Custers José A E, Döking Sarah, van der Hoeven Yvonne C W, Thewes Belinda, Dekker Joost, Braamse Annemarie M J, Prins Judith B
Department of Medical Psychology, Radboud University Medical Center, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.
University of Sydney, Camperdown, New South Wales, Australia.
Psychooncology. 2023 Apr;32(4):558-568. doi: 10.1002/pon.6100. Epub 2023 Jan 23.
High psychological distress is reported by one third of colorectal cancer survivors (CRCS). However, intervention studies for CRCS have reported low participation rates. In this study, reasons for non-participation and low uptake in a psychological intervention trial were investigated.
CRCS were recruited for a randomized clinical trial on the efficacy of blended cognitive behavior therapy for psychological distress via databases, follow-up consultations, advertisements and an ongoing population-based study. The recruitment flow and reasons for non-participation were analyzed for patients recruited between 2016 and 2020. Subgroups were compared based on demographic, clinical and screening data. High distress as study entry criterion was measured with the Distress Thermometer (DT ≥ 5) and the problem list (PL).
From all recruitment methods together, 1326 CRCS responded to the invitation letter of whom 510 (38%) were interested in receiving a screening questionnaire. Interested CRCS were significantly younger than non-interested CRCS (p < 0.001). Most non-interested CRCS reported having no complaints. Of interested CRCS, 448 (88%) completed screening with the DT of which 213 (48%) CRCS scored above the DT cutoff for high distress. The majority expressed no need for help resulting in 84 (4% of eligible) CRCS included in the trial. Younger age, shorter time since diagnosis and more problems on the PL were positively related to participation.
In this study a low participation rate was found. However, patients with high distress and most in need for help were included in the trial. For future research it is recommended to perform pilot- and feasibility studies to optimize recruitment.
据报道，三分之一的结直肠癌幸存者（CRCS）存在高度心理困扰。然而，针对CRCS的干预研究报告显示参与率较低。在本研究中，对一项心理干预试验中不参与和参与率低的原因进行了调查。
通过数据库、随访咨询、广告以及一项正在进行的基于人群的研究，招募CRCS参与一项关于混合认知行为疗法对心理困扰疗效的随机临床试验。分析了2016年至2020年期间招募患者的招募流程和不参与原因。根据人口统计学、临床和筛查数据对亚组进行比较。使用苦恼温度计（DT≥5）和问题清单（PL）来衡量作为研究入选标准的高度困扰。
综合所有招募方法，1326名CRCS回复了邀请信，其中510名（38%）有兴趣接收筛查问卷。有兴趣的CRCS明显比无兴趣的CRCS年轻（p<0.001）。大多数无兴趣的CRCS表示没有不适。在有兴趣的CRCS中，448名（88%）完成了DT筛查，其中213名（48%）CRCS的DT得分高于高度困扰的截断值。大多数人表示不需要帮助，因此试验纳入了84名（符合条件者的4%）CRCS。年龄较小、诊断后时间较短以及PL上问题较多与参与呈正相关。
在本研究中发现参与率较低。然而，高度困扰且最需要帮助的患者被纳入了试验。对于未来的研究，建议进行试点和可行性研究以优化招募。
