Skip to main content

Advertisement

SpringerLink
Log in

Validation of the QLQ-EN24 instrument for the assessment of health-related quality of life for women with endometrial cancer in México

  • Gynecologic Oncology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

The impact of disease activity or treatments on health-related quality of life (HRQL) is crucial in Oncology, but adequate instruments for this assessment are scarce. Our aim is to validate the Mexican-Spanish version of the QLQ-EN24 questionnaire to evaluate HRQL in women with endometrial cancer (EC).

Methods

This is a prospective study of Mexican women with EC, attending a single cancer centre, who responded the QLQ-C30 and QLQ-EN24 instruments; usual psychometric analysis were performed as well as the association of HRQL scales and relevant clinical data. Correlation analysis was performed with the Spearman’s method, reliability analysis with the Cronbach’s alpha, known-group comparisons with the Kruskal–Wallis test, and survival analysis with the Kaplan–Meier method and Log-rank test.

Results

One hundred and eighty-nine women with EC were assessed. Most functional scales reported high values, and most symptom scales, low. Questionnaire compliance rates were high and internal consistency tests demonstrated adequate convergent and divergent validity. Cronbach’s α coefficients of the five multi-item scales the QLQ-EN24 instruments were from 0.659 to 0.887. Scales of the QLQ-C30 and QLQ-EN24 instruments distinguished among clinically distinct groups of patients, particularly based on serum albumin levels. The Urological symptoms, Gastrointestinal symptoms, Body image, Pelvic pain and Taste change scales were significantly associated with OS.

Conclusion

The Mexican-Spanish version of the QLQ-EN24 questionnaire is reliable and valid for the assessment of HRQL in patients with EC and can be broadly used in multi-national clinical trials. However, conclusions derived from scales evaluating sexual function should be handled carefully.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Availability of data and material

The database in XLS format for this study is included in the supplementary material.

References

  1. Ferlay J EM, Lam F, Colombet M, Mery L, Pieros M, Znaor A, Soerjomataram I, Bray F. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Cancer Research; c2018. Available from: https://gco.iarc.fr/today. (Accessed 17 Feb 2019)

  2. Morice P, Leary A, Creutzberg C, Abu-Rustum N, Darai E (2016) Endometrial cancer. Lancet 387:1094–1108

    Article  Google Scholar 

  3. Ruvalcaba-Limon E, Cantu-de-Leon D, Leon-Rodriguez E, Cortes-Esteban P, Serrano-Olvera A, Morales-Vasquez F et al (2010) The first Mexican consensus of endometrial cancer. Grupo de investigacion en cancer de ovario y tumores ginecologicos de Mexico. Rev Invest Clin 62(583):5–605

    Google Scholar 

  4. Siegel RL, Miller KD, Jemal A (2020) Cancer statistics, 2020. CA Cancer J Clin 70:7–30

    Article  Google Scholar 

  5. von Gruenigen VE, Tian C, Frasure H, Waggoner S, Keys H, Barakat RR (2006) Treatment effects, disease recurrence, and survival in obese women with early endometrial carcinoma : a gynecologic oncology group study. Cancer 107:2786–2791

    Article  Google Scholar 

  6. Group AES, Blake P, Swart AM, Orton J, Kitchener H, Whelan T, et al (2009) Adjuvant external beam radiotherapy in the treatment of endometrial cancer (MRC ASTEC and NCIC CTG EN5 randomised trials) pooled trial results, systematic review, and meta-analysis. Lancet 373:137–146

    Article  Google Scholar 

  7. Salvesen HB, Haldorsen IS, Trovik J (2012) Markers for individualised therapy in endometrial carcinoma. Lancet Oncol 13:e353–e361

    Article  Google Scholar 

  8. Angioli R, Plotti F, Cafa EV, Dugo N, Capriglione S, Terranova C et al (2013) Quality of life in patients with endometrial cancer treated with or without systematic lymphadenectomy. Eur J Obstet Gynecol Reprod Biol 170:539–543

    Article  Google Scholar 

  9. Preston NJ, Wilson N, Wood NJ, Brine J, Ferreira J, Brearley SG (2015) Patient-reported outcome measures for use in gynaecological oncology: a systematic review. BJOG 122:615–622

    Article  CAS  Google Scholar 

  10. Pisani C, Deantonio L, Surico D, Brambilla M, Galla A, Ferrara E et al (2016) Quality of life in patients treated by adjuvant radiotherapy for endometrial and cervical cancers: correlation with dose-volume parameters. Clin Transl Oncol 18:901–908

