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

J Clin Oncol. 2015 May 1;33(13):1438-45. doi: 10.1200/JCO.2014.58.6362. Epub 2015 Mar 23.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Affect
  • Aged
  • Antineoplastic Agents / therapeutic use
  • Counseling
  • Emergency Service, Hospital / statistics & numerical data
  • Female
  • Health Resources / statistics & numerical data
  • Humans
  • Intensive Care Units / statistics & numerical data
  • Kaplan-Meier Estimate
  • Length of Stay
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Neoplasms / diagnosis
  • Neoplasms / mortality
  • Neoplasms / nursing
  • Neoplasms / psychology
  • Neoplasms / therapy*
  • Palliative Care / methods*
  • Quality of Life
  • Referral and Consultation
  • Telemedicine
  • Time Factors
  • Time-to-Treatment*
  • Treatment Outcome
  • United States

Substances

  • Antineoplastic Agents

Associated data

  • ClinicalTrials.gov/NCT01245621