Quality of Life and Function of Patients After Hemipelvectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy
研究概览
简要总结
This study aims to determine the functional outcomes of patients who underwent internal hemipelvectomy with or without reconstruction or external hemipelvectomy for pelvic tumors. Learning about the outcomes of these patients may help researchers determine the long-term effects of different types of hemipelvectomy procedures and may help improve quality of life.
详细描述
PRIMARY OBJECTIVE:
I. To determine functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy.
SECONDARY OBJECTIVES:
I. To determine factors that influence the functional outcomes of these patients following surgery.
II. Assess sexual and urinary function in patients who have undergone internal or external hemipelvectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients within the institution who have undergone or will undergo a hemipelvectomy
排除标准
- 未提供
研究组 & 干预措施
Observational (Physical tests, questionnaires, record review)
Patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years. Patients who are 1 year out from surgery complete pain-related questionnaires once. Patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.
干预措施: Physical Performance Testing (Other)
Observational (Physical tests, questionnaires, record review)
Patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years. Patients who are 1 year out from surgery complete pain-related questionnaires once. Patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.
干预措施: Quality-of-Life Assessment (Other)
Observational (Physical tests, questionnaires, record review)
Patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years. Patients who are 1 year out from surgery complete pain-related questionnaires once. Patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.
干预措施: Questionnaire Administration (Other)
Observational (Physical tests, questionnaires, record review)
Patients undergo physical performance assessments and complete quality of life assessments and questionnaires pre-hemipelvectomy, at 6 weeks post-hemipelvectomy, and then every 3 months up to 12 months and yearly thereafter for 10 years. Patients who are 1 year out from surgery complete pain-related questionnaires once. Patients who have already undergone hemipelvectomy prior to enrollment undergo medical record review.
干预措施: Electronic Health Record Review (Other)
结局指标
主要结局
Functions of patients who underwent internal hemipelvectomy with or without reconstruction or have had an external hemipelvectomy
时间窗: Through study completion, average of 1 year
All continuous variables including the scoring systems will be described as mean with standard deviation or median with range. Frequencies and percentages will be obtained for all categorical variables. Pediatric participants' data measures will be collected and analyzed separately from the adult populations.
次要结局
未报告次要终点