PaCCSC Newsletter Palliative Care Clinical Studies Collaborative ISSUE 13: MAY 2012

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1 PaCCSC Newsletter Palliative Care Clinical Studies Collaborative ISSUE 13: MAY 2012 this issue PaCCSC Annual Research Forum 1 In the Spotlight: Royal Melbourne 2 Meet Natalie Cutri 2 PaCCSC Annual Research Forum 2012 As many of you will know, the 2012 PaCCSC Annual Research Forum was held in Sydney on the 15 th and 16 th March. Day one showcased a range of research being conducted across PaCCSC collaborating sites with 11 presentations. Day two provided a forum for the discussion of new projects and ideas followed by a face-toface meeting of the Trials Management Committee. Evaluation of the forum was conducted electronically and we would like to thank the 20 respondents who took part in this process. The information and feedback will be utilised in the planning of future forums and hopefully more closely align with the needs of all attendees. In particular I note a number of recurring responses in relation to the timing and conduct of meetings to ensure that sufficient time is afforded both to individual speakers and the various committees/meetings that take the opportunity to meet face-to-face. In the Spotlight: Sacred Heart 3 News from the Study Sites 4 Nausea Studies Update 4 PaCCSC Studies Update 5 National Palliative Care Week 5 PaCCSC 800th Randomisation 6 Upcoming Conferences & Events 6 Recent Member Publications 6 I would like to highlight a couple of particular comments which thanked personally two PaCCSC sponsor office staff, Rhiannon Haines for her event management expertise, and Belinda Fazekas for keeping speakers to their allocated timeslots a somewhat challenging task! Importantly, I would also like to thank all our collaborating sites and members for your continuing support in our common pursuit of improving clinical practice in palliative care. - Linda Devilee, National Manager Day One- PaCCSC Annual Research Forum PaCCSC Newsletter May 2012: Issue 13 1.

2 In the Spotlight: As part of the revamp of the PaCCSC newsletter we will be selecting two sites each edition to showcase. This month we showcase the Royal Melbourne Hospital and Sacred Heart. If you would like to be showcased in our next edition please contact Rhiannon: The Royal Melbourne Hospital The Royal Melbourne Hospital (RMH) is a 350-bed hospital located just to the north of the City of Melbourne, in Parkville, Victoria. The Palliative Care Service provides a hospital-wide consultative service, and an inpatient 10-bed unit on the acute hospital campus. The service is also closely affiliated with Melbourne Citymission Palliative Care Service - providing community based care - and The University of Melbourne. Part of the Melbourne Health network, RMH is a specialist centre in cancer care, neurosciences and nephrology, and is one of two designated trauma centres in Victoria. The hospital is also planning for the future development of the Victorian Comprehensive Cancer Centre, which will see Peter MacCallum Cancer Centre relocate to a new facility located adjacent, within the Parkville precinct, together with The Royal Women's Hospital, The Royal Children's Hospital and The University of Melbourne. Our first PaCCSC trial opened for patient accrual in mid 2011, and we currently have open to accrual the Dyspnoea and the Delirium trials. In addition, we currently have open one other multinational sponsored study, examining the use of a novel agent Anamorelin, in the treatment of cachexia in non-small cell lung cancer, and are soon to open a further sponsored pain study using Sativex in refractory cancer pain. We have participated in previous sponsored trials in the areas of constipation and refractory pain. Our foray into clinical trials research was made possible by receipt of a competitive grant from the Victorian Cancer Agency in early 2011, allowing us to employ a full-time clinical trials coordinator. We work in close collaboration with our hospital s well established oncology clinical trials team, and Cancer Trials Australia. Associate Professor Brian Le is the director of the Palliative Care Service and is site principal investigator for the current trials. Drs Alexandra Clinch and Charmaine Foo are medical consultants on the service and are sub-investigators. Dr Esther Lin is a palliative care fellow who commenced in her role in February 2012, and is a sub-investigator of the current studies. Gillian McCarthy RN is our senior clinical trials coordinator, and brings a vast experience in clinical trials research from a background in neurosciences, stroke and palliative care, and a clinical background in acute and community nursing. James Watt RN is our second clinical trials coordinator, with an extensive clinical and research background in palliative care. Meet Natalie Cutri PaCCSC Recruitment Officer Natalie commenced in the role of Recruitment Officer in March. She has an extensive research background having recently earned a PhD in cardiology. Natalie has worked as a clinical trial coordinator for over five years and she brings to this role her knowledge of clinical trials and a passion for research in patients with chronic disease. Natalie s role at PaCCSC is to work with the sites in order to improve and maintain the expected recruitment targets, identify recruitment difficulties and build and provide training and informational materials. In the coming months, Natalie will visit each site to share and build on experiences and to ensure participants are recruited and retained to meet the larger PaCCSC objectives. The Team at Royal Melbourne - L-R Brian Le, Esther Lee, Gillian McCarthy, James Watt PaCCSC Newsletter May 2012: Issue 13 2.

