Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
Center for Psychiatric Rehabilitation, University Hospital for Mental Health, University of Bern, Bern, Switzerland.
Cancer Med. 2023 Jul;12(13):14731-14741. doi: 10.1002/cam4.6096. Epub 2023 May 18.
Meeting intervention requirements is crucial in behavioral trials. We examined patterns and predictors of physical activity (PA) adherence and contamination in a 1-year individualized randomized controlled PA behavioral intervention in childhood cancer survivors (CCS).
CCS aged ≥16 at enrolment, <16 at diagnosis, and ≥5 years in remission were identified from the Swiss Childhood Cancer Registry. We asked participants randomized to the intervention group to perform an additional ≥2.5 h of intense PA/week and controls to continue as usual. Adherence to the intervention was assessed by online diary (adherent if ≥2/3 of individual PA goal reached) and contamination for the control group by pre- and post-questionnaire including PA levels (contaminated if >60 min increase/week in PA). Predictors of adherence/contamination including quality of life (36-Item Short Form Survey) were assessed by questionnaire. We used logistic (control group) and mixed logistic regression models (exercise group) to estimate predictors of study adherence and contamination.
One hundred and forty-four survivors (30.4 ± 8.7 years old, 43% females) were included. Adherence was 48% (35/73) in the intervention group, while 17% (12/71) of controls contaminated group allocation. Predictors for PA adherence were female sex (OR 2.35, p = 0.03), higher physical (OR 1.34, p = 0.01) and mental quality of life (OR 1.37, p = 0.001), and week into the intervention (OR 0.98, p < 0.001). Clear differences in PA behavior of adherent and non-adherent participants were seen from week four. No significant predictors for contamination were found for controls.
Adherence to PA behavior interventions remain challenging in both groups. Further long-term trials should consider intense motivational support within the first month, more detailed data collection for the control group, adjustments to power calculations and other study designs to minimize non-adherence and contamination.
在行为试验中,满足干预要求至关重要。我们研究了在儿童癌症幸存者(CCS)中进行的为期 1 年的个体化随机对照 PA 行为干预中,PA 依从性和污染的模式和预测因素。
从瑞士儿童癌症登记处确定了入组时年龄≥16 岁、诊断时年龄<16 岁、缓解期≥5 年的 CCS。我们要求随机分配到干预组的参与者每周额外进行≥2.5 小时的剧烈 PA,对照组则继续保持原来的习惯。通过在线日记评估干预的依从性(如果达到个人 PA 目标的 2/3 以上则为依从),通过预问卷和后问卷评估对照组的污染情况,包括 PA 水平(如果每周 PA 增加>60 分钟则为污染)。通过问卷评估依从性/污染的预测因素,包括生活质量(36 项简短健康调查问卷)。我们使用逻辑(对照组)和混合逻辑回归模型(运动组)来估计研究依从性和污染的预测因素。
共有 144 名幸存者(30.4±8.7 岁,43%为女性)被纳入研究。干预组的依从率为 48%(35/73),对照组污染组的依从率为 17%(12/71)。PA 依从性的预测因素包括女性性别(OR 2.35,p=0.03)、较高的身体(OR 1.34,p=0.01)和精神生活质量(OR 1.37,p=0.001),以及干预开始后的第 4 周(OR 0.98,p<0.001)。从第 4 周开始,就可以看到依从和不依从参与者的 PA 行为有明显差异。对照组没有发现污染的显著预测因素。
两组的 PA 行为干预依从性仍然具有挑战性。未来的长期试验应考虑在第一个月内提供强烈的动机支持,更详细地收集对照组的数据,调整功率计算和其他研究设计,以最大限度地减少不依从和污染。