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.
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.