Tsiouris Angeliki, Mayer Anna, Wiltink Jörg, Ruckes Christian, Beutel Manfred E, Zwerenz Rüdiger
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
Interdisciplinary Center for Clinical Trials, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
JMIR Cancer. 2023 Nov 27;9:e42123. doi: 10.2196/42123.
Participant recruitment poses challenges in psycho-oncological intervention research, such as psycho-oncological web-based intervention studies. Strict consecutive recruitment in clinical settings provides important methodological benefits but is often associated with low response rates and reduced practicability and ecological validity. In addition to preexisting recruitment barriers, the protective measures owing to the COVID-19 pandemic restricted recruitment activities in the clinical setting since March 2020.
This study aims to outline the recruitment strategy for a randomized controlled trial evaluating the unguided emotion-based psycho-oncological online self-help (epos), which combined traditional and web-based recruitment.
We developed a combined recruitment strategy including traditional (eg, recruitment in clinics, medical practices, cancer counseling centers, and newspapers) and web-based recruitment (Instagram, Facebook, and web pages). Recruitment was conducted between May 2020 and September 2021. Eligible participants for this study were adult patients with any type of cancer who were currently receiving treatment or in posttreatment care. They were also required to have a good command of the German language and access to a device suitable for web-based interventions, such as a laptop or computer.
We analyzed data from 304 participants who were enrolled in a 17-month recruitment period using various recruitment strategies. Web-based and traditional recruitment strategies led to comparable numbers of participants (151/304, 49.7% vs 153/304, 50.3%). However, web-based recruitment required much less effort. Regardless of the recruitment strategy, the total sample did not accurately represent patients with cancer currently undergoing treatment for major types of cancer in terms of various sociodemographic characteristics, including but not limited to sex and age. However, among the web-recruited study participants, the proportion of female participants was even higher (P<.001), the mean age was lower (P=.005), private internet use was higher (on weekdays: P=.007; on weekends: P=.02), and the number of those who were currently under treatment was higher (P=.048). Other demographic and medical characteristics revealed no significant differences between the groups. The majority of participants registered as self-referred (236/296, 79.7%) instead of having followed the recommendation of or study invitation from a health care professional.
The combined recruitment strategy helped overcome general and COVID-19-specific recruitment barriers and provided the targeted participant number. Social media recruitment was the most efficient individual recruitment strategy for participant enrollment. Differences in some demographic and medical characteristics emerged, which should be considered in future analyses. Implications and recommendations for social media recruitment based on personal experiences are presented.
German Clinical Trials Register DRKS00021144; https://drks.de/search/en/trial/DRKS00021144.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1016/j.invent.2021.100410.
在心理肿瘤学干预研究中，如基于网络的心理肿瘤学干预研究，参与者招募面临挑战。在临床环境中严格的连续招募具有重要的方法学优势，但往往与低响应率、实用性降低和生态效度降低相关。除了先前存在的招募障碍外，自2020年3月以来，由于COVID-19大流行而采取的保护措施限制了临床环境中的招募活动。
本研究旨在概述一项随机对照试验的招募策略，该试验评估了基于情感的非指导性心理肿瘤学在线自助干预（epos），该干预结合了传统招募和基于网络的招募。
我们制定了一种综合招募策略，包括传统招募（如在诊所、医疗实践机构、癌症咨询中心和报纸上招募）和基于网络的招募（Instagram、Facebook和网页）。招募于2020年5月至2021年9月进行。本研究的合格参与者为正在接受治疗或处于治疗后护理阶段的任何类型癌症的成年患者。他们还需要精通德语，并能使用适合基于网络干预的设备，如笔记本电脑或计算机。
我们分析了在为期17个月的招募期内使用各种招募策略招募的304名参与者的数据。基于网络的招募策略和传统招募策略招募的参与者数量相当（151/304，49.7%对153/304，50.3%）。然而，基于网络的招募所需的工作量要少得多。无论采用何种招募策略，就包括但不限于性别和年龄在内的各种社会人口学特征而言，总样本均不能准确代表目前正在接受主要癌症类型治疗的癌症患者。然而，在通过网络招募的研究参与者中，女性参与者的比例更高（P<0.001），平均年龄更低（P=0.005），私人互联网使用频率更高（工作日：P=0.007；周末：P=0.02），目前正在接受治疗的人数更多（P=0.048）。其他人口统计学和医学特征在两组之间没有显著差异。大多数参与者是自行报名的（236/296，79.7%），而不是听从医疗保健专业人员的建议或研究邀请。
综合招募策略有助于克服一般的和COVID-19特定的招募障碍，并提供了目标参与者数量。社交媒体招募是参与者招募中最有效的个体招募策略。出现了一些人口统计学和医学特征方面的差异，在未来的分析中应予以考虑。基于个人经验提出了社交媒体招募的影响和建议。
德国临床试验注册中心DRKS00021144；https://drks.de/search/en/trial/DRKS00021144。
国际注册报告识别码（IRRID）：RR2-10.1016/j.invent.2021.100410。
