Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials.

Journal Article (Journal Article;Review;Systematic Review)

BACKGROUND: The National Cancer Institute's Symptom Management and Health-Related Quality of Life Steering Committee held a clinical trials planning meeting (September 2011) to identify a core symptom set to be assessed across oncology trials for the purposes of better understanding treatment efficacy and toxicity and to facilitate cross-study comparisons. We report the results of an evidence-synthesis and consensus-building effort that culminated in recommendations for core symptoms to be measured in adult cancer clinical trials that include a patient-reported outcome (PRO). METHODS: We used a data-driven, consensus-building process. A panel of experts, including patient representatives, conducted a systematic review of the literature (2001-2011) and analyzed six large datasets. Results were reviewed at a multistakeholder meeting, and a final set was derived emphasizing symptom prevalence across diverse cancer populations, impact on health outcomes and quality of life, and attribution to either disease or anticancer treatment. RESULTS: We recommend that a core set of 12 symptoms--specifically fatigue, insomnia, pain, anorexia (appetite loss), dyspnea, cognitive problems, anxiety (includes worry), nausea, depression (includes sadness), sensory neuropathy, constipation, and diarrhea--be considered for inclusion in clinical trials where a PRO is measured. Inclusion of symptoms and other patient-reported endpoints should be well justified, hypothesis driven, and meaningful to patients. CONCLUSIONS: This core set will promote consistent assessment of common and clinically relevant disease- and treatment-related symptoms across cancer trials. As such, it provides a foundation to support data harmonization and continued efforts to enhance measurement of patient-centered outcomes in cancer clinical trials and observational studies.

Full Text

Duke Authors

Cited Authors

  • Reeve, BB; Mitchell, SA; Dueck, AC; Basch, E; Cella, D; Reilly, CM; Minasian, LM; Denicoff, AM; O'Mara, AM; Fisch, MJ; Chauhan, C; Aaronson, NK; Coens, C; Bruner, DW

Published Date

  • July 2014

Published In

Volume / Issue

  • 106 / 7

PubMed ID

  • 25006191

Pubmed Central ID

  • PMC4110472

Electronic International Standard Serial Number (EISSN)

  • 1460-2105

Digital Object Identifier (DOI)

  • 10.1093/jnci/dju129


  • eng

Conference Location

  • United States