mindfulness-based intervention in alleviating chronic pain (i.e. intensity and interference with daily life) and associated distress (i.e. depression, anxiety and stress). The aim is to determine whether an online delivery of this mindfulness-based task is effective for individuals experiencing CP. It is hoped that the results will help improve treatments for people with CP. Namely, it is hypothesised that participants will experience reduced intensity of pain and reduced associated distress post midfulness intervention.

This trial aims to explore the clinical outcomes of commonly used dental implant designs on the market. The tissue stability around dental implants is associated with aesthetic and biological success. Both designs have independent evidence suggesting the potential to increase tissue stability. Patients from the Griffith University Dental School requiring two implants fulfilling criteria will be offered inclusion in the study. The study will involve monitoring routine parameters during associated procedures and recalls; along with the addition of a one off non-invasive dental plaque sample. It is expected that both implant designs will show at least equal results to industry standards if not benefits. Although, there is limited data directly comparing these designs in the literature, this study aims to reduce that void.

The aim of the proposed study, 'Minimising Immunisatin Pain in Older Children (MIPO) is to evaluate the efficacy of two novel devices, Coolsense®(cools and numbs the skin) and Buzzy® (vibration) with cooling pads (wings) versus standard care, and to minimise pain during immunisations in older (aged 10 - 17 years inclusive) children (MIPO). Outcome measures will include 1. Child/adolescent self report of pain using the Visual Analogue Scale (VAS), 2. child/adolescent assessment of fear/anxiety using the Child Fear Scale (CFS) (Pre and post procedure), 3. Nurse assessment of child/adolescent's fear/anxiety using the CFS scale (Pre and post procedure) 4. Nurse report of observed pain using the VAS Scale, 5. Child and Parent perception of usefulness of Intervention and Nurse observed compliance with intervention. We estimate it will take up to 6 months to recruit the required number of children for these studies based on 75% uptake of those that meet the inclusion criteria. The study groups will be assigned randomly by a computer. It is hoped 492 children/adolescents will participate in this study, with 164 participants in each group. Before each child has their vaccine, we will either apply Buzzy® (with the cooling pad) or the Coolsense®device, or use the standard distraction method (technology with an IPAD). Possible outcomes will be reduced pain and fear/anxiety scores and improved patient and family experience of vaccination.

Multiple sclerosis (MS) is the most common non-traumatic neurological disorder that affects young adults. Cladribine tablets (Mavenclad®) is a new oral therapy for MS. The current dosing for cladribine tablets is 2 courses given one year apart. This has been shown to be effective in reducing relapses in 75% of patients for up to 4 years (based on annualised relapse rate). However, re-initiation of treatment after year 4 has not been studied. This will be a multicenter, 6-year, phase IV, low interventional trial. Subjects meeting the eligibility criteria will receive an initial treatment course in year 1 and a continuing treatment course in year 2. After 3 years, patients will have the option for re-initiation of treatment, if clinically indicated or the option to switch to another disease modifying therapy (DMT). This study is testing the hypothesis that patients who receive an additional course of cladribine tablets will experience less disease activity than those who chose to change DMT. During the study we will evaluate blood-based molecules called biomarkers, brain scans and brain function tests. At the end of the study, we will use the results of these tests to determine if there are ways to decide if re-initiation of treatment after the initial 2-year course is appropriate. This may be one test or a combination of several tests. In addition, we determine if these biomarkers can be used at onset of disease to determine if patients will respond to cladribine therapy before they start.

At the Royal Brisbane and Women's Hospital, Herston, Queensland, Australia, procedure mandates that patients lie flat for two (2) hours following a lumbar puncture (LP) with or without intrathecal chemotherapy. Most research to date has examined the prevalence of post-dural puncture headache (PDPH) and the length of time a patient needs to lie flat following an LP in non-cancer settings, with limited research examining patients in a cancer setting following intrathecal chemotherapy via LP. It is not clear if time spent lying flat impacts on outcomes such as patient reported PDPH and its severity. Some medical facilities within Australia and overseas have patients lying flat for one (1) hour. However, there is minimal evidence to support this practice. This research seeks to compare the practice of patients lying flat for one (1) hour versus two (2) hours following an LP with/without intrathecal chemotherapy and the prevalence of PDPH. Who is it for? You may be eligible for this study if you are an adult with a haematological cancer diagnosis who requires lumbar puncture for either diagnostic or therapeutic purposes. Study details As a participant in this study, you will be randomly allocation to either lying flat on your back for 1 hour or two hours after your lumbar puncture. Routine bloods tests will be performed prior to your lumbar puncture. At the time of lumbar puncture cerebral spinal fluid will be collected for pathology. This is considered standard care and these tests do not form part of the research project. It is hoped that this research will help determine whether one or two hours of lying down is more beneficial in reducing post-dural puncture headaches.

Guidelines recommended moderate intensity aerobic exercise for all patients with HF, however many exercise training studies include a patient group much younger than the 'real world' patient with HF who is elderly. This study was designed with a dual focus to address the age gap seen in HF exercise trials, while simultaneous gathering preliminary data for a novel rehabilitation technique called Peripheral Remodelling through Intermittent Muscular Exercise: “PRIME”. The PRIME approach offers a ‘hybrid’ aerobic-resistance solution for individuals with HF who may be unable to participate in conventional exercise training. This study will assess the feasibility of conducting a future large trial, to determine if 4 weeks of PRIME training, followed by 4 weeks of traditional HF rehabilitation (combination aerobic plus resistance exercise) can produce superior gains in aerobic capacity and muscle strength in comparison to 8 weeks of traditional HF rehabilitation, in elderly patients with HF.

This study is the second part of a larger project with the overall aim to establish an evidence-based program (the “PITCH program”) for dementia care that can be delivered to front-line home care workers (non-clinically trained paid personal carers). The first part of the project used participatory design workshops to develop the content of the PITCH program, as well as piloted PITCH by training a small number of participants to assess the feasibility and acceptability of the training program. The second part of the project (this study) will comprehensively evaluate the PITCH program in a larger randomized controlled trial. Approximately 120 people living with dementia at home and receiving a home care service will participate in the trial, as well as their family carers and paid home care staff. Over 200 home care workers will be trained in the PITCH program.