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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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“As there are no established cut-offs in guidelines regarding the EORTC QLQ-C30 and EORTC QLQ-FA12 questionnaires, we dichotomized the scales of pain and emotional and physical fatigue using the 75th percentile as cutoff (Table 1) to identify PC survivors who suffered from fatigue or pain.”
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“(4) Fatigue Questionnaire EORTC QLQ-FA12: the FA12 is a new fatigue module designed to complement the EORTC QLQ-C30 and consists of 12 items, with four response categories for each item, coded with values from 1 to 4 [35].”
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“On the other hand, the European Organization for Research and Treatment of Cancer (EORTC) has developed the questionnaire module EORTC QLQ-FA12 [23], a new multidimensional instrument specifically for measuring CRF.”
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“Socioeconomic characteristics and validated patientreported outcome data including European Organization for Research and Treatment of Cancer quality-of-life questionnaires (EORTC QLQ-C30 and EORTC-QLQ-FA12 [fatigue-specific module]) (11,25), Global Physical Activity Questionnaire-16,(12) and Hospital Anxiety and Depr…”
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Friedrich, M., Hinz, A., Kuhnt, S., Schulte, T., Rose, M., & Fischer, F. H. (2019) · Quality of Life Research · doi:10.1007/s11136-019-02147-3 · Cited by 21
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“In order to depict the particular relevance of physical, emotional and cognitive fatigue, EORTC QLQ-FA13 was added (12, 13).”
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“Fatigue is measured with the EORTC-FA12, which has been validated in large international and multicentre studies [31].”
MethodCancer-Related Fatigue After Esophageal Cancer Surgery: Impact of Postoperative Complications
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“Both questionnaires are validated and sensitive to change.(18,19) The QLQ-C30 is a 30-item questionnaire evaluating the quality of life of cancer patients, within which cancer-related fatigue is measured by a three-item scale.”
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“The psychometric properties of QLQ-FA12 have been validated according to EORTC guidelines in 11 European countries with corresponding translations, including Swedish.(22)”
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Screening Properties of the Diagnostic Criteria for Cancer-Related Fatigue
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“Physical, emotional and cognitive fatigue were measured with the EORTC QLQ-FA12 scale [28], with a score ≥ 40 considered as severe fatigue.”
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“- FA12: EORTC module assessing the impact of fatigue on quality of life for oncological patients (41).”
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Sweegers, M. G., Depenbusch, J., Kampshoff, C. S., Aaronson, N. K., Hiensch, A. E., Wengström, Y., Backman, M., Gunasekara, N., Clauss, D., Peláez, M., et al. (2023) · Supportive Care in Cancer · doi:10.1007/s00520-023-08124-4 · Cited by 17
“…items on demographic and clinical characteristics, physical activity (assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire) [16], fatigue (assessed using the EORTC QLQ-FA12 questionnaire) [17], and quality of life (assessed using the EORTC QLQ-C30 questionnaire) [18].”
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“X Multiple health behaviour (MHB-39; Wiesmann et al., 2003)* The questionnaire Multiple Health Behavior (MHB-39) is an instrument designed for assessing habitual health-related behavior.”
BackgroundLong-term surveillance recommendations for young adult cancer survivors
Egger‐Heidrich, K., Wolters, F., Frick, M., Halbsguth, T. V., Müller, T., Woopen, H., Tausche, K., Richter, D., & Gebauer, J. (2025) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2025.102992 · Cited by 15
Fatigue in Long‐Term Head and Neck Cancer Survivors From Diagnosis Until Five Years After Treatment
Berg, M., Silander, E. M., Bove, M., Johansson, L., Nyman, J., & Hammerlid, E. B. (2023) · The Laryngoscope · doi:10.1002/lary.30534 · Cited by 15
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“The total fatigue score on a 0–100 scale was calculated according to the scoring manual, with higher values indicating greater levels of fatigue [30].”
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“, fatigue among non-small cell lung cancer or NSCLC patients [26]).”
BackgroundSelf-citationMurri, A., Vitucci, D., Tranchita, E., Grazioli, E., Gori, S., Modena, A., Turazza, M., Filippini, R., Galeazzi, S., Verzè, M., et al. (2022) · Cancers · doi:10.3390/cancers15010034 · Cited by 13
“The psychometric coefficients were calculated with a sum score [23,24].”
