Lally P, Miller N, Roberts A, Beeken R J, Greenfield D M, Potts H W W, Counsell N, Latimer N, Thomas C, Smith L, Gath J, Kennedy F, Martin C, Wyld L, Fisher A
Behavioural Science and Health, UCL, Gower Street, London, WC1E 6BT, UK.
Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.
Pilot Feasibility Stud. 2022 Mar 29;8(1):74. doi: 10.1186/s40814-022-01028-w.
There are multiple health benefits from participating in physical activity after a cancer diagnosis, but many people living with and beyond cancer (LWBC) are not meeting physical activity guidelines. App-based interventions offer a promising platform for intervention delivery. This trial aims to pilot a theory-driven, app-based intervention that promotes brisk walking among people living with and beyond cancer. The primary aim is to investigate the feasibility and acceptability of study procedures before conducting a larger randomised controlled trial (RCT).
This is an individually randomised, two-armed pilot RCT. Patients with localised or metastatic breast, prostate, or colorectal cancer, who are aged 16 years or over, will be recruited from a single hospital site in South Yorkshire in the UK. The intervention includes an app designed to encourage brisk walking (Active 10) supplemented with habit-based behavioural support in the form of two brief telephone/video calls, an information leaflet, and walking planners. The primary outcomes will be feasibility and acceptability of the study procedures. Demographic and medical characteristics will be collected at baseline, through self-report and hospital records. Secondary outcomes for the pilot (assessed at 0 and 3 months) will be accelerometer measured and self-reported physical activity, body mass index (BMI) and waist circumference, and patient-reported outcomes of quality of life, fatigue, sleep, anxiety, depression, self-efficacy, and habit strength for walking. Qualitative interviews will explore experiences of participating or reasons for declining to participate. Parameters for the intended primary outcome measure (accelerometer measured average daily minutes of brisk walking (≥ 100 steps/min)) will inform a sample size calculation for the future RCT and a preliminary economic evaluation will be conducted.
This pilot study will inform the design of a larger RCT to investigate the efficacy and cost-effectiveness of this intervention in people LWBC.
ISRCTN registry, ISRCTN18063498 . Registered 16 April 2021.
癌症诊断后参与体育活动对健康有诸多益处，但许多癌症患者及康复者未达到体育活动指南的要求。基于应用程序的干预措施为提供干预提供了一个有前景的平台。本试验旨在试点一种基于理论的、以应用程序为基础的干预措施，以促进癌症患者及康复者进行快走。主要目的是在开展更大规模的随机对照试验（RCT）之前，调查研究程序的可行性和可接受性。
这是一项个体随机、双臂试点RCT。年龄在16岁及以上、患有局部或转移性乳腺癌、前列腺癌或结直肠癌的患者将从英国南约克郡的一家医院招募。干预措施包括一个旨在鼓励快走的应用程序（Active 10），并辅以基于习惯的行为支持，形式为两次简短的电话/视频通话、一份信息传单和步行计划。主要结局将是研究程序的可行性和可接受性。将通过自我报告和医院记录在基线时收集人口统计学和医学特征。试点的次要结局（在0个月和3个月时评估）将是通过加速度计测量和自我报告的体育活动、体重指数（BMI）和腰围，以及患者报告的生活质量、疲劳、睡眠、焦虑、抑郁、自我效能感和步行习惯强度的结局。定性访谈将探讨参与的经历或拒绝参与的原因。预期主要结局指标（加速度计测量的平均每日快走分钟数（≥100步/分钟））的参数将为未来RCT的样本量计算提供信息，并将进行初步的经济评估。
这项试点研究将为设计一项更大规模的RCT提供信息，以调查该干预措施对癌症患者及康复者的疗效和成本效益。
ISRCTN注册库，ISRCTN18063498。2021年4月16日注册。
