Oncology/Hematology 3/24/15
by Kay Jackson
Contributing Writer
Early concurrent palliative care in patients with advanced cancer had a significantly beneficial effect on 1-year survival, even for patients living in a remote rural setting, according to results from the ENABLE trial.
The 1-year survival rate was 63% for those who received early palliative care (PC) compared with 48% in the group that received delayed care (15% difference, P=0.038), reported J. Nicholas Dionne-Odom, PhD, of the University of Alabama in Birmingham, and colleagues.
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Most of the patients lived in rural New Hampshire or Vermont, making ENABLE “the only feasible and effective telehealth early [palliative care] model for patients with advanced cancer and family caregivers in a rural setting,” the authors wrote in the Journal of Clinical Oncology.
In a second study done as part of the ENABLE (Educate, Nurture, Advise Before Life Ends) III trial, parallel caregiver telehealth intervention demonstrated that caregivers also benefited when cancer patients received palliative care 30 to 60 days after an advanced cancer diagnosis, Dionne-Odom’s group reported in the same issue of the journal.
Specifically, early palliative care led to improved depression scores for caregivers versus those who received palliative care 3 months after diagnosis.
The results regarding patient survival aligns with previous research, pointed out Barbara Gomes, PhD, of the Cicely Saunders Institute in London in an accompanying editorial. But “it is the first time that a benefit for family caregivers has been shown. This suggests that receiving palliative care earlier in the course of illness is better not only for patients but also for their families,” she stated.
Study Details
ENABLE enrolled 207 patients with advanced cancer and 122 caregivers from a National Cancer Institute cancer center, a Veterans Affairs Medical Center, and community outreach clinics. The study took place from October 2010 to March 2013.
Participants with an advanced cancer diagnosis were randomly assigned to receive palliative care 30 to 60 days following diagnosis (early group) or 3 months’ after diagnosis (control group).
Intervention consisted of an in-person consultation by a board-certified palliative care physician and then six structured palliative care telehealth advanced practice nurse coaching sessions using a manual curriculum such as “Charting Your Course: An Intervention for Patients with Advanced Cancer.”
Coaching sessions lasted 30 to 45 minutes and were conducted every week for 6 weeks followed by monthly follow-up.
Caregivers were randomized to receive three structured weekly telephone coaching sessions, monthly follow-up, and a bereavement call either early after enrollment or 3 months later.
“This design has the strength of a randomized, controlled trial but may be more acceptable to patients and clinicians because no one is denied access to the intervention,” Gomes noted.
The authors found that 88% of the early group and 69% of the control group had at least three coaching sessions.
Of the 207 patients, 53% had died by September 2013. The median overall survival was 18.3 months for the early group versus 11.8 months for the control group.
“However, the overall log-rank test was not signi?cant (P=0.18), suggesting a convergence in overall survival after 12 months,” the authors cautioned.
The overall patient-reported outcomes were not statistically signi?cant after enrollment, the authors found.
The relative rates of resource use for the early versus control group were similar:
Hospital days: 0.73 (95% CI 0.41-1.27, P=0.26)
ICU days: 0.68 (95% CI 0.23-2.02, P=0.49)
Emergency room visits: 0.73 (95% CI 0.45-1.19, P=0.21)
Chemotherapy in last 14 days: 1.57 (95% CI 0.37-6.7, P=0.27)
Home death: 54% versus 47% (P=0.60)
Dionne-Odom and colleagues acknowledged that their study did not show a statistically signi?cant improvement in quality of life (QOL) or mood related to early palliative care, both of which are thought to be drivers of mechanisms of improved survival.
“Our results raise the question of how survival improvement occurred,” they stated, adding that possible explanations include that a 3-month delay was not long enough to observe potential palliative care bene?ts. Also, survival bene?ts may have come about through “unmeasured PC effects. For example, delaying exposure to advance care planning and decision support may have affected these patients’ overall decisions,” they wrote.
For the second intervention, the 122 caregivers (CG) were randomized into fast-track or control group. The caregivers had an average age of 60 and the majority were female (78.7%) and white (92.6%).
The authors found that between-group differences in depression scores from enrollment to 3 months favored the early group (mean difference -3.4, P=0.002). There were no statistically significant differences in other factors such as QOL, burden, or stress.
In the early caregiver group, terminal decline analysis showed that depression and stress burden had moderate effect-size differences from the group that received delayed palliative care. On the other hand, average delayed-group scores surpassed the cutpoint for clinically significant depression and high stress burden.
“Together, these findings suggest that providing CG support at the time of advanced cancer diagnosis may be the essential ingredient to achieving positive outcomes,” Dionne-Odom and colleagues wrote.
‘Enough to Justify Early Introduction’
In her editorial, Gomes stated that “even with evidence of no effect on other outcomes, improved survival for patients and less depression for family members would be enough to justify early introduction of palliative care.”
She pointed out that in other studies, palliative care has been offered even later than in ENABLE’s delayed care group. For example, a 6-month chart review of patients at MD Anderson Cancer Center in Houston revealed that for patients with respiratory cancers, the median time from diagnosis to palliative care consultation was 5 months.
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Since 81% of countries worldwide have no integrated palliative care, referrals could take even longer, Gomes added.
Gomes acknowledged that there are valid reasons that may prevent or delay an oncologist from referring patients to early palliative care, such as “prognostication inaccuracy, the curative potential of anticancer therapies … and the need to respect patient and family adaptation processes and coping mechanisms, and fears (of all involved parties) of engaging in sensitive end-of-life conversations.”
But she emphasized that not all cancer patients can be cured and that half of all patients with cancer die as a result of the disease within 5 years.
“The ENABLE III trial urges a change of practice and culture,” she wrote. “If palliative care makes a difference for patients and family caregivers, and if earlier is better, why wait?”
The study was supported by the National Institute for Nursing Research, a Cancer and Leukemia Group B Foundation Clinical Scholar Award, the Foundation for Informed Medical Decision-Making, an NIH/NINR Small Research Grant, the Norris Cotton Cancer Center, the Dartmouth-Hitchcock Section of Palliative Medicine, a National Palliative Care Research Center Junior Career Development Award, the University of Alabama at Birmingham Cancer Prevention and Control Training Program, and the American Cancer Society.
Dionne-Odom disclosed no relevant relationships with industry.
Gomes disclosed no relevant relationships with industry.