PALLiative care in ONcology (PALLiON): A cluster-randomised trial investigating the effect of palliative care on the use of anticancer treatment at the end of life

Abstract

Background: Effects on anticancer therapy following the integration of palliative care and oncology are rarely investigated. Thus, its potential effect is unknown. Aim: To investigate the effects of the complex intervention PALLiON versus usual care on end-of-life anticancer therapy. Design: Cluster-randomised controlled trial (RCT), registered at ClinicalTrials.gov (No. NCT01362816). The complex intervention consisted of a physician education program enhancing theoretical, clinical and communication skills, a patient-centred care pathway and patient symptom reporting prior to all consultations. Primary outcome was overall use, start and cessation of anticancer therapy in the last 3 months before death. Secondary outcomes were patient-reported outcomes. Mixed effects logistic regression models and Cox proportional hazard were used. Setting: A total of 12 Norwegian hospitals (03/2017–02/2021). Participants: Patients ⩾18 years, advanced stage solid tumour, starting last line of anticancer therapy, estimated life expectancy ⩽12 months. Results: A total of 616 (93%) patients were included (intervention: 309/control:307); 63% males, median age 69, 77% had gastrointestinal cancers. Median survival time from inclusion was 8 (IQR 3–14) and 7 months (IQR 3–12), and days between anticancer therapy start and death were 204 (90–378) and 168 (69–351) (intervention/control). Overall, 78 patients (13%) received anticancer therapy in the last month (intervention: 33 [11%]/control: 45 [15%]). No differences were found in patient-reported outcomes. Conclusion: We found no significant differences in the probability of receiving end-of-life anticancer therapy. The intervention did not have the desired effect. It was probably too general and too focussed on communication skills to exert a substantial influence on conventional clinical practice.

Standardizing Integrated Oncology and Palliative Care Across Service Levels: Challenges in Demonstrating Effects in a Prospective Controlled Intervention Trial

“…The authors of that study suggested that intervention adherence should be ensured before study start. Another Norwegian cluster-randomized trial investigating the effect of PC on the use of anticancer treatment at the EOL found no differences between the groups [ 42 ]. As in our study, the intervention did not have the desired effect, probably due to the HCPs having a too low fidelity to the intervention to change clinical practice [ 42 ].…”

“…Another Norwegian cluster-randomized trial investigating the effect of PC on the use of anticancer treatment at the EOL found no differences between the groups [ 42 ]. As in our study, the intervention did not have the desired effect, probably due to the HCPs having a too low fidelity to the intervention to change clinical practice [ 42 ]. The reasons for insufficient implementation in our study are heterogenous and may include factors such as differences in hospital and primary care cultures, lack of management anchoring, different information and communications technology systems, and preconceptions about PC referrals [ 17 , 18 , 43 , 44 ].…”