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

Completed

• Conditions: Quality of Life; Bone Neoplasm

• Registration Number: NCT04074291
• Lead Sponsor: 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).

Study Timeline

• Study First Submitted: 2019-07-17
• Study Start: 2019-08-20
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-30
• Primary Completion: 2020-01-30
• Study Completion: 2020-01-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bt-DUX.it	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 .

Secondary Outcome Measures

Name	Time	Method
The Toronto Extremity Salvage Score (TESS)	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.	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy