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International Psychometric Validation of an EORTC Quality of Life Module Measuring Cancer Related Fatigue (EORTC QLQ-FA12)
Open accessAbstract
Background: The European Organisation for Research and Treatment of Cancer (EORTC) Group has developed a new multidimensional instrument measuring cancer-related fatigue to be used in conjunction with the quality of life core questionnaire (EORTC QLQ-C30). The module EORTC QLQ-FA13 assesses physical, cognitive, and emotional aspects of cancer-related fatigue. Methods: The methodology follows the EORTC guidelines for phase IV validation of modules. This paper focuses on the results of the psychometric validation of the factorial structure of the module. For validation and cross-validation confirmatory factor analysis (maximum likelihood estimation), intraclass correlation and Cronbach alpha for internal consistency were employed. The study involved an international multicenter collaboration of 11 European and non-European countries. Results: A total of 946 patients with various tumor diagnoses were enrolled. Based on the confirmatory factor analysis, we could approve the three-dimensional structure of the module. Removing one item and reassigning the factorial mapping of another item resulted in the EORTC QLQ-FA12. For the revised scale, we found evidence supporting good local (indicator reliability ≥ 0.60, factor reliability ≥ 0.82) and global model fit (GFI t1|t2 = 0.965/0.957, CFI t1|t2 = 0.976/0.972, RMSEA t1|t2 = 0.060/0.069) for both measurement points. For each scale, test-retest reliability proved to be very good (intraclass correlation: R t1-t2 = 0.905-0.921) and internal consistency proved to be good to high (Cronbach alpha = .79-.90). Conclusion: Based on the former phase III module, the multidimensional structure was revised as a phase IV module (EORTC FA12) with an improved scale structure. For a comprehensive validation of the EORTC FA12, further aspects of convergent and divergent validity as well as sensitivity to change should be determined.
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Self-citationImpact of Vulvar Cancer Surgery on Quality of Sex Life: A Review of Literature
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“The validity of the EORTC score has also been fully demonstrated through psychometric validation.(23,24) The Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, scale is a widely validated scale used primarily in psychiatry.”
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“This supports previous findings that fatigue is a severe problem in cancer patients (Weis et al., 2017).”
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“…QLQ)-C30 Health-related QoL summary score 21 ; the EORTC QLQ-C30 and EORTC PAN26 function and symptom scores 22,23 ; fatigue from the EORTC QLQ-FA12 24 ; sleep problems from the Pittsburgh Sleep Quality Index (PSQI) 25 ; perceived cognitive impairments and impact of cognitive changes from the…”
BackgroundGates, P., Green, H. J., Gough, K., Dhillon, H. M., Vardy, J. L., Dickinson, M. J., Guarnera, J., Krishnasamy, M., Livingston, P. M., WHITE, V. M., et al. (2024) · BMJ Open · doi:10.1136/bmjopen-2023-081084 · Cited by 5
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“, 2006), the Multidimensional Fatigue Inventory (MFI-20), for measuring fatigue (Weis et al., 2017), the Patient Health Questionnaire-15 (PHQ-15), for measuring physical complaints (Kroenke et al.”
MethodDelrieu, L., Hamy, A., Coussy, F., Kassara, A., Asselain, B. J. R., Antero, J., de Villèle, P., Dumas, É., Forstmann, N., Guérin, J., et al. (2022) · BMC Cancer · doi:10.1186/s12885-022-09608-y · Cited by 5
“Fatigue Fatigue will be evaluated with the EORTC QLQ-FA12 version 1 module, which was validated for cancer-related fatigue in 2017 [36].”
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“It is composed of 12 questions, 10 unidirectional and 2 criteria variables which measure the extent to which fatigue interferes with daily activities and social life [89].”
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Weis, J. (2022) · Springer eBooks · doi:10.1007/978-3-030-84702-9_16 · Cited by 4
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“26,27 An academic user agreement was in place with the EORTC for the use of each questionnaire.”
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Self-citationWiese, M. L., Schwarz, L., von Rheinbaben, S., Schmidt, S. M., Blaurock, M., Krönke, J., Lerch, M. M., Valentini, L., & Aghdassi, A. A. (2026) · The Oncologist · doi:10.1093/oncolo/oyag028 · Cited by 3
Cytera, C., Baust, K., Borgmann‐Staudt, A., Calaminus, G., Egger‐Heidrich, K., Faber, J., Grabow, D., Halbsguth, T. V., Kock-Schoppenhauer, A.-K., König, I. R., et al. (2025) · BMC Cancer · doi:10.1186/s12885-025-14355-x · Cited by 3
“EORTC QLQ C30 [12] EORTC QLQ FA12 [13] EORTC QLQ FA12 [13] Distress Thermometer with problem areas [14] Distress Thermometer without problem areas [14] PHQ‑4 [15] PHQ‑4 [15] PHQ‑9 (last seven questions) [16] IES‑”
Physical Activity and Patient-Reported Outcomes in Monoclonal Plasma Cell Disorders
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“• Self-reported fatigue will be assessed by means of the validated EORTC Fatigue questionnaire EORTC QLQ-FA12 [16, 17].”
Methodde Souza, A. C. L., Dantas, J. B. D. L., Martins, G. B., Sanches, A. C. B., Carrera, M., & Medrado, A. R. A. P. (2021) · Revista Brasileira de Cancerologia · doi:10.32635/2176-9745.rbc.2021v67n3.1202 · Cited by 3
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“Additionally, two single items evaluate interference with daily life (IDL) and social sequelae (SOC) [34].”
BrECADD vs BEACOPP and Health-Related Quality of Life in Advanced-Stage Hodgkin Lymphoma
Ferdinandus, J., Müller, H., Jablonski, J., Kerkhoff, A., Scholl, S., Ko, Y., Topp, M. S., Vučinić, V., Jung, W. E., Schroers, R., et al. (2026) · JAMA Oncology · doi:10.1001/jamaoncol.2025.6327 · Cited by 2
Noh, H., Anota, A., Mongondry, R., Meyrand, R., Dupuis, C., Schiffler, C., Marijnen, P., Rinaldi, S., Lachuer, J., Keski‐Rahkonen, P., et al. (2024) · BMC Cancer · doi:10.1186/s12885-024-11824-7 · Cited by 2
“Other dimensions of CRF [Time points: D0, end CT (M3), M6, M12, then annually until Y10]: CRF will be assessed by the EORTC QLQ-FA12 [37].”
MethodChiodi, C., Epstein, J., Arvis, J., Martin, É., Barbier, A., Meglio, A. D., Gillanders, E., Jacob, G., Menvielle, G., Everhard, S., et al. (2024) · Quality of Life Research · doi:10.1007/s11136-024-03600-8 · Cited by 2
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Psychometric properties of the Multidimensional Fatigue Inventory-10 in breast cancer patients
Yang, M., Chen, S., Wan, Y., & Hu, X. P. (2020) · Contemporary Nurse · doi:10.1080/10376178.2020.1742178 · Cited by 2
“CRF is a highly prevalent and bothersome symptom in cancer patients (Weis et al., 2017).”
BackgroundTumorassoziierte Fatigue in der Palliativsituation
Fischer, I., Weis, J., Rüffer, J. U., Heim, M., Bojko, P., & Ostgathe, C. (2017) · Frauenheilkunde up2date · doi:10.1055/s-0043-106955 · Cited by 2
Self-citationErfassung und Behandlung krebsassoziierter Fatigue
Blickle, P., Schmidt, M. E., & Steindorf, K. (2024) · Die Onkologie · doi:10.1007/s00761-024-01501-6 · Cited by 1
Erfassung und Behandlung krebsassoziierter Fatigue
Blickle, P., Schmidt, M. E., & Steindorf, K. (2025) · Im Focus Onkologie · doi:10.1007/s15015-025-4247-5 · Cited by 1
“Im europäi-schen Raum hat sich vor allem der Fa-tiguefragebogen der European Organization for Research and Treatment of Cancer (EORTC QLQ-FA12) etabliert, der Fatigue mit insgesamt zwölf Items auf drei Dimensionen (physisch, emotional und kognitiv) erfasst [14].”
Meng, K., Reis, J. M., Kruse, A., van der Lee, I., Ballweg, A., Wallis, M., Rücker, V., Heuschmann, P. U., & Jentschke, E. (2025) · Trials · doi:10.1186/s13063-025-09211-z · Cited by 1
Lopes, M., Cassaroti, V. S. S., Cella, P. S., da Palma, L. P., Sosciarelli, V., de Moura, M. O., Prianti, D. E., Borges, M. B. D. S., Godinho, L. C., Terziotti, F., et al. (2025) · International Journal of Sports Medicine · doi:10.1055/a-2707-5058 · Cited by 1
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“Other patient-reported outcomes (PROs) assessed included fatigue, which was measured with the EORTC QLQ-FA12, where scores range from 0 to 100 [37].”
Haussmann, A., Schmidt, M. E., Goldschmidt, S., Hiensch, A. E., Wiskemann, J., & Steindorf, K. (2026) · BMC Medicine · doi:10.1186/s12916-026-04669-3 · Cited by 1
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“The assessment will focus on potential depression using the Patient Health Questionnaire-9, 36 fatigue using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-FA12 questionnaire 37 and anxiety using the Generalised Anxiety Disorder-7 questionnaire.”
Nordhausen, T., Jahn, P., Meyer, G., Ullrich, F., Vordermark, D., Al‐Ali, H. K., & Schmidt, H. (2025) · Die Onkologie · doi:10.1007/s00761-024-01660-6 · Cited by 1
Self-citationScreening tools for cancer-related fatigue: how do they overlap with validated assessment tools?
Blickle, P., Haussmann, A., Schmidt, M. E., Holzner, B., Berger, A.-K., & Steindorf, K. (2025) · Fatigue Biomedicine Health & Behavior · doi:10.1080/21641846.2025.2521231 · Cited by 1
“It assesses CRF multidimensionally (in terms of the physical, emotional and cognitive dimensions) and has demonstrated excellent psychometric properties [15].”
Self-citationMyeloma; living better and living longer - a look at the advances
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“Recently, the EORTC Group has developed an updated phase IV module (EORTC-FA12) for Fatigue measurement [51].”
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“Verfahren Das oben erwähnte Fragebogenset besteht aus EORTC QLQ-FA13 [13], PHQ4 [14], iPOS [15], EORTC QLQ-C15-PAL und MAAS [16].”
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53/m mit Erschöpfung nach Abschluss der Chemoimmuntherapie
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“…scores between the two arms at week 12 of chemotherapy, assessing differences in the incidence of adverse events, and evaluating fatigue levels at baseline, week 6, and week 12 using the European Organization for Research and Treatment of Cancer (EORTC) Fatigue Assessment Questionnaire (FA-12) [9].”
Comorbid symptoms in cancer patients and caring for the caregiver
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“The EORTC QLQ-FA12 [36] measures cancer-related fatigue and consists of three symptom scales and two single items.”
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“Cancer-related physical fatigue is assessed with the EORTC QLQ-FA12 questionnaire [28].”
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“Only the scales are shown in this study [23].”
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Liu, M., Kilbreath, S. L., Yee, J., Beith, J. M., & Dylke, E. S. (2026) · Cancers · doi:10.3390/cancers18020338 · Cited by 2
“…quality of life and fatigue (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire— Core 30 [24] and Fatigue 12 [34]), and behavioural factors (Transtheoretical Model of Behaviour Change scales for Stage of Change (5-item), Self-Efficacy (18-item), Decisional…”
Ng, C., Sousa, M., Patterson, T., Mulhern, B. J., & Luckett, T. (2026) · Journal of Patient-Reported Outcomes · doi:10.1186/s41687-026-01045-w
“[25].”
