BOMET-QoL-10 questionnaire for breast cancer patients with bone metastasis: the prospective MABOMET GEICAM study

A Barnadas, M Muñoz, M Margelí, J I Chacón, J Cassinello, S Antolin, E Adrover, M Ramos, E Carrasco, M A Jimeno, B Ojeda, X González, S González, M Constenla, J Florián, A Miguel, A Llombart, A Lluch, M Ruiz-Borrego, R Colomer, S Del Barco, GEICAM, Spanish Breast Cancer Group, A Barnadas, M Muñoz, M Margelí, J I Chacón, J Cassinello, S Antolin, E Adrover, M Ramos, E Carrasco, M A Jimeno, B Ojeda, X González, S González, M Constenla, J Florián, A Miguel, A Llombart, A Lluch, M Ruiz-Borrego, R Colomer, S Del Barco, GEICAM, Spanish Breast Cancer Group

Abstract

Background: Bone metastasis (BM) is the most common site of disease in metastatic breast cancer (MBC) patients. BM impacts health-related quality of life (HRQoL). We tested prospectively the psychometric properties of the Bone Metastasis Quality of Life (BOMET-QoL-10) measure on MBC patients with BM.

Methods: Patients completed the BOMET-QoL-10 questionnaire, the Visual Analogue Scale (VAS) for pain, and a self-perceived health status item at baseline and at follow-up visits. We performed psychometric tests and calculated the effect size of specific BM treatment on patients´ HRQoL.

Results: Almost 70% of the 172 patients reported symptoms, 23.3% experienced irruptive pain, and over half were receiving chemotherapy. BOMET-QoL-10 proved to be a quick assessment tool performing well in readability and completion time (about 10 min) with 0-1.2% of missing/invalid data. Although BOMET-QoL-10 scores remained fairly stable during study visits, differences were observed for patient subgroups (e.g., with or without skeletal-related events or adverse effects). Scores were significantly correlated with physician-reported patient status, patient-reported pain, symptoms, and perceived health status. BOMET-QoL-10 scores also varied prospectively according to changes in pain intensity.

Conclusions: BOMET-QoL-10 performed well as a brief, easy-to-administer, useful, and sensitive HRQoL measure for potential use for clinical practice with MBC patients.

Trial registration: NCT03847220. Retrospectively registered on clinicaltrials.gov (February the 20th 2019).

Keywords: Assessments; Bone metastasis; Metastatic breast cancer; Psychometric; Quality of life; Treatment.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study timeline
Fig. 2
Fig. 2
BOMET-QoL-10 mean scores for each visit over time reported by patients with AEs and/or SREs versus patients with neither. Higher scores indicate better Health Related Quality of Life.*Mean scores are statistically different between patient groups (p < 0.05)

