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

Identifieur interne : 001267 ( Main/Exploration ); précédent : 001266; suivant : 001268

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

Auteurs : Bryce B. Reeve [États-Unis] ; Sandra A. Mitchell ; Amylou C. 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

Source :

RBID : pubmed:25006191

Descripteurs français

English descriptors

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.


DOI: 10.1093/jnci/dju129
PubMed: 25006191
PubMed Central: PMC4110472


Affiliations:


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Le document en format XML

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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo). bbreeve@email.unc.edu.</nlm:affiliation>
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<name sortKey="Fisch, Michael J" sort="Fisch, Michael J" uniqKey="Fisch M" first="Michael J" last="Fisch">Michael J. Fisch</name>
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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
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<name sortKey="Chauhan, Cynthia" sort="Chauhan, Cynthia" uniqKey="Chauhan C" first="Cynthia" last="Chauhan">Cynthia Chauhan</name>
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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
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<title xml:lang="en">Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials.</title>
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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo). bbreeve@email.unc.edu.</nlm:affiliation>
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<name sortKey="Basch, Ethan" sort="Basch, Ethan" uniqKey="Basch E" first="Ethan" last="Basch">Ethan Basch</name>
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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
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<name sortKey="Cella, David" sort="Cella, David" uniqKey="Cella D" first="David" last="Cella">David Cella</name>
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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
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<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
<wicri:noCountry code="subField">Belgium (CCo)</wicri:noCountry>
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<name sortKey="Minasian, Lori M" sort="Minasian, Lori M" uniqKey="Minasian L" first="Lori M" last="Minasian">Lori M. Minasian</name>
<affiliation>
<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
<wicri:noCountry code="subField">Belgium (CCo)</wicri:noCountry>
</affiliation>
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<name sortKey="Denicoff, Andrea M" sort="Denicoff, Andrea M" uniqKey="Denicoff A" first="Andrea M" last="Denicoff">Andrea M. Denicoff</name>
<affiliation>
<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
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<author>
<name sortKey="O Mara, Ann M" sort="O Mara, Ann M" uniqKey="O Mara A" first="Ann M" last="O'Mara">Ann M. O'Mara</name>
<affiliation>
<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
<wicri:noCountry code="subField">Belgium (CCo)</wicri:noCountry>
</affiliation>
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<author>
<name sortKey="Fisch, Michael J" sort="Fisch, Michael J" uniqKey="Fisch M" first="Michael J" last="Fisch">Michael J. Fisch</name>
<affiliation>
<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
<wicri:noCountry code="subField">Belgium (CCo)</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Chauhan, Cynthia" sort="Chauhan, Cynthia" uniqKey="Chauhan C" first="Cynthia" last="Chauhan">Cynthia Chauhan</name>
<affiliation>
<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
<wicri:noCountry code="subField">Belgium (CCo)</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Aaronson, Neil K" sort="Aaronson, Neil K" uniqKey="Aaronson N" first="Neil K" last="Aaronson">Neil K. Aaronson</name>
<affiliation>
<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
<wicri:noCountry code="subField">Belgium (CCo)</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Coens, Corneel" sort="Coens, Corneel" uniqKey="Coens C" first="Corneel" last="Coens">Corneel Coens</name>
<affiliation>
<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
<wicri:noCountry code="subField">Belgium (CCo)</wicri:noCountry>
</affiliation>
</author>
<author>
<name sortKey="Bruner, Deborah Watkins" sort="Bruner, Deborah Watkins" uniqKey="Bruner D" first="Deborah Watkins" last="Bruner">Deborah Watkins Bruner</name>
<affiliation>
<nlm:affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</nlm:affiliation>
<wicri:noCountry code="subField">Belgium (CCo)</wicri:noCountry>
</affiliation>
</author>
</analytic>
<series>
