Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2018 Nov 12;18(1):1104.
doi: 10.1186/s12885-018-5036-8.

International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26

Monika Sztankay  1   2 , Neil K Aaronson  3 , Juan I Arraras  4 , Umberto Basso  5 , Uros Bumbasirevic  6 , Fabio Efficace  7 , Johannes M Giesinger  8 , Colin D Johnson  9 , Marieke van Leeuwen  3 , Anne S Oberguggenberger  8 , Roman Sosnowski  10 , Teresa Young  11 , Bernhard Holzner  8 ; European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG)
Affiliations
Multicenter Study

International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26

Monika Sztankay et al. BMC Cancer. .

Abstract

Background: Given the high cure-rate for testicular cancer (TC) and the patients' young age, comprehensive evaluation of health-related quality of life (HRQOL) is an important consideration in this patient population. The EORTC QLQ-TC26 questionnaire module has been developed to supplement the EORTC QLQ-C30 in assessing TC-specific HRQOL in clinical trials and routine clinical practice. This international, multicentre phase IV validation study evaluated the psychometric properties of the new module.

Methods: This international, multicentre phase IV validation study enrolled testicular cancer patients from seven European countries. Patients completed the EORTC quality of life core questionnaire EORTC QLQ-C30 and the QLQ-TC26 at two consecutive time points and a debriefing questionnaire regarding the QLQ-TC26 after baseline assessment. Psychometric evaluation included examination of the hypothesized module scale structure, internal consistency and test-retest reliability, known-groups validity, responsiveness to change over time and cross-cultural acceptability.

Results: Data from 313 patients (mean age 38.6, SD 9.5) were analysed. All items exhibited a high completion rate with less than 2.4% missing values except for the sexuality items (up to 8.8%). The confirmatory factor analysis supported the hypothesised scale structure of the QLQ-TC26. Test-retest reliability was good for 8 of 12 scales (intraclass correlation: R t1|t2 ranged from 0.71-0.91) and four scales did not meet the acceptable criteria. Internal consistency was good for all twelve scales (Cronbach alpha = 0.79-0.90), except Communication (alpha = 0.67) and Sexual Functioning (alpha = 0.62). The module was able to distinguish clearly between patients with differing clinical status. Responsiveness to change over time was acceptable.

Conclusion: The EORTC QLQ-TC26 is a valid, reliable and well-accepted condition-specific questionnaire, supplementing the EORTC QLQ-C30, for the assessment of testicular cancer patients' HRQOL in clinical trials.

Keywords: EORTC; Health-related quality of life; Patient-reported outcome; Psychometric validation; Testicular cancer.

PubMed Disclaimer

Conflict of interest statement

Consent for publication

Not applicable.

Competing interests

Bernhard Holzner is an owner of the intellectual property rights of the software CHES. None of the other authors has a conflict of interest to declare.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

    1. Shanmugalingam T, Soultati A, Chowdhury S, Rudman S, Van Hemelrijck M. Global incidence and outcome of testicular cancer. Clin Epidemiol. 2013;5:417–427. - PMC - PubMed
    1. Trabert B, Chen J, Devesa SS, Bray F, McGlynn KA. International patterns and trends in testicular cancer incidence, overall and by histologic subtype, 1973-2007. Andrology. 2015;3(1):4–12. doi: 10.1111/andr.293. - DOI - PMC - PubMed
    1. Aparicio J, Maroto P, Garcia del Muro X, Sanchez-Munoz A, Guma J, Margeli M, Saenz A, Sagastibelza N, Castellano D, Arranz JA, et al. Prognostic factors for relapse in stage I seminoma: a new nomogram derived from three consecutive, risk-adapted studies from the Spanish Germ Cell Cancer Group (SGCCG) Ann Oncol. 2014;25(11):2173–2178. doi: 10.1093/annonc/mdu437. - DOI - PubMed
    1. Tandstad T, Smaaland R, Solberg A, Bremnes RM, Langberg CW, Laurell A, Stierner UK, Stahl O, Cavallin-Stahl EK, Klepp OH, et al. Management of seminomatous testicular cancer: a binational prospective population-based study from the Swedish norwegian testicular cancer study group. J Clin Oncol. 2011;29(6):719–725. doi: 10.1200/JCO.2010.30.1044. - DOI - PubMed
    1. Rajpert-De Meyts E, McGlynn KA, Okamoto K, Jewett MA, Bokemeyer C. Testicular germ cell tumours. Lancet. 2016;387(10029):1762–1774. doi: 10.1016/S0140-6736(15)00991-5. - DOI - PubMed

Publication types