Elsevier

The Lancet

Volume 383, Issue 9930, 17–23 May 2014, Pages 1721-1730
The Lancet

Articles
Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial

https://doi.org/10.1016/S0140-6736(13)62416-2Get rights and content

Summary

Background

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.

Methods

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.

Findings

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.

Interpretation

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.

Funding

Canadian Cancer Society, Ontario Ministry of Health and Long Term Care.

Introduction

The complex needs of patients with advanced cancer and their caregivers arise many months before the patient's death.1 Correspondingly, WHO defines palliative care as “an approach that improves the quality of life of patients and their families…by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.”2 Specialised palliative care teams enact this approach, through the holistic care of patients dying from cancer or other terminal illnesses, and their presence is increasing worldwide.3 However, most of these teams provide terminal care at home or to inpatients rather than in outpatient settings,4, 5, 6 and referral to palliative care teams for most patients occurs in the last 2 months of life or not at all.7, 8

We did a systematic review9 of randomised controlled trials from 1984 to 2007 assessing the effectiveness of specialised palliative care. Not all studies assessed a palliative care team, with interventions including a coordinating service, a nursing intervention, or counselling. Only four of 13 studies assessing quality of life had significant findings. However, most lacked statistical power and were done late in the disease process, resulting in difficulties with recruitment, attrition, and co-intervention. None specifically assessed an early palliative care intervention in patients with cancer.

Since publication of this review,9 results have been reported from two randomised controlled trials assessing early palliative care interventions in patients with advanced cancer. The first was a study10 of 322 participants with advanced cancer and a prognosis of about 1 year; patients were randomised to routine care or to a palliative care problem-solving intervention through telephone contact from advanced practice nurses. In this study, and in the second, a trial11 of 151 patients with advanced non-small-cell lung cancer, patients randomised to the early palliative care group had better quality of life and mood. However, the former study10 did not assess intervention by a palliative care team and the latter11 included only patients with non-small-cell lung cancer.

We report a cluster-randomised controlled trial of early palliative care in patients with advanced cancer. We opted for cluster rather than individual randomisation (randomising clinics, rather than individual patients) on the basis of evidence from the health-services literature9, 12, 13 and advice from oncologists that it is difficult to recruit patients to be individually randomised (or not) to an intervention such as palliative care, in view of strong preconceived preferences among patients and their oncologists. The design implications of cluster-randomised trials were thoroughly taken into account in our trial.14

We postulated that, compared with standard cancer care, early intervention (clinical prognosis of 6–24 months) by a palliative care team would be associated with improved patient quality of life, symptom control, and satisfaction with care, and less difficulty with clinician–patient interactions.

Section snippets

Study design and participants

The study took place at Princess Margaret Cancer Centre, a comprehensive cancer centre and part of the University Health Network in Toronto, ON, Canada, between Dec 1, 2006, and Feb 28, 2011. Recruitment involved daily screening of participating oncology clinics by research personnel to establish eligibility. Eligible patients were aged 18 years or older, had stage IV cancer (for breast or prostate cancer, refractory to hormonal therapy was an additional criterion; patients with stage III

Results

992 patients were eligible and 461 completed baseline measures: 223 patients were in the control group (mean number of patients per cluster 19·4 [SD 12·1]) and 228 were in the intervention group (mean number of patients per cluster 19·0 [12·9]). Figure 1 shows reasons for declining participation. Although presence of symptoms was not an entry criterion, 54 patients eligible for the intervention group declined to participate on the basis of lack of symptoms. 301 patients completed measures at 3

Discussion

In this trial of 461 patients with advanced cancer, early referral to a palliative care team did not significantly improve quality of life (measured by the FACIT-Sp scale) at 3 months compared with usual cancer care. However, quality of life according to the QUAL-E scale was significantly improved in the intervention group compared with the control group at 3 months, as was satisfaction with their care (FAMCARE-P16). Changes in symptom severity (ESAS) and problems with medical interactions

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