Berkman AM, Murphy KM, Siembida EJ, Lau N, Geng Y, Parsons SK, Salsman JM, Roth ME. Inclusion of Patient-Reported Outcomes in Adolescent and Young Adult Phase III Therapeutic Trials: An Analysis of Cancer Clinical Trials Registered on ClinicalTrials.gov. Value Health. 2021 Dec;24(12):1820-1827. doi: 10.1016/j.jval.2021.06.012. Epub 2021 Aug 8. PubMed PMID: 34838280; PubMed Central PMCID: PMC8630401.
Study ID Citation
Abstract
There is a paucity of research on the impact of cancer treatment on the health-related quality of life (HRQOL) of adolescent and young adult (AYA) cancer patients. Patient-reported outcomes (PROs) are self-report measures used to assess HRQOL and symptom burden. The extent to which PROs have been included in trials that include common AYA cancer types has not been previously assessed. Therapeutic phase 3 trials among common AYA cancer types (Hodgkin lymphoma, non-Hodgkin lymphoma, acute lymphoblastic leukemia, sarcomas, and germ cell tumors) initiated between 2007 and 2020 were identified on Clinicaltrials.gov. The proportions and characteristics of trials including a PRO endpoint were assessed. For comparison to an older population, the proportion of breast and colorectal therapeutic phase 3 trials including PRO endpoints were assessed.