Bluethmann Shirley M, Tooze Janet, Evans Joni K, Katula Jeffrey, Wood Kristy, Hitariansingh Lesley, Crotts Charlotte, Klepin Heidi D, Paluri Ravi, Kadakia Kunal, Ansley Katherine
Atrium Health Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, NC, USA.
Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Contemp Clin Trials Commun. 2025 Aug 7;47:101530. doi: 10.1016/j.conctc.2025.101530. eCollection 2025 Oct.
The majority of the 18 million US adults with cancer history ("survivors") do not meet recommendations for obtaining regular physical activity (PA) or limiting sedentary behavior in their daily lives. Breast cancer survivors (BCS) and colon cancer survivors (CCS) are particularly at risk of insufficient PA and excessive sedentary behavior (i.e., sitting) that may increase physical impairments, worsen cancer treatment symptoms, limit optimal cancer recovery, and limit opportunities to potentially reduce cancer risk. Research has shown that completion of clinical cancer treatment may serve as a 'teachable moment' for patients as they transition to recovery at home. Many of these survivors are uncertain about building a healthier lifestyle without guidance from the medical team, but few validated clinical tools exist to assess and counsel survivors on their behavioral choices relative to PA and sedentary behavior. Based on our recent findings, a simple screener that collects measures on PA, strength training, and sedentary behavior, the Physical Activity Index (PAI), may be effective for clinical use to monitor patient behaviors and provide specific, tailored recommendations on how to achieve and maintain behavioral goals. We propose a multicomponent, two-arm pilot 1:1 randomized controlled trial with waitlist control in which we will recruit (n = 20) BCS and CCS within three years of diagnosis to leverage the 'teachable moment' in early recovery. The PAI intervention will include standard survivorship follow-up care plus a PA assessment using the PAI screener that is supplied to the provider plus five remote coaching consultations with a certified exercise physiologist. All participants will also receive resistance bands to keep and an activity tracker to self-monitor their behaviors at home. We will determine feasibility by examining recruitment, retention, acceptability, and PAI intervention adherence goals. Secondarily, we will measure changes/variability in achievement of behavioral outcomes for PA and sedentary behaviors to inform future trial planning.
在美国，1800万曾患癌症的成年人（“幸存者”）中，大多数人在日常生活中未达到定期进行体育活动（PA）或限制久坐行为的建议标准。乳腺癌幸存者（BCS）和结肠癌幸存者（CCS）尤其面临体育活动不足和久坐行为过多（即长时间坐着）的风险，这可能会增加身体损伤、加重癌症治疗症状、限制癌症的最佳康复，并减少潜在降低癌症风险的机会。研究表明，完成临床癌症治疗可能是患者在家过渡到康复阶段的一个“可教时刻”。许多这些幸存者在没有医疗团队指导的情况下，对于建立更健康的生活方式感到不确定，但几乎没有经过验证的临床工具可用于评估和指导幸存者关于他们在体育活动和久坐行为方面的行为选择。基于我们最近的研究结果，一个简单的筛查工具——身体活动指数（PAI），它可以收集有关体育活动、力量训练和久坐行为的测量数据，可能在临床应用中有效地监测患者行为，并就如何实现和维持行为目标提供具体的、量身定制的建议。我们提议进行一项多组分、双臂试点1:1随机对照试验，并设置等待名单对照组，在该试验中，我们将在诊断后的三年内招募（n = 20）名乳腺癌幸存者和结肠癌幸存者，以利用早期康复阶段的“可教时刻”。PAI干预将包括标准的幸存者后续护理，加上使用提供给医疗服务提供者的PAI筛查工具进行体育活动评估，以及与一名认证运动生理学家进行五次远程指导咨询。所有参与者还将收到用于在家中使用的弹力带和一个活动追踪器，以自我监测他们的行为。我们将通过检查招募、留存、可接受性和PAI干预依从性目标来确定可行性。其次，我们将测量体育活动和久坐行为的行为结果实现情况的变化/差异，为未来的试验规划提供信息。
