Effectiveness of a Psychosocial Care Quality Improvement Strategy to Address Quality of Life in Patients with Cancer: The HuCare2 Stepped-Wedge Cluster Randomized Trial

Caterina Caminiti, Maria Antonietta Annunziata, Claudio Verusio, Carmine Pinto, Mario Airoldi, Marcello Aragona, Francesca Caputo, Saverio Cinieri, Paolo Giordani, Stefania Gori, Rodolfo Mattioli, Silvia Novello, Antonio Pazzola, Giuseppe Procopio, Antonio Russo, Giuseppina Sarobba, Filippo Zerilli, Francesca Diodati, Elisa Iezzi, Giuseppe MagliettaRodolfo Passalacqua

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Article numbere2128667
JournalJAMA network open
Issue number10
Publication statusPublished - Oct 14 2021

ASJC Scopus subject areas

  • Medicine(all)


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