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移动医疗支持的综合干预模式(CIMmH)改善食管癌术后患者生活质量的开发和可行性:前瞻性、单臂、非随机试验研究。

Development and Feasibility of a Mobile Health-Supported Comprehensive Intervention Model (CIMmH) for Improving the Quality of Life of Patients With Esophageal Cancer After Esophagectomy: Prospective, Single-Arm, Nonrandomized Pilot Study.

机构信息

Department of Thoracic Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.

Department of Social Work & Social Administration, The University of Hong Kong, Hong Kong, China.

出版信息

J Med Internet Res. 2020 Aug 18;22(8):e18946. doi: 10.2196/18946.

DOI:10.2196/18946
PMID:32808933
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7463393/
Abstract

BACKGROUND

Patients with esophageal cancer often experience clinically relevant deterioration of quality of life (QOL) after esophagectomy owing to malnutrition, lack of physical exercise, and psychological symptoms.

OBJECTIVE

This study aimed to evaluate the feasibility, safety, and efficacy of a comprehensive intervention model using a mobile health system (CIMmH) in patients with esophageal cancer after esophagectomy.

METHODS

Twenty patients with esophageal cancer undergoing the modified McKeown surgical procedure were invited to join the CIMmH program with both online and offline components for 12 weeks. The participants were assessed before surgery and again at 1 and 3 months after esophagectomy. QOL, depressive symptoms, anxiety, stress, nutrition, and physical fitness were measured.

RESULTS

Of the 20 patients, 16 (80%) completed the program. One month after esophagectomy, patients showed significant deterioration in overall QOL (P=.02), eating (P=.005), reflux (P=.04), and trouble with talking (P<.001). At the 3-month follow-up, except for pain (P=.02), difficulty with eating (P=.03), dry mouth (P=.04), and trouble with talking (P=.003), all other QOL dimensions returned to the preoperative level. There were significant reductions in weight (P<.001) and BMI (P=.02) throughout the study, and no significant changes were observed for physical fitness measured by change in the 6-minute walk distance between baseline and the 1-month follow-up (P=.22) or between baseline and the 3-month follow-up (P=.52). Depressive symptoms significantly increased 1 month after surgery (P<.001), while other psychological measures did not show relevant changes. Although there were declines in many measures 1 month after surgery, these were much improved at the 3-month follow-up, and the recovery was more profound and faster than with traditional rehabilitation programs.

CONCLUSIONS

The CIMmH was feasible and safe and demonstrated encouraging efficacy testing with a control group for enhancing recovery after surgery among patients with esophageal cancer in China.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (ChiCTR-IPR-1800019900); http://www.chictr.org.cn/showprojen.aspx?proj=32811.

摘要

背景

食管癌患者术后常因营养不良、缺乏体力活动和心理症状而经历临床相关的生活质量(QOL)恶化。

目的

本研究旨在评估使用移动健康系统(CIMmH)对食管癌患者术后进行综合干预模型的可行性、安全性和疗效。

方法

邀请 20 名接受改良 McKeown 手术的食管癌患者参加包含在线和线下部分的 CIMmH 计划,为期 12 周。参与者在术前和术后 1 个月和 3 个月进行评估。测量 QOL、抑郁症状、焦虑、压力、营养和身体状况。

结果

20 名患者中,16 名(80%)完成了该计划。食管癌术后 1 个月,患者整体 QOL 明显恶化(P=.02),进食(P=.005)、反流(P=.04)和说话困难(P<.001)。在 3 个月随访时,除疼痛(P=.02)、进食困难(P=.03)、口干(P=.04)和说话困难(P=.003)外,所有其他 QOL 维度均恢复到术前水平。研究期间体重(P<.001)和 BMI(P=.02)均显著下降,6 分钟步行距离的变化在基线和 1 个月随访(P=.22)或基线和 3 个月随访(P=.52)之间没有显著变化。术后 1 个月抑郁症状明显加重(P<.001),而其他心理测量没有相关变化。尽管术后 1 个月许多指标下降,但在 3 个月随访时明显改善,且恢复速度比传统康复计划更快、更明显。

结论

CIMmH 是可行和安全的,并在与中国食管癌患者的对照组进行疗效测试时显示出令人鼓舞的效果。

试验注册

中国临床试验注册中心(ChiCTR-IPR-1800019900);http://www.chictr.org.cn/showprojen.aspx?proj=32811。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/403d/7463393/0e6294d6edc8/jmir_v22i8e18946_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/403d/7463393/0e6294d6edc8/jmir_v22i8e18946_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/403d/7463393/0e6294d6edc8/jmir_v22i8e18946_fig1.jpg

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