title: Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial.
abstract: BACKGROUND
  Patients with advanced cancer have reduced quality of life, which tends to worsen towards the end of life. We assessed the effect of early palliative care in patients with advanced cancer on several aspects of quality of life.
  
  
  METHODS
  The study took place at the Princess Margaret Cancer Centre (Toronto, ON, Canada), between Dec 1, 2006, and Feb 28, 2011. 24 medical oncology clinics were cluster randomised (in a 1:1 ratio, using a computer-generated sequence, stratified by clinic size and tumour site [four lung, eight gastrointestinal, four genitourinary, six breast, two gynaecological]), to consultation and follow-up (at least monthly) by a palliative care team or to standard cancer care. Complete masking of interventions was not possible; however, patients provided written informed consent to participate in their own study group, without being informed of the existence of another group. Eligible patients had advanced cancer, European Cooperative Oncology Group performance status of 0-2, and a clinical prognosis of 6-24 months. Quality of life (Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being [FACIT-Sp] scale and Quality of Life at the End of Life [QUAL-E] scale), symptom severity (Edmonton Symptom Assessment System [ESAS]), satisfaction with care (FAMCARE-P16), and problems with medical interactions (Cancer Rehabilitation Evaluation System Medical Interaction Subscale [CARES-MIS]) were measured at baseline and monthly for 4 months. The primary outcome was change score for FACIT-Sp at 3 months. Secondary endpoints included change score for FACIT-Sp at 4 months and change scores for other scales at 3 and 4 months. This trial is registered with ClinicalTrials.gov, number NCT01248624.
  
  
  RESULTS
  461 patients completed baseline measures (228 intervention, 233 control); 393 completed at least one follow-up assessment. At 3-months, there was a non-significant difference in change score for FACIT-Sp between intervention and control groups (3·56 points [95% CI -0·27 to 7·40], p=0·07), a significant difference in QUAL-E (2·25 [0·01 to 4·49], p=0·05) and FAMCARE-P16 (3·79 [1·74 to 5·85], p=0·0003), and no difference in ESAS (-1·70 [-5·26 to 1·87], p=0·33) or CARES-MIS (-0·66 [-2·25 to 0·94], p=0·40). At 4 months, there were significant differences in change scores for all outcomes except CARES-MIS. All differences favoured the intervention group.
  
  
  CONCLUSIONS
  Although the difference in quality of life was non-significant at the primary endpoint, this trial shows promising findings that support early palliative care for patients with advanced cancer.
  
  
  BACKGROUND
  Canadian Cancer Society, Ontario Ministry of Health and Long Term Care.
authors.affiliation: Division of Medical Oncology and Haematology, Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Department of Psychosocial Oncology and Palliative Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada; Campbell Family Cancer Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. Electronic address: camilla.zimmermann@uhn.ca.
authors.forename: Camilla
authors.initials: C
authors.lastname: Zimmermann
authors.affiliation: Department of Psychosocial Oncology and Palliative Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Nadia
authors.initials: N
authors.lastname: Swami
authors.affiliation: Division of Medical Oncology and Haematology, Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Monika
authors.initials: M
authors.lastname: Krzyzanowska
authors.affiliation: Division of Medical Oncology and Haematology, Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Psychosocial Oncology and Palliative Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Breffni
authors.initials: B
authors.lastname: Hannon
authors.affiliation: Division of Medical Oncology and Haematology, Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Natasha
authors.initials: N
authors.lastname: Leighl
authors.affiliation: Division of Medical Oncology and Haematology, Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Amit
authors.initials: A
authors.lastname: Oza
authors.affiliation: Division of Medical Oncology and Haematology, Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Malcolm
authors.initials: M
authors.lastname: Moore
authors.affiliation: Department of Psychosocial Oncology and Palliative Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Anne
authors.initials: A
authors.lastname: Rydall
authors.affiliation: Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Department of Psychosocial Oncology and Palliative Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada; Campbell Family Cancer Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Gary
authors.initials: G
authors.lastname: Rodin
authors.affiliation: Division of Medical Oncology and Haematology, Department of Medicine, University of Toronto, Toronto, ON, Canada; Department of Medical Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada; Campbell Family Cancer Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Ian
authors.initials: I
authors.lastname: Tannock
authors.affiliation: Western University, London, ON, Canada.
authors.forename: Allan
authors.initials: A
authors.lastname: Donner
authors.affiliation: Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Department of Psychosocial Oncology and Palliative Care, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
authors.forename: Christopher
authors.initials: C
authors.lastname: Lo
mesh_terms: D000368:Aged; D061345:Early Medical Intervention / Q000458:organization & administration*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000523:psychology / Q000628:therapy*; D009864:Ontario; D010044:Outpatient Clinics, Hospital / Q000458:organization & administration; D010166:Palliative Care / Q000458:organization & administration* / Q000523:psychology; D017060:Patient Satisfaction; D011594:Psychometrics; D011788:Quality of Life; D016037:Single-Blind Method; D016896:Treatment Outcome