International validation of the EORTC QLQ-PRT20 module for assessment of quality of life symptoms relating to radiation proctitis: a phase IV study

Georgia K B Halkett, Charles Adam Wigley, Samar M Aoun, Maurizio Portaluri, Francesco Tramacere, Lorenzo Livi, Beatrice Detti, Stefano Arcangeli, Jo-Asmund Lund, Are Kristensen, Nathalie McFadden, Arne Grun, Sean Bydder, Irina Sackerer, Elfriede Greimel, Nigel Spry, EORTC Quality of Life Group, Celine Fournier, Melissa Berg, Myriam Bouchard, Anne-Sophie Lessard, Julie Villa, Georgia K B Halkett, Charles Adam Wigley, Samar M Aoun, Maurizio Portaluri, Francesco Tramacere, Lorenzo Livi, Beatrice Detti, Stefano Arcangeli, Jo-Asmund Lund, Are Kristensen, Nathalie McFadden, Arne Grun, Sean Bydder, Irina Sackerer, Elfriede Greimel, Nigel Spry, EORTC Quality of Life Group, Celine Fournier, Melissa Berg, Myriam Bouchard, Anne-Sophie Lessard, Julie Villa

Abstract

Background: Although patients experience radiation proctitis post radiotherapy no internationally tested instruments exist to measure these symptoms. This Phase IV study tested the scale structure, reliability and validity and cross-cultural applicability of the EORTC proctitis module (QLQ-PRT23) in patients who were receiving pelvic radiotherapy.

Methods: Patients (n = 358) from six countries completed the EORTC QLQ-C30, QLQ-PRT23 and EORTC Quality of Life Group debriefing questions. Clinicians completed the EORTC Radiation Therapy Oncology Group scale. Questionnaires were completed at four time-points. The module's scale structure was examined and validated using standard psychometric analysis techniques.

Results: Three items were dropped from the module (QLQ-PRT23 → QLQ-PRT20). Factor analysis identified five factors in the module: bowel control; bloating and gas; emotional function/lifestyle; pain; and leakage. Inter-item correlations were within r = 0.3-0.7. Test-Retest reliability was high. All multi-item scales discriminated between patients showing symptoms and those without symptomology. The module discriminated symptoms from the clinician completed scoring and for age, gender and comorbidities.

Conclusion: The EORTC QLQ-PRT20 is designed to be used in addition to the EORTC QLQ-C30 to measure quality of life in patients who receive pelvic radiotherapy. The EORTC QLQ-PRT20 is quick to complete, acceptable to patients, has good content validity and high reliability.

Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000972224 .

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval was gained from Curtin University and participating sites. Participants were provided with an information sheet and informed consent was gained prior to participating in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interest.

