Department of Physiotherapy, University of Dublin Trinity College, Dublin, Ireland.
School of Medicine, University of Dublin Trinity College, Dublin, Ireland.
BMJ Open. 2019 Mar 8;9(3):e024999. doi: 10.1136/bmjopen-2018-024999.
Exercise and physical activity (PA) are established and effective treatment options for various side effects of cancer treatments such as surgery, chemotherapy and radiotherapy. The advent of eHealth brings new opportunities to influence healthy behaviours, using interactive and novel approaches. Influencing PA behaviours in people with cancer presents a potential application of this. The aim of this study is to evaluate the feasibility and preliminary efficacy of an intervention, using eHealth, for increasing PA in cancer survivors.
This will be a single-arm pre-post feasibility study. We aim to recruit a heterogeneous sample of 60 participants from cancer clinics in St. James's Hospital, Dublin, Ireland. Eligibility criteria will include patients who have completed chemotherapy and/or radiotherapy with curative intent between 3 and 36 months prior to enrolment. The intervention will include the delivery of a 12-week PA programme. The eHealth aspect of the intervention will involve the provision of a Fitbit activity tracker, which will be used in conjunction with specific PA goals remotely prescribed and monitored by a physiotherapist. Primary outcomes will be feasibility measures related to the study (recruitment capability, data collection procedures, adherence and compliance, evaluation of the resources to implement the study and evaluation of participant responses to the intervention). Secondary measures will evaluate preliminary efficacy of the intervention in terms of clinical outcomes (body composition, PA (objective and self-report), quality of life and aerobic capacity). Primary and secondary outcomes will be assessed at baseline (as appropriate), at conclusion of the intervention and at a 6-month follow-up.
Ethical approval has been granted by the St. James's Hospital/AMNCH Joint Ethics Committee (2016/05/02). Results from this study will be submitted for publication in peer-reviewed journals, as well as for presentation and dissemination at conferences in the field of oncology and survivorship.
NCT03036436; Pre-results.
运动和身体活动（PA）是治疗手术、化疗和放疗等癌症治疗副作用的既定有效治疗方法。电子健康的出现为影响健康行为带来了新的机会，可采用互动和新颖的方法。影响癌症患者的 PA 行为是这种方法的潜在应用。本研究的目的是评估使用电子健康增加癌症幸存者 PA 的干预措施的可行性和初步效果。
这将是一项单臂前后预可行性研究。我们的目标是从爱尔兰都柏林圣詹姆斯医院的癌症诊所招募 60 名异质样本的参与者。纳入标准将包括在入组前 3 至 36 个月接受过治愈性化疗和/或放疗的患者。干预措施将包括为期 12 周的 PA 计划。干预的电子健康方面将包括提供 Fitbit 活动追踪器，该追踪器将与由物理治疗师远程规定和监测的特定 PA 目标一起使用。主要结果将是与研究相关的可行性措施（招募能力、数据收集程序、依从性和遵守情况、实施研究的资源评估以及参与者对干预的反应评估）。次要措施将根据临床结果（身体成分、PA（客观和自我报告）、生活质量和有氧能力）评估干预的初步效果。主要和次要结果将在基线时（如适当）、干预结束时和 6 个月随访时进行评估。
这项研究已获得圣詹姆斯医院/AMNCH 联合伦理委员会的伦理批准（2016 年 5 月 2 日）。本研究的结果将提交给同行评议期刊发表，并在肿瘤学和生存领域的会议上展示和传播。
NCT03036436；预结果。
