Department of Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, CA, USA
David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
BMJ Open. 2023 Jun 16;13(6):e071041. doi: 10.1136/bmjopen-2022-071041.
Physical activity (PA) promotes significant physical and psychosocial benefits for breast cancer survivors. While evidence exists regarding recommendations for the frequency, duration and intensity of exercise that optimise PA benefits for cancer survivors, the role of the environment in achieving optimal outcomes has yet to be determined. This paper presents a protocol for a clinical trial to evaluate the feasibility of a 3-month nature-based walking programme for breast cancer survivors. Secondary outcomes assessed include the impact of the intervention on fitness, quality of life outcomes, and biomarkers of ageing and inflammation.
The trial is a 12-week single-arm pilot study. Twenty female breast cancer survivors will engage in a supervised moderate intensity walking intervention in small groups in a nature reserve for 50 minutes three times per week. Data will be collected at baseline and end of study, and include assessment of inflammatory cytokines and anti-inflammatory myokines (TNF-α, IL-1ß, IL-6, CRP, TGF-ß, IL-10, IL-13), as well as ageing (DNA methylation, ageing genes) biomarkers; surveys (Patient-Reported Outcomes Measurement Information System-29, Functional Assessment of Cancer Therapy-General, Post-Traumatic Growth Inventory); and fitness assessments (6 min Walk Test, Grip-Strength, One Repetition-Maximum Leg Press). Participants will also complete weekly surveys assessing social support and participate in an exit interview. This is an important first step for future research on the influence of exercise environment on cancer survivor PA outcomes.
This study was approved by the Cedars Sinai Medical Center Institutional Review Board (IIT2020-20). Findings will be disseminated through academic manuscripts, conferences, and community presentations.
NCT04896580.
身体活动(PA)可显著促进乳腺癌幸存者的身心健康。虽然已经有证据表明,为了使癌症幸存者从身体活动中获得最大益处,推荐了运动的频率、持续时间和强度,但环境在实现最佳结果方面的作用尚未确定。本文介绍了一项临床试验的方案,该试验旨在评估针对乳腺癌幸存者的为期 3 个月的基于自然的步行计划的可行性。次要评估结果包括干预对健康相关体能、生活质量结果以及衰老和炎症生物标志物的影响。
该试验为 12 周的单臂先导研究。20 名女性乳腺癌幸存者将在自然保护区的小团体中进行 50 分钟的中等强度步行干预,每周 3 次,由监督者进行监督。数据将在基线和研究结束时收集,包括炎症细胞因子和抗炎肌因子(TNF-α、IL-1β、IL-6、CRP、TGF-β、IL-10、IL-13)以及衰老(DNA 甲基化、衰老基因)生物标志物的评估;问卷调查(患者报告的结局测量信息系统-29 项、癌症治疗一般功能评估、创伤后成长量表);以及健康相关体能评估(6 分钟步行测试、握力、一次最大重复腿部按压)。参与者还将每周完成一次评估社会支持的调查,并参加一次退出访谈。这是未来研究运动环境对癌症幸存者身体活动结果影响的重要的第一步。
本研究已获得 Cedars Sinai Medical Center 机构审查委员会(IIT2020-20)的批准。研究结果将通过学术论文、会议和社区演讲进行传播。
NCT04896580。