References

    1. Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA: a Cancer Journal for Clinicians. 2015;65(2):87–108.
    1. Network MBC. 13 Facts About Metastatic Breast Cancer 2016 [Available from: .
    1. Cardoso F, Harbeck N, Fallowfield L, Kyriakides S, Senkus E, Group EGW Locally recurrent or metastatic breast cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Annals of Oncology. 2012;23(Suppl 7):vii11–vii19. doi: 10.1093/annonc/mds232.
    1. Yu HH, Tsai YY, Hoffe SE. Overview of diagnosis and management of metastatic disease to bone. Cancer Control. 2012;19(2):84–91. doi: 10.1177/107327481201900202.
    1. Hagberg KW, Taylor A, Hernandez RK, Jick S. Incidence of bone metastases in breast cancer patients in the United Kingdom: Results of a multi-database linkage study using the general practice research database. Cancer Epidemiology. 2013;37(3):240–246. doi: 10.1016/j.canep.2013.01.006.
    1. Caissie A, Culleton S, Nguyen J, Zhang L, Zeng L, Holden L, et al. EORTC QLQ-C15-PAL quality of life scores in patients with advanced cancer referred for palliative radiotherapy. Support Care Cancer. 2012;20(4):841–848. doi: 10.1007/s00520-011-1160-6.
    1. Costa L, Badia X, Chow E, Lipton A, Wardley A. Impact of skeletal complications on patients' quality of life, mobility, and functional independence. Support Care Cancer. 2008;16(8):879–889. doi: 10.1007/s00520-008-0418-0.
    1. McDonald R, Chow E, Rowbottom L, Bedard G, Lam H, Wong E, et al. Quality of life after palliative radiotherapy in bone metastases: A literature review. Journal Bone Oncology. 2015;4(1):24–31. doi: 10.1016/j.jbo.2014.11.001.
    1. Zeng L, Chow E, Bedard G, Zhang L, Fairchild A, Vassiliou V, et al. Quality of life after palliative radiation therapy for patients with painful bone metastases: Results of an international study validating the EORTC QLQ-BM22. International Journal of Radiation Oncology, Biology, Physics. 2012;84(3):e337–e342. doi: 10.1016/j.ijrobp.2012.05.028.
    1. Di Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, et al. Symptomatic toxicities experienced during anticancer treatment: Agreement between patient and physician reporting in three randomized trials. Journal of Clinical Oncology. 2015;33(8):910–915. doi: 10.1200/JCO.2014.57.9334.
    1. Osoba D. Health-related quality-of-life assessment in clinical trials of supportive care in oncology. Support Care Cancer. 2000;8(2):84–88. doi: 10.1007/s005200050020.
    1. Porter GA, Skibber JM. Outcomes research in surgical oncology. Annals of Surgical Oncology. 2000;7(5):367–375. doi: 10.1007/s10434-000-0367-4.
    1. Roila F, Cortesi E. Quality of life as a primary end point in oncology. Annals of Oncology. 2001;12(Suppl 3):S3–S6. doi: 10.1093/annonc/12.suppl_3.S3.
    1. Schwartz CE, Sprangers MA. An introduction to quality of life assessment in oncology: The value of measuring patient-reported outcomes. The American Journal of Managed Care. 2002;8(18 Suppl):S550–S559.
    1. Chow E, Bottomley A. Understanding the EORTC QLQ-BM22, the module for patients with bone metastases. Expert Review of Pharmacoeconomics & Outcomes Research. 2009;9(5):461–465. doi: 10.1586/erp.09.50.
    1. Adrover EAJ, Sureda A, Domine M, Barnadas A, Constela M, Lluch A, Ruiz M, Piera J, Mayordomo JI, Morales A, Muñoz M, Alcover J, Colomer R, Llombart A, Massutti B, Carballido J, Garrido P, García R, Badia X, Lizan L, Gilabert M. Development of a questionnaire to measure health related quality of life (HRQoL) in patients with bone metastases (BM) (BOMET-QoL) Journal Outcomes Research. 2005;9:15–28.
    1. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the eastern cooperative oncology group. American Journal of Clinical Oncology. 1982;5(6):649–655. doi: 10.1097/00000421-198212000-00014.
    1. Sureda A, Isla D, Cózar J, Ruiz M, Domine M, Margelí M, Adrover E, Ramos M, Pastor M, Martín A, Llombart A, Massuti B, Muñoz M, Barnadas A, Fernández J, Colomer R, Allepuz C, Gilabert M, Badia X. Final development and validation of the Bomet-QoL questionnaire for assessing quality of life in patients with malignant bone disease due to neoplasia (BOMET-QoL) Journal of Medical Economics. 2007;10:41–53. doi: 10.3111/200710027039.
