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

TitleRecommended patient-reported core set of symptoms to measure in adult cancer treatment trials.
Publication TypeJournal Article
Year of Publication2014
AuthorsReeve 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
JournalJournal of the National Cancer Institute
Volume106
Issue7
Date Published2014 Jul
ISSN1460-2105
KeywordsAdult; Anorexia; Anxiety; Clinical Trials as Topic; Constipation; Depression; Diarrhea; Dyspnea; Fatigue; Female; Health Status; Humans; Mild Cognitive Impairment; National Cancer Institute (U.S.); Neoplasms; Outcome Assessment (Health Care); Pain; Peripheral Nervous System Diseases; Prevalence; Quality of Life; Questionnaires; Self Report; Severity of Illness Index; Sleep Initiation and Maintenance Disorders; Treatment Outcome; United States
AbstractBACKGROUND: 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.
DOI10.1093/jnci/dju129
Alternate JournalJ. Natl. Cancer Inst.