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
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.