Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: The project ENABLE II randomized controlled trial Journal Article


Authors: Bakitas, M.; Lyons, K. D.; Hegel, M. T.; Balan, S.; Brokaw, F. C.; Seville, J.; Hull, J. G.; Li, Z.; Tosteson, T. D.; Byock, I. R.; Ahles, T. A.
Article Title: Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: The project ENABLE II randomized controlled trial
Abstract: Context: 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. Design, Setting, and Participants: 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. Interventions: 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). Main Outcome Measures: 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. Conclusion 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. Trial Registration: clinicaltrials.gov Identifier: NCT00253383. ©2009 American Medical Association. All rights reserved.
Keywords: adult; cancer chemotherapy; controlled study; treatment outcome; treatment response; aged; middle aged; functional assessment; major clinical study; clinical trial; advanced cancer; cancer patient; cancer radiotherapy; outcome assessment; antineoplastic agent; neoplasms; cancer palliative therapy; palliative care; quality of life; controlled clinical trial; breast cancer; lung non small cell cancer; randomized controlled trial; patient education as topic; lung cancer; oncology; urogenital tract cancer; cancer mortality; digestive system cancer; kaplan-meiers estimate; patient participation; sickness impact profile; social support; adaptation, psychological; health services; patient care team; terminally ill; cancer center; depression; electronic medical record; emergency ward; intensive care unit; length of stay; liver metastasis; lung metastasis; lung small cell cancer; mood; nursing care; nursing intervention; psychoeducation; symptom; affect; emergency service, hospital; hospitalization; intensive care units
Journal Title: JAMA - Journal of the American Medical Association
Volume: 302
Issue: 7
ISSN: 0098-7484
Publisher: American Medical Association  
Date Published: 2009-08-19
Start Page: 741
End Page: 749
Language: English
DOI: 10.1001/jama.2009.1198
PUBMED: 19690306
PROVIDER: scopus
PMCID: PMC3657724
DOI/URL:
Notes: --- - "Cited By (since 1996): 12" - "Export Date: 30 November 2010" - "CODEN: JAMAA" - "Source: Scopus"
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  1. Tim A Ahles
    112 Ahles