Koutoukidis Dimitrios A, Beeken Rebecca J, Manchanda Ranjit, Burnell Matthew, Knobf M Tish, Lanceley Anne
Department of Women's Cancer, EGA Institute for Women's Health, University College London, London, UK.
Health Behaviour Research Centre, Department of Epidemiology & Public Health, University College London, London, UK.
Trials. 2016 Mar 10;17(1):130. doi: 10.1186/s13063-016-1260-1.
Endometrial cancer survivors comprise a high-risk group for obesity-related comorbidities. Healthy eating and physical activity can lead to better health and well-being, but this population may experience difficulties adopting healthy lifestyle practices. Personalised behaviour change programmes that are feasible, acceptable and cost-effective are needed. The aim of this trial is to pilot a manualised programme about healthy eating and physical activity.
METHODS/DESIGN: This is a phase II, individually randomized, parallel, controlled, two-site, pilot clinical trial. Adult endometrial cancer survivors (n = 64) who have been diagnosed with endometrial cancer within the previous 3 years and are not on active treatment will be invited to participate. Participants will be assigned in a 1:1 ratio through minimisation to either an 8-week, group-based, behaviour-change programme with weekly 90-min sessions about healthy eating and physical activity or usual care. The intervention will focus on self-monitoring, goal setting and self-rewards. Follow-up assessments will be conducted at 8 and 24 weeks from the baseline assessment. Primary feasibility outcomes will include rates of recruitment, adherence, and retention.
The study results will inform the development of a definitive randomised controlled trial to test if the programme can improve the health and quality of life of this population. It will also provide guidance on costing the intervention and the health care resource use in this population.
ClinicalTrials.gov identifier: NCT02433080, 20 April 2015.
子宫内膜癌幸存者是肥胖相关合并症的高危人群。健康饮食和体育活动有助于改善健康状况和幸福感，但这一人群在采取健康生活方式时可能会遇到困难。因此需要可行、可接受且具有成本效益的个性化行为改变计划。本试验的目的是试点一项关于健康饮食和体育活动的手册化计划。
方法/设计：这是一项II期、个体随机、平行、对照、双中心的试点临床试验。将邀请在过去3年内被诊断为子宫内膜癌且未接受积极治疗的成年子宫内膜癌幸存者（n = 64）参与。参与者将通过最小化法以1:1的比例被分配到一个为期8周、基于小组的行为改变计划组或常规护理组，行为改变计划组每周有90分钟关于健康饮食和体育活动的课程。干预将侧重于自我监测、目标设定和自我奖励。将在基线评估后的8周和24周进行随访评估。主要可行性结果将包括招募率、依从率和保留率。
研究结果将为开展一项确定性随机对照试验提供依据，以检验该计划是否能改善这一人群的健康状况和生活质量。它还将为该干预措施的成本核算以及这一人群的医疗资源使用提供指导。
ClinicalTrials.gov标识符：NCT02433080，2015年4月20日。