MethodCancer-related fatigue trajectories up to 5 years after curative treatment for oesophageal cancer
Cheng, Z., Johar, A. M., Nilsson, M., Schandl, A. R., & Lagergren, P. (2023) · British Journal of Cancer · doi:10.1038/s41416-023-02551-0 · Cited by 13
“…Age at surgery (continuous variable), sex (male or female), education level (< 9, 9 – 12 or >12 years of formal education), proxy baseline QLQ-C30 fatigue score (continuous variable), comorbidity (Charlson comorbidity index 0, 1 or ≥ 2, excluding oesophageal cancer) [22], tumour histology…”
Symptom clusters and symptom network analysis during immunotherapy in lung cancer patients
Yang, X., Bai, J., Liu, R., Wang, X., Zhang, G., & Zhu, X. (2024) · Supportive Care in Cancer · doi:10.1007/s00520-024-08918-0 · Cited by 13
Symptom management in adult brain tumours: A literature review
Zhang, R., Wang, D., Liu, Y., Tian, M., Zhu, L., Chen, J., & Zhang, J. (2023) · Nursing Open · doi:10.1002/nop2.1795 · Cited by 13
Patient-caregiver relationship in cancer fatigue and distress. A dyadic approach
Taurisano, P., De Feudis, R. L., Graziano, G., Marzano, N., Curci, A., Fidanzio, A., Annunziata, M. A., Antinone, V., Brovelli, S., Carone, M., et al. (2023) · Current Psychology · doi:10.1007/s12144-022-03860-y · Cited by 12
“Additionally, there is data that suggests reciprocity may lessen caregiver stress (McPherson et al., 2010; Reid et al., 2005; Ybema et al., 2002).”
Silvaggi, F., Mariniello, A., Leonardi, M., Silvani, A., Lamperti, E., Cosimo, S. D., Folli, S., Trapani, A., & Schiavolin, S. (2023) · Journal of Health Psychology · doi:10.1177/13591053231151286 · Cited by 12
“The score ranges from 0 to 100: higher scores indicate more fatigue (Weis et al., 2017).”
BackgroundKoeppel, M., Körbi, C., Winkels, R. M., Schmitz, K. H., & Wiskemann, J. (2021) · Frontiers in Sports and Active Living · doi:10.3389/fspor.2021.687365 · Cited by 13
“Reported Cronbach’s alpha were good for all three dimensions with 0.88–0.90 for PF, 0.87–0.88 for EF and 0.79–0.82 for CF (Weis et al., 2017).”
BackgroundMethodInfluentialCancer‐related fatigue: Identification of hallmarks to enable refined treatment approaches
Schmidt, M. E., Blickle, P., & Steindorf, K. (2022) · Psycho-Oncology · doi:10.1002/pon.6061 · Cited by 12
“It was shown that it can detect clinically significant fatigue in cancer patients.(20) Additionally, to gain insights into change of patients' fatigue burden during the cancer continuum, patients were asked to retrospectively rate their pre‐diagnostic fatigue level and their highest fatigue level since diagnosis in ad…”
MethodHardy‐Léger, I., Charles, C., Lange, M., Joly, F., Roux, P., Capel, A., Petrucci, J., Rigal, O., Fel, J. L., Vanlemmens, L., et al. (2020) · Psycho-Oncology · doi:10.1002/pon.5572 · Cited by 12
Onyedibe, M. C., Blickle, P., Schmidt, M. E., & Steindorf, K. (2023) · Stress and Health · doi:10.1002/smi.3299 · Cited by 13
Ferdinandus, J., Müller, H., Damaschin, C., Jacob, A. S., Meißner, J., Krasniqi, F., Mey, U., Schöndube, D., Thiemer, J., Mathas, S., et al. (2023) · Annals of Oncology · doi:10.1016/j.annonc.2023.11.014 · Cited by 13
Delrieu, L., Anota, A., Trédan, O., Freyssenet, D. G., Maire, A., Canada, B., Fournier, B., Febvey‐Combes, O., Pilleul, F., Bouhamama, A., et al. (2020) · BMC Cancer · doi:10.1186/s12885-020-07093-9 · Cited by 10
“Multidimensional aspects of fatigue will be assessed by the EORTC QLQ-FA12 cancer related fatigue module [48].”
