Research and Innovation Unit, University Hospital of Parma, Parma, Italy.
Oncological Psychology Unit, National Cancer Institute, Aviano, Pordenone, Italy.
JAMA Netw Open. 2021 Oct 1;4(10):e2128667. doi: 10.1001/jamanetworkopen.2021.28667.
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.
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.
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).
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.
ClinicalTrials.gov Identifier: NCT03008993.
许多本应接受心理社会关怀的癌症患者并未得到此类关怀。实施策略可能有利于将心理社会关怀融入实践，并改善患者的预后。
评估人性化癌症关怀（HuCare）质量改进策略与标准护理相比，在基线和 3 个月时改善患者健康相关生活质量至少 1 个领域（情感或社会功能）的有效性。一个关键的次要目标包括调查长期效果。
设计、地点和参与者：HuCare2 是一项多中心、不完全、阶梯式楔形群随机临床试验，于 2016 年 5 月 30 日至 2019 年 8 月 28 日在意大利的三个 5 中心癌症中心集群中进行，这些集群代表了医院规模和地理位置。该研究分为 5 个等分的时期。实施顺序由一位盲法统计学家定义；干预的性质使临床工作人员无法进行盲法。参与者包括新诊断为任何类型和阶段癌症的连续成年门诊患者，开始接受癌症治疗。
HuCare 质量改进策略包括（1）临床医生沟通培训，（2）现场访问以进行情况分析和解决问题，以及（3）实施 6 项基于证据的建议。
主要结局是在基线和 3 个月随访（每组内）以及干预后时期（与对照组相比）期间，个体健康相关生活质量的情感或社会功能变化的平均值之间的差异。作为次要结果评估了干预的长期效果（在 12 个月时）。采用意向治疗分析。
共纳入 762 名患者（475 名[62.3%]为女性）（400 名接受 HuCare 质量改进策略，362 名接受常规护理）；平均（SD）年龄为 61.4（13.1）岁。HuCare 质量改进策略在治疗期间显著改善了情感功能（优势比[OR]，1.13；95%CI，1.04-1.22；P = .008），但对社会功能没有影响（OR，0.99；95%CI，0.89-1.09；P = .80）。情感功能的效果在 12 个月时仍然存在（OR，1.05；95%CI，1.00-1.10；P = .04）。
在这项试验中，HuCare 质量改进策略在癌症治疗期间和 12 个月时显著改善了健康相关生活质量的情感方面，表明临床医生行为和病房组织发生了变化。这些发现支持需要引入心理社会关怀的策略；然而，需要更多的研究来确定可能最大化效果的因素。
ClinicalTrials.gov 标识符：NCT03008993。
