Trends in Patient-Reported Outcomes Measurement Information System (PROMIS) utilization in oncology research: A scoping review of ClinicalTrials.gov and PubMed (2015-2025).

Abstract

e23256 Background: PROMIS (Patient-Reported Outcomes Measurement Information System) has seen rapid adoption in clinical research, yet comprehensive trends in oncology-specific utilization over the past decade remain uncharacterized. Analysis of both ClinicalTrials.gov registry and PubMed published literature provides a comprehensive view of PROMIS utilization patterns, capturing both planned and completed research. This scoping review examined annual trends in PROMIS oncology use across ClinicalTrials.gov and PubMed from January 2015 through November 2025. Methods: ClinicalTrials.gov searched for trials and PubMed for studies registered between January 2015 and November 2025 using: (PROMIS OR "Patient-Reported Outcomes Measurement Information System") AND (oncology OR cancer OR malignancy). For ClinicalTrials.gov, data extraction was performed using Python scripts with AI assistance (Claude Opus 4.5, Anthropic), followed by manual validation. For PubMed, records . Extracted variables: year, PROMIS domain(s), cancer type, measure type (short form/CAT/profile), and intended respondent (adult/pediatric/parent-proxy). Results: From 2015 to 2025, annual oncology trial registrations grew from 27 to 154 (5.7-fold), while oncology publications with PROMIS increased from 28 to 191 (6.8-fold). Within clinical trials, the most frequently assessed PROMIS domains were Fatigue (n=192, 19%), Anxiety (n=172, 17%), and Depression (n=162, 16%). The most common cancer types were multiple/general cancer (n=358, 36%), breast cancer (n=258, 26%), and hematologic malignancies (n=106, 11%). Breast cancer-specific trials decreased proportionally (48% to 25%) while multiple/general-cancer studies increased (15% to 37%). Adult trials comprised 89% (n=898), growing from 26 to 137 annually. Pediatric and adolescent trials increased from 1 (2015) to 17 (2025), representing growth from 4% to 11% of oncology PROMIS trials. Conclusions: PROMIS utilization in oncology research has grown substantially over 11 years, with parallel trends observed across trial registrations and published literature. Fatigue, anxiety, and depression remain core assessment domains. Breast cancer-specific trials using PROMIS decreased (48% to 25%) while studies including multiple cancer types increased (15% to 37%).