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. 2014 Jul 8;106(7):dju132.
doi: 10.1093/jnci/dju132. Print 2014 Jul.

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

Ronald C Chen  1 , Peter Chang  2 , Richard J Vetter  2 , Himansu Lukka  2 , William A Stokes  2 , Martin G Sanda  2 , Deborah Watkins-Bruner  2 , Bryce B Reeve  2 , Howard M Sandler  2
Affiliations

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

Ronald C Chen et al. J Natl Cancer Inst. .

Abstract

The National Cancer Institute (NCI) Symptom Management and Health-Related Quality of Life Steering Committee convened four working groups to recommend core sets of patient-reported outcomes to be routinely incorporated in clinical trials. The Prostate Cancer Working Group included physicians, researchers, and a patient advocate. The group's process included 1) a systematic literature review to determine the prevalence and severity of symptoms, 2) a multistakeholder meeting sponsored by the NCI to review the evidence and build consensus, and 3) a postmeeting expert panel synthesis of findings to finalize recommendations. Five domains were recommended for localized prostate cancer: urinary incontinence, urinary obstruction and irritation, bowel-related symptoms, sexual dysfunction, and hormonal symptoms. Four domains were recommended for advanced prostate cancer: pain, fatigue, mental well-being, and physical well-being. Additional domains for consideration include decisional regret, satisfaction with care, and anxiety related to prostate cancer. These recommendations have been endorsed by the NCI for implementation.

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Flowchart of the selection process of articles for the literature review.
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