A randomised phase II trial to examine feasibility of standardised, early palliative (STEP) care for patients with advanced cancer and their families [ACTRN12617000534381]: A research protocol

Abstract

Background: Current international consensus is that 'early' referral to palliative care services improves cancer patient and family carer outcomes; however, in practice, these referrals are not routine. Uncertainty about the 'best time' to refer has been highlighted as contributing to care variation. Previous work has identified clear diseasespecific transition points in the cancer illness which heralded subsequent poor prognosis (less than 6 months) and which, we contest, represent times when palliative care should be routinely introduced as a standardised approach, if not already in place, to maximise patient and carer benefit. This protocol details a trial that will test the feasibility of a novel standardised outpatient model of early palliative care [Standardised Early Palliative Care (STEP Care)] for advanced cancer patients and their family carers, with referrals occurring at the defined disease-specific evidence-based transition points. The aims of this study are to (1) determine the feasibility of conducting a definitive phase 3 randomised trial, which evaluates effectiveness of STEP Care (compared to usual best practice cancer care) for patients with advanced breast or prostate cancer or high grade glioma; (2) examine preliminary efficacy of STEP Care on patient/family caregiver outcomes, including quality of life, mood, symptoms, illness understanding and overall survival; (3) document the impact of STEP Care on quality of end-of-life care; and (4) evaluate the timing of palliative care introduction according to patients, families and health care professionals. Methods: Phase 2, multicenter, open-label, parallel-arm, randomised controlled trial (RCT) of STEP Care plus standard best practice cancer care versus standard best practice cancer care alone. Discussion: The research will test the feasibility of standardised palliative care introduction based on illness transitions and provide guidance on subsequent development of phase 3 studies of integration. This will directly address the current uncertainty about palliative care timing.