Patients Experience Improved Emotional Function With Novel Intervention


The implementation of the HuCare Quality Improvement Strategy supported superior emotional function for patients newly diagnosed with cancer.

Patients with cancer experienced a significant improvement in emotional function of health-related quality of life (HRQOL) following the implementation of the Humanization in Cancer Care (HuCare) Quality Improvement Strategy, according to a study published in JAMA.

These results highlight an unmet need for psychosocial care introductions strategies, wrote the study authors.

Specifically, the HuCare Quality Improvement Strategy (HQIS) resulted in a significant improvement in patient emotional function (odds ratio [OR], 1.13; 95% CI, 1.04-1.22; P = .008), but not in social function (OR, 0.99; 95% CI, 0.89-1.09; P = .80). Notably, emotional function was still improved at 12 months (OR, 1.05; 95% CI, 1.00-1.10; P = .04).

“To our knowledge, this randomized clinical trial is the first report that a quality improvement strategy aimed at integrating evidence-based psychosocial care interventions into practice significantly improved [emotional function] of HRQOL in patients during cancer treatment,” wrote the study authors. “The effect persisted at 12 months, suggesting that once the HQIS strategy is learned and implemented, a lasting change occurs in clinical staff behavior and in ward organization.”

The HuCare2 Stepped-Wedge Cluster Randomized Trial (NCT03008993) was a multicenter, incomplete, stepped-wedge cluster, randomized clinical trial which evaluated the efficacy of the HQIS in comparison with standard care. The trial was deemed incomplete because data was not initially collected during implementation. Throughout the trial, the intervention strategy was executed in 3 clusters across 5 centers with 4-month periods in between each assessment. The study period occurred from May 30, 2016, to August 28, 2019.

The study enrolled a total of 762 adult patients (women, 62.3%) in the outpatient setting with a newly diagnosed cancer of any type or stage and who were beginning medical treatment for their disease. The mean age was 61.4 years. The most common cancer type was genitourinary cancer (35.7%). Metastases were present in 25.5% of patients and a total of 86.6% of patients were actively receiving chemotherapy during the study period.

Components of the HQIS included clinician communication training, on-site visits for context analysis and problem-solving, and implementation of 6 evidence-based recommendations. The strategy occurred over 16 weeks and included 3 separate phases. The first phase taught medical and nursing staff communication skills in accordance with literature-reported indications. The second phase involved on-site visits from the improvement team (sociologist, psychologist, and research nurse). The third phase implemented 5 psychosocial interventions for patients, including an assignment of a specialist nurse, screening for psychological distress and social needs, activation of appropriate services, and more.

The study’s key outcome was the change in emotional or social function on the individual level. The HRQOL functions were first measured at baseline, again at a 3-month follow-up, and then during the postintervention epoch compared with control periods. Secondary outcome included a long-term assessment of the intervention at 12 months.

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

The study authors acknowledged that although the difference in the mean change in HRQOL between the 2 groups was statistically significant, it was also trivial. Further investigation may be needed to determine why the difference was so small. One possibility is that the design of randomized clinical trials does not permit the adjustments needed by different cancer centers. Another possibility that the study authors proposed is that the 2-year period did not allow adequate time to properly observe all 3 clusters, and finally, that 4-months may not be enough time for the implementation of such an intervention to affect significant change within a ward.


Caminiti C, Annunziata MA, Verusio C, et al. Effectiveness of a psychosocial care quality improvement strategy to address quality of life in patients with cancer. JAMA Netw Open. 2021;4(10):e2128667. doi:10.1001/jamanetworkopen.2021.28667

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