Peer-reviewed article
Identifying caregiver-reported modifiable barriers to pediatric oncology clinical trial enrollment and participation.
Whitmire R, Wikstrom D, Lockridge R, Holland E, Van Sprang A et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This study surveyed caregivers of children with cancer to understand why some families do not participate in clinical trials. The researchers found that families with lower income, limited health literacy, and unmet material needs reported more barriers to trial participation. The most common barrier was difficulty understanding the risks involved in clinical trials. These barriers are potentially modifiable through better communication and support.
Key points
- 62% of surveyed caregivers reported their child had not participated in a clinical trial
- Under-resourced caregivers reported significantly higher barriers to trial participation than adequately resourced caregivers (p = 0.001)
- Lower health literacy and higher household material hardship were both strongly associated with more reported barriers (correlations of -0.51 and 0.57 respectively, both p < 0.001)
- Over 90% of caregivers identified difficulty understanding study risks as a barrier
- 64% of participants were socioeconomically under-resourced, and 52.5% identified as racially or ethnically underrepresented
Limitations
The study was small (59 participants) and used an anonymous online survey, which may not capture all caregivers, particularly those with lower technology access or health literacy. The cross-sectional design cannot establish whether barriers cause non-participation or result from it.
Abstract
Purpose Clinical trial (ClTr) participation is critical to high-quality pediatric oncology care, but significant sociodemographic disparities in trial enrollment exist. Identifying modifiable barriers to participation such as household material hardship (HMH) and limited health literacy (HL) is essential to improving ClTr access. We compared differences in caregiver-reported barriers to pediatric oncology ClTr participation across socioeconomic status (SES) and racial and ethnic groups through a nationwide anonymous online survey of caregivers of children with cancer. We also explored associations among caregiver HL, HMH, and barriers to trial participation. Methods English- and/or Spanish-speaking caregivers of children diagnosed with cancer in the last 5 years completed the Research Participation Survey - Caregiver (RPS-C) assessing caregiver-reported barriers to ClTr participation, the validated Health Literacy Survey-12 (HLS19-Q12) assessing HL, and the WellRx questionnaire measuring unmet needs. Results Of 59 participants, 64% were socioeconomically under-resourced, 52.5% identified as racially or ethnically underrepresented per NIH criteria, and 62% reported their child had not participated in a ClTr. Under-resourced caregivers reported higher RPS-C barrier scores than adequately resourced caregivers (z = 3.18, p = 0.001). There were no significant differences in barrier scores across underrepresented vs represented racial and ethnic groups (p = 0.069). Lower HL (rho = -0.51, p < 0.001) and higher HMH (rho = 0.57, p < 0.001) were associated with higher barrier scores. The most frequently identified barrier was difficulty understanding study risks (> 90%). Conclusions Under-resourced SES, HMH, and lower HL were associated with increased reported barriers to ClTr participation. Caregivers reported modifiable barriers that could be targets for intervention to improve ClTr participation and reduce disparities in childhood cancer outcomes.