Quality of life for patients with advanced gastrointestinal cancer randomized to early specialized home-based palliative care – the ALLAN trial

Abstract

Abstract Introduction: The primary outcome of specialized palliative care (SPC) is to improve the quality of life (QoL) for patients with a high symptom-burden from a life-threatening disease. This randomized study aimed to assess the impact of early integration of SPC alongside tumor-specific palliative treatment in patients with gastrointestinal (GI) cancers by studying the QoL. Material and methods We randomly assigned ambulatory patients with advanced GI cancer to early integration of SPC and palliative tumor-specific treatment or tumor-specific treatment alone. The primary endpoint was QoL assessed at baseline and every 6th week using the Functional Assessment of Cancer Therapy – General (FACT-G), with points ranging from 0 to 108 points, with a higher score indicating better QoL. Results A total of 118 patients were randomized. The difference in the mean total change in FACT-G score between patients assigned to early integration with SPC and controls was 5.2 points (95% CI: -0.1–10.5, p = 0.054), 6.7 points (95% CI: 0.2–13.3, p = 0.043), and 13 points (95% CI: 5.7–20.2, p = 0.001) at weeks 6, 12 and 24 respectively. At the last assessment, at a median of 4.1 weeks (range 0.4–6.7 weeks) before death, the difference between the two groups regarding the mean change in FACT-G score was 3 points (95% CI: -4–9.9, p = 0.395). After adjustment of the p-values, for multiple comparisons, there was a statistically significant difference of 13 points between the mean change in the two groups at week 24 (adjusted p-value = 0.004). Conclusion This prospective randomized trial strengthens the argument for early integration of SPC with tumor-specific treatment in patients with advanced GI cancers. We found an improved QoL for patients with advanced GI cancer 24 weeks after randomization to early integration of home-based SPC. Trial Registration: Registered at ClinicalTrials.gov (ref: NCT02246725).