title: Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial.
abstract: BACKGROUND
  There are few randomized controlled trials on the effectiveness of palliative care interventions to improve the care of patients with advanced cancer.
  
  
  OBJECTIVE
  To determine the effect of a nursing-led intervention on quality of life, symptom intensity, mood, and resource use in patients with advanced cancer.
  
  
  METHODS
  Randomized controlled trial conducted from November 2003 through May 2008 of 322 patients with advanced cancer in a rural, National Cancer Institute-designated comprehensive cancer center in New Hampshire and affiliated outreach clinics and a VA medical center in Vermont.
  
  
  METHODS
  A multicomponent, psychoeducational intervention (Project ENABLE [Educate, Nurture, Advise, Before Life Ends]) conducted by advanced practice nurses consisting of 4 weekly educational sessions and monthly follow-up sessions until death or study completion (n = 161) vs usual care (n = 161).
  
  
  METHODS
  Quality of life was measured by the Functional Assessment of Chronic Illness Therapy for Palliative Care (score range, 0-184). Symptom intensity was measured by the Edmonton Symptom Assessment Scale (score range, 0-900). Mood was measured by the Center for Epidemiological Studies Depression Scale (range, 0-60). These measures were assessed at baseline, 1 month, and every 3 months until death or study completion. Intensity of service was measured as the number of days in the hospital and in the intensive care unit (ICU) and the number of emergency department visits recorded in the electronic medical record.
  
  
  RESULTS
  A total of 322 participants with cancer of the gastrointestinal tract (41%; 67 in the usual care group vs 66 in the intervention group), lung (36%; 58 vs 59), genitourinary tract (12%; 20 vs 19), and breast (10%; 16 vs 17) were randomized. The estimated treatment effects (intervention minus usual care) for all participants were a mean (SE) of 4.6 (2) for quality of life (P = .02), -27.8 (15) for symptom intensity (P = .06), and -1.8 (0.81) for depressed mood (P = .02). The estimated treatment effects in participants who died during the study were a mean (SE) of 8.6 (3.6) for quality of life (P = .02), -24.2 (20.5) for symptom intensity (P = .24), and -2.7 (1.2) for depressed mood (P = .03). Intensity of service did not differ between the 2 groups.
  
  
  CONCLUSIONS
  Compared with participants receiving usual oncology care, those receiving a nurse-led, palliative care-focused intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher scores for quality of life and mood, but did not have improvements in symptom intensity scores or reduced days in the hospital or ICU or emergency department visits.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00253383.
authors.affiliation: Department of Anesthesiology, Section of Palliative Medicine, Dartmouth Medical School, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, USA. marie.bakitas@dartmouth.edu
authors.forename: Marie
authors.initials: M
authors.lastname: Bakitas
authors.forename: Kathleen Doyle
authors.initials: KD
authors.lastname: Lyons
authors.forename: Mark T
authors.initials: MT
authors.lastname: Hegel
authors.forename: Stefan
authors.initials: S
authors.lastname: Balan
authors.forename: Frances C
authors.initials: FC
authors.lastname: Brokaw
authors.forename: Janette
authors.initials: J
authors.lastname: Seville
authors.forename: Jay G
authors.initials: JG
authors.lastname: Hull
authors.forename: Zhongze
authors.initials: Z
authors.lastname: Li
authors.forename: Tor D
authors.initials: TD
authors.lastname: Tosteson
authors.forename: Ira R
authors.initials: IR
authors.lastname: Byock
authors.forename: Tim A
authors.initials: TA
authors.lastname: Ahles
mesh_terms: D000223:Adaptation, Psychological; D000339:Affect; D000368:Aged; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data; D005260:Female; D006296:Health Services / Q000706:statistics & numerical data*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data; D053208:Kaplan-Meier Estimate; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000401:mortality / Q000451:nursing / Q000523:psychology / Q000628:therapy*; D010166:Palliative Care / Q000379:methods; D010348:Patient Care Team; D010353:Patient Education as Topic; D010358:Patient Participation; D011788:Quality of Life; D018434:Sickness Impact Profile; D012944:Social Support; D019452:Terminally Ill / Q000523:psychology; D016896:Treatment Outcome
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