title: Integrated collaborative care for major depression comorbid with a poor prognosis cancer (SMaRT Oncology-3): a multicentre randomised controlled trial in patients with lung cancer.
abstract: BACKGROUND
  The management of depression in patients with poor prognosis cancers, such as lung cancer, creates specific challenges. We aimed to assess the efficacy of an integrated treatment programme for major depression in patients with lung cancer compared with usual care.
  
  
  METHODS
  Symptom Management Research Trials (SMaRT) Oncology-3 is a parallel-group, multicentre, randomised controlled trial. We enrolled patients with lung cancer and 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 lung cancer treatment programme or usual care by a database software algorithm that used stratification (by trial centre) and minimisation (by age, sex, and cancer type) with allocation concealment. Depression care for people with lung cancer is a manualised, multicomponent collaborative care treatment that is systematically delivered by a team of cancer nurses and psychiatrists in collaboration with primary care physicians. Usual care is provided by primary care physicians. The primary outcome was depression severity (on the Symptom Checklist Depression Scale [SCL-20], range 0-4) averaged over the patient's time in the trial (up to a maximum of 32 weeks). Trial statisticians and data collection staff were masked to treatment allocation, but patients and clinicians could not be masked to the allocations. Analyses were by intention to treat. This trial is registered with Current Controlled Trials, number ISRCTN75905964.
  
  
  RESULTS
  142 participants were recruited between Jan 5, 2009, and Sept 9, 2011; 68 were randomly allocated to depression care for people with lung cancer and 74 to usual care. 43 (30%) of 142 patients had died by 32 weeks, all of which were cancer-related deaths. No intervention-related serious adverse events occurred. 131 (92%) of 142 patients provided outcome data (59 in the depression care for people with lung cancer group and 72 in the usual care group) and were included in the intention-to-treat primary analysis. Average depression severity was significantly lower in patients allocated to depression care for people with lung cancer (mean score on the SCL-20 1·24 [SD 0·64]) than in those allocated to usual care (mean score 1·61 [SD 0·58]); difference -0·38 (95% CI -0·58 to -0·18); standardised mean difference -0·62 (95% CI -0·94 to -0·29). Self-rated depression improvement, anxiety, quality of life, role functioning, perceived quality of care, and proportion of patients achieving a 12-week treatment response were also significantly better in the depression care for people with lung cancer group than in the usual care group.
  
  
  CONCLUSIONS
  Our findings suggest that major depression can be treated effectively in patients with a poor prognosis cancer; integrated depression care for people with lung cancer was substantially more efficacious than was usual care. Larger trials are now needed to estimate the effectiveness and cost-effectiveness of this care programme in this patient population, and further adaptation of the treatment will be necessary to address the unmet needs of patients with major depression and even shorter life expectancy.
  
  
  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: jane.walker@psych.ox.ac.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 Holm
authors.initials: CH
authors.lastname: 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, Edinburgh, UK.
authors.forename: David
authors.initials: D
authors.lastname: Weller
authors.affiliation: University of Edinburgh Centre for Population Health Sciences, Edinburgh, UK.
authors.forename: Gordon
authors.initials: G
authors.lastname: Murray
authors.affiliation: Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Sharpe
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000627:therapeutic use; D015897:Comorbidity; D019033:Delivery of Health Care, Integrated; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000453:epidemiology* / Q000628:therapy*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000453:epidemiology* / Q000473:pathology / Q000523:psychology* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010348:Patient Care Team / Q000458:organization & administration*; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D011379:Prognosis; D011613:Psychotherapy / Q000379:methods; D018570:Risk Assessment; D012737:Sex Factors; D016019:Survival Analysis; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000928:Antidepressive Agents