Prospective Evaluation of Quality of Life and Utilities Following Surgical Treatment of Rectal Cancer
概览
- 阶段
- 不适用
- 干预措施
- Quality-of-Life Assessment
- 疾病 / 适应症
- 未指定
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- Health state utilities
- 状态
- 招募中
- 最后更新
- 26天前
概览
简要总结
This study evaluates quality of life and utilities following surgical treatment of stage I-IV rectal cancer. This study may help researches learn more about quality of life in patients who have or have had rectal cancer.
详细描述
PRIMARY OBJECTIVE: I. To assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years. SECONDARY OBJECTIVES: I. To longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy. II. To characterize the impact of treatment on quality of life and utilities among patients with rectal cancer. III. To assess changes in quality of life and utilities among patients treated for rectal cancer over time. OUTLINE: Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.
研究者
入排标准
入选标准
- •Patient has histologically proven adenocarcinoma of the rectum (stage I - IV) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment
- •Patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in English
排除标准
- •Patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer
- •Patient has a concurrent cancer diagnosis at the time of consent
- •Patient has recurrent disease
研究组 & 干预措施
Observational (questionnaire)
Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.
干预措施: Quality-of-Life Assessment
Observational (questionnaire)
Patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.
干预措施: Questionnaire Administration
结局指标
主要结局
Health state utilities
时间窗: At 24 months post-surgery
A health state utility is the degree of preference that individuals or society has for a particular health state or condition.