ANZCTR search results

The purpose of the current study is to evaluate the feasibility and efficacy of adding a telephone coaching element to the Healthy living after Cancer Online program. Who is it for? You may be eligible for this study if you are aged 18 years or older, live in Australia, you have been diagnosed with a localised cancer and you have completed your cancer treatment, which may include surgery, chemotherapy, radiation. Patients on hormonal treatment or Herceptin will still be eligible. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to receive either the Healthy living after Cancer Online program plus telephone coaching, or to receive the Healthy living after Cancer Online program only. Participants in both groups will be asked to work through an online program for 12 weeks that addresses multiple areas of health, including physical activity, healthy eating, mental health, finding the new normal after cancer treatment, fatigue, and weight management. Questionnaires will be collected before and after the intervention. Participants who are allocated to the telephone coaching group will also receive 2x one-on-one 15 minute telephone sessions with a Provisional Psychologist during the first and fourth weeks of the program. The purpose of these sessions will be to help the participants to identify goals that are meaningful to them, to help plan activities that will assist them to meet their goals and to check their progress in meeting these goals over time. It is hoped this research will determine whether the combination of an online cancer program and telephone support sessions are feasible and acceptable to cancer patients. If this pilot program is successful, a larger study enrolling a greater number of patients may go ahead and could lead to future benefits for more cancer patients.

This online mental health check aims to identify and detect symptoms of anxiety and depression in children, while triaging aims to increase children’s access to evidence-based care to support children’s mental health. The primary purpose of this study is to evaluate whether the mental health check and the provision of triage information increases access to care by conducting a school based randomised controlled trial. Specifically, this study aims to answer the following question: Does personalized triaging significantly improve access to evidence-based mental health care for children aged 6 to 12 years compared to children aged 6 to 12 years receiving standard care?

Acupuncture is known as a safe, non-pharmacological treatment for a range of conditions that occur in pregnancy, labour, birth and the postpartum period. Acupuncture is currently not offered in maternity and obstetric units in Australia. A dearth in the literature exists about the use of acupuncture for fetal malposition (occipito posterior, deflexion, asynclitism) when administered by a midwife (acuneedling). The aim of the research is to develop an expert opinion-based protocol for acuneedling using press needles for managing intrapartum fetal malposition, evaluate its feasibility and acceptability, explore women’s feelings and experiences of receiving intrapartum acuneedling in semi-structured interviews and explore midwives’ feelings and experiences of administering intrapartum acuneedling and how it impacts on job satisfaction with a focus group.. For the quantitative (RCT) arm, a double-consent Zelen design will be used. The qualitative aspect will follow a generic qualitative descriptive design. The pilot RCT will take place with privately practicing endorsed midwives. A non-probability convenience sampling technique will be employed for the twelve-month duration of the pilot RCT. A Participant Information Statement and Consent Form (PICF) for midwives to administer the intervention will be signed and collected before the pilot RCT begins to provide education and training. Women will be recruited through midwife antenatal visits with a PICF for women. Quantitative data will be gathered using a newly designed measurement tool created in the form of a questionnaire. All documentation emailed/text will be uploaded to a centrally provisioned secure storage solution as per the university's data management plan.

The Well-Ahead app has been uniquely tailored for female ex-serving military and former emergency services members to help build resilience, develop mental fitness, and recover from the impacts of experiencing stress or trauma. The overall aim of this study is to establish the feasibility of the SOLAR (Skills fOr Life Adjustment and Resilience) intervention in optimising wellbeing in female ex-serving military and former emergency services members. All participants will be asked to use the Well-Ahead smartphone app over 5 weeks and will be provided with weekly check-in calls. Participants will also be asked to complete self-report measures at pre-treatment, post-treatment, and at a 3-month follow-up. We hypothesise that the Well-Ahead app will be associated with improvements in primary and secondary psychological and functional outcome measures post-treatment.

Being physically active is important for preventing stroke and other cardiovascular diseases. People who have already suffered a stroke are at a higher risk of future health problems. It can be challenging for stroke survivors to be active. This research aims to test a pathway to personalised physical activity programs that our team has designed together with stroke survivors and clinicians. The aim is to determine what physical activity dose (how much and how intense) is acceptable, feasible and safe for stroke survivors with moderate severity stroke, and is also effective at improving their cardiovascular health. This will ultimately reduce their risk of future stroke and cardiovascular disease. This trial will specifically investigate light and moderate to vigorous intensity physical activity in people with moderate severity stroke. Participants will be prescribed a personalised physical activity program. The process will involve a shared decision-making and planning process to develop a personalised physical activity program. The first 2 weeks will involve program set up. Support will be provided by a physiotherapist or exercise physiologist at least weekly over the first 3 months and may be face to face, via videoconference, phone or email–depending on the participants’ preference. Monitoring and support will continue, but decrease in frequency over the following 3 months.

