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Quality of LifeNCT04074291

Cross Cultural Validation of the Italian Version of the Bt-DUX

An observational study of Quality of Life and Bone Neoplasm, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 15 to 25 years
Conditions the study is for
Quality of Life, Bone Neoplasm
How many people
51 participants
Where
1 siteItaly
Study dates
20 Aug 2019to 30 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 25 years
  • All sexes
  • Child, Adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

Other trials in Italy

About this study

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

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).

Read the 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).

Medical subject headings
Bone Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bt-DUX.it

    The disease specific Bt-DUX relates to the patient's subjective feeling about a specific aspect, using abstract faces (smiley's) as answer categories. The expressions from very happy to sad (score 1-5) form a five-point Likert scale. The Bt-DUX consists of 20 questions which cover the domains social, emotional, cosmetical and physical functioning. Single item scores were recoded and computed into raw total and domain scores. These raw scores were converted into total and domain scores, ranging from 0-100, with the highest scores indicating better QoL .

    Measured: Between 12 and 60 months after the surgery

Secondary outcomes (2)

  1. The Toronto Extremity Salvage Score (TESS)

    The Toronto Extremity Salvage Score (TESS), a validated and reliable disease-specific measure developed to evaluate physical disability in patients treated for extremity sarcoma. The self-administered questionnaire includes 30 items on activity limitations in daily life, such as restrictions in body movement, mobility, self-care and performance of daily tasks and routine. The degree of physical disability is rated from 0 (not possible) to 5 (without any problem). The raw score is converted to a score ranged from 0 to 100 points, with higher scores indicating no functional limitations.

    Measured: Between 12 and 60 months after the surgery

  2. EORTC QLQ (Quality of Life Questionnaire) C-30.

    The 30-item EORTC QLQ-C30 questionnaire is composed of scales that evaluate physical functioning and role functioning, as well as emotional, social, and cognitive functioning and global QOL. Three symptom scales measure fatigue, pain, and emesis, while six single items assess financial impact and physical symptoms such as dyspnoea, sleep disturbance, appetite, diarrhoea, and constipation. The time frame is the past week. The questions are formatted with either yes or no answers, or by using four-answer categories that range from 1, not at all, to 4, very much. The two questions on general health and global QOL are to be answered on a numbered visual-analogue scale from I to 7.

    Measured: Between 12 and 60 months after the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2019
  2. Study start20 Aug 2019
  3. Primary completion30 Jan 2020
  4. Study completion30 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04074291
Sponsor's protocol ID
441/2019/Oss/IOR
Status last verified
Feb 2021
First submitted
17 Jul 2019
Last updated
12 May 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 19459200

  • 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.

    PubMed 22806913

  • 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.

    PubMed 8973131

  • 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.

    PubMed 9653497

  • 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.

    PubMed 18664865

  • 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.

    PubMed 18819122

  • 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.

    PubMed 21990185

  • 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.

    PubMed 21974808

  • 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.

    PubMed 11124735

  • 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.

    PubMed 8263569

  • 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.

    PubMed 8433390

  • 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.

    PubMed 15924359

  • 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.

    PubMed 17161752

Questions about this trial

What is this clinical trial studying?

An observational study of Quality of Life and Bone Neoplasm, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bt-DUX.it (time frame: Between 12 and 60 months after the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04074291, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2021.

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