OBJECTIVES: Patients’ own assessment of the impact of anti-cancer therapy has been considered important from a patient, physician, payor and regulatory perspective. Approximately 12% of all oncology clinical trials list at least one patient-reported outcome (PRO) measure; 50% of these are phase II trials. Use and publication of PROs results were systematically reviewed for breast, colorectal, ovarian and non-small cell lung cancer (NSCLC). METHODS: Citeline’s TrialTrove database was searched for oncology trials that included PROs and were planned, ongoing or completed as of October 2009. Specific trial factors examined include phase, disease type, location, sponsorship, type of PRO instrument(s) and publication of PRO endpoint results. RESULTS: Of the 5483 phase II trials retrieved for breast, colorectal, ovarian and NSCLC, 9% listed PROs. PRO measures were more frequently included in NSCLC (13%) and ovarian cancer (10%) than in breast (7%) or colorectal (8%) cancer phase II trials. Fifty-two percent of these trials were sponsored by industry, with 25% and 19% being sponsored by academic and cooperative groups, respectively. One-third of the trials were conducted in the United States only. PROs were most frequently measured with the EORTC and FACT series of questionnaires. Phase II PRO results were published 24%, 36% and 39% of the time for breast, ovarian, and NSCLC, respectively, and only 18% of the time for colorectal cancer. This compares with an overall publication frequency for PRO trials (any endpoints) of 58%-67% which was highest in NSCLC. PRO results were published more frequently for trials conducted in Asia or Europe. However, trial sponsorship did not impact publication frequency. CONCLUSIONS: PROs are infrequently assessed in phase II cancer trials. PRO measures were most frequently included in NSCLC trials and sponsored by industry. PRO results were published less frequently than other endpoints in these trials. Publication frequency differed by tumor type and trial location.