    Article  CAS  Google Scholar 

  11. Peter M, Fayers DM (2016) Quality of life: the assessment, analysis and reporting of patient-reported outcomes, 3rd edn. Wiley-Blackwell, Chichester West

    Google Scholar 

  12. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ et al (1993) The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365–376

    Article  CAS  Google Scholar 

  13. Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A et al (1993) The functional assessment of cancer therapy scale: development and validation of the general measure. J Clin Oncol 11:570–579

    Article  CAS  Google Scholar 

  14. Greimel E, Nordin A, Lanceley A, Creutzberg CL, van de Poll-Franse LV, Radisic VB et al (2011) Psychometric validation of the European Organisation for Research and Treatment of Cancer quality of life questionnaire-endometrial cancer module (EORTC QLQ-EN24). Eur J Cancer 47:183–190

    Article  Google Scholar 

  15. Stukan M, Zalewski K, Mardas M, Filarska D, Szajewski M, Kmiec A et al (2018) Independent psychometric validation of European Organization for Research and treatment of cancer quality of life questionnaire-endometrial cancer module (EORTC QLQ-EN24). Eur J Cancer Care (Engl) 27:9

    Article  Google Scholar 

  16. Lewin SN (2011) Revised FIGO staging system for endometrial cancer. Clin Obstet Gynecol 54:215–218

    Article  Google Scholar 

  17. Giesinger JM, Kieffer JM, Fayers PM, Groenvold M, Petersen MA, Scott NW et al (2016) Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust. J Clin Epidemiol 69:79–88

    Article  Google Scholar 

  18. Onate-Ocana LF, Alcantara-Pilar A, Vilar-Compte D, Garcia-Hubard G, Rojas-Castillo E, Alvarado-Aguilar S et al (2009) Validation of the Mexican Spanish version of the EORTC C30 and STO22 questionnaires for the evaluation of health-related quality of life in patients with gastric cancer. Ann Surg Oncol 16:88–95

    Article  Google Scholar 

  19. Fayers PM AN, Bjordal K, Groenvold M, Curran D, Bottomley A. On behalf of the EORTC (2001) Quality of Life Group. Scoring procedures In: EORTC QLQ-C30 Scoring Manual Bruss. Eur J Cancer 38:125–133

    Google Scholar 

  20. Tabachnick BGFL (2019) Using multivariate statistics, 7th edn. California State University, Northridge

    Google Scholar 

  21. Thomas CR Jr (2016) The importance of quality of life assessment. JAMA Oncol 2:367–368

    Article  Google Scholar 

  22. Salas-Vega S, Iliopoulos O, Mossialos E (2017) Assessment of overall survival, quality of life, and safety benefits associated with new cancer medicines. JAMA Oncol 3:382–390

    Article  Google Scholar 

  23. Quinten C, Martinelli F, Coens C, Sprangers MA, Ringash J, Gotay C et al (2014) A global analysis of multitrial data investigating quality of life and symptoms as prognostic factors for survival in different tumor sites. Cancer 120:302–311

    Article  Google Scholar 

  24. Oldenburg CS, Boll D, Nicolaije KA, Vos MC, Pijnenborg JM, Coebergh JW et al (2013) The relationship of body mass index with quality of life among endometrial cancer survivors: a study from the population-based PROFILES registry. Gynecol Oncol 129:216–221

    Article  Google Scholar 

  25. van de Poll-Franse LV, Pijnenborg JM, Boll D, Voc MC, van den Berg H, Lybeert ML et al (2012) Health related quality of life and symptoms after pelvic lymphadenectomy or radiotherapy vs. no adjuvant regional treatment in early-stage endometrial carcinomaa large population-based study. Gynecol Oncol 127:153–160

    Article  Google Scholar 

  26. Janda M, Gebski V, Brand A, Hogg R, Jobling TW, Land R et al (2010) Quality of life after total laparoscopic hysterectomy versus total abdominal hysterectomy for stage I endometrial cancer (LACE): a randomised trial. Lancet Oncol 11:772–780

    Article  Google Scholar 

  27. Basch E, Geoghegan C, Coons SJ, Gnanasakthy A, Slagle AF, Papadopoulos EJ et al (2015) Patient-reported outcomes in cancer drug development and US regulatory review: perspectives from industry, the food and drug administration, and the patient. JAMA Oncol 1:375–379

    Article  Google Scholar 

  28. Dueck AC, Mendoza TR, Mitchell SA, Reeve BB, Castro KM, Rogak LJ et al (2015) Validity and reliability of the US national cancer institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). JAMA Oncol 1:1051–1059

    Article  Google Scholar 

Download references

Acknowledgments

The authors sincerely thank the European Organization for Research and Treatment of Cancer, Quality of Life Group, particularly Ms. Maria Arnott, for her extensive support. We also thank Professor Deborah Aleman-Hoey, MD., for her English-language editorial review.

