SynthesisJournal of the National Cancer Institute2014
Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials.
Abstract readConsensus Development Conference, NIHSystematic Review
In one paragraph
Synthesis in Journal of the National Cancer Institute, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 154 papers, 11 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
154citing papers in PubMed, 11 pooled it
–field-weighted citation impact
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
154 citing papers in PubMed, 11 syntheses or guidelines pooled it.
- Toxicity profiles of antibody-drug conjugates for anticancer treatment: a systematic review and meta-analysis.JNCI cancer spectrum · 2023Pooled it
- Systematic review of the use of translated patient-reported outcome measures in cancer trials.Trials · 2021Pooled it
- Development of a core outcome set for myelodysplastic syndromes - a Delphi study from the EUMDS Registry Group.British journal of haematology · 2020Pooled it
- Quality of life in patients with gastroenteropancreatic tumours: A systematic literature review.World journal of gastroenterology · 2020Pooled it
- Efficacy of olanzapine for quality of life improvement among patients with malignant tumor: A systematic review.Cancer reports (Hoboken, N.J.) · 2019Pooled it
- The management strategies of cancer-associated anorexia: a critical appraisal of systematic reviews.BMC complementary and alternative medicine · 2018Pooled it
- Safety and Tolerability of PD-1/PD-L1 Inhibitors Compared with Chemotherapy in Patients with Advanced Cancer: A Meta-Analysis.The oncologist · 2017Pooled it
- Systematic review reveals lack of quality in reporting health-related quality of life in patients with gastroenteropancreatic neuroendocrine tumours.Health and quality of life outcomes · 2016Pooled it
- Recommended patient-reported core set of symptoms to measure in prostate cancer treatment trials.Journal of the National Cancer Institute · 2014Pooled it
- Hypnosis for Symptom Control in Cancer Patients at the End-of-Life: A Systematic Review.The International journal of clinical and experimental hypnosisPooled it
- The Effectiveness of Immersive Virtual Reality as A Complementary Approach and a New Direction in Cancer Related Fatigue Management.Integrative cancer therapiesPooled it
- The Effect of Laughter Yoga on Chemotherapy-Induced Symptoms and Sleep Quality in Patients with Haematologic Cancer.Asian Pacific journal of cancer prevention : APJCP · 2025Trial
- Quality of life outcomes in patients participating in the CALGB 30610 trial (CALGB 70702): Alliance.Cancer · 2025Trial
- Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial.International journal of radiation oncology, biology, physics · 2024Trial
- Implementation of Patient-Reported Outcomes in a Medical Oncology Setting (the iPROMOS Study): Type II Hybrid Implementation Study.Journal of medical Internet research · 2024Trial
- Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Equivalence testing of a newly developed interviewer-led telephone script for the EORTC QLQ-C30.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022Trial
- Electronic Patient Reporting of Adverse Events and Quality of Life: A Prospective Feasibility Study in General Oncology.JCO oncology practice · 2021Trial
- Microbial Diversity and Composition Is Associated with Patient-Reported Toxicity during Chemoradiation Therapy for Cervical Cancer.International journal of radiation oncology, biology, physics · 2020Trial
- Development and evaluation of the Cancer Symptom Management System: Symptom Management Improves your LifE (SMILE)-a randomized controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Trial
94 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
14 authors.
Bryce B ReeveAffiliations 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.
Sandra A MitchellAffiliations 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).
Amylou C DueckAffiliations 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).
Ethan BaschAffiliations 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).
David CellaAffiliations 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).
Carolyn Miller ReillyAffiliations 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).
Lori M MinasianAffiliations 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).
Andrea M DenicoffAffiliations 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).
Ann M O'MaraAffiliations 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).
Michael J FischAffiliations 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).
Cynthia ChauhanAffiliations 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).
Neil K AaronsonAffiliations 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).
Corneel CoensAffiliations 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).
Deborah Watkins BrunerAffiliations 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).
Funding
Virology Research Program (Program 4)P30CA016086 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Deborah F. Tate · 1985 to 2026
$201.5MNCI NIH HHS P30 CA016086
Abstract
backgroundThe 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).
methodsWe 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.
resultsWe 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.
conclusionsThis 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.
Indexed as
Quality of LifeSelf ReportAdultAnorexiaAnxietyClinical Trials as TopicCognitive DysfunctionConstipationDepressionDiarrheaDyspneaFatigueFemaleHealth StatusHumansNational Cancer Institute (U.S.)
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