International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26
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 t...
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doaj-0889ef84f21f448e958a60ab30f2dc002020-11-25T02:34:44ZengBMCBMC Cancer1471-24072018-11-0118111110.1186/s12885-018-5036-8International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26Monika Sztankay0Neil K. Aaronson1Juan I. Arraras2Umberto Basso3Uros Bumbasirevic4Fabio Efficace5Johannes M. Giesinger6Colin D. Johnson7Marieke van Leeuwen8Anne S. Oberguggenberger9Roman Sosnowski10Teresa Young11Bernhard Holzner12on behalf of the European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG)Medical University of Innsbruck, University Hospital Innsbruck, Psychiatry IIDivision of Psychosocial Research & Epidemiology, The Netherlands Cancer InstituteMedical Oncology Department, Hospital of NavarreMedical Oncology 1, Istituto Oncologico Veneto (IOV) IRCCSClinic of Urology, Clinical Center of Serbia, University of BelgradeHealth Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA)Medical University of Innsbruck, University Hospital Innsbruck, Psychiatry IIUniversity Surgical Unit, University of Southampton, Southampton University HospitalsDivision of Psychosocial Research & Epidemiology, The Netherlands Cancer InstituteMedical University of Innsbruck, University Hospital Innsbruck, Psychiatry IIUrooncology Department, Maria Sklodowska Curie Memorial Cancer HospitalJackson Macmillan Centre, East & North Hertfordshire NHS Trust including Mount Vernon Cancer CenterMedical University of Innsbruck, University Hospital Innsbruck, Psychiatry IIAbstract 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.http://link.springer.com/article/10.1186/s12885-018-5036-8Testicular cancerHealth-related quality of lifeEORTCPsychometric validationPatient-reported outcome |
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language |
English |
format |
Article |
sources |
DOAJ |
author |
Monika Sztankay Neil K. Aaronson Juan I. Arraras Umberto Basso Uros Bumbasirevic Fabio Efficace Johannes M. Giesinger Colin D. Johnson Marieke van Leeuwen Anne S. Oberguggenberger Roman Sosnowski Teresa Young Bernhard Holzner on behalf of the European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) |
spellingShingle |
Monika Sztankay Neil K. Aaronson Juan I. Arraras Umberto Basso Uros Bumbasirevic Fabio Efficace Johannes M. Giesinger Colin D. Johnson Marieke van Leeuwen Anne S. Oberguggenberger Roman Sosnowski Teresa Young Bernhard Holzner on behalf of the European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26 BMC Cancer Testicular cancer Health-related quality of life EORTC Psychometric validation Patient-reported outcome |
author_facet |
Monika Sztankay Neil K. Aaronson Juan I. Arraras Umberto Basso Uros Bumbasirevic Fabio Efficace Johannes M. Giesinger Colin D. Johnson Marieke van Leeuwen Anne S. Oberguggenberger Roman Sosnowski Teresa Young Bernhard Holzner on behalf of the European Organisation for Research and Treatment of Cancer Quality of Life Group (EORTC QLG) |
author_sort |
Monika Sztankay |
title |
International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26 |
title_short |
International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26 |
title_full |
International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26 |
title_fullStr |
International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26 |
title_full_unstemmed |
International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26 |
title_sort |
international phase iv validation study of an eortc quality of life questionnaire for testicular cancer patients: the eortc qlq-tc26 |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2018-11-01 |
description |
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. |
topic |
Testicular cancer Health-related quality of life EORTC Psychometric validation Patient-reported outcome |
url |
http://link.springer.com/article/10.1186/s12885-018-5036-8 |
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