title: Integrated collaborative care for comorbid major depression in patients with cancer (SMaRT Oncology-2): a multicentre randomised controlled effectiveness trial.
abstract: BACKGROUND
  Medical conditions are often complicated by major depression, with consequent additional impairment of quality of life. We aimed to compare the effectiveness of an integrated treatment programme for major depression in patients with cancer (depression care for people with cancer) with usual care.
  
  
  METHODS
  SMaRT Oncology-2 is a parallel-group, multicentre, randomised controlled effectiveness trial. We enrolled outpatients with major depression from three cancer centres and their associated clinics in Scotland, UK. Participants were randomly assigned in a 1:1 ratio to the depression care for people with cancer intervention or usual care, with stratification (by trial centre) and minimisation (by age, primary cancer, and sex) with allocation concealment. Depression care for people with cancer is a manualised, multicomponent collaborative care treatment that is delivered systematically by a team of cancer nurses and psychiatrists in collaboration with primary care physicians. Usual care is provided by primary care physicians. Outcome data were collected up until 48 weeks. The primary outcome was treatment response (≥50% reduction in Symptom Checklist Depression Scale [SCL-20] score, range 0-4) at 24 weeks. Trial statisticians and data collection staff were masked to treatment allocation, but participants could not be masked to the allocations. Analyses were by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN40568538.
  
  
  RESULTS
  500 participants were enrolled between May 12, 2008, and May 13, 2011; 253 were randomly allocated to depression care for people with cancer and 247 to usual care. 143 (62%) of 231 participants in the depression care for people with cancer group and 40 (17%) of 231 in the usual care group responded to treatment: absolute difference 45% (95% CI 37-53), adjusted odds ratio 8·5 (95% CI 5·5-13·4), p<0·0001. Compared with patients in the usual care group, participants allocated to the depression care for people with cancer programme also had less depression, anxiety, pain, and fatigue; and better functioning, health, quality of life, and perceived quality of depression care at all timepoints (all p<0·05). During the study, 34 cancer-related deaths occurred (19 in the depression care for people with cancer group, 15 in the usual care group), one patient in the depression care for people with cancer group was admitted to a psychiatric ward, and one patient in this group attempted suicide. None of these events were judged to be related to the trial treatments or procedures.
  
  
  CONCLUSIONS
  Our findings suggest that depression care for people with cancer is an effective treatment for major depression in patients with cancer. It offers a model for the treatment of depression comorbid with other medical conditions.
  
  
  BACKGROUND
  Cancer Research UK and Chief Scientist Office of the Scottish Government.
authors.affiliation: Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.
authors.forename: Michael
authors.initials: M
authors.lastname: Sharpe
authors.affiliation: Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: Walker
authors.affiliation: MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Christian
authors.initials: C
authors.lastname: Holm  Hansen
authors.affiliation: Psychological Medicine Research, University of Edinburgh Department of Psychiatry, Edinburgh, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Martin
authors.affiliation: University of Edinburgh Cancer Research UK Centre, Western General Hospital, Edinburgh, UK.
authors.forename: Stefan
authors.initials: S
authors.lastname: Symeonides
authors.affiliation: University of Edinburgh Cancer Research UK Centre, Western General Hospital, Edinburgh, UK.
authors.forename: Charlie
authors.initials: C
authors.lastname: Gourley
authors.affiliation: University of Edinburgh Cancer Research UK Centre, Western General Hospital, Edinburgh, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Wall
authors.affiliation: University of Edinburgh Centre for Population Health Sciences, Teviot Place, Edinburgh, UK.
authors.forename: David
authors.initials: D
authors.lastname: Weller
authors.affiliation: University of Edinburgh Centre for Population Health Sciences, Teviot Place, Edinburgh, UK.
authors.forename: Gordon
authors.initials: G
authors.lastname: Murray
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000928:Antidepressive Agents / Q000627:therapeutic use; D019033:Delivery of Health Care, Integrated; D003865:Major Depressive Disorder / Q000523:psychology* / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009369:Neoplasms / Q000523:psychology* / Q000628:therapy; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D010348:Patient Care Team; D011613:Psychotherapy / Q000706:statistics & numerical data; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents