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

Publication ,  Journal Article
Reeve, BB; Mitchell, SA; Dueck, AC; Basch, E; Cella, D; Reilly, CM; Minasian, LM; Denicoff, AM; O'Mara, AM; Fisch, MJ; Chauhan, C; Coens, C ...
Published in: J Natl Cancer Inst
July 2014

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.

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Published In

J Natl Cancer Inst

DOI

EISSN

1460-2105

Publication Date

July 2014

Volume

106

Issue

7

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Surveys and Questionnaires
  • Sleep Initiation and Maintenance Disorders
  • Severity of Illness Index
  • Self Report
  • Quality of Life
  • Prevalence
  • Peripheral Nervous System Diseases
  • Pain
 

Citation

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Reeve, B. B., Mitchell, S. A., Dueck, A. C., Basch, E., Cella, D., Reilly, C. M., … Bruner, D. W. (2014). Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst, 106(7). https://doi.org/10.1093/jnci/dju129
Reeve, Bryce B., Sandra A. Mitchell, Amylou C. Dueck, Ethan Basch, David Cella, Carolyn Miller Reilly, Lori M. Minasian, et al. “Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials.J Natl Cancer Inst 106, no. 7 (July 2014). https://doi.org/10.1093/jnci/dju129.
Reeve BB, Mitchell SA, Dueck AC, Basch E, Cella D, Reilly CM, et al. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst. 2014 Jul;106(7).
Reeve, Bryce B., et al. “Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials.J Natl Cancer Inst, vol. 106, no. 7, July 2014. Pubmed, doi:10.1093/jnci/dju129.
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. Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst. 2014 Jul;106(7).
Journal cover image

Published In

J Natl Cancer Inst

DOI

EISSN

1460-2105

Publication Date

July 2014

Volume

106

Issue

7

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Surveys and Questionnaires
  • Sleep Initiation and Maintenance Disorders
  • Severity of Illness Index
  • Self Report
  • Quality of Life
  • Prevalence
  • Peripheral Nervous System Diseases
  • Pain