Publisher’s Note

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

References

    1. Jones K, Evans AW, Bistrow RG, Levin W. Treatment of radiation proctitis with hyperbaric oxygen. Radiother Oncol. 2006;78:91–94. doi: 10.1016/j.radonc.2005.11.004.
    1. van de Wetering FT, Verleye L, Andreyev HJ, Maher J, Vlayen J, Pieters B, van Tienhoven G, Scholten R. Non‐surgical interventions for late rectal problems (proctopathy) of radiotherapy in people who have received radiotherapy to the pelvis. Cochrane Systematic Review. 2016.
    1. Andreyev HJ, Wotherspoon A, Denham JW, Hauer-Jensen M. Defining pelvic-radiation disease for the survivorship era. Lancet Oncol. 2010;11:310–312. doi: 10.1016/S1470-2045(10)70026-7.
    1. Andreyev HJ, Wotherspoon A, Denham JW, Hauer-Jensen M. "Pelvic radiation disease": new understanding and new solutions for a new disease in the era of cancer survivorship. Scand J Gastroenterol. 2011;46:389–97.
    1. Dent O, Galt E, Chapuis P, Yuiles P, Sinclair G, Bokey E. Quality of life in patients undergoing treatment for chronic radiation induced rectal bleeding. Br J Surg. 1998;85:1251–1254. doi: 10.1046/j.1365-2168.1998.00821.x.
    1. Hille A, Schmidberger H, Hermann RM, et al. A phase III randomized, placebo controlled, double-blind study of misoprostal rectal suppositories to prevent acute radiation proctitis in patients with prostate cancer. Int J Radiat Oncol Biol Phys. 2005;63:1488–1493. doi: 10.1016/j.ijrobp.2005.05.063.
    1. Tagkalidis P, Tjandra J. Chronic radiation proctitis. Aust N Z J Surg. 2001;71:230–237. doi: 10.1046/j.1440-1622.2001.02081.x.
    1. Ashman J, Zelefsky M, Hunt M, Leibel S, Fuks Z. Whole pelvic radiotherapy for prostate cancer using 3D conformal and intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2005;63:765–771. doi: 10.1016/j.ijrobp.2005.02.050.
    1. Shelley LEA, Scaife JE, Romanchikova M, et al. Delivered dose can be a better predictor of rectal toxicity than planned dose in prostate radiotherapy. Radiother Oncol. 2017;123:466–471. doi: 10.1016/j.radonc.2017.04.008.
    1. Borghetti P, Spiazzi L, Cozzaglio C, et al. Postoperative radiotherapy for prostate cancer: the sooner the better and potential to reduce toxicity even further. Radiol Med. 2018; 123: 63-70.
    1. Zapatero A, Pios P, Marin A, Minguez R, Garcia-Vicente F. Dose escalation with three-dimensional conformal radiotherapy for prostate cancer. Is more dose really better in high-risk patients treated with androgen deprivation? Clin Oncol (R Coll Radiol). 2006;18:600–7.
    1. Halkett GS, M, Aoun S, Joseph D, Bydder S, Meng R, Spry N. What pelvic radiation disease symptoms are experienced by patients receiving external beam radiotherapy and a high dose rate brachytherapy boost for prostate cancer?. J Contemp Brachytherapy 2017; 9: 393-407.
    1. Bolla M, van Poppel H, Collette L, et al. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911) Lancet. 2005;366:524–525. doi: 10.1016/S0140-6736(05)67101-2.
    1. Colwell J, Goldberg M. A review of radiation proctitis in the treatment of prostate cancer. J Wound Ostomy Continence Nurs. 2000;27:179–187.
    1. Hamoen EH, De Rooij M, Witjes JA, Barentsz JO, Rovers MM. Measuring health-related quality of life in men with prostate cancer: a systematic review of the most used questionnaires and their validity. Urol Oncol. 2015;33(69):e19–e28.
    1. Fayers P, Aaronson N, Bjordal K, Grønvold M, Curran D, Bottomley A. EORTC. QLQ-C30 Scoring Manual. Brussels: European Organisation for Research and Treatment of Cancer (EORTC) 2001.
    1. Spry N, Halkett G, Aoun S, Spry J, Yeoh E. Development of a European organization for research and treatment of cancer module to assess the quality of life of patients with proctitis after pelvic radiotherapy for malignancy. Int J Radiat Oncol Biol Phys. 2008;72:522–528. doi: 10.1016/j.ijrobp.2007.12.062.
    1. Halkett G, Aoun S, Hayne D, et al. EORTC radiation proctitis-specific quality of life module - pretesting in four European countries. Radiother Oncol. 2010;97:294–300. doi: 10.1016/j.radonc.2010.04.001.
    1. Blazeby J, Sprangers M, Cull A, Mogens G, Bottomley A. EORTC Quality of Life Group: Guidelines for Developing Questionnaire Modules. Brussels: EORTC Quality of Life Group; 2002.
    1. de Wolf L, Koller M, Velikova G, et al. EORTC translating procedures. Brussels: EORTC Publications; 2009.
    1. Denham J, O'Brien P, Dunstan R, Johansen J et al. Is there more than one late radiation proctitis syndrome? Radiother Oncol 1999;51:43–53.
    1. Johnson C, Aaronson N, Blazeby JM et al. EORTC Quality of Life Group Guidelines for Developing Questionnaire Module Guidelines (4th ed.). Brussels: EORTC Quality of Life Group; 2011.
    1. Fayers PM, Machin D. Quality of Life: The assessment, analysis and interpretation of patient-reported outcomes. Second edition ed. Chichester: Wiley; 2007.
    1. Hjermstad MJ, Fossa SD, Bjordal K, Kaasa S. Test/retest study of the European Organization for Research and Treatment of Cancer Core quality-of-life questionnaire. J Clin Oncol. 1995;13:1249–1254. doi: 10.1200/JCO.1995.13.5.1249.
    1. Special Advisory Committee of the Medical Outcomes Trust Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002;11:193–205. doi: 10.1023/A:1015291021312.
    1. Hampson LA, Cowan JE, Zhao S, Carroll PR, Cooperberg MR. Impact of age on quality-of-life outcomes after treatment for localized prostate cancer. Eur Urol. 2015;68:480–486. doi: 10.1016/j.eururo.2015.01.008.
    1. Pinkawa M, Fischedick K, Gagel B, et al. Impact of age and comorbidities on health-related quality of life for patients with prostate cancer: evaluation before a curative treatment. BMC Cancer. 2009;9:296. doi: 10.1186/1471-2407-9-296.
    1. Nunnally JC. Psychometric theory. 3. New York: McGraw-Hill; 1994.
    1. Lund JA, Kaasa S, Wibe A, Widmark A, Fransson P. Late radiation effects to the rectum and anus after treatment for prostate cancer; validity of the LENT/SOMA score. Acta Oncol. 2013;52:727–735. doi: 10.3109/0284186X.2013.747695.
    1. Kaupp-Roberts SD, Yadegarfar G, Friend E, et al. Validation of the EORTC QLQ-BIL21 questionnaire for measuring quality of life in patients with cholangiocarcinoma and cancer of the gallbladder. Br J Cancer. 2016;115:1032–1038. doi: 10.1038/bjc.2016.284.

Source: PubMed

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