Feasibility of oncology clinical trial-embedded evaluation of social determinants of health.
Rahela Aziz-BoseDaniel J ZhengPuja J UmaretiyaLenka A IlcisinKristen StevensonVictoria KochAriana ValenzuelaPeter D ColeLisa M GennariniJustine M KahnKara M KellyThai Hoa TranBruno MichonJennifer J G WelchLewis B SilvermanJoanne WolfeKira O BonaPublished in: Pediatric blood & cancer (2022)
Social determinants of health (SDoH) are associated with stark disparities in cancer outcomes, but systematic SDoH data collection is virtually absent from oncology clinical trials. Trial-based SDoH data are essential to ensure representation of marginalized populations, contextualize outcome disparities, and identify health-equity intervention opportunities. We report the feasibility of a pediatric oncology multicenter therapeutic trial-embedded SDoH investigation. Among 448 trial participants, 392 (87.5%) opted-in to the embedded SDoH study; 375 (95.7%) completed baseline surveys, with high longitudinal response rates (88.9-93.1%) over 24 months. Trial-embedded SDoH data collection is feasible and acceptable and must be consistently included within future oncology trials.
Keyphrases
- clinical trial
- phase ii
- phase iii
- study protocol
- palliative care
- healthcare
- public health
- open label
- mental health
- double blind
- electronic health record
- randomized controlled trial
- health information
- big data
- cross sectional
- papillary thyroid
- machine learning
- health promotion
- risk assessment
- placebo controlled
- human health
- skeletal muscle
- metabolic syndrome
- data analysis
- insulin resistance
- current status
- social media
- lymph node metastasis