School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, Leicestershire, UK.
Diabetes Research Centre, University of Leicester, Leicester, Leicestershire, UK.
BMJ Open. 2022 Jan 3;12(1):e048203. doi: 10.1136/bmjopen-2020-048203.
Cervical cancer treatment can have life changing sequelae and be associated with poor short-term and long-term quality of life. Physical activity (PA; that is, bodily movement) is known to improve health outcomes and quality of life for cancer survivors, both physically and psychologically. To date, no interventions to increase PA following cervical cancer have been evaluated. This study aims to (1) determine the feasibility of conducting a PA intervention after cervical cancer and (2) to explore the acceptability of the programme and evaluation measures.
The design is a pre study and post study design. Thirty participants aged between 18 and 60 years from the Midlands region, UK, who have completed primary treatment for cervical cancer at least 6 months previously and do not meet the national PA guidelines will be recruited. Identification of potential participants will take place through the University Hospitals of Leicester National Health Service (NHS) Trust. Participants will receive an intervention focused on increasing PA through the provision of education, action planning, goal setting, problem solving and self-monitoring of PA behaviour, particularly steps per day. Device assessed PA and questionnaires will be completed at baseline, week 6, week 12 and week 24. Feasibility will be assessed in terms of recruitment, retention, attrition, completion of measures and intervention compliance, for which specific feasibility criteria have been established. The process evaluation will explore the experiences and acceptability of the intervention components and evaluation measures.
Ethical approval has been granted by the West of Scotland Research Ethics Committee 1 for this study. Results will inform intervention refinement for the design of a definitive pilot trial. These results will be disseminated via peer-reviewed publications and international conferences while input from a patient and public involvement (PPI) group will inform effective ways to circulate results among the wider community.
ISRCTN16349793, Registered 30 September 2020.
宫颈癌的治疗可能会带来改变生活的后遗症，并与短期和长期生活质量较差有关。身体活动（即身体运动）已知可改善癌症幸存者的健康结果和生活质量，无论是身体上还是心理上。迄今为止，尚未评估过任何旨在增加宫颈癌后身体活动的干预措施。本研究旨在：（1）确定在宫颈癌后进行身体活动干预的可行性；（2）探索该计划和评估措施的可接受性。
本设计是一项预研究和后研究设计。将招募 30 名年龄在 18 至 60 岁之间的参与者，他们来自英国中部地区，已完成至少 6 个月前的宫颈癌主要治疗，且不符合国家身体活动指南。将通过莱斯特大学医院国民保健服务信托基金确定潜在参与者。参与者将接受一项专注于通过提供教育、行动计划、目标设定、解决问题和自我监测身体活动行为（特别是每天的步数）来增加身体活动的干预措施。在基线、第 6 周、第 12 周和第 24 周时将完成设备评估的身体活动和问卷调查。将根据招募、保留、流失、完成措施和干预措施的依从性来评估可行性，为此已制定了具体的可行性标准。过程评估将探讨干预措施组成部分和评估措施的经验和可接受性。
这项研究已获得西苏格兰研究伦理委员会 1 的伦理批准。研究结果将为设计一项确定性试点试验提供干预措施的改进信息。这些结果将通过同行评审的出版物和国际会议进行传播，同时患者和公众参与（PPI）小组的意见将为在更广泛的社区中传播结果提供有效途径。
ISRCTN85550263，注册于 2020 年 9 月 30 日。
