Department of Surgery, Royal Alexandra Hospital, Paisley, UK.
Institute of Sport, Physical Education and Health Sciences, Moray House School of Education, Edinburgh, UK.
Colorectal Dis. 2019 May;21(5):548-562. doi: 10.1111/codi.14560. Epub 2019 Feb 16.
Rectal cancer patients undergoing neoadjuvant chemoradiotherapy (NACRT) experience physical deterioration and reductions in their quality of life. This feasibility study assessed prehabilitation (a walking intervention) before, during and after NACRT to inform a definitive multi-centred randomized clinical trial (REx trial).
Patients planned for NACRT followed by potentially curative surgery were approached (August 2014-March 2016) (www.isrctn.com; 62859294). Prior to NACRT, baseline physical and psycho-social data were recorded using validated tools. Participants were randomized to either the intervention group (exercise counselling session followed by a 13-17 week telephone-guided walking programme) or a control group (standard care). Follow-up testing was undertaken 1-2 weeks before surgery.
Of the 296 screened patients, 78 (26%) were eligible and 48 (61%) were recruited. N = 31 (65%) were men with a mean age of 65.9 years (range 33.7-82.6). Mean intervention duration was 14 weeks with 75% adherence. n = 40 (83%) completed follow-up testing. Both groups recorded reductions in daily walking but the reduction was less in the intervention group although not statistically significant. Participants reported high satisfaction and fidelity to trial procedures.
This study demonstrates that prehabilitation is feasible in rectal cancer patients undergoing NACRT. Good recruitment, adherence, retention and patient satisfaction rates support the development of a fully powered trial. The effects of the intervention on physical outcomes were promising.
接受新辅助放化疗(NACRT)的直肠癌患者会经历身体恶化和生活质量下降。本可行性研究评估了 NACRT 前、中、后进行的预康复(步行干预),为一项确定的多中心随机临床试验(REx 试验)提供信息。
计划接受 NACRT 后进行潜在治愈性手术的患者被纳入研究(2014 年 8 月至 2016 年 3 月)(www.isrctn.com;62859294)。在 NACRT 之前,使用经过验证的工具记录基线身体和心理社会数据。参与者被随机分配到干预组(运动咨询会议,随后进行 13-17 周的电话指导步行计划)或对照组(标准护理)。随访测试在手术前 1-2 周进行。
在 296 名筛查患者中,有 78 名(26%)符合条件,48 名(61%)被招募。n=31(65%)为男性,平均年龄为 65.9 岁(范围 33.7-82.6)。干预持续时间平均为 14 周,依从率为 75%。n=40(83%)完成了随访测试。两组患者的日常步行量都有所减少,但干预组的减少幅度较小,但无统计学意义。参与者报告了对试验程序的高度满意度和忠实度。
本研究表明,预康复在接受 NACRT 的直肠癌患者中是可行的。良好的招募、依从性、保留率和患者满意度支持开展一项完全有效的试验。该干预对身体结果的影响是有希望的。