Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial
Abstract
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.
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Early integration of palliative care in oncology improves quality of life and reduces depressive symptoms in advanced cancer patients compared with standard oncologic care.
“Previous studies have demonstrated the benefit of early integration of palliative care (PC) in oncology.”
In a general oncology population in Canada, early palliative care improved overall quality of life at 3 and 4 months, spiritual quality of life after 4 months, and patient satisfaction.
“Improvements in the overall QL at 3 and 4 months after randomization, the spiritual QL after 4 months and patient satisfaction were observed in the patients who received early PC.”
Palliative care has been associated with equal or longer survival in randomized and nonrandomized trials of patients with advanced cancer.
“In distinction from chemotherapy after the second-line setting, palliative care has been associated with equal103–106 or longer107–109 survival in randomized and nonrandomized110 trials of patients with advanced cancer.”
From Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update (2015) · cites this paper as [104]
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- Authors
- Zimmermann, C., Swami, N., Krzyzanowska, M., Hannon, B., Leighl, N., Oza, A., Moore, M., Rydall, A., Rodin, G., Tannock, I., Donner, A., & Lo, C.
- Affiliations
- University Health Network (CA)
- Western University (CA)
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2014-05
- Volume
- 383
- Issue
- 9930
- Pages
- 1721-1730
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2103903454
- Cited by
- 1,781
- References
- 43
- Citations by year
- 2026: 103 · 2025: 131 · 2024: 142 · 2023: 120 · 2022: 162 · 2021: 191 · 2020: 175 · 2019: 153 · 2018: 166 · 2017: 163 · 2016: 120 · 2015: 113 · 2014: 39
- FWCI
- 142.45
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- ResearchOnline at James Cook University (James Cook University) (submittedVersion)
- Funders
- Canadian Cancer Society (CZ) and by the Ontario Ministry of Health and Long Term Care (017257 and 020509)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative Care and End-of-Life Issues
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Palliative and Oncologic Care
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Keywords
- early palliative care, advanced cancer, quality of life, spiritual well-being, symptom severity, satisfaction with care, medical interaction, palliative care team, end-of-life care, FACIT-Sp, Edmonton Symptom Assessment System, symptom management, quality of life interventions
- MeSH terms
- Aged, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasms, Ontario, Outpatient Clinics, Hospital, Palliative Care, Psychometrics, Quality of Life, Single-Blind Method, Treatment Outcome, Patient Satisfaction, Early Medical Intervention
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