ANZCTR search results

Botulinum A Toxin is currently used to treat refractory urinary urgency. This research uses a part existing retrospective and part (with regard to concept)- prospectively collected dataset that is very detailed, and which documents the care of real-world treatment-seeking women in the community. Existing patient records will be used to compile a large study data set that in turn will be used to create a predictive model for Botox treatment outcome. This will be internally and if promising, externally validated, and finally, clinically trialed for its usefulness as a predictive model to guide initial and also subsequent Botox use. Additionally, any negative effects for those receiving Botox and other treatments over time such as deterioration in bladder function will be tracked. The aim is to achieve more effective, efficient treatment of storage symptoms that is relevant to real-world treatment-seeking women. Such a model does not currently exist.

This trial aims to determine the acceptability, appropriateness, and feasibility of a 7-week online mindfulness course on individuals with a cancer diagnosis, and to evaluate its impact on coping and empowerment skills, cancer symptoms, and emotional wellbeing. Who is it for? You may be eligible for this study if you are 18 or above and have been diagnosed with cancer. Study details Participants will attend one 90-minute Zoom session per week, which will cover various mindfulness techniques and practices. Participants will also be given access to online course materials in the form of videos, text, and audio accessed online to support the content of the mindfulness course. A number of questionnaires will be given for completion before the course and at the end of the 7-week course as part of the study. It is hoped that this study may help to ascertain the main symptoms of cancer patients and whether mindfulness training is an acceptable, appropriate, and feasible way of effectively improving these symptoms.

Project Aims - This project aims to assess the feasibility of conducting a study to determine a patient’s individual taste status prior to receiving cancer treatment, and how these radiotherapy and chemotherapy treatments impact on their taste and dietary behaviour after treatment completion. Who is it for? - You may be eligible for this study if you are aged 18 years or older and you are undergoing radiotherapy or chemoradiotherapy treatment for head and neck squamous cell cancer. Study Details - Participants who enrol in this study will be asked to complete a series of questionnaires about their diet and taste perceptions prior to starting treatment, and again at 1 month, 3 months and 6 months after treatment completion. It is anticipated that participants will be able to complete these questionnaires & assessments via a telehealth appointment of approximately 45 minutes, and an additional 30 minutes completing an online survey, at each of the timepoints described. Study Outcomes - It is hoped this research will provide valuable data on the effect cancer treatments may have on the taste and smell perceptions of patients with head and neck cancer and how this impacts on their ability to eat. This data will also be used to inform a larger study to identify possible genetic markers for these individual variations.

This study has been designed to provide evidence of the effectiveness of self-management programs for adolescents with chronic medical conditions aged 15-18 years prior to their transfer to adult care. It is the first study to use the validated and internationally recognised Flinders Chronic Condition Management Program (Flinders Program™) with this important but under researched age group. The study hypothesis is that a modified adult, generic chronic condition self-management program provided to adolescents with a chronic condition would be more effective than standard usual care in achieving adherence to chronic condition management as measured by quantitative condition specific validated markers of illness control, global quality of life, self-efficacy, time management, and in reducing health related distress. This study will provide a better understanding of the components required for effective self-management programs in adolescents with a chronic condition. Participants will be randomised to either standard care or the modified Flinders Program™ plus standard care. Data collection will include measures of specific chronic condition control, unscheduled hospital admissions and questionnaires to record self-management competencies, quality of life, self-efficacy and outcomes measures specific to the program at baseline, 3 months, 6 and 12 months after delivery.

Healthcare workers are sometimes required to wear N95 respirators as part of their clinical duties. In Australia, there are many different brands and styles of N95 respirators. It is unclear if certain styles of N95 respirators (e.g. cup style, fold style) are more likely to fit a greater proportion of Australian healthcare workers. This study intends to find out the pass rate of different styles of N95 respirators using quantitative fit testing. We will also assess the ease of donning and doffing the respirator as well as the comfort of wearing each respirator. Data on age, weight, gender, ethnicity and facial characteristics will also be collected to see if this correlates with ability to pass fit testing. This will allow healthcare settings to stock the styles of N95 respirators that are more likely to fit Australian healthcare workers.

