Recruitment of Patients With Cancer for a Clinical Trial Evaluating a Web-Based Psycho-Oncological Intervention: Secondary Analysis of a Diversified Recruitment Strategy in a Randomized Controlled Trial.

Background: 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.

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Trial registration: German Clinical Trials Register DRKS00021144; https://drks.de/search/en/trial/DRKS00021144.

International registered report identifier (irrid): RR2-10.1016/j.invent.2021.100410.