A Prospective Study of Quality of Life in Patients Undergoing Pelvic Exenteration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 8
- 主要终点
- To characterize the extent of physical and psychological stress, and overall quality of life in patients undergoing total, anterior or posterior pelvic exenteration.
研究概览
简要总结
The purpose of this study is to learn more about the personal experiences of patients who are treated with pelvic exenteration surgery. Pelvic exenteration is a surgical procedure in which the pelvic organs including the reproductive organs, bladder and/or rectum are removed. We would like to understand more about the physical, emotional, educational, and sexual needs of patients who are treated with this surgery. We will use what we learn from this study to help find better ways of preparing patients for this type of surgery. This will also allow us to be more helpful to patients' needs after surgery.
详细描述
This protocol represents the first study to comprehensively evaluate QOL in a mixed population of male and female patients treated with total, anterior or posterior pelvic exenteration. This unique approach to QOL assessment which is both domain-centered and able to emphasize individual differences through the C-SHIP model has the potential to set the standard for evaluating QOL in patients who undergo extensive pelvic surgery. The longitudinal design of this study facilitates the documentation of patients'responsiveness to change. By analyzing participants' responses at intervals we will be able to document the redefinition of life goals which occurs as patients adapt to their new health status. The data and analysis completed in first three years of this study will be used to generate further hypotheses for future investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (male and female) who are scheduled to undergo total, anterior or posterior pelvic exenteration for pelvic malignancies arising in gynecologic, colorectal or urologic organs are eligible for participation in the study. Anterior or posterior pelvic exenteration must involve formation of a permanent ostomy (urostomy or colostomy).
- •Participants must be able to speak and read English proficiently.
- •Participants must be able to provide written informed consent.
- •Patients must be 18 years of age or older to enroll.
排除标准
- •Subjects may be excluded or withdrawn from the study based on the following criteria.
- •Development of a cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent
- •Inability to speak or read in English.
结局指标
主要结局
To characterize the extent of physical and psychological stress, and overall quality of life in patients undergoing total, anterior or posterior pelvic exenteration.
时间窗: conclusion of study
次要结局
- To determine how patients ratings of the specific QOL domains predict response to surgery, (ie; QOL, level of stress, function and symptoms).(conclusion of study)