MethodYoga therapy to reduce fatigue in cancer: effects of reminder e-mails and long-term efficacy
Zetzl, T., Pittig, A., Renner, A., van Oorschot, B., & Jentschke, E. (2021) · Supportive Care in Cancer · doi:10.1007/s00520-021-06345-z · Cited by 11
Rothmund, M., Pilz, M. J., Egeter, N., Lidington, E. K., Piccinin, C., Arrarás, J. I., Grøenvold, M., Holzner, B., van Leeuwen, M., Petersen, M. A., et al. (2024) · Health and Quality of Life Outcomes · doi:10.1186/s12955-024-02316-0 · Cited by 10
Self-citationPertz, M., Kowalski, T. E., Jetschke, K., Schmieder, K., Schlegel, U. S., & Miller, D. (2022) · Journal of Clinical Neuroscience · doi:10.1016/j.jocn.2022.10.026 · Cited by 11
Uptake of Recommendations for Posttreatment Cancer-Related Fatigue Among Breast Cancer Survivors
Meglio, A. D., Charles, C., Martin, É., Havas, J., Gbenou, A. S., Flaysakier, J.-D., Martin, A., Everhard, S., Laas, E., Chopin, N., et al. (2021) · Journal of the National Comprehensive Cancer Network · doi:10.6004/jnccn.2021.7051 · Cited by 11
“Two sets of models were fit by outcome: (1) global CRF, and (2) physical, emotional, and cognitive CRF dimensions as independent variables.”
MethodFactors associated with enrolment in clinical trials among women with early-stage breast cancer
Presti, D., Havas, J., Soldato, D., Lapidari, P., Martin, É., Pistilli, B., Jouannaud, C., Emile, G., Rigal, O., Fournier, M., et al. (2022) · ESMO Open · doi:10.1016/j.esmoop.2022.100513 · Cited by 10
“Patient-reported outcomes (PROs) were collected using the European Organisation for Volume 7 - Issue 3 - 2022 Research and Treatment of Cancer (EORTC) quality-of-life (QoL) questionnaires QLQ-C30,21 BR23,22 and FA12.”
MethodБахромовна, У. Е., Shchelkova, O. Y., Yakovleva, M. V., Цыренов, Д. Д., Sofronov, D. I., Obidin, I. Y., Berezantseva, M. S., & Yacevich, A. A. (2022) · Bone and soft tissue sarcomas tumors of the skin · doi:10.17650/2782-3687-2022-14-1-33-39 · Cited by 9
Brock, H., Schröter, K., Friedrich, M., Sender, A., Richter, D., Mehnert, A., Geue, K., & Leuteritz, K. (2024) · Journal of Cancer Research and Clinical Oncology · doi:10.1007/s00432-024-06050-4 · Cited by 10
“The general cancer-related fatigue was measured using the EORTC QLQ-FA-12 (Weis et al. 2017).”
Rutsch, M., & Deck, R. (2023) · Die Rehabilitation · doi:10.1055/a-2105-5810 · Cited by 9
“Am häufigsten berichten Long Co - vid-Betroffene Dyspnoe, Fatigue, Kopfschmerzen und Konzentrations - schwierigkeiten [4].”
InfluentialTuğral, A., Arıbaş, Z., Akyol, M., & Bakar, Y. (2023) · BMC Cancer · doi:10.1186/s12885-023-11494-x · Cited by 9
Vlaški, T., Slavić, M., Caspari, R., Bilsing, B., Fischer, H., Brenner, H., & Schöttker, B. (2024) · Cancers · doi:10.3390/cancers16010202 · Cited by 10
“Physical fatigue, emotional fatigue, cognitive fatigue, interference with daily life, and social sequelae were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Fatigue Module 12 (EORTC QLQ-FA12) questionnaire [26].”
