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Randomized Controlled Trial
. 2015 May 1;33(13):1438-45.
doi: 10.1200/JCO.2014.58.6362. Epub 2015 Mar 23.

Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial

Marie A Bakitas  1 , Tor D Tosteson  2 , Zhigang Li  2 , Kathleen D Lyons  2 , Jay G Hull  2 , Zhongze Li  2 , J Nicholas Dionne-Odom  2 , Jennifer Frost  2 , Konstantin H Dragnev  2 , Mark T Hegel  2 , Andres Azuero  2 , Tim A Ahles  2
Affiliations
Randomized Controlled Trial

Early Versus Delayed Initiation of Concurrent Palliative Oncology Care: Patient Outcomes in the ENABLE III Randomized Controlled Trial

Marie A Bakitas et al. J Clin Oncol. .

Abstract

Purpose: Randomized controlled trials have supported integrated oncology and palliative care (PC); however, optimal timing has not been evaluated. We investigated the effect of early versus delayed PC on quality of life (QOL), symptom impact, mood, 1-year survival, and resource use.

Patients and methods: Between October 2010 and March 2013, 207 patients with advanced cancer at a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics were randomly assigned to receive an in-person PC consultation, structured PC telehealth nurse coaching sessions (once per week for six sessions), and monthly follow-up either early after enrollment or 3 months later. Outcomes were QOL, symptom impact, mood, 1-year survival, and resource use (hospital/intensive care unit days, emergency room visits, chemotherapy in last 14 days, and death location).

Results: Overall patient-reported outcomes were not statistically significant after enrollment (QOL, P = .34; symptom impact, P = .09; mood, P = .33) or before death (QOL, P = .73; symptom impact, P = .30; mood, P = .82). Kaplan-Meier 1-year survival rates were 63% in the early group and 48% in the delayed group (difference, 15%; P = .038). Relative rates of early to delayed decedents' resource use were similar for hospital days (0.73; 95% CI, 0.41 to 1.27; P = .26), intensive care unit days (0.68; 95% CI, 0.23 to 2.02; P = .49), emergency room visits (0.73; 95% CI, 0.45 to 1.19; P = .21), chemotherapy in last 14 days (1.57; 95% CI, 0.37 to 6.7; P = .27), and home death (27 [54%] v 28 [47%]; P = .60).

Conclusion: Early-entry participants' patient-reported outcomes and resource use were not statistically different; however, their survival 1-year after enrollment was improved compared with those who began 3 months later. Understanding the complex mechanisms whereby PC may improve survival remains an important research priority.

Trial registration: ClinicalTrials.gov NCT01245621.

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Conflict of interest statement

Authors' disclosures of potential conflicts of interest are found in the article online at www.jco.org. Author contributions are found at the end of this article.

Figures

Fig 1.
Fig 1.
CONSORT diagram: patient recruitment, treatment, and analysis. PCT, palliative care treatment; psych, psychiatric disorder.
Fig 2.
Fig 2.
Kaplan-Meier estimates of 1-year survival by treatment group.
Fig A1.
Fig A1.
Study schema. CYC, Charting Your Course; FCG, family caregiver; PC, palliative care; PT, patient.
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References

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