A Randomised Control Trial Of Non-specific Clinical Management Versus CBT In Chronic Anorexia Nervosa
Funder
National Health and Medical Research Council
Funding Amount
$555,843.00
Summary
Anorexia nervosa (AN) is a serious mental illness that usually starts in adolescence and often runs a chronic course. With an estimated prevalence rate between 0.5% and 3.7% of women, and up to 50% remaining chronically ill, the illness poses a disproportionate burden on health and social services. AN has inpatient costs alone that exceed that for schizophrenia. Chronic AN has the highest mortality rate of any mental illness. Chronic AN patients are known for their ambivalence about engaging in ....Anorexia nervosa (AN) is a serious mental illness that usually starts in adolescence and often runs a chronic course. With an estimated prevalence rate between 0.5% and 3.7% of women, and up to 50% remaining chronically ill, the illness poses a disproportionate burden on health and social services. AN has inpatient costs alone that exceed that for schizophrenia. Chronic AN has the highest mortality rate of any mental illness. Chronic AN patients are known for their ambivalence about engaging in treatment and poor motivation to change their eating disorder behaviours. They often fail to respond to traditional treatments and develop a history of negative treatment experiences and repeated treatment failures. A new approach is needed to reduce both the personal suffering and the burden of the illness on social and medical services. To date, there has been little scientific investigation into the development of specific treatment for those patients with chronic AN. This study will trial a recently manualised therapy - non-specific supportive clinical management - which initial evidence suggests may hold promise for chronic AN because it offers a more indirect, motivationally-matched approach. This treatment will be compared to the establishment therapy Cognitive Behavioural Therapy. Patients will be randomly allocated to one of the two treatment conditions and will receive 40 sessions over 12 months. They will be thoroughly assessed prior to during and after they have completed treatment and followed up for 6 months. This is the worlds first trial of a psychological treatment for chronic AN; it is hoped the study will establish an effective treatment for this debilitating and expensive illness. Further, as the project aims to explore the core, but often over-looked, feature of AN - poor motivation for recovery - it will also be in a position to shed light on the deep psychological processes that maintain this illness.Read moreRead less
A Phase III Trial Comparing Adjuvant Versus Salvage Radiotherapy For High Risk Patients Post Radical Prostatectomy
Funder
National Health and Medical Research Council
Funding Amount
$819,138.00
Summary
About half of all patients Treated with an operation to remove their prostate cancer have a high chance of the cancer coming back. Giving immediate radiotherapy to all patients will improve cure rates but does not benefit all men and can cause significant side effects. This study explores whether it is safe to wait and only give radiotherapy when there is a rising PSA after surgery indicating active cancer. A total of 470 men from Australasia will enter this study comparing the two approaches.
Benefits Of Home-based Multidisciplinary Rehabilitation In Non Small Cell Lung Cancer
Funder
National Health and Medical Research Council
Funding Amount
$581,039.00
Summary
Lung cancer is the third leading cause of death in Australia. People with lung cancer experience a complex mix of symptoms that can provoke significant distress and impair physical function. This study aims to develop and test a home based exercise and self-management support program to increase function and physical activity levels, reduce levels of depression and improve quality of life of people with lung cancer.
Developing An Australian Valuation For The EQ-5D-5L Quality Of Life Instrument
Funder
National Health and Medical Research Council
Funding Amount
$348,357.00
Summary
In the assessment of gains resulting from a health technology, it is standard to consider both mortality and quality of life effects. This project explores how Australians value different components of quality of life. To do this, we are running an online survey called a discrete choice experiment, and analysing the data using a range of cutting-edge econometric techniques. This will allow policy-makers to better reflect people's preferences when making decisions about new technologies.