MethodMarker, R. J., Wechsler, S., & Leach, H. J. (2024) · Rehabilitation Oncology · doi:10.1097/01.reo.0000000000000354 · Cited by 9
Blickle, P., Schmidt, M. E., & Steindorf, K. (2025) · Cancer Medicine · doi:10.1002/cam4.70404 · Cited by 7
Anundi, H., Dolling, A., & Pálsdóttir, A. M. (2023) · Forests · doi:10.3390/f14020333 · Cited by 8
Luo, H., Galvao, D. A., Newton, R. U., Tang, C., Dean, A. P., Jasas, K., Johansson, M., Yusoff, I. F., Spry, N. A., & Taaffe, D. R. (2021) · BMJ Open Gastroenterology · doi:10.1136/bmjgast-2021-000642 · Cited by 8
Joseph, N., Cicchetti, A., McWilliam, A., Webb, A. J., Seibold, P., Fiorino, C., Cozzarini, C., Veldeman, L., Bultijnck, R., Fonteyne, V., et al. (2022) · Frontiers in Oncology · doi:10.3389/fonc.2022.937934 · Cited by 7
“Since this study was based on a secondary analysis of the data that were already collected as part of the REQUITE study, we could not use more robust tools to assess fatigue such as the Functional Assessment of Cancer Therapy: Fatigue (FACT-F) or European Organisation for Research and Treatment of Cancer Quality of Li…”
MethodSleimann, M., Balcerek, M., Cytera, C., Richter, F., Borgmann‐Staudt, A., Wormann, B. J., Kronziel, L. L., Calaminus, G., Kock-Schoppenhauer, A.-K., Grabow, D., et al. (2023) · Journal of Cancer Research and Clinical Oncology · doi:10.1007/s00432-023-05145-8 · Cited by 7
Cohort Profile: The Danish SEQUEL cohort
Levinsen, A. K. G., Dalton, S. O., Thygesen, L. C., Jakobsen, E. H., Gögenür, I., Borre, M., Zachariae, R. H., Christiansen, P., Laurberg, S., Christensen, P., et al. (2023) · International Journal of Epidemiology · doi:10.1093/ije/dyad189 · Cited by 7
Kikawa, Y., Uemura, Y., Taira, T., Kitagawa, C., Maeda, H., Kato, H., Hashimoto, N., Hosoda, M., Hamanaka, Y., Tanabe, Y., et al. (2025) · JAMA Network Open · doi:10.1001/jamanetworkopen.2025.27403 · Cited by 7
Singer, S., Hammerlid, E. B., Tomaszewska, I. M., Amdal, C. D., Herlofson, B. B., Santos, M. A., Silva, J. C., Mehanna, H. M., Fullerton, A. L., Young, T., et al. (2024) · European Journal of Cancer · doi:10.1016/j.ejca.2024.115062 · Cited by 7
Self-citationCampbell, R., Shaw, J., Carlick, T., Banks, H. I., Faris, M. M., Jeon, M. S., Legge, D. M., Foster, C. L., Leonard, R., Chan, R. J., et al. (2024) · Journal of Cancer Survivorship · doi:10.1007/s11764-024-01691-3 · Cited by 8
“Rather, multidimensional measures such as the EORTC QLQ-FA12 [30], that generate separate scores for physical, emotional, and cognitive fatigue, will provide more holistic assessment of CRF. Clinicians should also probe into these different aspects when performing assessments of fatigue in clinical…”
Cancer‐related fatigue measures in palliative care: A psychometric systematic review
Montagut‐Martínez, P., Pérez‐Cruzado, D., & Sánchez, D. G. (2022) · European Journal of Cancer Care · doi:10.1111/ecc.13642 · Cited by 7
Tumorassoziierte Fatigue in der Palliativsituation
Fischer, I., Weis, J., Rüffer, J. U., Heim, M., Bojko, P., & Ostgathe, C. (2017) · Zeitschrift für Palliativmedizin · doi:10.1055/s-0042-124041 · Cited by 7
Self-citationSchlecht, S., Neubert, S., Meng, K., Rabe, A., & Jentschke, E. (2023) · International Journal of Environmental Research and Public Health · doi:10.3390/ijerph20206933 · Cited by 7
“The reasons for maintaining or quitting video usage were also asked about, with multiple response options.”
Background
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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