3 In the Spotlight: Sacred Heart Operated by St Vincent s Public Health Service, Sacred Heart provides supportive and palliative care, and rehabilitation services. It is one of Australia s largest and leading inpatient palliative care providers and has extended this care to supporting patients receiving treatment for their cancers, even if the treatment is of curative intent. Over the past two years Sacred Heart has gradually increased the number of trials open at this site and is currently actively recruiting to the PaCCSC trials: Constipation, Megestrol, MOP, Nausea 1 and 2, Octreotide, Rapid Pharmacovigilance, Risperidone and Sertraline. During this period the clinical trials team has expanded and been reconfigured to optimise recruitment at a both the hospice and the adjacent acute care setting. As part of this expansion a shared oncology-palliative care clinical trials nursing position has been created, to enhance opportunities to offer the suite of trials to eligible patients, from oncology and respiratory care services that are not currently known to the specialist palliative care team. The Sacred Heart palliative care clinical trials team members are: Penny West is a RN who has been in the Sacred Heart Clinical Trials Nurse position for the past year. Penny has worked extensively in oncology, palliative and aged care, in both the acute care and community settings. Penny has been a Project Coordinator for several Local Palliative Care Grants in residential aged care and the project nurse for the Mid North Coast Rural Palliative Care Project ( ). Penny has completed her Graduate Certificate in Oncology Nursing and also her Masters in Palliative Care. Jo Chambers is a part time Clinical Trials Nurse and the longest serving member of the nursing research team at Sacred Heart. Jo also works two days per week with Community Palliative Care. Jo has vast knowledge in oncology and palliative care and has completed her Graduate Certificate in Oncology Nursing. Jo has also previously worked at St Vincent s in another role with bone marrow transplant. In this role Jo has an opportunity to promote the PaCCSC trials to the Sacred Heart and Prince of Wales palliative care teams. Sandra Montez is the newest member of the team. Sandra is a Clinical Trials Nurse and has been with Sacred Heart since January working full time but shared with oncology. Sandra s background lies in ICU and critical care where she completed her Masters of Intensive Care and has been involved in research for the past three years. Sandra recently moved back to Australia after working in the UK for three years as a Clinical Trials Coordinator at University College London for the Infection and Immunity Department. This position involved recruiting patients from the Hospital of Tropical Diseases and A&E into several investigator lead trials that were trying to correlate the effects of acquired immunity with different infectious diseases such as TB, malaria, herpes zoster and parasitic infections. Professor Richard Chye is the Area Director of Palliative Care, covering Prince of Wales Hospital, St Vincent's Hospital and Sacred Heart Hospice. He directs palliative care services for a population of 350,000 across two teaching/university hospitals in Eastern Sydney. (The team at Sacred Heart L-R: Sandra Montez, Jo Chambers, Richard Chye. Absent: Jane Phillips, Penny West) He is also a conjoint Associate Profesor at the University of New South Wales. He is currently developing academic and research capacity in palliative care at the University of NSW and The University of Notre Dame in conjunction with the Cancer Institute NSW. Richard co-leads the PaCCSC clinical trials team at Sacred Heart in partnership with Jane Phillips. Jane is the Professor of Palliative Nursing at The University of Notre Dame Australia and the Co-director of The Cunningham Centre for Palliative Care based at Sacred Heart Hospice, St Vincent s in Sydney. Since commencing on a research pathway in 2004, Jane has been involved in extending palliative care delivery outside of specialist settings, with a particular emphasis on increasing the palliative care capacity of health professionals to deliver end-of-life care to vulnerable and underserved populations. Jane has worked extensively in urban and rural specialist palliative care services across Australia caring in both the acute and community care settings. PaCCSC Newsletter May 2012: Issue 13 3.