A Randomised Phase III Study Of Radiation Doses And Fractionation Schedules In Non-low Risk DCIS Of The Breast
Funder
National Health and Medical Research Council
Funding Amount
$1,751,209.00
Summary
Treatment of ductal carcinoma in-situ (DCIS), a preinvasive form of breast cancer, is aimed at preventing invasive cancer recurrence. Women with higher-risk DCIS have an increased risk of recurrence. This study aims to individualise treatment for women with DCIS to achieve long-term tumour control with minimal treatment toxicity. After local excision of DCIS, radiotherapy (RT) to the whole breast reduces the recurrence rate. However, it is unclear if escalating radiation dose to the tumour bed i ....Treatment of ductal carcinoma in-situ (DCIS), a preinvasive form of breast cancer, is aimed at preventing invasive cancer recurrence. Women with higher-risk DCIS have an increased risk of recurrence. This study aims to individualise treatment for women with DCIS to achieve long-term tumour control with minimal treatment toxicity. After local excision of DCIS, radiotherapy (RT) to the whole breast reduces the recurrence rate. However, it is unclear if escalating radiation dose to the tumour bed in higher-risk women increases tumour control. It is also uncertain if giving fewer but larger radiation doses over 3-4 weeks would achieve the same tumour control as the standard 5-7 week course of RT to improve patient convenience and access to RT. Thus, this multicentre study of 610 women with higher-risk DCIS will investigate if adding a tumour bed radiation boost after whole breast RT improves tumour control, and the shorter RT course achieves the same tumour control as the standard longer course. Currently, the ability to predict the malignant potential of DCIS and RT toxicity is limited. This study will investigate if there are biological and genetic markers predictive of invasive recurrence and normal tissue toxicity in women with DCIS using state of the art technology. Women need to weigh up the likelihood of cancer control against adverse treatment effects to make an informed treatment decision. However, very little is known about the quality of life (QoL) consequences of the diagnosis and treatment of DCIS. In this study, the QoL, psychological distress, perceived risk of invasive cancer recurrence and perceived cosmetic outcomes of women with DCIS, will be assessed using a questionnaire of validated measures. This study will refine treatment for women with DCIS according to their risks of recurrence. It will significantly advance the understanding of the biology of DCIS and its psychological and QoL outcomes after treatment.Read moreRead less
Psychosocial Disability And Return To Work In Younger Stroke Survivors
Funder
National Health and Medical Research Council
Funding Amount
$511,216.00
Summary
Each year about 12,000 Australians of working age survive a stroke. These younger survivors have responsibility for generating an income or providing care for families and state that their main objective is to return to work for financial reasons and to help rebuild confidence and independence. This observational 3 year study will determine thefactors are associated with returning to work, improving the wellbeing of thousands of stroke survivors and their families using multivariate regression.
A Trial Of A Multidisciplinary, Group Based Intervention To Meet The Needs Of Men With Prostate Cancer
Funder
National Health and Medical Research Council
Funding Amount
$524,285.00
Summary
This study will test an innovative approach to meeting the physical and psychosocial needs of men with early stage prostate cancer using a randomised controlled trial. This novel approach involves a combination of individual and group-based consultations which encourages peer-to-peer support, promotes self-care and enhances appropriate multidisciplinary referrals and communication. It provides a new model of care for patients with chronic diseases that can be translated into clinical practice.
CKD-FIX: A Randomised, Controlled Trial Of Allopurinol In The Slowing Of Kidney Disease Progression
Funder
National Health and Medical Research Council
Funding Amount
$1,917,147.00
Summary
Chronic kidney disease (CKD) is a major public health problem affecting over 1.5 million Australians and is associated with increased risk of death, heart disease and progression to end-stage kidney disease (ESKD). Current treatments to slow progression to ESKD are limited. The CKD-FIX trial aims to find out whether treatment with allopurinol, a commonly used drug for gout prevention, safely and effectively slows CKD progression. This could lead to significant health and economic benefits.
