Table 1.
Randomized trials of early incorporation of palliative care into standard oncological care
| Study (country, year) | Design and comparison | Cohort | Intervention and outcomes | Key finding |
|---|---|---|---|---|
| Zimmermann et al.110 (Canada, 2014) | Cluster-randomization of medical oncology clinics; early palliative care team consultation and regular follow-up monitoring versus standard oncological care | Patients with advanced cancer (22% lung, 30% GI, 17% GU, 16% breast, 15% Gyn) | Baseline and 4-monthly survey measuring quality of life (FACIT-Spiritual), symptom severity (QUAL-E), and satisfaction and problems with medical interactions (CARES-MIS) | 85% completed at least one follow-up survey; at 4 months, the adjusted difference between change scores favoured the intervention group; FACIT-Sp: 6.44 (95% CI 2.1–10.8), P = 0.006, ES 0.44; QUAL-E: 3.51 (95% CI 1.3–5.7), P = 0.003, ES 0.45; CARES-MIS: −0.84 (−1.9 to 0.2), P = 0.11 |
| 228 intervention; 233 control | ||||
| Bakitas et al.111 (USA, 2015) | Randomized control trial, 1:1 block randomization by cancer type and enrolment site; early versus delayed concurrent palliative care and standard oncological care | Advanced cancer (46% lung, 24% GI, 11% breast, 10% other, 8% GU, 5% haematological) | In-person outpatient palliative care physician consultation, 6 weekly nurse-led phone coaching sessions, monthly phone follow-up monitoring; q3 monthly quality of life (FACIT-palliative care), symptom impact (QUAL-E), mood (CES-D), 1-year survival and resource use (hospital admission and ICU days, ED visits, and chemotherapy use) | 66% completed in-person consultation (early by day 24 and late by day 79 after enrolment). 88% of the intervention group completed three or more coaching sessions, compared with 69% of the control group; no significant difference in quality of life, symptom impact or mood at 2, 6 or 12 months after enrolment or 12, 6 or 3 months prior to death; 53% of the cohort died, 15% fewer intervention patients died at 1 year (P = 0.038), median survival was 18.3 and 11.8 months for intervention and control groups, respectively (NS); no difference in resource use |
| 104 early; 103 delayed | ||||
| Maltoni et al.112 (Italy, 2016) | Multicentre randomized trial, 1:1 block randomization by centre, no blinding; early versus on-demand palliative care | Newly diagnosed metastatic or locally advanced inoperable pancreatic cancer at 21 centres | Consultation within 2–4 weeks of randomization and 2–4-weekly thereafter; control group was seen by palliative care only if the patient, family or oncologist requested a consultation. Health-related quality of life (FACT-Hepatobiliary), mood (HADS), and satisfaction with care | All patients in the trial received at least one palliative care consultation but intervention patients received more consultations (mean 8.9 versus 3.9). Upon analysis, 77% of participants died and there was no difference in survival (38% in the intervention group and 32% in the control group); significantly improved quality of life in the intervention group for hepatobiliary cancer subscale (mean difference of 2.5, P = 0.013) and trial outcome index score (mean difference 3.8, P = 0.041) |
| 97 early; 89 on-demand | ||||
| Vanbutsele et al.113 (Belgium, 2018) | Randomized controlled trial, 1:1 block randomization by treating department; early, systematic palliative care versus usual multidisciplinary standard oncological care | Advanced solid malignancy (38% GI, 17% lung, 10% head and neck, 9% GU, 8% breast, 8% melanoma) | Monthly symptom assessment and incorporation of palliative care into multidisciplinary meetings. Change in overall quality of life from baseline at 12 weeks (EORTC QOL C30 and MQOL), as well as 18 and 24 weeks. Anxiety and depression measured via HADS | By 12 weeks, 89% and 27% of intervention patients had at least one palliative care nurse and one palliative care physician consultation, respectively (compared with 18% and 1% in the usual care arm) but 11% of intervention patients did not have any consultations; at 12 weeks, quality of life was significantly improved in the intervention arm via EORTC QLQ C30 (mean difference 7.6, P = 0.03) and MQOL (mean difference 1.11, P = 0.0006); at analysis, 65% of participants had died and there was no significant difference in median overall survival (312 days for intervention and 343 days for control, P = 0.97) |
| 92 early systemic; 94 usual | ||||
| Temel et al.114 (USA, 2017) | Randomized trial, 1:1 randomization stratified by cancer type; early palliative care versus usual oncological care | Incurable cancer (55% lung and 45% non-colorectal GI) | Palliative care consultation within 4 weeks of enrolment and at least monthly follow-up monitoring until death; change in overall quality of life from baseline at 12 weeks. Change in FACT-General (primary end-point), change in depression (PHQ-9) and end of life communication (secondary end points) | The mean number of palliative care visits was 6.5 and 0.9 by 24 weeks for intervention and control patients, respectively; at 12 weeks, quality of life was not significantly improved (P = 0.09); at 24 weeks, quality of life was improved overall (P = 0.002); patients with lung cancer had improved quality of life and depression at both 12 and 24 weeks (adjusted mean difference of 5.0 and −1.6/6.5 and −1.2, respectively (all P<0.05)); patients with GI cancer did not experience improved quality of life or depression; more intervention patients discussed end-of-life wishes with their oncologist (30% versus 15%, P = 0.004) |
| 175 early; 175 usual |
CARES-MIS, Cancer Rehabilitation Evaluation System Medical Interaction Subscale; CES-D, Center for Epidemiologic Studies — Depression scale; ED, emergency department; EORTC QLQ C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items; ES, effect size; ESAS, Edmonton Symptom Assessment Scale; FACIT, Functional Assessment of Chronic Illness Therapy; FACT, Functional Assessment of Cancer Therapy; GI, gastrointestinal; GU, genitourinary; Gyn, gynaecological; HADS, Hospital Anxiety and Depression Scale; ICU, intensive care unit; MQOL, McGill Quality of Life Questionnaire; NS, not significant; PHQ-9, Patient Health Questionaire-9; QUAL-E, Quality of Life at the End of Life.