ANZCTR search results

The purpose of this study is to evaluate the effectiveness of a digital health behaviour change intervention in promoting ergonomic ways of using technology to children aged 11 to 14 years in Australia. Specifically, it aims to determine if the resource can be effective in improving children's knowledge, attitude, subjective norms, perceived behavioural control, and behaviours relating to ergonomic use of technology. A cluster group, two-arm trial will be conducted to determine the effectiveness of the resource. Study hypothesis: The use of a digital intervention can improve children's ergonomic behaviours when using technologies.

The purpose of this study is to determine whether the combination of Iberdomide, Isatuximab and Dexamethasone combined improves response to treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or over, you have been diagnosed with multiple myeloma and you have demonstrated disease progression within 12 months of commencing first-line therapy. Study Details Eligible participants will receive Iberdomide, Isatuximab and Dexamethasone. Treatment (each cycle is 28 days) will be given until disease progression, unacceptable toxicity, or withdrawal of consent. Participants will be required to have blood samples taken at the beginning of each cycle along with a medical exam in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the myeloma. It is hoped that the findings of this trial will establish the benefits of this combination of treatment of multiple myeloma patients early in the course of their disease.

Access to safe, effective pain relief is a hallmark of high quality maternity care. For women in labour the pharmacological options for pain relief have changed little in over 50 years. The choices of opioids and nitrous oxide have been reported as having a limited effect on labour pain and undesirable side effects. Epidurals provide excellent analgesia, however they severely limit mobility in labour, require advanced medical skills, close monitoring of mother and baby and can increase the risk of further medical interventions in birth. This trial will test the novel, off-label use of sterile water injections (six injections of 0.1 - 0.3 millilitres each) administered into the abdominal skin of laboring women to relieve contraction pain. Our research team’s previous work has provided definitive evidence for the effectiveness of water injections to relieve back pain (not contraction pain) in labour for approximately two hours. The injections can be repeated with no side effects. However, injections given into the back have no effect on abdominal contraction labour pain. Our proposed trial will use a randomised, double blind, placebo-controlled design to test the safety and analgesic effectiveness of water injections to relieve labour contraction pain. We will conduct survey and qualitative studies to assess satisfaction, acceptability and impact on the birth experience alongside a cost-effectiveness study. If successful, our study will provide a new option for labour pain relief that is safe, effective, cost efficient, only requiring skills available to many health care providers and ideal for women wanting to avoid the side effects of other pharmacological analgesic options. The common availability of sterile water and the simplicity of administration would make the procedure useful in regional areas and settings (e.g. homebirth), where other pharmacological analgesic options such as epidurals may not be available, and women in countries with developing health systems.

The aims of this registry are to: • Create a registry of patients with POTS to better understand the condition and its associated conditions. • Collect clinical data to support future research with the aim to: o improve quality of life and outcomes for patients with POTS o characterize disease course and reasons for the onset of POTS o characterize the health and economic burden for patients with POTS o study incidence, cause, prognosis and treatment of POTS • Collect baseline and ongoing information about POTS • Collect data on treatment for patients with POTS to report outcomes and impact of that treatment • Link data from the Medical Benefits Scheme and Pharmaceutical Benefits Scheme to determine the associated health service and economic burden associated with POTS. This will assist us to understand the economic impacts of POTS on the public health system. • Collect baseline and longitudinal health information to better understand and report treatment, health, economic, and social impacts of POTS..

The aim of this study is to investigate the efficacy of a new tracer called indocyanine green compared to the traditional radioactive tracer technetium-99m in identification and biopsy of sentinel lymph nodes for patients with breast cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have clinically node-negative early breast cancer, and are scheduled to undergo a sentinel lymph node biopsy. Study details Participants will receive sentinel lymph node biopsy with both indocyanine green and technetium-99m techniques. The procedure is anticipated to take up to approximately 60 minutes. After the procedure, all participants will followup in 7 days and 30 days. It is hoped that this study may demonstrate that use of indocyanine green for sentinel node biopsy is equivalent to technetium-99m, and therefore may provide a safe and effective alternative to use of a radioactive tracer for future breast cancer patients undergoing a sentinel node biopsy.