Value Of Androgen Deprivation And Bisphosphonate In Patients Treated By Radiotherapy For Localised Prostate Cancer
Funder
National Health and Medical Research Council
Funding Amount
$2,533,827.00
Summary
Following on from significant findings in the TROG 96.01 trial, the 03.04 trial, known as the RADAR trial was developed. This is a large-scale randomised controlled clinical trial currently conducted at 23 cancer treatment centres throughout Australia and New Zealand. The RADAR trial aims to recruit 1000 men with localised but inoperable prostate cancer. It was anticipated that the length of time required to enrol 1000 participants to the trial would be 5 years. However, because enrolment has ex ....Following on from significant findings in the TROG 96.01 trial, the 03.04 trial, known as the RADAR trial was developed. This is a large-scale randomised controlled clinical trial currently conducted at 23 cancer treatment centres throughout Australia and New Zealand. The RADAR trial aims to recruit 1000 men with localised but inoperable prostate cancer. It was anticipated that the length of time required to enrol 1000 participants to the trial would be 5 years. However, because enrolment has exceeded expectations and 728 patients have already been recruited, it is anticipated that the recruitment target will be reached in mid 2007. Patients are randomly assigned to receive one of four treatment options in the RADAR trial. The first option: Option A: Radiation Therapy and 6 months of Hormone Therapy (Leuprorelin acetate), is currently the standard of care. Option C is a further 12 months of hormone therapy after the current standard of care. Two of the options (B and D) are identical to options A and C except that subjects also receive 18 months of zoledronate (a 'bone' drug) in addition to hormone therapy and radiotherapy. The main goal of the RADAR trial is to determine whether 12 months of hormone therapy using Leuprorelin acetate starting immediately after standard therapy (ie 6 months of Leuprorelin acetate before and during radiotherapy) will reduce risk of return of the cancer, either within the prostate region or at remote sites in the body, and prolong life. An additional goal is to see whether 18 months of bisphosphonate therapy (bone density therapy) using zoledronate will reduce the risk of cancer returning in the bones as well as stopping dangerous bone thinning which can sometimes be caused by hormone therapy. The trial also seeks to determine whether the additional therapy given in this trial alters quality of life.Read moreRead less
Optimal Duration Of Neoadjuvant Androgen Deprivation Therapy In Localised Prostate Cancer Treated By Radiotherapy
Funder
National Health and Medical Research Council
Funding Amount
$422,335.00
Summary
The 96.01 trial aims to find out whether androgen deprivation (AD) administered prior to and during radiotherapy (i.e., neo-adjuvant AD) will improve outcomes in patients with locally advanced prostate cancer that is considered inoperable and is treated for cure by radiotherapy. The trial also aims to find out whether six months AD produces outcomes superior to those achieved by three months AD. The trial has been running since 1996 and involves 802 men who attend 19 cancer treatment centres acr ....The 96.01 trial aims to find out whether androgen deprivation (AD) administered prior to and during radiotherapy (i.e., neo-adjuvant AD) will improve outcomes in patients with locally advanced prostate cancer that is considered inoperable and is treated for cure by radiotherapy. The trial also aims to find out whether six months AD produces outcomes superior to those achieved by three months AD. The trial has been running since 1996 and involves 802 men who attend 19 cancer treatment centres across Australia and New Zealand. It would not have been possible without the continuous funding support of the NHMRC. So far this trial has shown that AD does prevent prostate cancer from returning after radiotherapy. This is very important because the need for treatment of recurrent cancer (usually AD for the rest of the patient's life) is halved by 6 months AD compared to standard treatment (radiotherapy alone). However, it is now necessary to observe the patients in this trial for another 5 years to find out whether AD also prolongs life, and whether 6 months AD is more effective than 3 months. Further patient follow up is also necessary to identify whether some men respond better to treatment than others. This is very important because it will enable treatment to be tailored to individual patients, in particular those who require more treatment than is given in this trial. This funding application is therefore to enable patient follow up on this large scale trial for another 5 years.Read moreRead less