Newsle er February 2014 ISSUE 20

Transcription

1 Newsle er February 2014 ISSUE 20 Welcome to 2014! Like many organisa ons the fes ve season enables our busy research teams across the country to take me out with family and friends and have an opportunity to rest and recharge. This period also means that many prospec ve study par cipants are spending precious me with their loved ones. Whilst this results in a significant slowdown to study recruitment over this period there has been a considerable forge in recruitment in recent weeks which would indicate that our site recrui ng teams are indeed recharged, energised and ready for a big 2014! Prepara ons are now in full swing for the annual scien fic mee ng of the Collabora ve the PaCCSC Annual Research Forum. This year is our 5 th Forum gathering and, like previous years, presenters will showcase a range of research being conducted across the country by answering three simple ques ons: what worked? what didn t work? and what would you do differently next me? Day one is set aside for the site coordinators to undertake a half day workshop addressing more advanced GCP items including interac ve sessions on the various responsibili es involved in running a clinical trial. Associate Professor Lyndal Trevena from the University of Sydney and member of the execu ve of PC4 will join as opening guest speaker on day two along with an a ernoon of member presenta ons. Whilst day three is packed with mee ngs of the commi ees that provide governance and oversight to the running and scien fic merit of the Collabora ve and its trials. Two current phase III studies have very small numbers of par cipants needed un l they can be successfully closed: 1. The risperidone study has completed the proposed recruitment however in reviewing the comple ons data, the three arms of the study are not equal which may result in a lack of sta s cal power. This has been reported to the Data and Safety Monitoring Commi ee in order to make the final decision regarding the ming of closure of the trial to recruitment. 2. this issue The Nausea 1 study needs less than 10 study par cipants and if no issues Welcome to are raised from monitoring, it will be closed successfully. The la er study PaCCSC Pilot Studies 2 will be the Collabora ve s first NHMRC funded study to achieve this success and our sincere thanks go to the lead study inves gators Professors Opioids News from the Study Sites 3 Yates and Hardy. Staff Feature Louise Fazekas 3 The Collabora ve s ninth progress report to the Commonwealth is due on Pallia ve Care Events st March. This is the second last report of the current funding agreement PaCCSC Annual Research Forum 5-6 and we remain hopeful that future funding submissions will be called for in the near future to con nue to build on the founda on work that underpins our research network. Upcoming Events 8 PaCCSC Study Updates 7 Member s Publica ons 8 I look forward to mee ng many of you face to face at the Forum in March. Linda Devilee, Na onal Manager PaCCSC Newsle er February 2014: Issue 20 1.

2 PaCCSC Pilot Studies Pyridos gmine Pilot Study Cons pa on may affect 50% of pa ents at the me of referral to specialist pallia ve care with more than 90% of people affected when admi ed to specialist pallia ve care units. Despite treatment, 40-70% of people con- nue to experience cons pa on. Opioids remain the most commonly cited contribu ng factor and the research to date around contribu ng factors to cons pa on remains predominantly focused in this area. This is despite the fact that it is probably over-simplifying the problem and there are likely to be numerous contribu ng factors. The team developing this protocol have already documented a rela onship between medica ons with an cholinergic effects and the number of laxa ves prescribed, with the higher the an cholinergic load, the greater the number of laxa ves. Given how commonly medica ons with an cholinergic adverse effects are administered in pallia- ve care to improve symptom control, a cholinergic agent like pyridos gmine that reverses the peripheral effect of these medica ons on the colon poten- ally offers clinicians the choice of another targeted agent to improve the management of cons pa on in advanced cancer. The lead inves gator is Associate Professor Katherine Clark and the primary aims of this pilot study are to examine if it is safe to conduct a phase III study of pyridos gmine. The study will focus on pallia ve care pa ents with reten on of more than 4/24 radiopaque markers when they are receiving medica ons with an cholinergic effects who, despite regular laxa ves, con nue to experience disturbed bowel func on. The outcomes will be assessed at the end of seven days of pyridos gmine. Melatonin Pilot Study This pilot is now open to recruitment at Braeside Hospital and Calvary Mater Newcastle. The lead inves gator is Associate Professor Meera Agar. The purpose is to inves gate whether melatonin can prevent delirium in people with cancer. As you will know from the current delirium study, delirium is a condi on that can develop quickly and is commonly experienced by people with cancer. Delirium has several features including: change in conscious level (fluctua ng between drowsiness and being hyper- vigilant); changes in cogni on; and disturbance of sleep/wake cycle which come on rapidly. There are many causes of delirium including: infec on, kidney and liver func on abnormali es, hypoxia, high calcium levels, and certain medica ons. Delirium can also affect a person s understanding and awareness, as well as their ability to communicate and interact with their environment. We know symptoms of delirium can be very distressing for the pa ent and their family. This study will specifically provide informa on about: 1. Whether melatonin shows promise in reducing the incidence of delirium. 2. Any side effects which are related to this treatment 3. Par cipants views about the assessments, in par cular their acceptability. This study requires 30 people to take part, and will inform the design of a larger study that will need 250 par cipants. PaCCSC Newsle er February 2014: Issue 20 2.

