Background Adolescent and young adult (AYA) cancer survivors (i.e. individuals diagnosed with cancer between 15 and 39 years and who completed treatment) may benefit from physical activity. Yet, few researchers have explored the effects of physical activity on physical and psychological outcomes among AYA cancer survivors. A pilot study exploring the feasibility and acceptability of a physical activity intervention and proposed trial methods to inform a definitive randomized controlled trial (RCT) is therefore necessary to fill this gap. Methods A two-arm, mixed-methods pilot RCT was conducted. Participants were randomized to a wait-list control group or a 12-week physical activity intervention comprised of 4 weekly aerobic and strength training sessions (intervention group). Feasibility measures included: number of AYA cancer survivors referred/self-referred, eligible, and recruited, retention to the trial (i.e. assessment completion), adherence to the physical activity intervention, and percentage of missing data for baseline (week 0), mid- (week 6), and post-intervention assessments (week 12). The acceptability of trial methods (all participants) and the intervention (intervention group only) was assessed via qualitative interviews post-intervention. Results Over a 12-month period, 31 AYA cancer survivors were referred/self-referred and 16 were eligible and consented to participate. Retention to the trial was 94% and adherence to the physical activity intervention ranged from 50 to 92%. With the exception of the assessment of aerobic capacity and directly measured physical activity behaviour, there were no missing data. Participants generally reported being satisfied with the trial methods and intervention; however, issues related to delivery of the physical activity intervention were identified. Conclusions The methods and intervention piloted require modification and further pilot testing in advance of a definitive RCT. Recruitment strategies identifying a greater number of younger AYA cancer survivors who have different types of cancers and who lack motivation to participate in physical activity-based studies should be explored. Refining the assessments of directly measured physical activity behaviour and aerobic capacity and incorporating behavioural support into the intervention may improve feasibility and acceptability. This study highlights the value of doing pilot work and provides critically useful data that can be used to refine studies seeking to assess causation and optimize physical activity interventions for AYA cancer survivors. Trial registration clinicaltrials.gov, NCT03016728. Registered January 11, 2017.

中文翻译：

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探索混合方法试点随机对照试验的可行性和可接受性，测试对青少年和年轻成人癌症幸存者进行为期 12 周的体育活动干预。

背景 青少年和年轻成人 (AYA) 癌症幸存者（即在 15 至 39 岁之间被诊断患有癌症并完成治疗的个体）可能会从体育锻炼中受益。然而，很少有研究人员探讨体育活动对 AYA 癌症幸存者身体和心理结果的影响。因此，有必要进行一项初步研究，探索体育活动干预的可行性和可接受性，并提出试验方法来为最终的随机对照试验 (RCT) 提供信息，以填补这一空白。方法 进行了一项双臂、混合方法的试点 RCT。参与者被随机分配到等待名单对照组或为期 12 周的身体活动干预，包括 4 次每周有氧和力量训练课程（干预组）。可行性措施包括：AYA 癌症幸存者转介/自我转介、合格和招募的人数、保留到试验（即评估完成）、对身体活动干预的依从性以及基线（第 0 周）、中期（第 6 周）缺失数据的百分比）和干预后评估（第 12 周）。试验方法（所有参与者）和干预（仅干预组）的可接受性通过干预后的定性访谈进行评估。结果在 12 个月期间，31 名 AYA 癌症幸存者被转诊/自我转诊，16 人符合条件并同意参与。对试验的保留率为 94%，对身体活动干预的依从性为 50% 至 92%。除了有氧能力评估和直接测量的身体活动行为外，没有缺失数据。参与者普遍报告对试验方法和干预感到满意；但是，确定了与提供身体活动干预有关的问题。结论 试点的方法和干预措施需要在最终 RCT 之前进行修改和进一步的试点测试。应探索确定更多年轻 AYA 癌症幸存者的招募策略，这些幸存者患有不同类型的癌症并且缺乏参与基于体育活动的研究的动力。改进对直接测量的身体活动行为和有氧能力的评估并将行为支持纳入干预措施可能会提高可行性和可接受性。这项研究强调了开展试点工作的价值，并提供了非常有用的数据，可用于完善旨在评估因果关系和优化 AYA 癌症幸存者的身体活动干预的研究。试验注册临床试验.gov，NCT03016728。2017 年 1 月 11 日注册。