4 News from the Study Sites... Peter Mac Peter Mac welcomes Joy Williams to the research nurse team. Joy is currently available two days each week, and is already proving to be a valuable asset to the team. Happily we managed to recruit a patient to the Megestrol study recently, which made it a year since the last recruitment! It is a tricky study for us, given the majority of the patient population is receiving dexamethasone, but it just goes to show how persistence can pay off. Courtney Bamford: Study Coordinator St Vincent s Hospital In 2009, Dr Jennifer Philip set up the Clinical Trials Team at St Vs with clinical support from the palliative care consultants across our two sites St Vincent s, a large, inner-city, acute hospital, Fitzroy, and Caritas Christi Hospice, a stand-alone hospice, Kew. Our Palliative Care Service does not have a community team. Catherine Duck joined our team in late 2011, adding research nursing to her already extensive palliative care experience. Cath is based at Kew and is already kicking goals! Dr Jo-An Seah, Research Registrar for 6 months, is focussing on symptom management with the team. Anne and Jo-An are spending more time in clinics as the inpatient area has proved a difficult recruitment ground. Many St Vs patients are NESB, very frail or with many comorbidities, which makes recruitment challenging. Despite trying different recruitment strategies we find personal approaches to clinicians and patients are still the most successful ones. We are having a lot of success in finding patients for the current Pharmacovigilance study, haloperidol for delirium! - Anne Harbison: Site Co-ordinator (R-L: Erica Cameron-Taylor & Katy Clark (Newcastle), Meera Agar (Braeside) Braeside We have had our first constipation study patient here at Braeside. Still haven t recruited a patient to Anamorelin but not for lack of trying. Both Julie and Nichole attended the PaCCSC Forum and enjoyed it immensely. I am now back on deck after having two months off with a total knee replacement. Still hobbling a little bit but getting better every week. Don t really have any other news just keep looking for patients to recruit to studies. - Jane Hunt: Site Coordinator The Alfred I had another baby (Harriet), and am now back at work. Paula Balchin, our research nurse moved on late last year to a new job down towards The Peninsula, closer to home. Francis Beaumont, the acting research coordinator moved back to a job in Ballarat, once again closer to home. So I am holding the fort. - Julia Brindson-Farr: Site Coordinator SAPS The SAPS unit has had a very busy start to the New Year. We are still unpacking after our recent move to our new office accommodation. With the commencement of the Medicines Management Pilot study in January and the conclusion of the Clonazepam study we hit the ground running after the Christmas break but both of these studies have met their recruitment targets. Recruitment to the other PaCCSC studies continue with much cooperation from the clinical teams. We are pleased to welcome Urska Cosic and Kerri Anne Hooper to our study nurse team. We know the additional staff will assist us to convert more referrals to randomizations.aileen is off to bonny Scotland this month for a very well deserved break Peter Allcroft our site investigator has also had a busy month. Peter joined a group in a RIDE FOR REPAT fundraiser where they rode from the hospice to Mt Gambier and back to the hospice a round trip of 930 k. He coped well with the trip and felt it assisted his Iron man training. - Aine Greene: Site Coordinator Nausea Studies Update Recruitment to Study 1 progresses steadily with 59 patients completed from 76 randomisations (as of 23/04/2012). Study 2 recruitment continues to lag; however further recent protocol changes (V2.12) will hopefully facilitate increased recruitment rates to this study. All sites have been busy pre-screening potential recruits. The study investigators presented interim data at the recent PaCCSC Research Forum which resulted in constructive feedback and discussion. Initial periodic monitoring of the first two randomised patients in each study has commenced with the Mater Hospital Brisbane being the first site to be visited. A schedule for monitoring of other sites will be negotiated according to recruitment numbers. St Vincent s Hospital Brisbane has received ethics approval for both nausea studies and is expected to open for recruitment by May. In addition, Sacred Heart Sydney is in the process of submitting their ethics application and will hopefully join the Nausea Studies team next month. Janene Leslie QUT Barwon Health Great news that PaCCSC have their 800th patient! Congratulations to Dr Martin s site who have randomized 7 subjects to the Anamorelin study. - Meg Harrison, Site Coordinator PaCCSC Newsletter May 2012 Issue 13 4.