Funding

The INCan provided all funds for this study, and no external support has been received.

Author information

Authors and Affiliations

  1. Programa de Cáncer de Ovario, Instituto Nacional de Cancerología (INCan), Mexico City, Mexico

    Dolores Gallardo-Rincón, Alfredo Toledo-Leyva, Antonio Bahena-González, Elizabeth Montes-Servín, Alejandra Rocío Pérez-Martín, Edgar Montes-Servín & Gabriela C. Alamilla-García

  2. Subdirección de Investigación Clínica, Instituto Nacional de Cancerología, San Fernando 22, Colonia Sección XVI, Delegación Tlalpan, México City, 14080, México

    D. Darlene Carmona-Herrera, Jaime Coronel-Martínez & Luis F. Oñate-Ocaña

  3. Departamento de Ginecología, Instituto Nacional de Cancerología (INCan), Mexico City, Mexico

    Dolores Gallardo-Rincón, Alfredo Toledo-Leyva, Antonio Bahena-González, Elizabeth Montes-Servín, Alejandra Rocío Pérez-Martín, Edgar Montes-Servín, Gabriela C. Alamilla-García, D. Darlene Carmona-Herrera, Jaime Coronel-Martínez & Luis F. Oñate-Ocaña

  4. Grupo de Investigación en Cáncer de Ovario y Tumores Ginecológicos de México, A.C. (GICOM), Mexico City, Mexico

    Dolores Gallardo-Rincón, Antonio Bahena-González, Gabriela C. Alamilla-García, Jaime Coronel-Martínez & Luis F. Oñate-Ocaña

  5. Facultad de Medicina, Universidad Nacional Autónoma de México (UNAM), Mexico City, Mexico

    D. Darlene Carmona-Herrera

Authors
  1. Dolores Gallardo-Rincón
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Alfredo Toledo-Leyva
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Antonio Bahena-González
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Elizabeth Montes-Servín
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Alejandra Rocío Pérez-Martín
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Edgar Montes-Servín
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Gabriela C. Alamilla-García
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. D. Darlene Carmona-Herrera
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Jaime Coronel-Martínez
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Luis F. Oñate-Ocaña
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

DGR, ATL, ABG, ElMS, DDCH and LFOO: study concepts, literature review, protocol writing. DGR and LFOO: project development. GCAG, ARPM, EMS and DDCH: interviews, data acquisition, database construction. DGR, ATL, ABG, ElMS, EdMS, DDCH and LFOO: data management and quality control of the database. DGR, ATL, EdMS and LFOO: data analysis and interpretation. DGR, ATL, ABG, ElMS and LFOO: manuscript drafting. All authors: manuscript final review and approval.

Corresponding author

Correspondence to Luis F. Oñate-Ocaña.

Ethics declarations

Conflict of interest

All authors declare that there are no financial or non-financial conflict of interest.

Ethics approval

The “Comité de Investigación” and the “Comité de Ética en Investigación” (registration numbers 016/046/ICI and CEI1049, respectively) approved the research protocol.

Informed consent

Both committees belong to the “Instituto Nacional de Cancerología, México” and all patients signed an informed consent form.

Consent for publication

The original questionnaires in their European-Spanish versions were adapted and pilot tested, whilst these entire processes were supervised by EORTC. Both instruments were used with the permission of EORTC.

Additional information

Publisher's Note

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

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Gallardo-Rincón, D., Toledo-Leyva, A., Bahena-González, A. et al. Validation of the QLQ-EN24 instrument for the assessment of health-related quality of life for women with endometrial cancer in México. Arch Gynecol Obstet 304, 773–782 (2021). https://doi.org/10.1007/s00404-021-05990-3

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00404-021-05990-3

Keywords

Search

Navigation