Daley Amanda J, Crank Helen, Mutrie Nanette, Saxton John M, Coleman Robert
The Department of Primary Care and General Practice, The Medical School, Clinical Sciences Building, University of Birmingham, Birmingham B15 2TT, UK.
Contemp Clin Trials. 2007 Sep;28(5):603-13. doi: 10.1016/j.cct.2007.02.009. Epub 2007 Mar 6.
The purpose of this study was to determine the effectiveness of different recruitment strategies used to recruit patients into the Sheffield Exercise and Breast Cancer Trial (SHERBERT), which involved exercise as a therapy, in sedentary women treated for breast cancer. We also evaluated whether the routes of recruitment distinguished patients participating in the trial in terms of socio-economic characteristics, lifestyle behaviours, cancer treatment(s), treatment side effects, length of treatment and time since treatment was completed.
SHERBERT aimed to recruit at least 114 sedentary women, aged 18-65 years, who had been treated for breast cancer between 1 and 3 years previously, to receive exercise therapy, an equal contact exercise-placebo intervention or usual care. Potentially eligible patients were recruited by postal invitation letters from their treating clinician (i.e. oncologist/surgeon) or by a range of community strategies.
We identified 572 potentially eligible patients via our various recruitment strategies. The response rate to clinician invitation letters was 39.3% (N=148/377), of patients who responded and remained available and interested (N=112) 46.4% (N=52) were eligible to be randomised. The community strategies derived a total of 195 interested responses, of these 66 patients (33.8%) were eligible to be randomised. On the basis of recruitment via clinician invitation letter we estimated the trial recruitment rate amongst eligible patients to be 28.6%. A total of 108 patients were eventually randomised. Responders to clinician invitation letters were more affluent compared to non-responders. Randomised patients recruited via different strategies did not vary significantly in terms of their socio-economic characteristics, lifestyle behaviours or variables related to cancer treatment.
The number of patients randomised was marginally lower than anticipated. We were able to identify and highlight valuable information for planning the recruitment of future trials involving similar populations.
本研究旨在确定不同招募策略用于招募患者参加谢菲尔德运动与乳腺癌试验（SHERBERT）的有效性，该试验将运动作为一种疗法应用于接受乳腺癌治疗的久坐女性。我们还评估了招募途径是否能根据社会经济特征、生活方式行为、癌症治疗方式、治疗副作用、治疗时长以及治疗结束后的时间，区分参与试验的患者。
SHERBERT旨在招募至少114名年龄在18 - 65岁之间、在1至3年前接受过乳腺癌治疗的久坐女性，她们将接受运动疗法、同等接触的运动安慰剂干预或常规护理。潜在符合条件的患者通过其主治医生（即肿瘤学家/外科医生）发出的邮政邀请信，或一系列社区策略进行招募。
通过各种招募策略，我们确定了572名潜在符合条件的患者。对医生邀请信的回复率为39.3%（N = 148/377），在回复且仍有空余时间并感兴趣的患者中（N = 112），46.4%（N = 52）有资格被随机分组。社区策略共收到195份感兴趣的回复，其中66名患者（33.8%）有资格被随机分组。基于通过医生邀请信进行的招募，我们估计符合条件的患者中试验招募率为28.6%。最终共有108名患者被随机分组。与未回复者相比，回复医生邀请信的患者更富裕。通过不同策略招募的随机分组患者在社会经济特征、生活方式行为或与癌症治疗相关的变量方面没有显著差异。
随机分组的患者数量略低于预期。我们能够识别并突出为规划未来涉及类似人群的试验招募提供有价值的信息。
