Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2018

PEARL: A randomised phase 3 trial of early referral to palliative care (PC) for patients with advanced thoracic malignancies. (#422)

Linda R Mileshkin 1 , Jaclyn Yoong 2 3 , Anna K Nowak 4 , Jennifer Philip 5 , Brian H Lee 6 , Meera Agar 7 8 , Jane Phillips 8 , Stephen Goodall 9 , Penelope Schofield 9 , Anna Ugalde 10 , David Ball 1 , David Currow 8 , Ian Stubbin 11 , Jennifer S Temel 12 , Katherine Clark 13 , Paula K Lorgelly 14 , Chris Brown 15 , Annette Tognela 16 , Hannora Jurkovic 15 , Antony Mersiades 15 , Martin R Stockler 15
  1. Peter MacCallum Cancer Centre, Melbourne, VIC, Australia
  2. Supportive and Palliative Care, Monash Health, Melbourne, VIC, Australia
  3. Department of Medical Oncology, The Northern Hospital, Melbourne, VIC, Australia
  4. School of Medicine, Faculty of Health and Medical Sciences, University of Western Australia, Perth, WA, Australia
  5. Centre for Palliative Care, St Vincent's Hospital, Melbourne, VIC, Australia
  6. Department of Palliative Care, Royal Melbourne Hospital, Melbourne, VIC, Australia
  7. Ingham Institute of Applied Medical Research, Sydney, NSW, Australia
  8. University of Technology Sydney, Sydney, NSW, Australia
  9. Swinburne University of Technology, Melbourne, VIC, Australia
  10. Deakin University, Melbourne, VIC, Australia
  11. Australasian Lung Cancer Trials Group (ALTG), Sydney, NSW, Australia
  12. Massachusetts General Hospital, Boston, MA, United States of America
  13. Calvary Mater Hospital, Newcastle, NSW, Australia
  14. Monash University, Melbourne, VIC, Australia
  15. NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, AUSTRALIA
  16. Medical Oncology, Macarthur Cancer Therapy Centre, South Western Sydney Local Health District, Campbelltown, NSW, AUSTRALIA

Background:

The benefits of early referral of people with advanced cancers to PC have yet to be demonstrated in Australia, where the model of PC services differs from the USA. The aim of this trial is to determine whether early referral to PC improves patient outcomes in patients with recently diagnosed, advanced thoracic malignancies.

Methods:

DESIGN: Open-label, multi-centre, randomised phase 3 trial. ELIGIBILITY: Advanced thoracic malignancy (NSCLC, small cell lung cancer or malignant pleural mesothelioma) diagnosed with 60 days. STRATIFICATION: Cancer type, age, gender, planned use of chemotherapy, performance status and participating site. ENDPOINTS: Health related quality of life (HRQOL; primary), health care resource utilisation, overall survival (OS), carer related outcomes, patient and carer understanding of illness, quality of end of life care and identification of key elements of PC consultations. STATISTICS: 200 patients allocated in 1:1 randomisation with 6 months minimum follow-up for 80% power to detect a 20% change in the proportion of patients with a sustained improvement in HRQOL. INTERVENTION: Arm A: Early referral to PC intervention within 60 days of diagnosis; Arm B: discretionary referral to PC. Both arms receive standard oncological care. Arm A intervention comprises initial structured hospital based consultation, case conference with patient’s family doctor, and regular prescribed follow-up with the local PC service. PEARL is an investigator-initiated cooperative group trial led by ALTG Cancer Trials Group with funding from Cancer Australia. Australian New Zealand Clinical Trials Registry: ACTRN12617000166370. CURRENT ENROLMENT: (as of 3 Aug 2018): 13 sites open, 46 patients enrolled since June 2017.