"随机临床试验：体力活动对晚期肺癌患者生活质量和肺癌生物标志物的影响：一项初步研究"。
"Randomized trial of physical activity on quality of life and lung cancer biomarkers in patients with advanced stage lung cancer: a pilot study".
机构信息
Department of Internal Medicine, Section of Pulmonary, Critical Care, and Sleep Medicine, Yale University School of Medicine, P.O. Box 208057 300 Cedar Street TAC - 441 South, New Haven, CT, 06520-8057, USA.
Yale Center for Analytical Sciences, Yale School of Public Health, New Haven, USA.
出版信息
BMC Cancer. 2021 Apr 1;21(1):352. doi: 10.1186/s12885-021-08084-0.
BACKGROUND
Lung cancer survivors need more options to improve quality of life (QoL). It is unclear to what extent patients with advanced stage disease are willing to participate in home-based physical activity (PA) and if these interventions improve QoL. The goal of our study was to determine interest in participating in our 3-month home-based walking regimen in patients with advanced stage lung cancer. We used a randomized design to evaluate for potential benefit in PA and patient-reported outcomes.
METHODS
We performed an open-label, 1:1 randomized trial in 40 patients with stage III/IV non-small cell lung cancer (NSCLC) evaluating enrollment rate, PA, QoL, dyspnea, depression, and biomarkers. Compared to usual care (UC), the intervention group (IG) received an accelerometer, in-person teaching session, and gain-framed text messages for 12 weeks.
RESULTS
We enrolled 56% (40/71) of eligible patients. Participants were on average 65 years and enrolled 1.9 years from diagnosis. Most patients were women (75%), and receiving treatment (85%) for stage IV (73%) adenocarcinoma (83%). A minority of patients were employed part-time or full time (38%). Both groups reported low baseline PA (IG mean 37 (Standard deviation (SD) 46) vs UC 59 (SD 56) minutes/week; p = 0.25). The IG increased PA more than UC (mean change IG + 123 (SD 212) vs UC + 35 (SD 103) minutes/week; p = 0.051)). Step count in the IG was not statistically different between baseline (4707 step/day), week 6 (5605; p = 0.16), and week 12 (4606 steps/day; p = 0.87). The intervention improved EORTC role functioning domain (17 points; p = 0.022) with borderline improvement in dyspnea (- 13 points; p = 0.051) compared to UC. In patients with two blood samples (25%), we observed a significant increase in soluble PD-1 (219.8 (SD 54.5) pg/mL; p < 0.001).
CONCLUSIONS
Our pilot trial using a 3-month, home-based, mobile health intervention enrolled over half of eligible patients with stage III and IV NSCLC. The intervention increased PA, and may improve several aspects of QoL. We also identified potential biomarker changes relevant to lung cancer biology. Future research should use a larger sample to examine the effect of exercise on cancer biomarkers, which may mediate the association between PA and QoL.
CLINICAL TRIAL REGISTRATION
Clinicaltrials.gov ( NCT03352245 ).
背景
肺癌幸存者需要更多改善生活质量 (QoL) 的选择。目前尚不清楚晚期疾病患者愿意参与多少家庭体育活动 (PA)，以及这些干预措施是否能改善 QoL。我们的研究目标是确定晚期肺癌患者对我们为期 3 个月的家庭步行方案的参与意向。我们采用随机设计来评估 PA 和患者报告结果的潜在益处。
方法
我们对 40 名 III/IV 期非小细胞肺癌 (NSCLC) 患者进行了一项开放性、1:1 随机试验，评估了入组率、PA、QoL、呼吸困难、抑郁和生物标志物。与常规护理 (UC) 相比，干预组 (IG) 在 12 周内接受了加速度计、面对面教学课程和以获益为导向的短信。
结果
我们入组了 56% (40/71) 的合格患者。参与者平均年龄为 65 岁，距诊断时间为 1.9 年。大多数患者为女性 (75%)，正在接受 IV 期 (73%) 腺癌 (83%) 治疗。少数患者兼职或全职工作 (38%)。两组患者的基线 PA 均较低 (IG 平均 37 [SD 46] 分钟/周与 UC 59 [SD 56] 分钟/周; p=0.25)。IG 的 PA 增加量高于 UC (IG 平均增加 123 [SD 212] 分钟/周，UC 增加 35 [SD 103] 分钟/周; p=0.051))。IG 的步幅在基线时(4707 步/天)、第 6 周(5605 步; p=0.16)和第 12 周(4606 步/天; p=0.87)之间没有统计学差异。与 UC 相比，干预组 EORTC 角色功能域评分提高了 17 分 (p=0.022)，呼吸困难评分略有改善 (-13 分; p=0.051)。在有两份血液样本的 25%的患者中，我们观察到可溶性 PD-1 显著增加 (219.8 [SD 54.5] pg/mL;p<0.001)。
结论
我们使用为期 3 个月的家庭、基于移动健康的干预措施进行的试点试验入组了超过一半的 III 和 IV 期 NSCLC 合格患者。该干预措施增加了 PA，并可能改善 QoL 的几个方面。我们还发现了与肺癌生物学相关的潜在生物标志物变化。未来的研究应使用更大的样本量来检查运动对癌症生物标志物的影响，这可能介导 PA 和 QoL 之间的关联。
临床试验注册
Clinicaltrials.gov (NCT03352245)。
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