University of Pittsburgh, United States.
UPMC Hillman Cancer Center, United States.
Contemp Clin Trials. 2021 Jun;105:106295. doi: 10.1016/j.cct.2021.106295. Epub 2021 Feb 5.
The NIH consensus statement on cancer-related symptoms concluded the most common and debilitating were depression, pain and fatigue [1-6]. Although the comorbidity of these symptoms is well known and may have similar underlying biological mechanisms no intervention has been developed to reduce these symptoms concurrently. The novel web-based stepped collaborative care intervention delivered by telemedicine is the first to be tested in people diagnosed with cancer.
We plan to test a web-based stepped collaborative care intervention with 450 cancer patients and 200 caregivers in the context of a randomized controlled trial. The primary endpoint is quality of life with other primary outcomes including patient-reported depression, pain, fatigue. Secondary outcomes include patient serum levels of pro-inflammatory cytokines and disease progression. We also will assess informal caregiver stress, depression, and metabolic abnormalities to determine if improvements in patients' symptoms also relate to improvement in caregiver outcomes.
The trial is ongoing and a total of 382 patients have been randomized. Preliminary analyses of the screening tools used for study entry suggest that Center for Epidemiological Studies-Depression (CESD) scale has good sensitivity and specificity (0.81 and 0.813) whereas the scale used to assess pain (0.47 and 0.91) and fatigue (0.11 and 0.91) had poor sensitivity but excellent specificity. Using the AUROC, the best cut point for the CES-D was 19, for pain was 4.5; and for fatigue was 2.5. Outcomes not originally proposed included health care utilization and healthcare charges. The first 100 patients who have been followed a year post-treatment, and who were less than 75 years and randomized to the web-based stepped collaborative care intervention, had lower rates of complications after surgery [χ = 5.45, p = 0.02]. For patients who survived 6 months or less and were randomized to the web-based stepped collaborative care intervention, had lower rates of 90-day readmissions when compared to patients randomized to the screening and referral arm [χ = 4.0, p = 0.046]. Patients randomized to the collaborative care intervention arm had lower overall health care activity-based costs of $16,758 per patient per year when compared to the screening and referral arm.
This novel web-based stepped stepped collaborative care intervention, delivered via telemedicine, is expected to provide a new strategy to improve the quality of life in those diagnosed with cancer and their caregivers.
ClinicalTrials.govNCT02939755.
NIH 癌症相关症状共识声明得出的最常见和最具致残性的症状是抑郁、疼痛和疲劳[1-6]。尽管这些症状的合并症是众所周知的，并且可能具有相似的潜在生物学机制，但尚未开发出干预措施来同时减轻这些症状。通过远程医疗提供的新型基于网络的分级协作护理干预措施是第一个在诊断为癌症的人群中进行测试的。
我们计划在一项随机对照试验中，对 450 名癌症患者和 200 名护理人员进行基于网络的分级协作护理干预测试。主要终点是生活质量，其他主要结果包括患者报告的抑郁、疼痛、疲劳。次要结果包括患者血清中促炎细胞因子水平和疾病进展。我们还将评估非正规护理人员的压力、抑郁和代谢异常，以确定患者症状的改善是否也与护理人员结果的改善有关。
该试验正在进行中，已有 382 名患者被随机分组。用于研究入组的筛查工具的初步分析表明，流行病学研究中心抑郁量表 (CESD) 具有良好的敏感性和特异性 (0.81 和 0.813)，而用于评估疼痛 (0.47 和 0.91) 和疲劳 (0.11 和 0.91) 的量表的敏感性较差，但特异性较好。使用 AUROC，CES-D 的最佳截断值为 19，疼痛为 4.5，疲劳为 2.5。最初未提出的结果包括卫生保健利用率和医疗费用。对 100 名接受治疗后随访一年且年龄小于 75 岁且随机分配至基于网络的分级协作护理干预组的患者进行的分析，发现手术并发症的发生率较低[χ²=5.45，p=0.02]。对于生存时间不足 6 个月且随机分配至基于网络的分级协作护理干预组的患者，与随机分配至筛查和转诊组的患者相比，90 天再入院率较低[χ²=4.0，p=0.046]。与筛查和转诊组相比，随机分配至协作护理干预组的患者每年的整体医疗保健活动成本较低，为每位患者 16758 美元。
这种新型基于网络的分级协作护理干预措施，通过远程医疗提供，有望为诊断为癌症的患者及其护理人员提供改善生活质量的新策略。
ClinicalTrials.gov NCT02939755。
