Kim Inah, Lim Ji Young, Kim Jong Kwang, Lee Jun Ho, Sohn Tae Sung, Park Sungsoo, Kang Seok Ho, Lee Ji Youl, Hwang Ji Hye
Department of Physical and Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Research Institute for Future Medicine, Samsung Medical Center, Seoul, Republic of Korea.
Digit Health. 2023 Jul 17;9:20552076231187602. doi: 10.1177/20552076231187602. eCollection 2023 Jan-Dec.
Patients with gastric cancer often encounter impaired quality of life and reduced tolerability to adjuvant treatments after surgery. Weight preservation is crucial for the overall prognosis of these patients, and exercise and supplemental nutrition play the main role. This study is the first randomized clinical trial to apply personalized, treatment stage-adjusted digital intervention with wearable devices in gastric cancer rehabilitation intervention for 12 months, commencing immediately after surgery.
This is a prospective, multicenter, two-armed, randomized controlled trial and aims to recruit 324 patients from two hospitals. Patients will be randomly allocated to two groups for 1 year of rehabilitation, starting immediately after the operation: a personalized digital therapeutic (intervention) group and a conventional education-based rehabilitation (control) group. The primary objective is to clarify the effect of mobile applications and wearable smart bands in reducing weight loss in patients with gastric cancer. The secondary outcomes are quality of life measured by the EORTC-QLQ-C30 and STO22; nutritional status by mini nutrition assessment; physical fitness level measured by grip strength test, 30-s chair stand test and 2-min walk test; physical activity measured by IPAQ-SF; pain intensity; skeletal muscle mass; and fat mass. These measurements will be performed on enrollment and at 1, 3, 6, and 12 months thereafter.
Digital therapeutic programs include exercise and nutritional interventions modified by age, body mass index, surgery type and postoperative days. Thus, expert intervention is pivotal for precise and safe calibration of this program.
Clinicaltrials.gov identifier: NCT04907591 (registration date: June 11, 2020; https://clinicaltrials.gov/ct2/show/NCT04907591).
胃癌患者术后常面临生活质量受损和辅助治疗耐受性降低的问题。体重维持对这些患者的总体预后至关重要，运动和补充营养起着主要作用。本研究是第一项将个性化、根据治疗阶段调整的数字干预与可穿戴设备应用于胃癌康复干预12个月的随机临床试验，于术后立即开始。
这是一项前瞻性、多中心、双臂、随机对照试验，旨在从两家医院招募324名患者。患者将被随机分为两组，从术后立即开始进行为期1年的康复治疗：个性化数字治疗（干预）组和传统的基于教育的康复（对照）组。主要目的是阐明移动应用程序和可穿戴智能手环对减少胃癌患者体重减轻的效果。次要结局包括用欧洲癌症研究与治疗组织生活质量核心问卷（EORTC-QLQ-C30）和STO22测量的生活质量；用微型营养评定法评估的营养状况；通过握力测试、30秒坐立试验和2分钟步行试验测量的体能水平；用国际体力活动问卷简表（IPAQ-SF）测量的身体活动；疼痛强度；骨骼肌质量；以及脂肪量。这些测量将在入组时以及此后的1、3、6和12个月进行。
数字治疗方案包括根据年龄、体重指数、手术类型和术后天数调整的运动和营养干预。因此，专家干预对于该方案的精确和安全校准至关重要。
Clinicaltrials.gov标识符：NCT04907591（注册日期：2020年6月11日；https://clinicaltrials.gov/ct2/show/NCT04907591）。
