Integrating psychosocial care into routine cancer care: A stepped-wedge design cluster randomized controlled trial (SWD-RCT) to evaluate effectiveness of the HuCare Quality Improvement Strategy (HQIS) on health-related quality of life (HRQoL)

6515 Background: Cancer patients (pts) often do not receive evidence-based psychosocial care. We evaluate the effects of an implementation strategy we previously demonstrated feasible, which includes communication skill training for all physicians and nurses; four support visits at the centers by an improvement team to assist staff in identifying obstacles, finding solutions, and strengthening motivation; screening for distress and social needs; individualized pts' education with a referring nurse; use of a question prompt list. Methods: Multicenter incomplete SWD-RCT with 3 clusters of 5 centers each. Consecutive outpatients requiring medical treatment and diagnosed in the previous 2 months were eligible. Primary endpoint: difference of at least one of the 2 domains of HRQoL emotional or social functions, at 3 months from baseline, in pts of the centers that implemented the HQIS vs standard of care (SoC). Secondary endpoints include: patient mood, long-term effect, overall HRQoL. Analyses were performed using a beta-binomial regression model. Results: 762 pts were enrolled. At baseline, 41% showed high anxiety (HADS-A>7), and 88% had at least one psychosocial need. 299 health professionals attended 3-day courses (84% of all clinical staff). 647 pts (85%) were available for analysis. The 315 pts who received HQIS exhibited better quality of life for the emotional domain than those assigned to SOC (OR=1.115, p=0.016). Pts who showed the greatest improvement were the older (OR=1.003, p=0.035), had lower anxiety basal levels (OR=0.853, p