After a senate inquiry into Australian Lyme-like illness in 2016, the Australian Government released a position statement specifying that “there is a group of Australian patients suffering from the symptoms of a chronic debilitating illness, which many associate with a tick bite” and described this patient group as having Debilitating Symptom Complexes Attributed to Ticks (DSCATT). Following extensive investigations, individuals with DSCATT are usually left without a clear explanation for their illness which can lead to further distress and potentially perpetuate their disease process. Thus, DSCATT is considered a medically unexplained syndrome (MUS), and one, at current, without recognised effective treatments. There has, however, been much research into treatments for other MUS and other chronic illnesses, including specific psychology-based interventions. The aims of this pilot study are to assess the feasibility and acceptability of a tailored, 12-week, psychology-based intervention (informed by Acceptance & Commitment Therapy; ACT) for patients with DSCATT. Specifically, we aim to explore DSCATT patients’: a) willingness to participate in the study (e.g. inquiry, enrolment & retention rates); b) willingness to be consented and enrolled; c) willingness to use the strategies explored in therapy; d) attendance of patients at therapy sessions; e) follow-up and response rates to questionnaires (data collection measures) f) explore their experiences and attitudes towards treatment, post intervention

This study will investigate the feasibility of collecting data on the satisfaction of end of life care from patients with advanced gynaecological malignancies. Who is it for? You may be eligible to join this study if you are aged 18 and above, have advanced gynaecological malignancy and a life expectancy of approximately 4 months as estimated by your treating physician. Study details All participants and their carers in this study will be asked to answer questionnaires about their experiences with the palliative care process, satisfaction with care and symptom management towards end of life. Patients and carers are expected to complete questionnaires at screening and every 8 weeks until the death of the patient. It is hoped that this research can provide preliminary insight on the satisfaction and expectations of care of patients with advanced gynaecological cancer, to inform future research aimed at understanding these issues fully and addressing unmet needs.

This study aims to investigate the impact of exercise on the risk of developing cardiac dysfunction in women undergoing chemotherapy for breast cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 or over who has been diagnosed with breast cancer and scheduled for anthracycline or trastuzumab containing chemotherapy, or a women aged 30 or over who does not have any history of heart disease. Study details Participants will have a choice to perform moderate intensity exercise three times per week for eight weeks, or to receive standard care. All participants regardless of their group allocation will attend 4 testing visits over 6 months, where they will undergo cardiac imaging, exercise testing and questionnaires. Data collected from this study will inform researchers of the role of exercise in preventing cardiac dysfunction from potentially toxic anti-cancer agents.

Autophagy is a critical process that helps keep the body’s cells clean and healthy. It is thought to be sensitive to nutrition. Using a test that we have developed to measure autophagic activity in humans for the first time, this project aims to determine whether autophagic activity in the blood is changed after healthy study participants have consumed a drink containing 30 g of whey protein compared to a fasted state. Our hypothesis is that autophagy is inhibited after a protein-rich drink in fasting healthy humans. Target sample size is 40, however HREC approval obtained to recruit between 40-60 participants as necessary.

The current study will investigate whether listening to self-compassion (SC) meditation audio recordings will increase levels of body appreciation (BA) and well-being (WB) whilst reducing body dissatisfaction. This experimental design will establish a cause and effect relationship of SC mediation on self-reported BA. A screening survey will ask whether participants have been diagnosed with an anxiety or eating disorder. Participants selecting yes on either question will be ineligible to participate further. The preliminary screening survey will also contain items from the Anxiety subscale from the DASS-21 and the EDE-QS, where if participants score greater than 15 (DASS) or greater than 15 (EDE-QS), they will be ineligible to participate further. Random allocation of participants will then occur. Those in both groups will complete the pre-intervention survey containing established measures of body appreciation, body dissatisfaction, self-compassion, and positive psychological wellbeing. Those in the experimental group (EXG) will then be provided links to audio recordings of self-compassion meditations which they are required to listen to daily for 3 weeks. Email and text reminders with the audio link will provided. After 3 weeks, participants from both groups will complete the post-intervention survey. Participants in the waitlist control group (CG) will then have be provided with links to the meditation recordings and will undergo the same intervention program as those in the main intervention group. Reminders with the link to the audio will be provided. 6 weeks after completion of the post-intervention survey, those in the EXG will be required to do a follow-up survey to determine if any improvements are maintained over time. Those in the CG will not do a follow-up survey. The project will yield information about factors facilitating positive body image, which could help with designing interventions based on risk factor models.