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.

Figure 1

Participant Enrollment, Randomization, Treatment, and Data Analysis

Figure 2. Intervention and Usual Care Groups Patterns of Quality of Life, Symptom Intensity, and Mood Scores: Total Sample

(A) The Functional Assessment of Chronic Illness Therapy-Palliative (FACIT-Pal) (range from 0 to 184; higher scores indicate better QOL), (B) Edmonton Symptom Assessment Scale (ESAS) (range from 0 to 900; higher scores indicate greater symptom intensity). (C) Center for Epidemiological Studies-Depression (CES-D) (range from 0 to 60; higher scores indicate more depressive symptoms). The numbers beneath each time point represent the groups’ sample size. Each analysis was adjusted for the respective baseline instrument score. Error bars signify 95% confidence intervals.

Figure 3. Intervention and Usual Care Groups Patterns of Quality of Life, Symptom Intensity, and Mood Scores: Participants Who Died During Study

(A) The Functional Assessment of Chronic Illness Therapy-Palliative (FACIT-Pal) (range from 0 to 184; higher scores indicate better QOL), (B) Edmonton Symptom Assessment Scale (ESAS) (range from 0 to 900; higher scores indicate greater symptom intensity). (C) Center for Epidemiological Studies-Depression (CES-D) (range from 0 to 60; higher scores indicate more depressive symptoms). The numbers beneath each time point represents the groups’ sample size. Error bars signify 95% confidence intervals.

Figure 4. Kaplan-Meier Estimates of Survival According to Treatment Group

Survival was calculated as the time of enrollment (within 8 weeks of diagnosis with new or recurrent advanced stage disease) to the time of death or study completion (5/01/08). Median survival for intervention group was 14 months (95% CI, 10.6–18.4) and 8.5 months (95% CI, 7.0–11.1); (P = .14) for usual care group. Tick lines on the curves represent participant deaths or censoring. The numbers beneath each time point represents the number of participants at risk.