HuCare Quality Improvement Strategy: Improving health-related QOL during cancer treatment

Despite numerous clinical practice guidelines, many patients who might benefit from psychosocial interventions do not receive them. These considerations formed the basis for the Humanization in Cancer Care (HuCare) Quality Improvement Strategy (HQIS) aiming to integrate into practice psychosocial interventions recommended by national and international guidelines selected by a multidisciplinary task force. Following the process for the development and evaluation of complex interventions of the Medical Research Council, the HuCare Study, conducted from 2008 to 2014, described the feasibility of the HQIS in 28 Italian cancer centers, obtaining a high level of adherence to all interventions (>85%). Caterina Caminiti and team conducted this randomized clinical trial (HuCare2) to evaluate the effectiveness of the HQIS vs standard care in terms of improvement of health-related quality of life (HRQOL).

HuCare 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.

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.

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.

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).

These positive results support the need for strategies to introduce psychosocial care capable of addressing the multiple obstacles and barriers that may hinder implementation. In particular, this study demonstrates the effectiveness of a system-based approach, which implies organizational change requiring collaboration and commitment across hospital departments, disciplines, and individual clinicians

Although these findings are positive, further research is needed. First, participation of different institution types nationwide ensures generalizability to Italian hospitals, but the effect of the HQIS in other contexts should be tested, because health care system characteristics are potential predictors of psychosocial outcomes. Second, it would be important to evaluate the effect in the longer term (3-5 years after implementation), investigating the need for strategy refreshes, as well as the longer-term effect on patient EF with a 6- and 12-month follow-up. Third, inclusion of in-depth interviews with participants (health professionals and patients) in studies of this kind may assist in defining core aspects of the intervention, which are considered beneficial, and in understanding factors underpinning acceptability. Evidence-based psychosocial care is important for all patients. The strategy tested in this trial is feasible and has the potential to improve patient outcomes. Further research will allow refinement of the HQIS, enabling us to understand the factors that can optimize its effects.

Source: JAMA Network Open. 2021;4(10):e2128667. doi:10.1001/jamanetworkopen.2021.28667