<title level="j">Journal of the National Cancer Institute</title>
<idno type="eISSN">1460-2105</idno>
<imprint>
<date when="2014" type="published">2014</date>
</imprint>
</series>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Adult (MeSH)</term>
<term>Anorexia (etiology)</term>
<term>Anxiety (etiology)</term>
<term>Clinical Trials as Topic (methods)</term>
<term>Clinical Trials as Topic (standards)</term>
<term>Clinical Trials as Topic (trends)</term>
<term>Cognitive Dysfunction (etiology)</term>
<term>Constipation (etiology)</term>
<term>Depression (etiology)</term>
<term>Diarrhea (etiology)</term>
<term>Dyspnea (etiology)</term>
<term>Fatigue (etiology)</term>
<term>Female (MeSH)</term>
<term>Health Status (MeSH)</term>
<term>Humans (MeSH)</term>
<term>National Cancer Institute (U.S.) (MeSH)</term>
<term>Neoplasms (complications)</term>
<term>Neoplasms (epidemiology)</term>
<term>Neoplasms (physiopathology)</term>
<term>Neoplasms (psychology)</term>
<term>Neoplasms (therapy)</term>
<term>Outcome Assessment, Health Care (MeSH)</term>
<term>Pain (etiology)</term>
<term>Peripheral Nervous System Diseases (etiology)</term>
<term>Prevalence (MeSH)</term>
<term>Quality of Life (MeSH)</term>
<term>Self Report (MeSH)</term>
<term>Severity of Illness Index (MeSH)</term>
<term>Sleep Initiation and Maintenance Disorders (etiology)</term>
<term>Surveys and Questionnaires (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
<term>United States (epidemiology)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr">
<term>Adulte (MeSH)</term>
<term>Anorexie (étiologie)</term>
<term>Anxiété (étiologie)</term>
<term>Autorapport (MeSH)</term>
<term>Constipation (étiologie)</term>
<term>Diarrhée (étiologie)</term>
<term>Douleur (étiologie)</term>
<term>Dysfonctionnement cognitif (étiologie)</term>
<term>Dyspnée (étiologie)</term>
<term>Dépression (étiologie)</term>
<term>Enquêtes et questionnaires (MeSH)</term>
<term>Essais cliniques comme sujet (méthodes)</term>
<term>Essais cliniques comme sujet (normes)</term>
<term>Essais cliniques comme sujet (tendances)</term>
<term>Fatigue (étiologie)</term>
<term>Femelle (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Indice de gravité de la maladie (MeSH)</term>
<term>National Cancer Institute (USA) (MeSH)</term>
<term>Neuropathies périphériques (étiologie)</term>
<term>Prévalence (MeSH)</term>
<term>Qualité de vie (MeSH)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Troubles de l'endormissement et du maintien du sommeil (étiologie)</term>
<term>Tumeurs (complications)</term>
<term>Tumeurs (physiopathologie)</term>
<term>Tumeurs (psychologie)</term>
<term>Tumeurs (thérapie)</term>
<term>Tumeurs (épidémiologie)</term>
<term>État de santé (MeSH)</term>
<term>États-Unis (épidémiologie)</term>
</keywords>
<keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en">
<term>United States</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en">
<term>Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en">
<term>Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en">
<term>Anorexia</term>
<term>Anxiety</term>
<term>Cognitive Dysfunction</term>
<term>Constipation</term>
<term>Depression</term>
<term>Diarrhea</term>
<term>Dyspnea</term>
<term>Fatigue</term>
<term>Pain</term>
<term>Peripheral Nervous System Diseases</term>
<term>Sleep Initiation and Maintenance Disorders</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Clinical Trials as Topic</term>
</keywords>
<keywords scheme="MESH" qualifier="méthodes" xml:lang="fr">
<term>Essais cliniques comme sujet</term>
</keywords>
<keywords scheme="MESH" qualifier="normes" xml:lang="fr">
<term>Essais cliniques comme sujet</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr">
<term>Tumeurs</term>
</keywords>
<keywords scheme="MESH" qualifier="physiopathology" xml:lang="en">
<term>Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="psychologie" xml:lang="fr">
<term>Tumeurs</term>
</keywords>
<keywords scheme="MESH" qualifier="psychology" xml:lang="en">
<term>Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="standards" xml:lang="en">
<term>Clinical Trials as Topic</term>
</keywords>
<keywords scheme="MESH" qualifier="tendances" xml:lang="fr">
<term>Essais cliniques comme sujet</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="thérapie" xml:lang="fr">
<term>Tumeurs</term>
</keywords>
<keywords scheme="MESH" qualifier="trends" xml:lang="en">
<term>Clinical Trials as Topic</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr">
<term>Tumeurs</term>
<term>États-Unis</term>
</keywords>
<keywords scheme="MESH" qualifier="étiologie" xml:lang="fr">
<term>Anorexie</term>
<term>Anxiété</term>
<term>Constipation</term>
<term>Diarrhée</term>
<term>Douleur</term>
<term>Dysfonctionnement cognitif</term>
<term>Dyspnée</term>
<term>Dépression</term>
<term>Fatigue</term>
<term>Neuropathies périphériques</term>