5 PaCCSC Studies Update National Palliative Care Week 20th -26th May 2012 PILOTS Medications Management. The management of medications in the palliative care setting has been tested in a pilot study at one site. Data collected from the pilot are now being collated and analysed, and will contribute to determining the feasibility of a larger Phase 3 trial that is currently seeking funding through the NMHRC. Clonazepam for breathlessness. This pilot study has looked at the feasibility of the use of clonazepam for the management of dyspnoea. This will also form a NHMRC submission for an adequately powered phase three study next year. PHASE 4 Rapid Pharmacovigilance in Palliative Care. The audit of the first medication, metoclopramide is now complete and a draft paper submitted for publication. Recruitment is now open for an audit of the second medication, haloperidol. There are 15 actively contributing sites for haloperidol and many more sites expressing interest both nationally and internationally. If you would like to be involved or have a colleague you believe may be interested please forward their details to Caroline Litster at caroline.litster@flinders.edu.au to make contact. OTHER Anamorelin. Anamorelin HCl is a drug which is currently being trialled in the treatment of nonsmall cell lung cancer in patients with cachexia. The aim of this clinical trial is evaluate the effect of lean body mass and muscle strength, as well as, the safety and tolerability of the trial drug. Join in and celebrate National Palliative Care Week. Palliative Care Australia are inviting all palliative care professionals to celebrate National Palliative Care Week by taking part in two events on Tuesday 22nd May. You can attend in person, or virtually via live streaming! The day will be facilitated by Dr Norman Swan, host of the Health Report on ABC Radio National and commence with breakfast at Parliament from 7.00am followed by an Education Day Palliative Care: It s not just about dying. For more details visit the PCA website at: Register your interest and listen online if you can t make it in person. Clinical study # needed # completed Leading recruitment sites Risperidone Royal Melbourne, Geelong, Sacred Heart Octreotide Southern Adelaide Palliative Services, St Vincent's Melbourne, Mater Megestrol Southern Adelaide Palliative Services, Sacred Heart, Barwon Morphine /Oxycodone Royal Melbourne, St Vincent's Melbourne, Mater Sertraline Southern Adelaide Palliative Services, Austin, Braeside Nausea Mater, Peter Mac, Barwon Nausea Mater, Southern Adelaide Palliative Services, St Vincent's Constipation Newcastle, Braeside, Sacred Heart PaCCSC Newsletter May 2012 Issue 13 5.

6 Upcoming Conferences & Events PaCCSC Randomises 800th Participant! The Palliative Care Clinical Studies Collaborative (PaCCSC) has recently randomised its 800th participant overall since recruitment commenced in early In addition, PaCCSC also reached 100 completed participants for the risperidone (n=165) and megestrol (n=159) studies. These are important studies seeking to address important clinical issues on a day to day basis. The findings allow PaCCSC to take a leading role in answering difficult questions in ways that were thought to be impossible in the past by building an evidence base to support the ongoing implementation of studies on medicine use and quality practice in palliative care. PaCCSC would like to express its thanks for the continuing support of all collaborating sites for their running of high quality phase III clinical trials. Aligned with the aim of conducting clinical trials research, PaCCSC also aims to build the research capacity of the palliative care sector so that clinical medication studies can become the norm with the results positively influencing the clinical care provided to people at the end of life. Thanks also to the Department of Health and Ageing for their continued funding support. These studies are making a difference already and will continue to influence practice in the foreseeable future. International Clinical Trials Day: 20 May 2012 National Palliative Care Week: May 2012 Cultural Diversity in Ageing 2012 Conference: June , Melbourne Victoria International Conference on Opioids: June , Boston Massachusetts 15th World Congress of Pain Clinicians: June , Granada Spain Singapore Palliative Care Conference 2012: July , Singapore PaCCSC Chief Investigator Professor David Currow will be spreading news about PaCCSC research far and wide in the June, including: MASCC/ISOO Multinational Association for Supportive Care in Cancer/International Symposium on Supportive Care in Cancer (New York): Off label prescribing in palliative care a cross-sectional national survey of Australian palliative medicine doctors 2012 ASCO American Society of Clinical Oncology Annual Meeting Collaborating to Conquer Cancer (Chicago): A randomized, double-blind, placebo-controlled study to assess the efficacy and toxicity of subcutaneous ketamine in the management of cancer pain 7 th World Research Congress of the European Association for Palliative Care (Norway) A Randomised Double Blind Placebo Controlled Trial of Infusional Subcutaneous Octreotide in the Management of Malignant Bowel Obstruction in People with Advanced Cancer Recent Member Publications Professor David Currow Currow DC, Abernethy AP. Breathlessness in an age of noncommunicable diseases. Curr Opin Support Palliat Care Apr 11. Currow DC, Tieman JJ, Greene A, Zafar SY, Wheeler JL, Abernethy AP. Refining a Checklist for Reporting Patient Populations and Service Characteristics in Hospice and Palliative Care Research. J Pain Symptom Manage Mar 21. To TH, Ong WY, Rawlings D, Greene A, Currow DC.The Disparity between Patient and Nurse Symptom Rating in a Hospice Population. J Palliat Med Mar 9. Yates P, Zhao I.Update on complex nonpharmacological interventions for breathlessness. Curr Opin Support Palliat Care Mar 30. PaCCSC Flinders University 700 Goodwood Road Daw Park SA 5041 t f e paccsc@flinders.edu.au PaCCSC is funded under the National Palliative Care Program and is supported by the Australian Government Department of Health and Ageing PaCCSC Newsletter May 2012: Issue 13 6.