    1. Irvin W, Jr, Muss HB, Mayer DK. Symptom management in metastatic breast cancer. Oncologist. 2011;16(9):1203–1214. doi: 10.1634/theoncologist.2011-0159.
    1. Converse JMP S. In: Quantitative applications in the social sciences: Survey questions. Ltd SP, editor. 1986.
    1. Rolstad S, Adler J, Rydén A. Response burden and questionnaire length: Is shorter better? A review and meta-analysis. Value in Health. 2011;14:1101–1108. doi: 10.1016/j.jval.2011.06.003.
    1. Bedard G, Zeng L, Poon M, Lam H, Lauzon N, Chow E. Comparison of the EORTC QLQ-BM22 and the BOMET-QOL quality of life questionnaires in patients with bone metastases. Asia-Pacific Journal of Clinical Oncology. 2014;10:118–123. doi: 10.1111/ajco.12064.
    1. Raman S, Ding K, Chow E, Meyer RM, Nabid A, Chabot P, et al. A prospective study validating the EORTC QLQ-BM22 bone metastases module in patients with painful bone metastases undergoing palliative radiotherapy. Radiotherapy and Oncology. 2016;119(2):208–212. doi: 10.1016/j.radonc.2016.04.035.
    1. Lin CY, Pakpour AH. Assessing the EORTC QLQ-BM22 module using Rasch modeling and confirmatory factor analysis across countries: A comprehensive psychometric evaluation in patients with bone metastases. Asian Pacific Journal of Cancer Prevention. 2016;17(3):1405–1410. doi: 10.7314/APJCP.2016.17.3.1405.
    1. Chow E, Nguyen J, Zhang L, Tseng LM, Hou MF, Fairchild A, et al. International field testing of the reliability and validity of the EORTC QLQ-BM22 module to assess health-related quality of life in patients with bone metastases. Cancer. 2012;118(5):1457–1465. doi: 10.1002/cncr.26410.
    1. Miki-Rosário NGFR, Garcia JG, Dini GM, Bottomley A, Chow E, Sabino NM. Translation into Portuguese, cross-cultural adaptation and validation of "the European Organization for Research and Treatment of cancer-quality of life questionnaire-bone Metastases-22". Palliative Medicine. 2016;5:190–195. doi: 10.21037/apm.2016.06.02.
    1. Snyder CF, Watson ME, Jackson JD, Cella D, Halyard MY, Mayo FDAP-ROCMG Patient-reported outcome instrument selection: Designing a measurement strategy. Value in Health. 2007;10(Suppl 2):S76–S85. doi: 10.1111/j.1524-4733.2007.00270.x.
    1. Diehr P, Chen L, Patrick D, Feng Z, Yasui Y. Reliability, effect size, and responsiveness of health status measures in the design of randomized and cluster-randomized trials. Contemporary Clinical Trials. 2005;26(1):45–58. doi: 10.1016/j.cct.2004.11.014.
    1. Jordhoy MS, Fayers P, Loge JH, Saltnes T, Ahlner-Elmqvist M, Kaasa S. Quality of life in advanced cancer patients: The impact of sociodemographic and medical characteristics. British Journal of Cancer. 2001;85(10):1478–1485. doi: 10.1054/bjoc.2001.2116.
    1. Hearn J, Higginson IJ. Do specialist palliative care teams improve outcomes for cancer patients? A systematic literature review. Palliative Medicine. 1998;12(5):317–332. doi: 10.1191/026921698676226729.
    1. Lee J, Hodgson D, Chow E, Bezjak A, Catton P, Tsuji D, et al. A phase II trial of palliative radiotherapy for metastatic renal cell carcinoma. Cancer. 2005;104(9):1894–1900. doi: 10.1002/cncr.21410.
    1. Canada S. Non-Probability Sampling [updated 2013-07-23. Available from: .
    1. Patrick DL, Cleeland CS, von Moos R, Fallowfield L, Wei R, Ohrling K, et al. Pain outcomes in patients with bone metastases from advanced cancer: Assessment and management with bone-targeting agents. Support Care Cancer. 2015;23(4):1157–1168. doi: 10.1007/s00520-014-2525-4.
    1. Puetzler J, Feldmann RE, Jr, Brascher AK, Gerhardt A, Benrath J. Improvements in health-related quality of life by comprehensive cancer pain therapy: A pilot study with breast cancer outpatients under palliative chemotherapy. Oncology Research Treatment. 2014;37(9):456–462. doi: 10.1159/000365537.

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