Department of Physical and Rehabilitation Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro Gangnam-gu, 06351, Seoul, Republic of Korea.
Research Institute for Future Medicine, Samsung Medical Center, 06351, Seoul, Republic of Korea.
BMC Cancer. 2023 Apr 3;23(1):304. doi: 10.1186/s12885-023-10728-2.
Colorectal cancer survivors often experience decline in physical performance and poor quality of life after surgery and during adjuvant therapies. In these patients, preserving skeletal muscle mass and high-quality nourishment are essential to reduce postoperative complications and improve quality of life and cancer-specific survival. Digital therapeutics have emerged as an encouraging tool for cancer survivors. However, to the best of our knowledge, randomized clinical trials applying personalized mobile application and smart bands as a supportive tool to several colorectal patients remain to be conducted, intervening immediately after the surgical treatment.
This study is a prospective, multi-center, single-blinded, two-armed, randomized controlled trial. The study aims to recruit 324 patients from three hospitals. Patients will be randomly allocated to two groups for one year of rehabilitation, starting immediately after the operation: a digital healthcare system rehabilitation (intervention) group and a conventional education-based rehabilitation (control) group. The primary objective of this protocol is to clarify the effect of digital healthcare system rehabilitation on skeletal muscle mass increment in patients with colorectal cancer. The secondary outcomes would be the improvement in quality of life measured by EORTC QLQ C30 and CR29, enhanced physical fitness level measured by grip strength test, 30-sec chair stand test and 2-min walk test, increased physical activity measured by IPAQ-SF, alleviated pain intensity, decreased severity of the LARS, weight, and fat mass. These measurements will be held on enrollment and at 1, 3, 6 and 12 months thereafter.
This study will compare the effect of personalized treatment stage-adjusted digital health interventions on immediate postoperative rehabilitation with that of conventional education-based rehabilitation in patients with colorectal cancer. This will be the first randomized clinical trial performing immediate postoperative rehabilitation in a large number of patients with colorectal cancer with a tailored digital health intervention, modified according to the treatment phase and patient condition. The study will add foundations for the application of comprehensive digital healthcare programs focusing on individuality in postoperative rehabilitation of patients with cancer.
NCT05046756. Registered on 11 May 2021.
结直肠癌患者在手术后和辅助治疗期间常经历身体机能下降和生活质量变差。在这些患者中，保留骨骼肌量和高质量营养对于减少术后并发症、提高生活质量和癌症特异性生存率至关重要。数字疗法已成为癌症患者的一种有希望的治疗工具。然而，据我们所知，应用个性化移动应用程序和智能手环作为支持工具对多种结直肠癌患者进行的即时干预的随机临床试验仍有待开展。
这是一项前瞻性、多中心、单盲、双臂、随机对照临床试验。该研究旨在从三家医院招募 324 名患者。患者将被随机分为两组，进行为期一年的康复治疗，从手术后立即开始：数字医疗系统康复（干预）组和常规教育为基础的康复（对照组）。本方案的主要目的是明确数字医疗系统康复对结直肠癌患者骨骼肌量增加的影响。次要结局将是通过 EORTC QLQ C30 和 CR29 测量生活质量的改善、握力测试、30 秒椅立测试和 2 分钟步行测试测量的身体适应力的提高、通过 IPAQ-SF 测量的身体活动的增加、疼痛强度的缓解、LARS 严重程度的降低、体重和体脂肪量的降低。这些测量将在入组时和此后的 1、3、6 和 12 个月进行。
本研究将比较个性化治疗阶段调整的数字健康干预对结直肠癌患者术后即刻康复的效果与常规教育为基础的康复的效果。这将是第一项对大量结直肠癌患者进行术后即刻康复的随机临床试验，采用了根据治疗阶段和患者情况进行调整的个体化数字健康干预措施。该研究将为专注于癌症患者术后康复的个体化的综合数字医疗方案的应用奠定基础。
NCT05046756。注册于 2021 年 5 月 11 日。
