Cross Cultural Validation of the Italian Version of the Bt-DUX
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|ClinicalTrials.gov Identifier: NCT04074291|
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
|Condition or disease|
|Quality of Life Bone Neoplasm|
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).
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
|Actual Study Start Date :||August 20, 2019|
|Estimated Primary Completion Date :||August 30, 2020|
|Estimated Study Completion Date :||August 30, 2020|
- Bt-DUX.it [ Time Frame: Between 12 and 60 months after the surgery ]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 .
- The Toronto Extremity Salvage Score (TESS) [ Time Frame: Between 12 and 60 months after the surgery ]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.
- EORTC QLQ (Quality of Life Questionnaire) C-30. [ Time Frame: Between 12 and 60 months after the surgery ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074291
|Contact: Mattia Morriemail@example.com|
|Study Chair:||Cristiana Forni||Isituto Ortopedico Rizzoli|