<term>Troubles de l'endormissement et du maintien du sommeil</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Female</term>
<term>Health Status</term>
<term>Humans</term>
<term>National Cancer Institute (U.S.)</term>
<term>Outcome Assessment, Health Care</term>
<term>Prevalence</term>
<term>Quality of Life</term>
<term>Self Report</term>
<term>Severity of Illness Index</term>
<term>Surveys and Questionnaires</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr">
<term>Adulte</term>
<term>Autorapport</term>
<term>Enquêtes et questionnaires</term>
<term>Femelle</term>
<term>Humains</term>
<term>Indice de gravité de la maladie</term>
<term>National Cancer Institute (USA)</term>
<term>Prévalence</term>
<term>Qualité de vie</term>
<term>Résultat thérapeutique</term>
<term>État de santé</term>
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<term>États-Unis</term>
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<front>
<div type="abstract" xml:lang="en">
<p>
<b>BACKGROUND</b>
</p>
<p>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).</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>METHODS</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>RESULTS</b>
</p>
<p>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.</p>
</div>
<div type="abstract" xml:lang="en">
<p>
<b>CONCLUSIONS</b>
</p>
<p>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.</p>
</div>
</front>
</TEI>
<pubmed>
<MedlineCitation Status="MEDLINE" Owner="NLM">
<PMID Version="1">25006191</PMID>
<DateCompleted>
<Year>2014</Year>
<Month>08</Month>
<Day>11</Day>
</DateCompleted>
<DateRevised>
<Year>2019</Year>
<Month>12</Month>
<Day>10</Day>
</DateRevised>
<Article PubModel="Electronic-Print">
<Journal>
<ISSN IssnType="Electronic">1460-2105</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>106</Volume>
<Issue>7</Issue>
<PubDate>
<Year>2014</Year>
<Month>Jul</Month>
</PubDate>
</JournalIssue>
<Title>Journal of the National Cancer Institute</Title>
<ISOAbbreviation>J Natl Cancer Inst</ISOAbbreviation>
</Journal>
<ArticleTitle>Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials.</ArticleTitle>
<ELocationID EIdType="doi" ValidYN="Y">10.1093/jnci/dju129</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">dju129</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="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).</AbstractText>
<AbstractText Label="METHODS" NlmCategory="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.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="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.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="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.</AbstractText>
<CopyrightInformation>© The Author 2014. Published by Oxford University Press. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y">
<Author ValidYN="Y">
<LastName>Reeve</LastName>
<ForeName>Bryce B</ForeName>
<Initials>BB</Initials>
<AffiliationInfo>
<Affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo). bbreeve@email.unc.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Mitchell</LastName>
<ForeName>Sandra A</ForeName>
<Initials>SA</Initials>
<AffiliationInfo>
<Affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Dueck</LastName>
<ForeName>Amylou C</ForeName>
<Initials>AC</Initials>
<AffiliationInfo>
<Affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Basch</LastName>
<ForeName>Ethan</ForeName>
<Initials>E</Initials>
<AffiliationInfo>
<Affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Cella</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
<AffiliationInfo>
<Affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Reilly</LastName>
<ForeName>Carolyn Miller</ForeName>
<Initials>CM</Initials>
<AffiliationInfo>
<Affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
<LastName>Minasian</LastName>
<ForeName>Lori M</ForeName>
<Initials>LM</Initials>
<AffiliationInfo>
<Affiliation>Affiliations of authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC (BBR, EB); Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD (SAM); Division of Cancer Prevention, National Cancer Institute, Bethesda, MD (LMM and AMO); Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (AMD); Division of Health Sciences Research, Mayo Clinic, Scottsdale, AZ (ACD); Feinberg School of Medicine, Northwestern University, Chicago, IL (DC); Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA (CMR, DWB); Department of General Oncology, MD Anderson Cancer Center, Houston, TX (MJF); Mayo Clinic Breast SPORE, Rochester, MN (CCh); Department of Psychological Research, The Netherlands Cancer Institute, Amsterdam, The Netherlands (NKA); Quality of Life Department, European Organization for the Research and Treatment of Cancer, Brussels, Belgium (CCo).</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y">
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