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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Quality of Life
- Sponsor
- Istituto Ortopedico Rizzoli
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Bt-DUX.it
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
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.
Outcomes
Primary Outcomes
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 .
Secondary Outcomes
- The Toronto Extremity Salvage Score (TESS)(Between 12 and 60 months after the surgery)
- EORTC QLQ (Quality of Life Questionnaire) C-30.(Between 12 and 60 months after the surgery)