3 Opioids + 1 Breathlessness can be a frightening and overwhelming problem that is difficult to treat when all the underlying causes of breathlessness that can be treated have been exhausted. This is a problem affec ng thousands of Australians every day. Many doctors around the world use low dose, regular oral morphine to relieve the sensa on of breathlessness however the benefits of using opioids for trea ng breathlessness have not been defined in a way that, to date, has been incorporated into a registered indica on. This study will explore regular low doses of sustained release morphine over the first phase ( tra on phase) with the addi on of further sustained release morphine or a benzodiazepine or placebo in the second phase (randomisa on phase). The protocol is currently being finalised and for those sites who have expressed an interest in the study there will be a study start up mee ng during this year s Forum. The mee ng will be held over breakfast from 7.30am 8.30am on Friday 21 st March. If you are a ending the Forum and haven t already provided a response to a end this mee ng please do so ASAP so that we can ensure sufficient catering. News from the Study Sites Royal Melbourne Hospital We started 2014 with our usual sense of op mism in regard to pa ent recruitment and with an cipa on that we will be able to contribute to the comple on of the risperidone study. The fes ve season was a chance for us to recharge our ba eries. Gillian had a 5 week break, and greatly enjoyed two of those weeks travelling through Japan. James had a stayca on in Melbourne and kept the home fires burning for PaCCSC. Every New Year comes with change, and 2014 is no different. James has been offered a posi on at The Northern Hospital as a Clinical Nurse Consultant with Pallia ve Care and finished up at RMH mid February. We are sad to see James go, but wish him the very best in his new posi on. We are looking forward to new challenges, milestones and studies throughout Braeside/Liverpool The PaCCSC chief inves gator, Professor David Currow will be giving a presenta on at Campbelltown Hospital tled Refractory dyspnoea management, in the context of current clinical trials. This presenta on will be held on Monday 10 th March at 9am and is being provided to raise awareness of the PaCCSC dyspnoea studies amongst the respiratory physicians at Campbelltown Hospital. Approvals are now through for Megestrol, Can Less Be Be er, MOP and Sertraline to commence at Liverpool Hospital. Nichole has started a ending the weekly pallia ve care ward MDT on a Tuesday, and whilst we are yet to actually recruit anyone this year, our fingers crossed we will get our first par cipant soon! Staff Feature e Louise Fazekas Giles Louise has been employed with PaCCSC since April Ini ally recruited for some temporary filing of the then-closing Octreo de study, Louise con nued in her post to provide ongoing data and filing tasks. Since that me, Louise has done a lot of work keeping the data records neat and up to date, and keeping in contact with the study sites to obtain all of the data that is collected throughout our trials. Louise s role also includes checking incoming data from the study sites to make sure that it matches the online database. She has also been involved in developing forms in Adobe PDF for an easier and more efficient process for data error resolu on, and ordering of pharmacy medica ons needed across the studies for the study sites. Louise Fazekas Giles Louise will be heavily involved in the data side of the upcoming Opioids +1 study star ng up soon. Her tasks will include construc ng the CRFs for the data collec on, and building up the data log to keep track of the data on file, what has been checked, and what is outstanding from the study sites. PaCCSC Newsle er February 2014: Issue 20 3.

4 Pallia ve Care Events 2014 Na onal Pallia ve Care Week Sunday 25th May to Saturday 31st May The dates for Na onal Pallia ve Care Week have been announced in May Once again there will be events held across the country and are sure to include some of the hits from last year such as: public forums; educa on days; public presenta ons; morning teas; gala dinners; new program launches; panel discussions and more! The theme for this year s event has not been announced yet but keep an eye on their website at: vecare.org.au/ Na onalpallia vecareweek.aspx World Hospice and Pallia ve Care Day Sunday 12th October World Hospice and Pallia ve Care Day (WHPC Day) is held every year on 12 October. Hospice and pallia ve care services from around the global are invited to mark the day by organising an event in their town, city or country. Last year s theme was: Achieving Universal Coverage of Pallia ve Care: Dispelling the myths. The theme for this year will deal with staffing for pallia ve care. Further details will be announced in the coming months. Find out more about WHPCDay on their website at: h p:// Interna onal Clinical Trial s Day Tuesday 20th May Each year, the Interna onal Clinical Trials' Day is celebrated around the world on or near the 20th of May. The challenges of clinical research are not restricted to a single country, thus transna onal communica on on clinical trials requires ini a on and co-ordina on by a transna onal organisa on, with the objec ve to facilitate be er clinical research, relevant to the needs of pa ents everywhere. The objec ve is to make the Interna onal Clinical Trials' Day a focal point for interna- onal communica on events, mee ngs, debates, and celebra ons of clinical research. Every year European Clinical Research Infrastructures Network (ECRIN) hosts a celebra on of the day in a European city. For more informa on check out their webpage at: h p:// PaCCSC Newsle er February 2014: Issue 20 4.

