Department of Sport and Physical Activity, Edge Hill University, Ormskirk, United Kingdom.
Health Research Institute, Edge Hill University, Ormskirk, Lancashire, United Kingdom.
PLoS One. 2023 Aug 25;18(8):e0289911. doi: 10.1371/journal.pone.0289911. eCollection 2023.
Attempts at personalisation of exercise programmes in head and neck cancer (HaNC) have been limited. The main aim of the present study is to investigate the feasibility and acceptability of introducing a remotely delivered, fully personalised, collaborative, and flexible approach to prescribing and delivering exercise programmes into the HaNC usual care pathway.
This is a single arm, feasibility study. Seventy patients diagnosed with HaNC will be recruited from two regional HaNC centres in the United Kingdom. Patients will undertake an 8-week exercise programme designed and delivered by cancer exercise specialists. The exercise programme will start any time between the time of diagnosis and up to 8 weeks after completing treatment, depending on patient preference. The content of the exercise programme will be primarily based on patient needs, preferences, and goals, but guided by current physical activity guidelines for people with cancer. The primary outcome measure is retention to the study. Secondary quantitative outcomes are uptake to the exercise programme, different measures of exercise adherence, pre- and post-intervention assessments of fatigue (Multidimensional Fatigue Symptom Inventory-Short Form), quality of life (SF-36), physical activity levels (International Physical Activity Questionnaire-Short Form), and various components of physical fitness. The outcomes of the nested qualitative study are acceptability and feasibility of the intervention evaluated via interviews with patients, health care professionals, and the cancer exercise specialists. Intervention and participant fidelity will be determined using checklists and scrutiny of each patient's logbook and the cancer exercise specialists' meeting notes. Analysis of quantitative data will be via standard summary statistics. Qualitative data will be analysed using thematic analysis.
This feasibility study will inform the design and conduct of a future randomised controlled trial. Success will be defined according to a traffic light system for identifying the appropriateness of progression to a randomised controlled trial.
International Standard Randomised Controlled Trial Number registry (ISRCTN82505455).
在头颈部癌症(HaNC)中,尝试进行个性化的运动方案一直受到限制。本研究的主要目的是探讨将一种远程提供的、完全个性化的、协作的和灵活的运动方案制定和实施方法引入 HaNC 常规护理途径的可行性和可接受性。
这是一项单臂可行性研究。将从英国两个区域性 HaNC 中心招募 70 名被诊断患有 HaNC 的患者。患者将接受由癌症运动专家设计和提供的 8 周运动方案。该运动方案将根据患者的偏好,在诊断后任何时间开始,最长可在治疗后 8 周内开始。运动方案的内容将主要基于患者的需求、偏好和目标,但以癌症患者的当前体力活动指南为指导。主要的结局指标是保留在研究中。次要的定量结局指标是对运动方案的参与度、不同的运动依从性测量、疲劳(多维疲劳症状量表-短表)、生活质量(SF-36)、体力活动水平(国际体力活动问卷-短表)以及身体各项体能的干预前和干预后评估。嵌套式定性研究的结果是通过对患者、医疗保健专业人员和癌症运动专家的访谈评估干预的可接受性和可行性。干预和参与者的保真度将通过检查表和审查每个患者的日志和癌症运动专家的会议记录来确定。定量数据分析将采用标准汇总统计。定性数据分析将采用主题分析。
这项可行性研究将为未来的随机对照试验的设计和实施提供信息。成功将根据识别向随机对照试验进展的适当性的红绿灯系统来定义。
国际标准随机对照试验编号注册处(ISRCTN82505455)。