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

Bryce B. Reeve, Sandra A. Mitchell, Amylou Dueck, Ethan Basch, David Cella, Carolyn Miller Reilly, Lori M. Minasian, Andrea M. Denicoff, Ann M. O'Mara, Michael J. Fisch, Cynthia Chauhan, Neil K. Aaronson, Corneel Coens, Deborah Watkins Bruner

Research output: Contribution to journalArticle

108 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Article numberdju129
JournalJournal of the National Cancer Institute
Volume106
Issue number7
DOIs
StatePublished - Jul 9 2014

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Clinical Trials
Neoplasms
Consensus
Quality of Life
Patient Advocacy
National Cancer Institute (U.S.)
Sleep Initiation and Maintenance Disorders
Anorexia
Appetite
Constipation
Therapeutics
Dyspnea
Nausea
Observational Studies
Fatigue
Diarrhea
Anxiety
Depression
Pain
Health

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. / Reeve, Bryce B.; Mitchell, Sandra A.; Dueck, Amylou; Basch, Ethan; Cella, David; Reilly, Carolyn Miller; Minasian, Lori M.; Denicoff, Andrea M.; O'Mara, Ann M.; Fisch, Michael J.; Chauhan, Cynthia; Aaronson, Neil K.; Coens, Corneel; Bruner, Deborah Watkins.

In: Journal of the National Cancer Institute, Vol. 106, No. 7, dju129, 09.07.2014.

Research output: Contribution to journalArticle

Reeve, BB, Mitchell, SA, Dueck, A, Basch, E, Cella, D, Reilly, CM, Minasian, LM, Denicoff, AM, O'Mara, AM, Fisch, MJ, Chauhan, C, Aaronson, NK, Coens, C & Bruner, DW 2014, 'Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials', Journal of the National Cancer Institute, vol. 106, no. 7, dju129. https://doi.org/10.1093/jnci/dju129
Reeve, Bryce B. ; Mitchell, Sandra A. ; Dueck, Amylou ; Basch, Ethan ; Cella, David ; Reilly, Carolyn Miller ; Minasian, Lori M. ; Denicoff, Andrea M. ; O'Mara, Ann M. ; Fisch, Michael J. ; Chauhan, Cynthia ; Aaronson, Neil K. ; Coens, Corneel ; Bruner, Deborah Watkins. / Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. In: Journal of the National Cancer Institute. 2014 ; Vol. 106, No. 7.
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AU - Reilly, Carolyn Miller

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AU - Denicoff, Andrea M.

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