Giuseppina Sarobba, Francesca Caputo, Francesca Diodati, Caterina Caminiti, Rodolfo Mattioli, Antonio Russo, Mario Airoldi, Filippo Zerilli, Antonio Pazzola, Maria Antonietta Annunziata, Paolo Giordani, Elisa Iezzi, Claudio Verusio, Marcello Aragona, Giuseppe Maglietta, Silvia Novello, Stefania Gori, Rodolfo Passalacqua, Saverio Cinieri, Giuseppe Procopio, Carmine Pinto, Caminiti C., Annunziata M.A., Verusio C., Pinto C., Airoldi M., Aragona M., Caputo F., Cinieri S., Giordani P., Gori S., Mattioli R., Novello S., Pazzola A., Procopio G., Russo A., Sarobba G., Zerilli F., Diodati F., Iezzi E., Maglietta G., and Passalacqua R.
Key Points Question Does an implementation strategy integrating psychosocial care into cancer centers improve at least 1 of 2 domains (emotional or social function) of health-related quality of life? Findings This stepped-wedge cluster randomized clinical trial included 762 patients with cancer at high risk for reduced quality of life. Health-related quality of life score improved from baseline to 3 months among participants in the Humanization in Cancer Care Quality Improvement Strategy arm vs the usual care arm, showing a statistically significant difference for emotional function, but not for social function. Meaning This study suggests the use of an implementation strategy aiming to provide routine psychosocial care in cancer centers may be beneficial to patients; further investigation is required on factors that can maximize its effects., Importance Many patients with cancer who would benefit from psychosocial care do not receive it. Implementation strategies may favor the integration of psychosocial care into practice and improve patient outcomes. Objective To evaluate the effectiveness of the Humanization in Cancer Care (HuCare) Quality Improvement Strategy vs standard care as improvement of at least 1 of 2 domains (emotional or social function) of patient health-related quality of life at baseline and 3 months. A key secondary aim included investigation of the long-term effect. Design, Setting, and Participants HuCare2 was a multicenter, incomplete, stepped-wedge cluster randomized clinical trial, conducted from May 30, 2016, to August 28, 2019, in three 5-center clusters of cancer centers representative of hospital size and geographic location in Italy. The study was divided into 5 equally spaced epochs. Implementation sequence was defined by a blinded statistician; the nature of the intervention precluded blinding for clinical staff. Participants included consecutive adult outpatients with newly diagnosed cancer of any type and stage starting medical cancer treatment. Interventions The HuCare Quality Improvement Strategy comprised (1) clinician communication training, (2) on-site visits for context analysis and problem-solving, and (3) implementation of 6 evidence-based recommendations. Main Outcomes and Measures The primary outcome was the difference between the means of changes of individual scores in emotional or social functions of health-related quality of life detected at baseline and 3-month follow-up (within each group) and during the postintervention epoch compared with control periods (between groups). Long-term effect of the intervention (at 12 months) was assessed as a secondary outcome. Intention-to-treat analysis was used. Results A total of 762 patients (475 [62.3%] women) were enrolled (400 HuCare Quality Improvement Strategy and 362 usual care); mean (SD) age was 61.4 (13.1) years. The HuCare Quality Improvement Strategy significantly improved emotional function during treatment (odds ratio [OR], 1.13; 95% CI, 1.04-1.22; P = .008) but not social function (OR, 0.99; 95% CI, 0.89-1.09; P = .80). Effect on emotional function persisted at 12 months (OR, 1.05; 95% CI, 1.00-1.10; P = .04). Conclusions and Relevance In this trial, the HuCare Quality Improvement Strategy significantly improved the emotional function aspect of health-related quality of life during cancer treatment and at 12 months, indicating a change in clinician behavior and in ward organization. These findings support the need for strategies to introduce psychosocial care; however, more research is needed on factors that may maximize the effects. Trial Registration ClinicalTrials.gov Identifier: NCT03008993, This randomized clinical trial examines the use of psychosocial interventions in cancer treatment centers to improve patients’ health-related quality of life.