5 PaCCSC 5th Annual Research Forum Sydney, Australia March 19 th 21 st 2014 The 5 th PaCCSC Annual Research Forum is scheduled for 19th 21st March 2014 in Sydney, Australia. Thursday, 20 th March 2014 will be the major day of warts-and-all presenta- ons, open to all members including : Special Guest Speakers Associate Professor Lyndal Trevena from the University of Sydney and Dr Susan Alder & Dr Jane Higgins from Minerva Medica Member Presenta ons New Study Presenta ons A endance on Thursday, 20th March 2014 is free to PaCCSC Members! It is free to join the PaCCSC Membership for further informa on or to obtain a membership form visit our website at or us at paccsc@flinders.edu.au Registra ons and presenta on submissions are now CLOSED (as of February 21 st 2014). If you would s ll like to enquire about a ending the Forum or wish to submit a presenta on at this late stage please contact Stacey ASAP at stacey.williams@flinders.edu.au or on (08) PaCCSC Newsle er February 2014: Issue 20 5.

6 Day 1 Wednesday, 19th March 2014 The Forum kicks off with our Site Coordinators Day at 12:00pm and will include lunch; a Minerva Media workshop focusing on advanced GCP techniques and a Site Coordinators face-to-face mee ng. Presenters Dr Susan Alder (MBBS, PhD) and Jane Higgins (BSc, MPH) collec vely have more than 50 years experience working in Pharmaceu cal and Medical Technology Companies; Government (Australia and Singapore); Clinical Laboratories; Hospitals; and Educa on. Both hold the Cer ficate IV in Training & Assessment and Lead Auditor in Quality Management Systems Training. Susan and Jane have science and medical backgrounds combined with experience in many therapeu c areas and all phases of clinical trials within a number of pharmaceu cal, CRO and medical device companies. Together they have held every role involved in a clinical trial-from Inves gator, CRA, Project Manager, and Auditor, right through to Clinical Opera ons Manager, Medical Director and Regulator. Day 2 Thursday, 20th March 2014 Our main presenta on day Day 2 is the day most of our a endees come for including presenta ons from our guest speakers Associate Professor Lyndal Trevena and Dr Susan Alder and Dr Jane Higgins of Minerva Medica. Dr Trevena's main research interest is the applica on of evidence in general prac ce, par cularly in evidencebased clinical decision-making. She con nues to develop and evaluate a number of decision tools and clinical prac ce guidelines which assist clinicians and pa ents to individualise popula on-level research into prac ce. Much of this work has been in cancer and other disease preven on. She is par cularly interested in preven- ve primary care strategies in disadvantaged groups and has worked with homeless people, low literacy groups and more recently, in low income country se ngs. Lyndal is also a member of the Execu ve Commi ee of the Primary Care Collabora ve Cancer Clinical Trials Group (PC4) which was established in February 2009, funded by Cancer Australia under its Boost Cancer Research program. Similarly to PaCCSC, they are a na onal, non-profit organisa on of researchers working in primary care with a focus on cancer. PC4 aims to improve cancer outcomes in Australia by fostering collabora on between researchers, to build capacity and enable the development of a series of pre-trial studies that will lead to large-scale, mul -site studies. The remainder of our presenta ons are made up of member presenta ons detailing what worked; what didn t work and what they would do differently next me. These presenta ons are a great way for those with an interest in pallia ve care to gain insight into the warts-and-all process of clinical research. We also feature new study presenta ons providing a fantas c outlook into the future of pallia ve care research. Many of our past new study presenta ons have eventually lead to fully-fledged research studies making this one of the more exci ng elements of our main forum day. Day 3 Friday, 21stMarch 2014 Once again the final day of the Forum is u lized for internal mee ngs including: a study start-up mee ng over breakfast for the Opioids + 1 study, the Trials Management Commi ee, the Management Advisory Board and Scien fic Commi ee. The PaCCSC Forum is a wonderful chance to network with like-minded professionals, learn about new studies and discover what PaCCSC has achieved in the past 12 months. We look forward to seeing you there! PaCCSC Newsle er February 2014: Issue 20 6.

