ANZCTR search results

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 Cancer related fatigue score of greater than or equal to 4/10 and have completed definitive primary adjuvant cancer treatment (surgery, chemotherapy, targeted therapy and/or radiotherapy), within the previous 6–60 months, with no evidence of recurrence. Study details Participants in this study will undergo a 12-week combined program of Physical Activity (PA) and standard Mindfulness Based Stress Reduction (MBSR ) or to the control group with Physical activity only. This will involve coming to the Sydney Survivorship Centre, for two to three sessions a week, regularly for 12 weeks. For the first 6 weeks, the Exercise sessions will be held at 3 different times a week. The mindfulness session is scheduled to occur after one of the Exercise sessions. You may choose which two Exercise sessions are most convenient for you to attend. The exercise will involve aerobic exercise (walking, cycling in the gym) or resistance training (weights). Sessions will be in a small group format and guided face to face by our Exercise Physiologist. You may share the gym with other patients who are not participating in this study. The mindfulness will involve group discussion, mindfulness practice, meditation and gentle yoga. Sessions will be in a group format and will be guided face to face by our Clinical Psychologist. All sessions will be a group activity. You will be given resources to take home, to help you practice. These resources may include: - handouts / 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 All 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.

The current study will investigate the feasibility and effectiveness of a stepped care approach for treating posttraumatic stress disorder (PTSD) in adults. Stepped care is defined as a hierarchy of evidence-based therapies where clients can be matched to an intervention level that suits their current needs. In an open trial, participants will initially complete a self-guided PTSD program online (This Way Up, developed by the Clinical Research Unit for Anxiety and Depression, CRUfAD, St Vincent’s Hospital, Sydney) that involves modest clinician involvement. Participants who show risk of disengagement and/or dropout, or do not make significant clinical gains will be offered traditional, one-to-one, PTSD treatment (Cognitive Processing Therapy) via telehealth. Outcome measures will be assessed at pre- and post-treatment and at a 3-month follow-up. Primary outcomes are PTSD (diagnosis, good end-state achievement, severity reduction) and treatment retention. Important secondary outcomes include comorbid conditions, quality of life, feasibility (i.e., ease of delivery), acceptability as rated by clients, and cost effectiveness. It is hypothesised that this approach will be both accessible and cost-effective as we predict that most clients will achieve good end state functioning without needing to be "stepped-up" to CPT.

The purpose of this study is to evaluate the effectiveness of low dose targeted drug delivery (TDD) therapy for chronic back pain patients who have failed spinal cord stimulation.

The primary objective of the study is to describe real world clinical and tumour characteristics of patients with HR+ HER2–ve MBC in Australia who have received ribociclib in combination with an AI as part of the ribociclib MAP and/or SPARK access program, and treatment details of AI + ribociclib. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and have been diagnosed with metastatic or advanced HR positive, HER2 –ve breast cancer, for which you have received combination treatment with ribociclib and an aromatase inhibitor as part of the Novartis ribociclib MAP/SPARK program between the period of 1 May 2017 to 30 June 2018. Study Details The information will be collected from the medical records of patients who were prescribed ribociclib in combination with an aromatase inhibitor as part of the ribociclib MAP and/or SPARK access program. We hope that this information will give is an opportunity to improve our understanding of real world ribociclib treatment in Australia.

Efforts to correct the physical inactivity pandemic have focused on leisure-time physical activity (PA) with limited impact. Public transport (PT) users accumulate more PA than motor vehicle users, yet intervention studies to increase PA through transported-related behaviour are sparse. Further, incentive-based strategies have demonstrated some promise for increasing leisure-time PA, but their impact on other types of PA, such as transport-related PA, is unclear. This study aims to fill a knowledge gap by determining the impact of an incentive-based strategy to increase transport-related PA by increasing PT use in a regional Australian setting. It is hypothesised that incentivising bus use will increase bus use and reduce motor vehicle use leading to PA gain.

WalkBack is a pragmatic randomised controlled trial comparing a walking and education program prescribed over 6 session by a physiotherapist, with a usual care control group. 698 participants, who have recently recovered from an episode of non-specific low back pain, will be recruited through the community and primary care clinicians (GPs, physiotherapists and chiropractors). Participants will be followed up for a minimum of 12 months. The primary outcome will be days from randomisation to first self-reported recurrence of an episode of activity-limiting LBP (somewhat or greater activity limitation measured using an adaptation of item PI9 of the PROMIS item bank to measure pain interference). The secondary outcomes will be days from randomisation to first self-reported recurrence of (i) an episode of non-specific LBP (intensity equal or greater than 3/10 on the numeric pain rating scale, lasting at least 24 hours), (ii) an episode of care seeking (with consultation to a health care provider) LBP and back pain related-disability measured by the 24-points Roland-Morris Disability Questionnaire (RMDQ). An assessment of effectiveness and cost effectiveness of the walking and education program compared to usual care will then occur.

Low back pain is the leading cause of disability worldwide. Most current treatments are only moderately effective at improving this condition and optimal ways to target factors linked to persistent low back pain are poorly understood. Despite the widespread belief of a relationship between movement, posture and low back pain, evidence of this relationship, and the influence of psychological factors on this relationship is sparse. This study aims to investigate this in 12 people with persistent, disabling low back pain using wearable motion sensors over a 22-week study period (5-week baseline, 12-week intervention, and 5-week follow-up). This will lead to a greater understanding of the factors related to an improvement in low back pain, leading to the generation of hypotheses and the refinement of approaches in the management of this burdensome condition.

This study attempts to validate or invalidate the consensus clinical scoring system for preoperative hypersensitivity reactions, comparing the results of the score to an expert clinician panel, and to the subsequent results of skin tests and in-vitro results.

This research project is being conducted to look at the safety, tolerability and pharmacokinetics (PK, how the human body processes a substance) of XG005 when given to healthy volunteers orally as a single dose, and when given as multiple oral doses for up to 7 consecutive days.

The Koori Active and Healthy Ageing Project aims to develop new, effective, culturally appropriate healthy ageing approaches in collaboration with older Aboriginal people and partner communities in regional and urban NSW. A balance-based exercise mobile application developed at NeuRA was the preferred option selected by partnering communities and has been redeveloped to provide a culturally appropriate interface, incorporating cognitive activities to boost the potential benefits for healthy brain ageing and maintaining functional independence. To evaluate the feasibility of this program, a pilot randomised control trial, developed in collaboration with Aboriginal health workers, will be conducted, with key outcomes including improvements in dual task walking speed, physical activity, balance and fall risk, cognitive function, and social and emotional well-being. By implementing a technological platform, this program has the potential to improve access to dementia prevention, enable low-cost individualised program tailoring and facilitate transferability across diverse community settings.