Alibhai Shabbir M H, Papadopoulos Efthymios, Durbano Sara, Tomlinson George, Mina Daniel Santa, Ritvo Paul, Sabiston Catherine M, Matthew Andrew G, Chiarotto James, Sidani Souraya, Culos-Reed S Nicole
Department of Medicine, University Health Network, Toronto, ON, Canada.
Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada.
Front Oncol. 2022 Dec 12;12:1033229. doi: 10.3389/fonc.2022.1033229. eCollection 2022.
Patients' unwillingness to be randomized to a mode of exercise may partly explain their poor recruitment, adherence, and attrition in randomized controlled trials (RCTs) of exercise in oncology. It is unknown whether a preference-based trial can improve recruitment, adherence, retention, and clinical outcomes compared to a RCT of the same exercise interventions.
We assessed the effects of a 2-arm exercise preference trial on adherence and clinical outcomes compared to a similar 2-arm RCT in men with prostate cancer (PC).
This was a two-arm preference-based trial of group-based training (GROUP) or home-based training (HOME). PC survivors on androgen deprivation therapy (ADT) who declined randomization to the RCT but chose to participate in a preference trial were recruited in four Canadian centers. All study participants engaged in aerobic and resistance training, 4-5 days weekly for 6 months, aiming for 150 minutes/week of moderate-to-vigorous physical activity. The primary outcomes were changes from baseline to 6 months in fatigue and functional endurance. Secondary outcomes were quality of life, physical fitness, body composition, blood markers, and adherence. Linear mixed models were used to assess the effects of HOME versus GROUP on primary outcomes. In pooled preference and RCT data, the selection effect (i.e., difference between those who were and were not willing to be randomized) and treatment effect (i.e., difference between GROUP and HOME) were estimated using linear regression.
Fifty-four participants (mean [SD] age, 70.2 [8.6] years) were enrolled (GROUP =17; HOME =37). Comparable effects on primary and secondary outcomes were observed following GROUP or HOME in the preference-based trial. Adherence was similar between preference and RCT participants. However, attrition was higher in the RCT (50.0% vs. 27.8%, p= 0.04). Compared to GROUP, HOME was more effective in ameliorating fatigue (mean difference: +5.2, 95%CI=1.3 to 9.3 =0.01) in pooled preference and RCT data. A preference-based trial results in comparable observed effects on clinical outcomes and adherence and lower attrition compared with a RCT of the same exercise interventions in PC survivors on ADT. Given the appeals of preference-based trials to study participants, additional studies are warranted.
clinicaltrials.gov, identifier (NCT03335631).
在肿瘤学运动随机对照试验（RCT）中，患者不愿被随机分配到某种运动模式可能部分解释了招募困难、依从性差和失访率高的问题。与相同运动干预措施的RCT相比，基于偏好的试验是否能改善招募、依从性、保留率和临床结局尚不清楚。
我们评估了一项双臂运动偏好试验与一项类似的针对前列腺癌（PC）男性的双臂RCT相比，对依从性和临床结局的影响。
这是一项基于偏好的双臂试验，比较团体训练（GROUP）和居家训练（HOME）。在加拿大的四个中心招募了接受雄激素剥夺治疗（ADT）的PC幸存者，他们拒绝随机分配到RCT，但选择参加偏好试验。所有研究参与者进行有氧和阻力训练，每周4至5天，共6个月，目标是每周进行150分钟的中等至剧烈体育活动。主要结局是从基线到6个月时疲劳和功能耐力的变化。次要结局包括生活质量、体能、身体成分、血液指标和依从性。使用线性混合模型评估HOME与GROUP对主要结局的影响。在汇总的偏好试验和RCT数据中，使用线性回归估计选择效应（即愿意和不愿意被随机分配者之间的差异）和治疗效应（即GROUP与HOME之间的差异）。
共纳入54名参与者（平均[标准差]年龄，70.2[8.6]岁）（GROUP组 = 17名；HOME组 = 37名）。在基于偏好的试验中，GROUP组或HOME组对主要和次要结局的影响相当。偏好试验参与者和RCT参与者的依从性相似。然而，RCT中的失访率更高（50.0%对27.8%，p = 0.04）。在汇总的偏好试验和RCT数据中，与GROUP组相比，HOME组在改善疲劳方面更有效（平均差异：+5.2，95%CI = 1.3至9.3，p = 0.01）。与针对接受ADT的PC幸存者进行相同运动干预措施的RCT相比，基于偏好的试验在临床结局和依从性方面观察到的效果相当，且失访率更低。鉴于基于偏好的试验对研究参与者有吸引力，有必要进行更多研究。
clinicaltrials.gov，标识符（NCT03335631）。
