Multimodal prehabilitation in patients with bone sarcomas around knee joint- a feasibility study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Since this is a feasibility study we shall be mentioning the scores (Performance components, DASS-21, MULTIDIMENSIONAL FATIGUE INVENTORY 20, SUBJECTIVE GLOBAL ASSESSMENT, CANADIAN OCCUPATIONAL PERFORMANCE MEASURE), proportion, ranges of patients who complete assessments.
研究概览
简要总结
THIS IS A FEASIBILITY STUDY, WE WILL BE RECRUITING PATIENT’S WHO ARE CASE OF DITAL FEMUR OR PORXIMAL TIBIA BONE SARCOMAS, PLANNED FOR ENDOPROSTHETIC RECONSTRUCTION AND NEO ADJUVANT CHEMOTHERAPY. THEY WILL BE EVALUTAED FOR POST-OPERATIVE STATUS TOO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Patients with primary bone sarcomas of i.e., proximal tibia and distal end of femur Patients planned for limb salvage surgery i.e., endoprosthetic reconstruction.
- •Before commencement of chemotherapy (3 weekly protocol, 4 cycles preoperatively and 4 cycles post operatively).
- •Age group- 18-60 years old.
- •Gender- Males and Females.
- •Patients who are literate, able to read and understand Hindi or English language.
- •Patients willing to follow-up to occupational therapy dept.
- •for defined prehabilitation period.
排除标准
- •Patients pre- operated for primary bone sarcomas of proximal end of tibia including endoprosthetic reconstruction.
- •Secondary bone sarcomas cases (bone metastasis).
- •Patients with disease progression Patients receiving chemotherapy outside Tata Memorial Hospital Patients with pathological fractures and distant metastasis and local recurrence.
- •Presence of prior mental, psychiatric, cognitive impairment that precludes self-care.
结局指标
主要结局
Since this is a feasibility study we shall be mentioning the scores (Performance components, DASS-21, MULTIDIMENSIONAL FATIGUE INVENTORY 20, SUBJECTIVE GLOBAL ASSESSMENT, CANADIAN OCCUPATIONAL PERFORMANCE MEASURE), proportion, ranges of patients who complete assessments.
时间窗: Assessments will be conducted on following time points- baseline which will be done on one day before 1st chemotherapy administration, 1 day before 2nd, 3rd, 4th and 21st day after last i.e. 4th chemotherapy cycle. post operatively assessments will be done on completion of 1st, 2nd and 3rd month of surgery
次要结局
未报告次要终点