Clinical trial NCT04074291: Cross Cultural Validation of the Italian Version of the Bt-DUX
Official title: Cross Cultural Validation of the Italian Version of the Bt-DUX: A Subjective Measure of Health Related Quality of Life in Patients Who Underwent Surgery for Lower Extremity Malignant Bone Tumour
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Bone Neoplasm
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 51
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent a surgical intervention due to a malignant bone tumour in the leg will be identified through hospital records of Istituto Ortopedico Rizzoli.

Brief summary: The purpose of the presented study is to translate the English Bt-DUX (Bt-DUX-Eng) questionnaire into the Italian language and then examine the validity of the Italian version of the Bt-DUX (Bt-DUX-It).

Detailed description: Validation of the Italian Bt-DUX:

Cross sectional study among patients of the Istituto Ortopedico Rizzoli, Bologna, Italy, will carry out. All patients who underwent a surgical intervention due to a malignant bone tumour in the leg will be identified through hospital records and a survey consisting of different QoL questionnaires will be executed:

Bt-DUX, EORTC QLQ C-30, The Toronto Extremity Salvage Score (TESS).

Eligibility criteria: Inclusion Criteria:

* Patients are eligible if they're aged between 15 and 25 years at the time of the selection, if the time since surgery is ranged between 12 and 60 months, if the malignant bone tumour (osteosarcoma or Ewing's sarcoma) was located around the hip or the knee and the surgical intervention consisted of limb sparing or ablative surgery.

Exclusion Criteria:

* Patients will be excluded if other medical conditions limit their physical activities.

Primary outcomes:
measure: Bt-DUX.it
timeFrame: Between 12 and 60 months after the surgery
Secondary outcomes:
measure: The Toronto Extremity Salvage Score (TESS)
timeFrame: Between 12 and 60 months after the surgery
measure: EORTC QLQ (Quality of Life Questionnaire) C-30.
timeFrame: Between 12 and 60 months after the surgery
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Isituto Ortopedico Rizzoli
name: Cristiana Forni
role: STUDY_CHAIR
References:
citation: Bekkering WP, Vlieland TP, Koopman HM, Schaap GR, Schreuder HW, Beishuizen A, Tissing WJ, Hoogerbrugge PM, Anninga JK, Taminiau AH. The Bt-DUX: development of a subjective measure of health-related quality of life in patients who underwent surgery for lower extremity malignant bone tumor. Pediatr Blood Cancer. 2009 Sep;53(3):348-55. doi: 10.1002/pbc.22078.
citation: Bekkering WP, Billing L, Grimer RJ, Vlieland TP, Koopman HM, Nelissen RG, Taminiau AH. Translation and preliminary validation of the English version of the DUX questionnaire for lower extremity bone tumor patients (Bt-DUX): a disease-specific measure for quality of life. J Surg Oncol. 2013 Mar;107(4):353-9. doi: 10.1002/jso.23218. Epub 2012 Jul 17.
citation: Davis AM, Wright JG, Williams JI, Bombardier C, Griffin A, Bell RS. Development of a measure of physical function for patients with bone and soft tissue sarcoma. Qual Life Res. 1996 Oct;5(5):508-16. doi: 10.1007/BF00540024.
citation: Apolone G, Filiberti A, Cifani S, Ruggiata R, Mosconi P. Evaluation of the EORTC QLQ-C30 questionnaire: a comparison with SF-36 Health Survey in a cohort of Italian long-survival cancer patients. Ann Oncol. 1998 May;9(5):549-57. doi: 10.1023/a:1008264412398.
citation: van Doorn RK, Winkler LM, Zwinderman KH, Mearin ML, Koopman HM. CDDUX: a disease-specific health-related quality-of-life questionnaire for children with celiac disease. J Pediatr Gastroenterol Nutr. 2008 Aug;47(2):147-52. doi: 10.1097/MPG.0b013e31815ef87d.
citation: Vrijmoet-Wiersma CM, Kooloos VM, Koopman HM, Kolk AM, van der Laan I, Grootenhuis MA, Egeler RM. Health-related quality of life, cognitive functioning and behaviour problems in children with Langerhans cell histiocytosis. Pediatr Blood Cancer. 2009 Jan;52(1):116-22. doi: 10.1002/pbc.21740.
citation: Bekkering WP, Vliet Vlieland TP, Koopman HM, Schaap GR, Beishuizen A, Anninga JK, Wolterbeek R, Nelissen RG, Taminiau AH. A prospective study on quality of life and functional outcome in children and adolescents after malignant bone tumor surgery. Pediatr Blood Cancer. 2012 Jun;58(6):978-85. doi: 10.1002/pbc.23328. Epub 2011 Oct 11.
citation: Bekkering WP, Vliet Vlieland TP, Fiocco M, Koopman HM, Schoones JW, Nelissen RG, Taminiau AH. Quality of life, functional ability and physical activity after different surgical interventions for bone cancer of the leg: A systematic review. Surg Oncol. 2012 Jun;21(2):e39-47. doi: 10.1016/j.suronc.2011.09.002. Epub 2011 Oct 4.
citation: Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
citation: Guillemin F, Bombardier C, Beaton D. Cross-cultural adaptation of health-related quality of life measures: literature review and proposed guidelines. J Clin Epidemiol. 1993 Dec;46(12):1417-32. doi: 10.1016/0895-4356(93)90142-n.
citation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. 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. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
citation: Koopman HM, Koetsier JA, Taminiau AH, Hijnen KE, Bresters D, Egeler RM. Health-related quality of life and coping strategies of children after treatment of a malignant bone tumor: a 5-year follow-up study. Pediatr Blood Cancer. 2005 Oct 15;45(5):694-9. doi: 10.1002/pbc.20408.
citation: Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.