Effects of a Palliative Care Intervention on Clinical Outcomes in Patients With Advanced Cancer: The Project ENABLE II Randomized Controlled Trial
Open accessAbstract
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.
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In cancer patients from rural areas of the United States, an early psychoeducational program improved quality-of-life scores and reduced depressive symptoms over time.
“A study by Bakitas et al. [7] evaluated the early introduction of a psychoeducational program in the treatment of cancer patients from rural areas in the United States. The authors observed improved QL scores and reduced symptoms of depression over time.”
Early integration of palliative care in oncology improves quality of life and reduces depressive symptoms in advanced cancer patients compared with standard oncologic care.
“Previous studies have demonstrated the benefit of early integration of palliative care (PC) in oncology.”
In Project ENABLE, intervention patients had only a limited decrease in health care service use (days in hospital p=.14; ER visits p=.53).
“Results of this study demonstrated higher QOL outcomes (p=.02), lower depressive symptoms (p.02), but limited decrease in symptom-intensity scores (p=.06) and health care service use (p=.14, days in the hospital, p=.53 for ER visits) on the part of intervention patients.”
From Self-management: Enabling and empowering patients living with cancer as a chronic illness (2011) · cites this paper as [25]
In Project ENABLE, intervention patients had only a limited decrease in symptom-intensity scores (p=.06).
“Results of this study demonstrated higher QOL outcomes (p=.02), lower depressive symptoms (p.02), but limited decrease in symptom-intensity scores (p=.06) and health care service use (p=.14, days in the hospital, p=.53 for ER visits) on the part of intervention patients.”
From Self-management: Enabling and empowering patients living with cancer as a chronic illness (2011) · cites this paper as [25]
In Project ENABLE, for newly diagnosed advanced cancer patients in rural settings, the APN intervention produced higher quality-of-life outcomes (p=.02).
“Results of this study demonstrated higher QOL outcomes (p=.02), lower depressive symptoms (p.02), but limited decrease in symptom-intensity scores (p=.06) and health care service use (p=.14, days in the hospital, p=.53 for ER visits) on the part of intervention patients.”
From Self-management: Enabling and empowering patients living with cancer as a chronic illness (2011) · cites this paper as [25]
In Project ENABLE, intervention patients had lower depressive symptoms (p=.02).
“Results of this study demonstrated higher QOL outcomes (p=.02), lower depressive symptoms (p.02), but limited decrease in symptom-intensity scores (p=.06) and health care service use (p=.14, days in the hospital, p=.53 for ER visits) on the part of intervention patients.”
From Self-management: Enabling and empowering patients living with cancer as a chronic illness (2011) · cites this paper as [25]
Palliative care has been associated with equal or longer survival in randomized and nonrandomized trials of patients with advanced cancer.
“In distinction from chemotherapy after the second-line setting, palliative care has been associated with equal103–106 or longer107–109 survival in randomized and nonrandomized110 trials of patients with advanced cancer.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [105]
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“Identifying the reasons patients are referred to PC services is essential because of the benefits of early PC in patients with advanced cancer [6-8,29].”
BackgroundStockdill, M. L., Dionne-Odom, J. N., Wells, R., Ejem, D., Azuero, A., Keebler, K., Sockwell, E., Tims, S., Burgio, K. L., Engler, S., et al. (2023) · Journal of Palliative Care · doi:10.1177/0825859720975978 · Cited by 11 · see citing works
Self-citation
- 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.
- Affiliations
- Dartmouth–Hitchcock Medical Center (US)
- Dartmouth College (US)
- Dartmouth Cancer Center (US)
- Corresponding author
- Bakitas, Marie
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2009-08-19
- Volume
- 302
- Issue
- 7
- Pages
- 741
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC3657724
- OpenAlex
- W2091343120
- Cited by
- 1,726
- References
- 68
- Citations by year
- 2026: 60 · 2025: 86 · 2024: 93 · 2023: 104 · 2022: 114 · 2021: 144 · 2020: 125 · 2019: 136 · 2018: 127 · 2017: 168 · 2016: 129 · 2015: 109 · 2014: 85 · 2013: 74 · 2012: 77
- FWCI
- 57.48
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by
- Locations
- JAMA (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (5r01ca101704-05)
- National Cancer Institute (R0-1 CA-101704, P30CA023108)
- National Institute of Nursing Research (T32NR008346, R01NR011871)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative and Oncologic Care
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Keywords
- palliative care, advanced cancer, nurse-led intervention, psychoeducational intervention, quality of life, symptom intensity, depression, hospitalization, intensive care utilization, emergency department visits, advanced practice nurses, gastrointestinal cancer, lung cancer, genitourinary cancer, breast cancer, rural cancer care, end-of-life care, health care utilization, rural veterans, rural Appalachia
- MeSH terms
- Adaptation, Psychological, Affect, Aged, Emergency Service, Hospital, Female, Health Services, Hospitalization, Humans, Intensive Care Units, Length of Stay, Male, Middle Aged, Neoplasms, Palliative Care, Patient Care Team, Patient Education as Topic, Patient Participation, Quality of Life, Social Support, Treatment Outcome, Sickness Impact Profile, Terminally Ill, Kaplan-Meier Estimate
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