Nutrition & Disease chair group, Division of Human Nutrition and Health, Wageningen University & Research, Wageningen, The Netherlands.
Consumption and Healthy Lifestyles Chair group, Wageningen University & Research, Wageningen, The Netherlands.
Br J Nutr. 2024 Jul 28;132(2):248-258. doi: 10.1017/S0007114524001107. Epub 2024 May 28.
Observational studies suggest that a healthy diet in combination with ample physical activity is associated with a lower prevalence of cancer-related fatigue. The SoFiT trial (SoFiT: Study on Fatigue: a lifestyle intervention among colorectal cancer survivors) will assess the effect of a personalised lifestyle programme on cancer-related fatigue in a randomised study. We designed a programme that aims to increase adherence to lifestyle recommendations on diet and physical activity. The programme was person-centred with regard to the lifestyle and personal characteristics of participants, to the determinants of behaviour of that participant, and to the preferences, opportunities and barriers of the participant. The effect of the programme was tested in the SoFiT trial: a two-armed, parallel, randomised controlled trial among adult stage I-III colorectal cancer survivors, who experience cancer-related fatigue after treatment completion; intended sample size 184. Participants randomised to the intervention group received the personalised lifestyle programme. During 6 months, participants in the intervention group had individual sessions with a lifestyle coach of which four sessions were face-to-face and eight sessions were remote. After 6 months, participants randomised to the control group had access to two lifestyle coaching sessions and to the same materials that the intervention group also received. The primary endpoint of the trial is cancer-related fatigue. Secondary endpoints are sleep quality and duration, health-related quality of life, physical performance, depression and anxiety, skeletal muscle echo intensity and cross-sectional area, and gut microbiota composition. This trial will show the effects of a personalised lifestyle programme on cancer-related fatigue and on an extensive set of secondary outcomes. Clinicaltrials.gov: NCT05390398.
观察性研究表明，健康饮食结合充足的身体活动与较低的癌症相关疲劳发生率有关。SoFiT 试验（SoFiT：疲劳研究：结直肠癌幸存者的生活方式干预）将评估个性化生活方式计划对随机研究中癌症相关疲劳的影响。我们设计了一个旨在提高饮食和身体活动生活方式建议依从性的计划。该计划在个人生活方式和特征、参与者行为的决定因素以及参与者的偏好、机会和障碍方面以参与者为中心。该计划在 SoFiT 试验中进行了测试：一项针对成人 I-III 期结直肠癌幸存者的双臂、平行、随机对照试验，这些患者在治疗完成后经历癌症相关疲劳；预期样本量为 184 名。随机分配到干预组的参与者接受个性化生活方式计划。在 6 个月内，干预组的参与者与生活方式教练进行了个人会议，其中 4 次是面对面的，8 次是远程的。6 个月后，随机分配到对照组的参与者可以获得两次生活方式指导会议，并获得与干预组相同的材料。该试验的主要终点是癌症相关疲劳。次要终点是睡眠质量和持续时间、健康相关生活质量、身体表现、抑郁和焦虑、骨骼肌回声强度和横截面积以及肠道微生物群组成。该试验将显示个性化生活方式计划对癌症相关疲劳和广泛的次要结果的影响。Clinicaltrials.gov：NCT05390398。
