Patients with advanced cancer have reduced quality of life, which tends to worsen
towards the end of life. We assessed the effect of early palliative care in patients
with advanced cancer on several aspects of quality of life.
The study took place at the Princess Margaret Cancer Centre (Toronto, ON, Canada),
between Dec 1, 2006, and Feb 28, 2011. 24 medical oncology clinics were cluster randomised
(in a 1:1 ratio, using a computer-generated sequence, stratified by clinic size and
tumour site [four lung, eight gastrointestinal, four genitourinary, six breast, two
gynaecological]), to consultation and follow-up (at least monthly) by a palliative
care team or to standard cancer care. Complete masking of interventions was not possible;
however, patients provided written informed consent to participate in their own study
group, without being informed of the existence of another group. Eligible patients
had advanced cancer, European Cooperative Oncology Group performance status of 0-2,
and a clinical prognosis of 6-24 months. Quality of life (Functional Assessment of
Chronic Illness Therapy--Spiritual Well-Being [FACIT-Sp] scale and Quality of Life
at the End of Life [QUAL-E] scale), symptom severity (Edmonton Symptom Assessment
System [ESAS]), satisfaction with care (FAMCARE-P16), and problems with medical interactions
(Cancer Rehabilitation Evaluation System Medical Interaction Subscale [CARES-MIS])
were measured at baseline and monthly for 4 months. The primary outcome was change
score for FACIT-Sp at 3 months. Secondary endpoints included change score for FACIT-Sp
at 4 months and change scores for other scales at 3 and 4 months. This trial is registered
with ClinicalTrials.gov, number NCT01248624.
461 patients completed baseline measures (228 intervention, 233 control); 393 completed
at least one follow-up assessment. At 3-months, there was a non-significant difference
in change score for FACIT-Sp between intervention and control groups (3·56 points
[95% CI -0·27 to 7·40], p=0·07), a significant difference in QUAL-E (2·25 [0·01 to
4·49], p=0·05) and FAMCARE-P16 (3·79 [1·74 to 5·85], p=0·0003), and no difference
in ESAS (-1·70 [-5·26 to 1·87], p=0·33) or CARES-MIS (-0·66 [-2·25 to 0·94], p=0·40).
At 4 months, there were significant differences in change scores for all outcomes
except CARES-MIS. All differences favoured the intervention group.
Although the difference in quality of life was non-significant at the primary endpoint,
this trial shows promising findings that support early palliative care for patients
with advanced cancer.
Canadian Cancer Society, Ontario Ministry of Health and Long Term Care.
Copyright © 2014 Elsevier Ltd. All rights reserved.