There are few randomized controlled trials of the effectiveness of palliative care.
To determine the effect of a palliative care intervention on quality of life (QOL), symptom intensity, mood, and resource utilization.
Design, Setting, and Participants
Randomized controlled trial (November 2003-May 2008) of 322 patients with advanced cancer and an identified caregiver in a rural, NCI-designated comprehensive cancer center (the Norris Cotton Cancer Center, Lebanon, NH) and affiliated outreach clinics and Veteran’s Affairs Medical Center (White River Junction, VT).
A multi-component, psycho-educational, palliative care intervention (Project ENABLE) conducted by an advanced practice nurse consisting of 4 weekly educational sessions and monthly follow-up until death or study completion.
Main Outcome Measures
(1) The Functional Assessment of Chronic Illness Therapy-Palliative (range: 0 to 184; higher scores indicate better QOL), (2) Edmonton Symptom Assessment Scale (range: 0 to 900; higher scores indicate greater symptom intensity), (3) Center for Epidemiological Studies-Depression (range: 0 to 60; higher scores indicate more depressive symptoms), completed at baseline, 1 month and every 3 months until death or study completion, (4) days in hospital, intensive care unit (ICU), and emergency department visits recorded in the medical record.
322 participants with gastrointestinal (41%), lung (36%), genitourinary (12%), and breast (10%) cancer were randomized. Estimated treatment effects (intervention minus usual care) for all subjects were 4.6 (P = .02) for QOL, −27.8 (P = .06) for symptom intensity, and −1.8 (P = .02) for depressed mood. Estimated average treatment effects in the sample of participants who died during the study were 8.6 (P = .02) for QOL, −24.2 (P = .24) for symptom intensity, and −2.7 (P = .03) for depressed mood. Days in hospital, intensive care unit, and emergency department visits were not different between groups.
Compared to participants receiving usual oncology care, participants receiving a palliative care intervention addressing physical, psychosocial, and care coordination provided concurrently with oncology care had higher QOL and mood; comparisons of symptom intensity and days in hospital, ICU, and emergency department visits were not statistically significant.
clinicaltrials.gov Identifier: NCT00253383