The mental health of the people of Australia and the world has deteriorated as a result of the COVID-19 pandemic. This COVID-19 related depression, anxiety and distress has and will continue to have long-lasting consequences for both mental and physical health. As mental and physical health are closely intertwined, sharing risk factors, pathways, prevention and management approaches, strategies that improve metabolic health can also provide substantial mental health benefits. However, while there is substantial evidence demonstrating the effectiveness of dietary or physical activity interventions in improving mental health, no such integrated programs exist within clinical practice. The CALM Trial will be the first study to determine the effectiveness and cost-effectiveness of an integrated lifestyle program (CALM), focused on both diet and physical activity, in reducing depression symptoms, compared to a psychotherapy program. As a secondary aim, we will also assess the relative effectiveness of the CALM program in improving other mental and physical health outcomes (e.g., cardiovascular biomarkers). The CALM Trial is a single-site, two-arm, individually randomised group treatment, non-inferiority trial. Both programs (CALM, psychotherapy) will be delivered over telehealth for an 8-week period (six 90-minute sessions). Group led sessions will be conducted by either allied health professionals (CALM) or an experienced Senior Clinical Psychologist and a Provisional Psychologist (psychotherapy). We plan to recruit 184 participants aged 18 years and above with with elevated distress, anxiety and/or depression (Distress Questionnaire-5, DQ5 score >8).

People with a spinal cord injury (SCI) have high rates of bowel related morbidity, even compared with those with other neurological disorders. This includes high rates of abdominal pain, constipation, faecal incontinence and bloating. These problems lower the quality of life of people with a SCI and place a financial burden on the health system. The abdominal muscles are one of the major muscle groups used during expiratory and expulsive manoeuvres such as defecation and coughing. Surface electrical stimulation of the abdominal muscles, termed Abdominal Functional Electrical Stimulation (FES), can make the abdominal muscles contract, even when ‘paralysed’. There is some limited evidence that abdominal FES may improve bowel function in people with SCI via increased intra-abdominal pressure. The primary objective of this study is to investigate the effectiveness of Abdominal FES to improve bowel management time for people with chronic Spinal Cord Injury (SCI). Secondary objectives will evaluate whether Abdominal FES can improve: 1) bowel related quality of life, 2) bowel function , 3) bowel management strategy 4) respiratory function and 5) bladder function . In addition, a cost-utility analysis will determine if there is a financial benefit resulting from improved bowel function associated with Abdominal FES.

ADAPT-MRL is a multi-site, multinational, observational cohort registry designed to collect data on the use of the MR-Linac machine for radiation therapy oncology and patient outcomes. The registry will provide a linked repository of technical and clinical data that will be shared with the device manufacturer. Who is it for? You may be eligible to be involved in this registry if you have cancer and are scheduled for treatment using an MR-Linac machine for radiation therapy. Study details Participants will be enrolled in the study, attend standard of care treatment and follow up visits at 3, 6, 9, 12, 18 and 24 months. Participants are asked to complete additional quality of life surveys at these visits and may choose to have additional scans performed. It is expected the registry will recruit patients for up to 10 years. This data will be used to leverage the MR-Linac’s capabilities and design new and improved treatment strategies. An estimated 10,000 patients will be enrolled to this registry across 10 or more study sites situated in Australia and internationally (additional sites to be added).

This research aims to work out how doctors should best manage wounds after minor skin surgery. Following excision surgery for minor skin lesions, dressings are used for a period of time to keep the wound clean and comfortable. This study is a randomised controlled trial of two types of dressings and dressing protocols following minor skin surgery in general practice. The first part of the study compares participant pain levels with a dressing containing a pain relief medication (ibuprofen) compared to an identical non-medicated dressing. The second part of this study will compare whether keeping the wound covered until stitches are removed, or removing the dressing at 48 hours is better in terms of patient pain and comfort, and infection rates. On the day of their skin surgery, participants will be randomised into one of four treatment groups: (plain dressing or ibuprofen dressing, with the dressing to be removed at 48 hours and the wound kept uncovered, or a further plain dressing applied until stitches are removed). Participants will be asked to fill out a pain score sheet once a day for 5 days after their surgery. Participants will be contacted by the researchers on day 3 after surgery and asked questions about their wound comfort. When they return for removal of stitches, participants will be again asked questions about wound comfort, and the wound will be inspected for signs of infection. Outcomes to be measured include participant pain scores, additional use of oral pain relief medication, presence of wound infection, and patient comfort levels.

This observational study will examine rates of compliance with calcium and vitamin D doses prescribed to cancer patients who may benefit from taking these supplements due to the type of cancer treatment drugs they have been given. Who is it for? You may be eligible for this study if you are 18 or older, you are receiving cancer treatment(s) including Denosumab, Pamidronate or Zoledronic acid and you are attending one of the Icon Cancer Centres in Queensland for treatment. Study details All enrolled participants will be asked to complete a survey that includes questions about their current cancer treatment, and whether they have been prescribed calcium and vitamin D in addition to their cancer treatment. It is expected that the survey will take approximately 15 minutes to complete, and participants will be asked to complete this during a scheduled clinic visit, therefore additional study visits are not required. It is hoped this research will determine the current rate of calcium and vitamin D dose compliance in patients whose cancer treatment may have a negative impact on their bone health. It is hoped this study will also identify barriers that may make it difficult for patients to maintain their calcium and vitamin D doses and will then be able to make adjustments to address these barriers.