School of Human Kinetics, University of Ottawa, 125 University Private, Montpetit Hall, Room 339, Ottawa, Ontario, K1N 6N5, Canada.
Cancer Therapeutics Program, Ottawa Hospital Research Institute, The Ottawa Hospital, Ottawa, Ontario, Canada.
Trials. 2021 Jan 6;22(1):26. doi: 10.1186/s13063-020-04958-z.
The aim of this paper is to share the methodological problems of an unsuccessful prospective single-arm feasibility trial conducted to evaluate the safety and feasibility of a 12-week progressive exercise intervention for adults undergoing neoadjuvant chemoradiotherapy for rectal cancer, as well as offer recommendations for future trials.
The initial plan was to recruit adults diagnosed with rectal cancer and scheduled for neoadjuvant chemoradiotherapy over a 12-month period. The exercise intervention was to consist of supervised exercise sessions delivered three times per week by a trained exercise specialist. Feasibility (i.e., recruitment, adherence, and compliance rates) and safety (i.e., adverse events) were to be assessed throughout the trial, and patient-reported and physical health outcomes were to be assessed pre- and post-intervention. After 8 months of open recruitment, we had been unable to successfully enroll patients into our trial. We therefore modified our eligibility criteria to increase the number of patients that could be recruited into our trial, and in turn increase our recruitment rate. We also amended our recruitment procedures to ensure we could reach patients who were either awaiting treatment, receiving treatment, or had completed treatments in the past 5 years. In doing so, we added a research objective, namely to determine the optimal timing of conducting an exercise intervention with adults diagnosed with rectal cancer (i.e., during neoadjuvant treatment, after surgery, during adjuvant treatment, or post-treatment).
Many problems continued to hinder the progress of our trial, particularly the low recruitment rate and the failure to enroll the required sample size that would make our results reliable.
This led us to conclude that our trial was not feasible and that it is advisable to consider some elements carefully (e.g., recruitment strategies, communication, and trial location) before designing and conducting future trials. If one or more of these elements still proves to be problematic, trial results risk being compromised and alternative approaches should be considered.
ClinicalTrials.gov NCT03049124 . Registered on 02 September 2017.
本文旨在分享一项不成功的前瞻性单臂可行性试验中所遇到的方法学问题，该试验旨在评估接受新辅助放化疗的直肠癌患者进行 12 周渐进式运动干预的安全性和可行性，同时为未来的试验提供建议。
最初计划在 12 个月的时间内招募被诊断患有直肠癌并计划接受新辅助放化疗的成年人。运动干预将由经过培训的运动专家每周进行三次监督的运动课程组成。在整个试验过程中，将评估可行性（即招募、依从性和遵守率）和安全性（即不良事件），并在干预前后评估患者报告的和身体健康的结果。在开放招募 8 个月后，我们未能成功招募到试验患者。因此，我们修改了纳入标准，以增加可纳入试验的患者数量，从而提高我们的招募率。我们还修改了招募程序，以确保能够接触到正在等待治疗、正在接受治疗或在过去 5 年内已完成治疗的患者。这样，我们增加了一个研究目标，即确定对诊断为直肠癌的成年人进行运动干预的最佳时机（即在新辅助治疗期间、手术后、辅助治疗期间或治疗后）。
许多问题继续阻碍试验的进展，特别是招募率低，以及未能招募到可使结果可靠的所需样本量。
这导致我们得出结论，我们的试验不可行，在设计和进行未来的试验之前，建议仔细考虑一些因素（例如招募策略、沟通和试验地点）。如果其中一个或多个因素仍然存在问题，试验结果可能会受到影响，应考虑替代方法。
ClinicalTrials.gov NCT03049124。于 2017 年 9 月 2 日注册。
