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The Project ENABLE II Randomized Controlled Trial

Marie Bakitas, DNSc, APRN; Kathleen Doyle Lyons, ScD, OTR; Mark T. Hegel, PhD; Stefan Balan, MD; Frances C. Brokaw, MD, MS; Janette Seville, PhD; Jay G. Hull, PhD; Zhongze Li, MS; Tor D. Tosteson, ScD; Ira R. Byock, MD; Tim A. Ahles, PhD

JAMA. 2009;302(7):741-749.

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

Author Affiliations: Departments of Anesthesiology, Section of Palliative Medicine (Drs Bakitas, Brokaw, and Byock), Psychiatry (Drs Lyons, Hegel, Seville, and Ahles), and Medicine (Drs Balan and Brokaw), Dartmouth Medical School, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire; Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire (Dr Hull); School of Nursing, Yale University, New Haven, Connecticut (Dr Bakitas); White River Junction VA Medical Center, White River Junction, Vermont (Dr Balan); Biostatistics Shared Resource, Norris Cotton Cancer Center, Lebanon, New Hampshire (Mr Li and Dr Tosteson); and Department of Psychiatry, Memorial Sloan-Kettering Cancer Center, New York, New York (Dr Ahles).

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