Basu, A., Kole, P., Chowdhury, H., & Malhotra, A. (2026) · Journal of Indira Gandhi Institute Of Medical Sciences · doi:10.4103/jigims.jigims_57_25
Fatigue chronique chez les survivants d'un lymphome
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Health Behaviors and Breast Cancer Survivorship
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“…cáncer, la European Organization for Research and Treatment of Cancer (EORTC) desarrolló el instrumento EORTC Quality of Life Questionnaire Fatigue Module 13 items (QLQ-FA13) 4 , renombrado EORTC QLQ-FA12 (FA12) porque, tras nuevos análisis psicométricos, un ítem fue reasignado y otro, excluido 5 .”
Jomar, R. T., Viana, V. S., Martins, V. M., Muzi, C. D., & Guimarães, R. M. (2026) · Revista Brasileira de Cancerologia · doi:10.32635/2176-9745.rbc.2026v72n2.5622en
Jomar, R. T., Viana, V. S., Martins, V. M., Muzi, C. D., & Guimarães, R. M. (2026) · Revista Brasileira de Cancerologia · doi:10.32635/2176-9745.rbc.2026v72n2.5622
Ali, F. K., Aljarrah, I., Haddad, R. H., El-Hamid, S. M. A., & Abuejheisheh, A. J. (2026) · Palliative Care and Social Practice · doi:10.1177/26323524261449266
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Metadata
- Authors
- Weis, J., Tomaszewski, K. A., Hammerlid, E., Ignacio Arraras, J., Conroy, T., Lanceley, A., Schmidt, H., Wirtz, M., Singer, S., Pinto, M., Alm El-Din, M., Compter, I., Holzner, B., Hofmeister, D., Chie, W.-C., Czeladzki, M., Harle, A., Jones, L., Ritter, S., Flechtner, H.-H., Bottomley, A., & on Behalf of the EORTC Quality of Life Group
- Affiliations
- Jagiellonian University (PL)
- Affiliations of authors: Tumor Biology Centre, University Clinic Centre, Freiburg, Germany (JW); Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland (KAT); Department of Otolaryngology Head and Neck Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden (EH); Oncology Departments, Complejo Hospitalario de Navarra, Pamplona, Spain (JIA); Department of Medical Oncology, Lorraine Cancer Insti
- ORCID
- Venue
- JNCI: Journal of the National Cancer Institute
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-02-07
- Volume
- 109
- Issue
- 5
- ISSN
- 0027-8874 (ISSN-L)
- 1460-2105
- OpenAlex
- W2606004101
- Cited by
- 182
- References
- 16
- Citations by year
- 2026: 15 · 2025: 25 · 2024: 24 · 2023: 26 · 2022: 29 · 2021: 15 · 2020: 15 · 2019: 13 · 2018: 12 · 2017: 7
- FWCI
- 5.75
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JNCI Journal of the National Cancer Institute (publishedVersion)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, other-oa)
- Homo Politicus (Academy of Humanities and Economics in Lodz) (submittedVersion, cc-by-nc-nd)
- Jagiellonian University Repository (Jagiellonian University) (submittedVersion, cc-by-nc-nd)
- UCL Discovery (University College London) (submittedVersion)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Funders
- European Organisation for Research and Treatment of Cancer Quality of Life Group (v1 04/09)
- Topics
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Childhood Cancer Survivors' Quality of Life
- Keywords
- cancer-related fatigue, EORTC QLQ-C30, quality of life, psychometric validation, factor structure, confirmatory factor analysis, test-retest reliability, internal consistency, scale revision, international multicenter study
- MeSH terms
- Adult, Aged, Aged, 80 and over, Egypt, Emotions, Europe, Factor Analysis, Statistical, Fatigue, Mental Fatigue, Female, Humans, Male, Middle Aged, Neoplasms, Palliative Care, Psychometrics, Quality of Life, Surveys and Questionnaires, Taiwan, Reproducibility of Results, Survivors, Internationality, Young Adult
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