7 PaCCSC STUDIES UPDATE The below graphs show the randomisa ons obtained per month for each site since the individual site commenced recruitment to the study. Risperidone Despite a slow start to the year risperidone is up and running. There has been some posi on shuffling here but Royal Melbourne and Calvary remain in front. Sertraline SAPS con nues to be the one to beat in breathlessness while Sacred Heart and The Aus n are too close to call in second place! MOPS SAPS has extended their lead here and con nues to be a strong recruiter to this study. Sacred Heart has now joined our update for this study a er their first MOP recruitment in February. Can Less be Be er? This re-launched study with an amended protocol is beginning to open at sites around Australia. Sacred Heart retains their crown for now but will hopefully see some compe on as new sites come on board here. Megestrol Similar to risperidone this study had a slow start to 2014 but is rapidly gaining momentum. Braeside remains in the lead but hopefully we will see some posi on challenges from our other sites this year. Nausea 1 There have been some shake-ups here. Although the Mater con nues in the front SAPS has made a big push: up into second place from fourth posi on last update! PaCCSC Newsle er February 2014: Issue 20 7.

8 Conferences, Events and Publica ons Upcoming Conferences & Events 2014 The 5th PaCCSC Annual Research Forum: March, Sydney, Australia Evidence & Wisdom upda ng professional prac ce in pallia ve care: March, Torquay, Victoria, Australia 3rd Asia Pacific Research Ethics Conference: March, Singapore Australian Grief and Bereavement Conference: March, Melbourne, Victoria, Australia 2nd Asian Congress on Pain: March, Taipei, Taiwan Pallia ve Care Nurses Australia 5th Biennial Conference: 6 7 April, Sydney, New South Wales, Australia Australian Pain Society 34th Annual Scien fic Mee ng: April, Hobart, Tasmania, Australia 7th World Congress World Ins tute of Pain: 7 10 May, Maastricht, The Netherlands St Francis Hospice 13th Annual Kaleidoscope Interna onal Pallia ve Care Conference: May, Dublin, Ireland 8th World Research Congress of the European Associa on for Pallia ve Care: 5 7 June, Lleida, Spain Interna onal Conference on Opioids: 8 10 June, Boston, MA, USA 10th Interna onal Conference on Grief and Bereavement in Contemporary Style: June, Hong Kong Risky Business 2 Interna onal Demen a Conference: June, Sydney, Australia Singapore Pallia ve Care Conference: June, Singapore Recent Member Publica ons If you have published a paper in the last three months, please write to us and let us know! Bush SH, Kanji S, Pereira JL, Davis D, Currow DC, Meagher D, Rabheru K, Wright D, Bruera E, Agar M, Hartwick M, Gagnon PR, Gagnon B, Breitbart W, Regnier L, Lawlor PG, 2014.Trea ng an Established Episode of Delirium in Pallia- ve Care: Expert Opinion and Review of the Current Evidence Base With Recommenda ons for Future Development, Journal of Pain and Symptom Management, Jan 28, 2014 [Epub ahead of print] Chan RJ, Phillips J, Currow DC, Do pallia ve care health professionals se le for low-level evidence? Pallia ve Medicine, 28(1):8-9 Clark K, Currow DC, Methylnaltrexone in pallia ve care: further research is needed, Journal of Pain and Symptom Management, 47(2):e5-6 Currow DC, Abernethy AP, Lessons from the Liverpool Care Pathway evidence is key, Lancet, 18;383 (9913):192-3 Currow DC, Ekstrom M, Abernethy AP, Opioids for chronic refractory breathlessness: right pa ent, right route? Drugs, 74(1):1-6 Hegarty M, Breaden K, Agar M, Devery K, Goh C, Shaw R, Swetenham K, Currow DC, Asia pacific pallia ve care development through educa on, Journal of Pain and Symptom Management, 47(2):e7-9 Russell BJ, Rowe D, Abernethy AP, Currow DC, Prescribing for Comorbid Disease in a Pallia ve Popula on: Focus on the Use of Lipid-Lowering Medica ons, Internal Medicine Journal, Dec 16, 2013 [Epub ahead of print] Sweet L, Adamis D, Meagher D, Davis D, Currow D, Bush SH, Barnes C, Hartwick M, Agar M, Simon J, Breitbart W, Macdonald N, Lawlor PG, Ethical Challenges and Solu ons Regarding Delirium Studies in Pallia ve Care, Journal of Pain and Symptom Management, Dec 31, 2013 [Epub ahead of print] PaCCSC is funded by the Australian Government Department of Health 700 Goodwood Road Daw Park SA 5041 P: F: E: paccsc@flinders.edu.au PaCCSC Newsle er February 2014: Issue 20 8.