Falls are a major health issue, being the largest contributor to hospitalised injuries and a leading cause of injury death in Australia (AIHW 2022). Fear of falling (Yardley and Smith 2002) and reduced quality of life (Bjerk et al 2018) are well documented consequences of falls. In Australia, more than one in four people over the age of 65 years fall each year (Milat et al 2011). The Illawarra Shoalhaven Local Health District (ISLHD) and the University of Sydney recently completed a RCT with 617 people on the effectiveness of a home-based exercise program (BEST at Home) for preventing falls in older community-dwelling people (Bates et al, 2018; Bates et al 2022). The study showed a significant reduction in fear of falling as well as a significant improvement in gait speed (Bates et al 2022). People with COPD are known to have a high risk of falls and as such, there is the need for fall prevention programs (Roig et al 2011). An Australian study reported that people with COPD had a higher rate of fear of falling compared to healthy controls and that fear of falling was associated with lower quadriceps strength, impaired balance, lower levels of physical activity and an increased fall risk (Oliveira et al 2015). A recent systematic review reported that exercise-base interventions can improve balance in people with COPD and the most benefit was found when balance training was incorporated with pulmonary rehabilitation (Delbressine et al 2020). This study aims to determine the effects of the BEST at Home Program on balance, strength and fear of falling in people with COPD who attend a virtual care program. Clients with COPD accessing the VeCC will be invited to participate in the study. Eligible participants will receive a modified version of the BEST at Home lower limb exercise program. The exercise instruction will be delivered by an experienced pulmonary rehabilitation physiotherapist in two small group sessions (approximately one hour each). Exercise instruction will occur at weeks 1 and 13, with follow-up video calls from the physiotherapist at weeks 2, 4 and 8. Participants will be encouraged to perform the set of exercises three times per week at home for a period of six months. Participants will be provided with a weight, exercise manual and booklet about preventing falls. Participants will also be provided with a calendar and asked to record their exercise and falls on a monthly basis. Assessment of strength, balance and fear of falling will be assessed at baseline, 3 months and 6 months.

This clinical trial is a critical step in the development of the Vaxxas HD-MAP vaccine delivery system and will verify the safety and consistency of device performance in paediatric subjects at several potential anatomical application sites. The paediatric population represents a significant segment of the vaccination market; therefore, it is vital to know if the performance of the HD-MAP delivery system differs in this population and whether it presents any additional safety risks. Furthermore, the opinions of guardian/child dyads on the acceptability of the delivery system will be collected.

The program will evaluate the feasibility of the intervention, its delivery and its effectiveness in partnership with Maori & Pasifika community organisations and key stakeholders in Southeast Queensland. It will examine intervention efficacy (i.e. improved HbA1c levels, diabetes self-care, waist circumference and BMI) aimed at reducing risks in MPI women with type 2 diabetes and prevent late hospital presentations from diabetes-related complications. Objectives 1. Primary objective: to examine efficacy where intervention women with type 2 diabetes have improved HbA1c clinical levels than those in control group from baseline to 24 weeks. 2.Secondary objectives: to determine whether, compared to controls, the intervention group achieves: •Change to bring body-composition measurements closer to recommended healthy range for specific cultural groups (e.g. BMI is less than or equal to 30 kg/m2; waist circumference <80cm based on WHO Criteria). • Improved diabetes self-care scores on diet, physical activity, routine health checks, diabetes distress and medication assessed using summary of diabetes self-care activities (SDSCA) (Toobert et al 2000) Hypothesis H1: Compared to controls, intervention participants who receive intensive Whanau face-to-face and virtual support for type 2 diabetes management report improved HbA1c levels at 12 weeks (end of intervention) and 24 weeks (post-intervention sustainability) H2: Compared to controls, intervention participants who receive intensive Whanau face-to-face and virtual support for type 2 diabetes management will have reduced waist circumference and BMI at 12 weeks and 24 weeks H3: Compared to controls, intervention participants who receive intensive Whanau face-to-face and virtual support for type 2 diabetes management have improved diabetes self-care at 12 weeks (end of intervention) and 24 weeks Expected Outcomes The primary outcome measure is HbA1c. Secondary outcome are changes in BMI, waist circumference, diabetes self-care, diet and physical activity and stress will be assessed. That is all endpoints will be measured at baseline (T0), 12 weeks (T1) and 24 weeks (T2) to assess program sustainability.

The study aims to assess the feasibility and effectiveness of guided self-help CPT (CPT-GSH) in a stepped care model in treating PTSD using a randomised controlled trial. It is hypothesized that those who have successful outcomes with CPT-GSH will improve PTSD (primary outcome) and depression symptoms and quality of life similar to that of standard CPT delivered via video call. The study will also assess other factors contributing to treatment outcomes in stepped-care condition (e.g. client's response to low-intensity versus high-intensity treatment approach). Stepped care is predicted to be a cost-effective treatment modality for participants because of minimal therapist input and sessions compared to a standard CPT.

Writing is a cost-efficient intervention that has been shown to help people cope with negative life events by expressively writing about that particular experience. This study investigates if a self-compassionate attitude influences the way in which we provide self-advice regarding our experiences, and to understand if this approach is more helpful than a relaxed mindset. Despite the growing evidence regarding self-compassion, there is a paucity of research on our understanding of the perceived usefulness of self-compassionate writing, and the likelihood of participants engaging in this treatment. The present study aims to examine the acceptability and effectiveness of self-compassionate writing to cope with personal problems. A randomised controlled design with longitudinal follow up was adopted for this study. Participants will be randomly assigned into either the self-compassion writing condition or the relaxation breathing control writing condition, with outcome measures administered at three intervals (pretest, post-test, and 1-week follow-up). In the initial phase, participants will be encouraged to write about a personal problem which caused them to feel failure, humiliation, or rejection. They will then be directed to listen to a 10 minute audio recording, either a self-compassionate or relaxation breathing recording dependant on random group assignment. and provide self-advice related to the problem previously described. All participants will be administered the Positive and Negative Affect Scale, the Compassion Motivation and Action Scale, and other questionnaires related to problem intensity, helpfulness of their self-advice, and the likelihood that would use this approach to address future personal problems.