Self Reported Changes in Quality of Life, Demands of Illness, and Sexual Function in Colon Cancer Survivors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Change in Quality of Life
研究概览
简要总结
The overall purpose of this study was to address the following questions by describing the trajectory of early survivorship in individuals who undergo both surgical and medical management of colon cancer. What are the changes in quality of life, demands of illness, sexual function, and peripheral neuropathy, following curative resection during the first year of treatment and recovery? Is there an interaction between exposures to chemotherapy and changes over time in these outcomes?
详细描述
The population of interest included colon cancer survivors of both sexes, 18 to 90 years of age, who underwent one of two types of surgical resection and who may receive adjuvant chemotherapy. The prospective design with two cohorts representing exposure to chemotherapy (chemotherapy vs. no-chemotherapy) described the changes in quality of life, demands of illness, sexual function, and peripheral neuropathy, which occurred following curative resection. An analysis of the interaction between time (four measurement occasions) and the independent variable of chemotherapy group by mean values of quality of life, sexual function, peripheral neuropathy, and demands of illness addressed the central thesis question.
Specific Aims
- Examine the relationships among quality of life, demands of illness, sexual functioning, and peripheral neuropathy, for the total sample and by chemotherapy group.
- Examine changes within-subjects (four measurement occasions), between-group (chemotherapy, no-chemotherapy) differences, and the interaction between time and chemotherapy group for quality of life, demands of illness, sexual functioning, and peripheral neuropathy across four measurement occasions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Male or Female at least 18 years of age
- •Biopsy Proven Colon Cancer
- •Plan to undergo open, laparoscopic or robotic surgical colectomy.
排除标准
- •Persons with rectal cancer
- •Surgical resection below the rectal sigmoid junction
- •Does not speak or read English
- •Scheduled to receive radiation therapy during the data collection period
- •Diagnosis of metastatic colon cancer (Stage IV)
- •A previous history of cancer diagnosed with the past five years with the exception of early basal cell or squamous skin cancer or early stage melanoma
结局指标
主要结局
Change in Quality of Life
时间窗: Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery)
The European Organization for Research and Treatment Quality of Life Questionnaire
次要结局
- Change in Patient Education and Support Utilized(Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery))
- Change in Demands of Illness(Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery))
- Change in Sexual Function(Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery))
- Change in Peripheral Neuropathy(Four measurements occasions over 42 weeks (Before surgery, 4-6 weeks after surgery, 20-24 weeks after surgery and 32-36 weeks after surgery))